Medical Devices; Effective Date of Requirement for Premarket Approval for Class III Preamendments Devices

[[Page 46718]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 864, 868, 870, 872, 876, 880, 882, 884, 888, and 890

[Docket No. 95N-0084]

RIN 0910-AA31

Medical Devices; Effective Date of Requirement for Premarket

Approval for Class III Preamendments Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; opportunity to request a change in

classification.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to require

the filing of a premarket approval application (PMA) or a notice of

completion of product development protocol (PDP) for 43 class III

medical devices. The agency also is summarizing its proposed findings

regarding the degree of risk of illness or injury designed to be

eliminated or reduced by requiring the devices to meet the statute's

approval requirements and the benefits to the public from the use of

the devices. In addition, FDA is announcing the opportunity for

interested persons to request the agency to change the classification

of any of the devices based on new information.

DATES: Written comments by January 5, 1996; request for a change in

classification by September 22, 1995. FDA intends that, if a final rule

based on this proposed rule is issued, PMA's will be required to be

submitted within 90 days of the effective date of the final rule.

ADDRESSES: Submit written comments or requests for a change in

classification to the Dockets Management Branch (HFA-305), Food and

Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices

and Radiological Health (HFZ-84), Food and Drug Administration, 2098

Gaither Rd., Rockville, MD 20850, 301-594-4765.

SUPPLEMENTARY INFORMATION:

I. Background

Section 513 of the Federal Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360c) requires the classification of medical devices into

one of three regulatory classes: Class I (general controls), class II

(special controls), and class III (premarket approval). Generally,

devices that were on the market before May 28, 1976, the date of

enactment of the Medical Device Amendments of 1976 (the amendments)

(Pub. L. 94-295), and devices marketed on or after that date that are

substantially equivalent to such devices, have been classified by FDA.

For the sake of convenience, this preamble refers to both the devices

that were on the market before May 28, 1976, and the substantially

equivalent devices that were marketed on or after that date as

``preamendments devices.''

Section 515(b)(1) of the act (21 U.S.C. 360e(b)(1)) establishes the

requirement that a preamendments device that FDA has classified into

class III is subject to premarket approval. A preamendments class III

device may be commercially distributed without an approved PMA or

notice of completion of a PDP until 90 days after FDA issues a final

rule requiring premarket approval for the device, or 30 months after

final classification of the device under section 513 of the act,

whichever is later. Also, a preamendments device subject to the

rulemaking procedure under section 515(b) of the act is not required to

have an approved investigational device exemption (IDE) (21 CFR part

812) contemporaneous with its interstate distribution until the date

identified by FDA in the final rule requiring the submission of a PMA

for the device. At that time, an IDE is required only if a PMA has not

been submitted or a PDP completed.

Section 515(b)(2)(A) of the act provides that a proceeding to issue

a final rule to require premarket approval shall be initiated by

publication of a notice of proposed rulemaking containing: (1) The

proposed rule; (2) proposed findings with respect to the degree of risk

of illness or injury designed to be eliminated or reduced by requiring

the device to have an approved PMA or a declared completed PDP and the

benefit to the public from the use of the device; (3) an opportunity

for the submission of comments on the proposed rule and the proposed

findings; and (4) an opportunity to request a change in the

classification of the device based on new information relevant to the

classification of the device.

Section 515(b)(2)(B) of the act provides that if FDA receives a

request for a change in the classification of the device within 15 days

of the publication of the notice, FDA shall, within 60 days of the

publication of the notice, consult with the appropriate FDA advisory

committee and publish a notice denying the request for change of

classification or announcing its intent to initiate a proceeding to

reclassify the device under section 513(e) of the act. If FDA does not

initiate such a proceeding, section 515(b)(3) of the act provides that

FDA shall, after the close of the comment period on the proposed rule

and consideration of any comments received, issue a final rule to

require premarket approval, or publish a notice terminating the

proceeding. If FDA terminates the proceeding, FDA is required to

initiate reclassification of the device under section 513(e) of the

act, unless the reason for termination is that the device is a banned

device under section 516 of the act (21 U.S.C. 360f).

If a proposed rule to require premarket approval for a

preamendments device is made final, section 501(f)(2)(B) of the act (21

U.S.C. 351(f)(2)(B)) requires that a PMA or a notice of completion of a

PDP for any such device be filed within 90 days of the date of

promulgation of the final rule or 30 months after final classification

of the device under section 513 of the act, whichever is later. If a

PMA or a notice of completion of a PDP is not filed by the later of the

two dates, commercial distribution of the device is required to cease.

The device may, however, be distributed for investigational use if the

manufacturer, importer, or other sponsor of the device complies with

the IDE regulations. If a PMA or a notice of completion of a PDP is not

filed by the later of the two dates, and no IDE is in effect, the

device is deemed to be adulterated within the meaning of section

501(f)(1)(A) of the act, and subject to seizure and condemnation under

section 304 of the act (21 U.S.C. 334) if its distribution continues.

Shipment of the device in interstate commerce will be subject to

injunction under section 302 of the act (21 U.S.C. 332), and the

individuals responsible for such shipment will be subject to

prosecution under section 303 of the act (21 U.S.C. 333). In the past,

FDA has requested that manufacturers take action to prevent the further

use of devices for which no PMA has been filed and may determine that

such a request is appropriate for the class III devices that are the

subjects of this regulation.

The act does not permit an extension of the 90-day period after

promulgation of a final rule within which an application or a notice is

required to be filed. The House Report on the amendments states that

``the thirty month `grace period' afforded after classification of a

device into class III * * * is sufficient time for manufacturers and

importers to develop the data and conduct the investigations necessary

to support an application for premarket

[[Page 46719]]

approval.'' (H. Rept. 94-853, 94th Cong., 2d sess. 42 (1976).)

The Safe Medical Devices Act of 1990 (Pub. L. 101-629) (SMDA) added

new section 515(i) to the act (21 U.S.C. 360e(i)). This section

requires FDA to review the classification of preamendments class III

devices for which no final rule has been issued requiring the

submission of PMA's and to determine whether each device should be

reclassified into class I or class II or remain in class III. For

devices remaining in class III, SMDA directed FDA to develop a schedule

for issuing regulations to require premarket approval. However, the

SMDA does not prevent FDA from proceeding immediately to rulemaking

under section 515(b) of the act on specific devices, in the interest of

public health, independent of the procedures in section 515(i). Indeed,

proceeding directly to rulemaking under section 515(b) of the act is

consistent with Congress' objective in enacting section 515(i) i.e.,

that preamendments class III devices for which PMA's have not been

required either be reclassified to class I or class II or be subject to

the requirements of premarket approval. Moreover, in this proposal,

interested persons are being offered the opportunity to request

reclassification of any of the devices.

In the Federal Register of May 6, 1994 (59 FR 23731), FDA issued a

notice of availability of a preamendments class III devices strategy

document. The strategy document set forth FDA's plans for implementing

the provisions of section 515(i) of the act for preamendments class III

devices for which FDA had not yet required premarket approval. FDA

divided this universe of devices into three groups:

1. Group 1 devices are devices that FDA believes raise significant

questions of safety and/or effectiveness but are no longer used or are

very limited in use. FDA's strategy is to call for PMA's for all Group

1 devices in an omnibus 515(b) rulemaking action. This proposed rule

implements that strategy and covers all Group 1 devices referenced by

the May 6, 1994, Federal Register notice.

2. Group 2 devices are devices that FDA believes have a high

potential for being reclassified into class II. For these devices, FDA

has issued an order under section 515(i) of the act requiring

manufacturers to submit safety and effectiveness information so that

FDA can make a determination as to whether the devices should be

reclassified.

3. Group 3 devices are devices that FDA believes are currently in

commercial distribution and are not likely candidates for

reclassification. FDA intends to issue proposed rules to require the

submission of PMA's for the 15 highest priority devices in this group

in accordance with the schedule set forth in the strategy document. FDA

has also issued an order under section 515(i) of the act for the

remaining 27 Group 3 devices requiring the submission of safety and

effectiveness information so that FDA can make a determination as to

whether the devices should be reclassified or retained in class III.

A. Dates New Requirements Apply

In accordance with section 515(b) of the act, FDA is proposing to

require that a PMA or a notice of completion of a PDP be filed with the

agency for class III devices within 90 days after promulgation of any

final rule based on this proposal. An applicant whose device was

legally in commercial distribution before May 28, 1976, or whose device

has been found by FDA to be substantially equivalent to such a device,

will be permitted to continue marketing such class III devices during

FDA's review of the PMA or notice of completion of the PDP. FDA intends

to review any PMA for the device within 180 days, and any notice of

completion of a PDP for the device within 90 days of the date of

filing. FDA cautions that, under section 515(d)(1)(B)(i) of the act,

the agency may not enter into an agreement to extend the review period

for a PMA beyond 180 days unless the agency finds that ``* * * the

continued availability of the device is necessary for the public

health.''

FDA intends that, under Sec. 812.2(d) (21 CFR 812.2(d)), the

preamble to any final rule based on this proposal will state that, as

of the date on which a PMA or a notice of completion of a PDP is

required to be filed, the exemptions in Sec. 812.2(c)(1) and (c)(2)

from the requirements of the IDE regulations for preamendments class

III devices will cease to apply to any device that is: (1) Not legally

on the market on or before that date, or (2) legally on the market on

or before that date but for which a PMA or notice of completion of PDP

is not filed by that date, or for which PMA approval has been denied or

withdrawn.

If a PMA or a notice of completion of a PDP for a class III device

is not filed with FDA within 90 days after the date of promulgation of

any final rule requiring premarket approval for the device, commercial

distribution of the device must cease. The device may be distributed

for investigational use only if the requirements of the IDE regulations

regarding significant risk devices are met. The requirements for

significant risk devices include submitting an IDE application to FDA

for its review and approval. An approved IDE is required to be in

effect before an investigation of the device may be initiated or

continued. FDA, therefore, cautions that IDE applications should be

submitted to FDA at least 30 days before the end of the 90-day period

after the final rule to avoid interrupting investigations.

B. Proposed Finding With Respect to Risks and Benefits

As required by section 515(b) of the act, FDA is publishing its

proposed findings regarding: (1) The degree of risk of illness or

injury designed to be eliminated or reduced by requiring that these

devices have an approved PMA or a declared completed PDP; and (2) the

benefits to the public from the use of the device.

These findings are based on the reports and recommendations of the

advisory committees (panels) for the classification of these devices

along with any additional information that FDA discovers. Additional

information can be found in the proposed and final rules classifying

these devices as listed below:

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Devices--- Proposed rule- Final rule

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Hematology/Pathology September 11, 1979 (44 September 12, 1980 (45

(21 CFR part 864). FR 52950). FR 60576

Anesthesiology 1982 (21 November 2, 1979 (44 FR July 16, (47 FR 31130)

CFR part 868). 63292).

Cardiovascular (21 CFR March 9, 1979- (44 FR February 5, 1980 (45

part 870). 13284). FR 7904)

Dental (21 CFR part December 30, 198 (45 FR August 12, 1987 (52 FR

872). 85962). 30082)

Gastroenterology- January 23, 1981 (46 FR November 23, 1983 (48

Urology (21 CFR part 7562). FR 53012)

876).

General Hospital and August 24, 1979 (44 FR October 21, 1980 (45

Personal Use (21 CFR 49844). FR 69678)

part 880).

Neurological (21 CFR November 28, 1978 (43 September 4, 1979 (44

part 882). FR 55640). FR 51726)

Obstetrical and April 3, 1979-(44 FR February 26, 1980 (45

Gynecological. 19894). FR 12682)

[[Page 46720]]

Orthopedic (21 CFR part July 2, 1982 (47 FR September 4, 1987 (52

888). 29052). FR 33686)

Physical Medicine (21 August 28, 1979 (44 FR November 23, 1983 (48

CFR part 890). 50458). FR 53032)

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C. Devices Subject to This Proposal

1. Hematology and Pathology Devices

Automated Differential Cell Counter (Sec. 864.5220)

(1) Identification. An automated differential cell counter is a

device used to identify and classify one or more of the formed elements

of the blood. The device is in class III when intended for uses other

than to flag or identify specimens containing abnormal blood cells.

Otherwise, the device is in class II.

(2) Summary of data. The members of the Hematology and Pathology

Devices Classification Panel based their recommendation upon the Panel

members' clinical experience with automated differential cell counters

and on information presented at a symposium entitled ``Differential

Counters in Hematology'' held at the Panel meeting. Among the speakers

at the symposium was Dr. Robert Miller of the Johns Hopkins University

Medical Center. Dr. Miller discussed difficulties concerning data

interpretation, precision and accuracy, correlation to reference

methods and error in terms of coincidence, nonreproducible results,

nonlinearity, and specific interferences.

FDA has reviewed medical literature concerning automated

differential cell counters (Refs. 1 through 5). The medical literature

reports two basic methodologies for automated differential cell

counting: Pattern recognition and flow-through techniques. Pattern

recognition systems microscopically scan a fixed, stained blood film.

Flow-through systems count and identify cells suspended in a liquid

medium.

Pattern recognition systems are handicapped by their lack of

accuracy (Ref. 1). In one study, 68.8 percent of the abnormal cells

that the system examined were classified as normal (Ref. 2). An error

of this sort could result in the failure to detect a pathological blood

sample (Ref. 1). Several studies (Refs. 3 through 5) show a discrepancy

between pattern recognition counts and manual counts of monocytes

(mononuclear leukocytes). It is suggested that the criteria for

identifying monocytes need to be better defined (Ref. 4). There also

have been reports of discrepancies between pattern recognition counts

and manual counts of plasma cells and atypical lymphocytes (Ref. 4).

The tendency of pattern recognition systems to underestimate the number

of atypical lymphocytes is ascribed to flaws in the recognition

criteria. Pattern recognition systems also cause difficulty in blood

film preparation. Overlapping cells must be avoided, and a uniform

distribution of cell types must be achieved (Ref. 1).

Flow-through systems allow a hundredfold increase in the rate at

which cells are counted. There is imperfect correlation between the

classification logic systems of the flow-through machines and

morphological features of the blood cell classes as defined by fixed,

Romanowsky-stained preparations (Ref. 1). Therefore, these machines

will fail to classify up to 10 percent of normal cells.

The device was the subject of a reclassification petition and was

partially reclassified into class II for the uses listed above. The

proposed rule for reclassification was published in the Federal

Register of April 5, 1989 (54 FR 13698) and the final rule was

published in the Federal Register of June 8, 1990 (55 FR 23510).

(3) Risks to health.

Hepatitis infection--Exposure of the user, donor, or

patient to blood, blood products, or blood aerosols presents a risk of

hepatitis infection. HIV was unknown in 1979 when the device was

classified and is also an important risk.

Misdiagnosis and inappropriate therapy--Failure of the

device to perform satisfactorily may lead to an error in the diagnosis

of a blood cell disorder. Inappropriate therapy based on inaccurate

diagnostic data may place the patient at risk.

2. Anesthesiology Devices

Electroanesthesia Apparatus (Sec. 868.5400)

(1) Identification. An electroanesthesia apparatus is a device used

for the induction and maintenance of anesthesia during surgical

procedures by means of an alternating or pulsed electric current that

is passed through electrodes fixed to the patient's head.

(2) Summary of data. The Anesthesiology Devices Classification

Panel and the Neurological Devices Classification Panel recommended

that electroanesthesia apparatus be classified into class III

(premarket approval) because the device presents a potential

unreasonable risk of illness or injury to the patient. The

Anesthesiology Devices Classification Panel based its recommendation on

the insufficient number of domestic studies on human subjects. The

Panel had not seen any medical data on which to judge the safety and

effectiveness of the device, and believed that the technique of

electroanesthesia is not considered a well-established or well-

recognized clinical procedure. The Neurological Devices Classification

Panel noted that many factors important to the clinical application of

this technique have not been sufficiently defined. The Neurological

Devices Classification Panel also based its recommendation on the Panel

members' experience with the device, and their judgment and knowledge

of the pertinent literature (Ref. 6). The National Research Council

recommended that electroanesthesia should be considered as a

potentially useful adjunct in the maintenance of anesthesia but that

electroanesthesia should be limited to investigational use until its

effects, advantages, and standardization can be adequately evaluated.

(3) Risks to health.

Electrical shock--Improper electrical grounding may allow

the patient or operator to receive an electrical shock.

Damage to central nervous system--Excessively high

electrical current or voltage could damage the central nervous system

and cerebral tissues.

Skin burns--If the electrodes are too small and yield a

high current density, skin burns may result.

Skin irritation--Electrode gels or pastes used to

establish electrical contact between the electrode and the skin may

cause skin irritation.

Cardiac or pulmonary interference--The position of the

electrode on the head may lead to electrical interference with cardiac

or pulmonary functions in the patient.

3. Cardiovascular Devices

Catheter Balloon Repair Kit (Sec. 870.1350)

(1) Identification. A catheter balloon repair kit is a device used

to repair or replace the balloon of a balloon catheter. The kit

contains the materials, such as glue and balloons, necessary to effect

the repair or replacement.

(2) Summary of data. The members of the Cardiovascular Devices

Classification Panel based their recommendation on the potential

hazards associated with the inherent properties of the device and on

their personal knowledge of, and experience with, the device. The Panel

was not aware of any published literature on this device.

[[Page 46721]]

(3) Risks to health.

Gas embolism--Balloon rupture caused by the repair

material or a leak in the repair material can allow potentially

debilitating or fatal gas emboli to escape into the bloodstream. -

Embolism--Pieces of the balloon that break or flake off

may form potentially debilitating or fatal emboli.

Thromboembolism--Inadequate blood compatibility of the

materials used in this device and inadequate surface finish and

cleanliness can lead to potentially debilitating or fatal

thromboemboli.

Cardiac arrhythmias--Toxic substances released from the

repair material (glue or other adhesive) can trigger cardiac

arrhythmias (irregularities in heart rhythm).

Trace Microsphere (Sec. 870.1360)

(1) Identification. A trace microsphere is a radioactively tagged

nonbiodegradable particle that is intended to be injected into an

artery or vein and trapped in the capillary bed for the purpose of

studying blood flood within or to an organ.

(2) Summary of data. The Panel members based their recommendation

on the potential hazards associated with the inherent properties of the

device and on their personal knowledge of, and experience with, the

device.

(3) Risks to health.

Thromboembolism--Inadequate blood compatibility of the

materials used in the device may lead to potentially debilitating or

fatal thromboemboli.

Embolism--If the microspheres are too large or tend to

clump together, they can lodge in a blood vessel and block the flow of

blood to an organ.

Tissue damage--Tissue damage can result from excessive

radioactivity of the particles.

Carotid Sinus Nerve Stimulator (Sec. 870.3850)

(1) Identification. A carotid sinus nerve stimulator is an

implantable device used to decrease arterial pressure by stimulating

Hering's nerve at the carotid sinus.

(2) Summary of data. The Panel members based their recommendation

on the potential hazards associated with the inherent properties of the

device and on their personal knowledge of, and experience with, the

device.

(3) Risks to health.

Tissue and blood damage--If the materials, surface finish,

or cleanliness of this device are inadequate, damage to the blood and

tissue may result.

Inability to control blood pressure--Failure of the device

to stimulate properly can prevent effective control of elevated blood

pressure.-

High-Energy DC-Defibrillator (Including Paddles) (Sec. 870.5300)

(1) Identification. A high-energy DC-defibrillator is a device that

delivers into a 50-ohm test load an electrical shock of greater than

360 joules of energy used for defibrillating the atria or ventricles of

the heart or to terminate other cardiac arrhythmias. The device may

either synchronize the shock with the proper phase of the

electrocardiogram or may operate asynchronously. The device delivers

the electrical shock through paddles placed either directly across the

heart or on the surface of the body.

(2) Summary of data. The Panel relied upon the potential hazards

associated with the inherent properties of the device and on the Panel

members' personal knowledge of, and experience with, the device. In

addition, the Panel sought information from the medical and scientific

community, industry, and medical literature (Refs. 20 through 25).

(3) Risks to health.

Electrical shock to operator--Improper electrical design

of the device can lead to a serious electrical shock to the operator.

Inability to defibrillate or persistence of the

arrhythmia--Inability to rhythmia may occur because of excessive

energy, excessive current, insufficient energy, insufficient current, a

difference between the indicated level of energy and the delivered into

a 50-ohm load, or excessive leakage current. -

Inability to defibrillate--Inability to defibrillate may

occur when certain drugs that can raise the defibrillation threshold

are used.

Inability to defibrillate due to paddle design--Inability

to defibrillate may result from inappropriate paddle size or

inappropriate paddle location on the subject.

4. Dental Devices

Karaya and Sodium Borate With or Without Acacia Denture Adhesive

(Sec. 872.3400)

(1) Identification. A karaya with sodium borate with or without

acacia denture adhesive is a device composed of karaya and sodium

borate with or without acacia intended to be applied to the base of a

denture before the denture is inserted into the patient's mouth. The

device is used to improve denture retention and comfort. If it contains

12 percent or more by weight of sodium borate, it is in class III;

otherwise it is in class I.

(2) Summary of data. The members of the Dental Devices

Classification Panel relied upon their personal knowledge of, and

clinical experience with, the device in the practice of dentistry and

on a report from the then-Bureau of Drugs' OTC Panel on Dentifrices and

Dental Care Agents (Ref. 26). This report states that there is a lack

of information concerning the safety of adhesives containing sodium

borate and a lack of information concerning the effectiveness of acacia

in denture adhesives. The report states that the sodium borate

concentration of 12 to 20 percent of the adhesive's total weight is

equivalent to 2.6 to 5.3 percent boron. Because at least a portion of a

denture adhesive is ingested, this amount of boron could cause chronic

toxicity in denture wearers (Ref. 27). The Panel agrees that there is a

lack of data concerning the safety and effectiveness of acacia and

karaya with sodium borate.

(3) Risks to health.

Chronic toxicity--The boron in this device may cause

chronic toxicity to users.

Adverse tissue reaction--If the materials in the device

are not biocompatible, the patient may have an adverse tissue reaction.

Carboxymethylcellulose Sodium and Cationic Polyacrylamide Polymer

Denture Adhesive (Sec. 872.3420)

(1) Identification. A carboxymethylcellulose sodium and cationic

polyacrylamide polymer denture adhesive is a device composed of

carboxymethylcellulose sodium and cationic polyacrylamide polymer

intended to be applied to the base of a denture before the denture is

inserted in a patient's mouth. The device is used to improve denture

retention and comfort.

(2) Summary of data. The Panel based its recommendation on the lack

of information available to demonstrate the effectiveness of

carboxymethylcellulose sodium and cationic polyacrylamide in dental

adhesives and on a report of the then-Bureau of Drugs' OTC Panel on

Dentifrices and Dental Care Agents. According to the report, the belief

that carboxymethylcellulose sodium is safe is based, in part, on its

widespread use in food products such as milk and ice cream (Ref. 28).

Tests of cationic polyacrylamide for acute oral toxicity, eye

irritation, and dermal and inhalation toxicity in subacute and chronic

feeding experiments in animals have been negative (Ref. 26). Human

patch tests also have been negative (Ref. 28). However, no data were

submitted to the Panel to demonstrate, and the literature did not

establish, the effectiveness of carboxymethylcellulose

[[Page 46722]]

sodium cationic polyacrylamide polymer as a denture adhesive.

(3) Risks to health.

Bone loss from lack of effectiveness--If the adhesive

fails to anchor the denture in its proper position, a change in the

distance between the upper and lower jaws may occur that may lead to

gum irritation and bone loss due to alteration of biting forces.

Adverse tissue reaction--if the materials in the device

are not biocompatible, the patient may have an adverse tissue reaction.

Polyacrylamide Polymer (Modified Cationic Denture Adhesive

(Sec. 872.3480)

(1) Identification. A polyacrylamide polymer (modified cationic)

denture adhesive is a device composed of polyacrylamide polymer

(modified cationic) intended to be applied to the base of a denture

before the denture is inserted in a patient's mouth. The device is used

to improve denture retention and comfort.

(2) Summary of data. The Panel based its recommendation on the

Panel members' personal knowledge of, and clinical experience with,

this device, and on a report of the then-Bureau of Drugs' OTC Panel on

Dentifrices and Dental Care Agents. Tests of polyacrylamide polymer

(modified cationic) for acute oral toxicity, eye irritation, and dermal

and inhalation toxicity in subacute and chronic feeding experiments in

animals have been negative (Ref. 26). Human patch tests also have been

negative (Ref. 28). However, no data were submitted to the Panel to

demonstrate, and the literature did not establish, the effectiveness of

polyacrylamide polymer as the sole ingredient of a denture adhesive.

(3) Risks to health.

Bone loss--If the adhesive fails to anchor the denture in

its proper position, and the distance between the upper and lower jaw

is changed, then bone loss and gum irritation may occur.

Adverse tissue reaction--If the materials in the device

are not biocompatible, the patient may have an adverse tissue reaction.

Polyvinylmethylether Maleic Anhydride (PVM-MA), Acid Copolymer, and

Carboxymethylcellulose Sodium (NACMC) Denture Adhesive (Sec. 872.3500)

(1) Identification. Polyvinylmethylether maleic anhydride (PVM-MA),

acid copolymer, and carboxymethylcellulose sodium (NACMC) denture

adhesive is a device composed of polyvinylmethylether maleic anhydride,

acid copolymer, and carboxymethylcellulose sodium intended to be

applied to the base of a denture before the denture is inserted in a

patient's mouth. The device is used to improve denture retention and

comfort.

(2) Summary of data. The Panel based it recommendation on the Panel

members' personal knowledge of, and clinical experience with the device

and on a report of the then-Bureau of Drugs' OTC Panel on Dentifrices

and Dental Care Agents. The report states that sufficient data are not

available to demonstrate the safety and effectiveness of a combination

of PVM--MA and NACMC used as a denture adhesive (Ref. 26). The Panel

also based its recommendation on a publication by Blacow (Ref. 27),

which states that the pH and stability of the anhydride and diacid

forms may be hazardous due to the possible presence of an acid pH of 2

to 3, which can burn the tissues in the mouth.

(3) Risks to health.

Toxicity--Ingestion of the materials in this device may

cause chronic toxicity to users.

Adverse tissue reaction--If the materials in the device

are not biocompatible, the patient may have an adverse tissue reaction.

Acidity of the adhesive may burn tissues in the mouth.

Over-the-Counter (OTC) Denture Reliner (Sec. 872.3560)

(1) Identification. An OTC denture reliner is a device consisting

of a material such as plastic resin that is intended to be applied as a

permanent coating or lining on the base or tissue-contacting surface of

a denture. The device is intended to replace a worn denture lining and

may be available for purchase over the counter.

(2) Summary of data. The Panel based its recommendation on the

Panel members' personal knowledge of, and clinical experience with, the

device. The Panel also based its recommendation on statements that

further studies are necessary to determine the safety and effectiveness

of this device (Ref. 26).

(3) Risks to health.

Bone degeneration--Use of the device may cause alteration

in the vertical dimension of a denture and result in bone degeneration

in the upper and lower jaw.

Carcinomas--Long-term irritation or oral tissues caused by

incorrect vertical dimension may cause formation of carcinomas.

Root Canal Filling Resin (Sec. 872.3820)

(1) Identification. A root canal filling resin is a device composed

of material, such as methylmethacrylate, intended for use during

endodontic therapy to fill the root canal of a tooth. If chloroform is

used as an ingredient in the device, the device is in class III.

Otherwise, it is in class I.

(2) Summary of data. The Panel based its recommendation on the

Panel members' personal knowledge of, and clinical experience with,

root canal filling resins in the practice of dentistry.

(3) Risks to health. FDA believes that root canal fillings

containing chloroform present a risk of carcinogenicity.

5. Gastroenterology-Urology Devices

Colonic Irrigation System (Sec. 876.5220)

(1) Identification. A colonic irrigation system is a device

intended to instill water into the colon through a nozzle inserted into

the rectum to cleanse (evacuate) the contents of the lower colon. The

system is designed to allow evacuation of the contents of the colon

during the administration of the colonic irrigation. The device

consists of a container for fluid connected to the nozzle via tubing

and includes a system which enables the pressure, temperature, or flow

of water through the nozzle to be controlled. The device may include a

console-type toilet and necessary fittings to allow the device to be

connected to water and sewer pipes. The device may use electrical power

to heat the water. This device does not include the enema kit

(Sec. 876.5210). When the device is intended for colon cleansing when

medically indicated, such as before radiologic or endoscopic

examinations, it is in class II. When the device is intended for other

uses, including colon cleansing routinely for general well being, it is

in class III.

(2) Summary of data. The members of the Gastroenterology-Urology

Devices Classification Panel based their recommendation on the Panel

members' personal knowledge of, and clinical experience with, the

device.

(3) Risks to health.

Tissue burns--The temperature-regulating mechanism for the

water heater used in this device may allow overheating of the water

which is delivered to the patient's colon, resulting in tissue burns.

Perforation of the colon--Excessive water pressure

delivered by this device could result in perforation of the wall of the

colon.

Colon irritation--Excessive or inappropriate use of this

device may result in irritation of the colon.

Electrical injury--Improper design, construction, or a

malfunction of the device could result in electrical injury to the

patient or operator.

[[Page 46723]]

Implanted Electrical Urinary Continence Device (Sec. 876.5270)

(1) Identification. An implanted electrical urinary continence

device is a device intended for treatment of urinary incontinence that

consists of a receiver implanted in the abdomen with electrodes for

pulsed-stimulation that are implanted either in the bladder wall or in

the pelvic floor, and a battery-powered transmitter outside the body.

(2) Summary of data. The Panel based its recommendation on a review

of the historical data concerning implanted electrical urinary

continence devices. Halverstadt and Parry (Ref. 29) discussed several

unsolved problems inherent in the electrical stimulation of the

bladder. These problems include breakage of lead wires, the cumbersome

nature of the electrodes, risk of preformation by wires of the bladder

cavity, difficulty of obtaining uniform contraction of the detrusor

muscle, and the spread of the stimulus to neighboring tissues producing

abdominal pain. The Panel also based its recommendation on the

experimental nature of these devices and on the lack of adequate

medical literature and experience supporting their safety and

effectiveness.

(3) Risks to health.

Adverse tissue reaction and erosion--Defects in the design

or the construction of the device, or lack of biocompatibility of the

materials used in the device, may cause an adverse tissue reaction and

tissue erosion adjacent to the device.

Infection--Defects in the design or construction of the

device preventing adequate cleaning or sterilization, or defects in

packaging or processing of a device sold as sterile, may allow

pathogenic organisms to be introduced and cause an infection in the

patient.

Tissue damage--Defects in the electrode wires may lead to

their breakage and consequent tissue damage.

Abdominal and leg pain--The amount of stimulation by the

electrodes necessary to obtain adequate bladder stimulation may lead to

abdominal and leg pain.

Electrical injury--Improper design, construction, or

malfunction of the device could result in electrical injury to the

patient or the operator.

6. General Hospital and Personal Use Devices

Chemical Cold Pack Snakebite Kit (Sec. 880.5760)

(1) Identification. A chemical cold pack snakebite kit is a device

consisting of a chemical cold pack and tourniquet used for first-aid

treatment of snakebites.

(2) Summary of data. The members of the General Hospital and

Personal Use Devices Classification Panel based their recommendation on

the Panel members' personal knowledge of, and clinical experience with,

the device and on several articles in the literature that evaluate

different types of treatment for snakebites (Refs. 30, 31, and 32).

Most of the literature showed that cryotherapy (the use of cold therapy

for the treatment of snakebites) is inappropriate. Clement and

Pietrusko found high rates of amputation, local tissue destruction, and

prolonged disability in patients treated by this method (Ref. 30). A

National Academy of Sciences report stated that doubts about the safety

and effectiveness of short-term cold therapy for treatment of

snakebites have not been resolved (Ref. 31). The report also stated

that the use of cold therapy for a long period of time appears to be

dangerous. Watt reported that, among children who had to have

amputations because of snakebites, 75 percent had received cryotherapy

for the snakebites (Ref. 32).

(3) Risks to health.

Local tissue damage--Exposure of tissue to cold

temperatures for long periods of time can freeze the tissue and cause

local tissue damage, sometimes necessitating limb amputations.

7. Neurological Devices

Rheoencephalograph (Sec. 882.1825)

(1) Identification. A rheoencephalograph is a device used to

estimate a patient's cerebral circulation (blood flow in the brain) by

electrical impedance methods with direct electrical connections to the

scalp or neck area.

(2) Summary of data. The members of the Neurological Devices

Classification Panel referenced the literature on this device (Refs. 43

through 46). Some of the panel members witnessed its clinical

application. Dr. William Jarzembski, one of the Panel members, provided

some detailed information concerning his research on this device.

(3) Risks to health.

Erroneous clinical conclusions--The device may indicate

that cerebral circulation is normal, when in fact it may be very

abnormal.

Electrical shock--Excessive current could cause injury,

and malfunction of the device could result in an electrical shock.

Skin reaction--The electrode materials and conductive

media may irritate the skin.

Intravascular Occluding Catheter (Sec. 882.5150)

(1) Identification. An intravascular occluding catheter is a

catheter with an inflatable or detachable balloon tip that is used to

block a blood vessel to treat malformations, e.g., aneurysms

(balloonlike sacs formed on blood vessels) of intracranial blood

vessels.

(2) Summary of data. The Panel members based their recommendation

on the lack of data available on this device. Although the Panel

members were aware of the use of this device in investigational

programs, they believed that there is not enough information or data to

demonstrate that its safety and effectiveness can be adequately

controlled by means other than premarket approval.

(3) Risks to health.

Infarction of nervous tissue--If the catheter is not

controllable or if the balloon or tip should fail or unexpectedly come

loose from the catheter, use of the device may cause infarction of

nervous tissue (death of nervous tissue due to stoppage of circulation)

and other serious injury to the brain and other nervous tissue.

Hemorrhage--The catheter or improper balloon inflation may

injure a blood vessel and result in bleeding.

Thrombogenesis--Blood coagulation and clotting may result

if the material of which the catheter is constructed is not compatible

with blood.

Implanted Spinal Cord Stimulator for Bladder Evacuation (Sec. 882.5850)

(1) Identification. An implanted spinal cord stimulator for bladder

evacuation is an electrical stimulator used to empty the bladder of a

paraplegic patient who has a complete transection of the spinal cord

and who is unable to empty his or her bladder by reflex means or by the

intermittent use of catheters. The stimulator consists of an implanted

receiver with electrodes that are placed on the conus medullaris

portion of the patient's spinal cord and an external transmitter for

transmitting the stimulating pulses across the patient's skin to the

implanted receiver.

(2) Summary of data. The Panel members based their recommendation

on information supplied by Dr. Blaine Nashold, one of the Panel

members, who had been one of the primary individuals engaged in the

development of the device (Ref. 37). Dr. Nashold reported that he had

implanted the device in a small group of paraplegic patients. Six of

the 12 patients had been successfully emptying their bladders by this

method for 5 years (Ref. 37).

(3) Risks to health.

[[Page 46724]]

Injury to neural tissue--Tissue fibrosis may develop

around the electrode on the spinal cord and cause a diminished response

to the electrical stimulus.

Tissue toxicity--The implanted stimulator, lead wires, or

electrodes may contain material that is not biocompatible.

Cerebrospinal fluid leakage--The fluid that surrounds the

spinal cord might leak out around the receiver wires.

8. Obstetrical and Gynecological Devices

Obstetric Data Analyzer (Sec. 884.2050)

(1) Identification. An obstetric data analyzer is a device designed

to interpret fetal status during labor and to warn of possible fetal

distress by analyzing electronic signal data obtained from fetal or

maternal electronic or other monitors. This generic type of device

includes signal analysis and display equipment, electronic interfaces

for other equipment, and power supplies and component parts.

(2) Summary of data. FDA reviewed the Obstetrical and Gynecological

Devices Classification Panel's recommendation and obtained additional

information and data describing the application of automatic analysis

techniques to the determination of possible fetal distress. The

technique was new in 1978, and very little definitive information was

available. It was reasonable to expect that as algorithms were

developed and tested, confidence in automatic analysis would increase

(Ref. 38).

(3) Risks to health.

Electrical shock--Malfunction of the device could result

in electrical shock to the patient.

Misdiagnosis--Inadequate design or calibration of the

device could lead to the generation of inaccurate diagnostic data. If

inaccurate diagnostic data is used in managing the patient, the

physician may prescribe a course of treatment which places the fetus

and patient at risk unnecessarily.

Fetal Electroencephalographic Monitor (Sec. 884.2620)

(1) Identification. A fetal electroencephalographic monitor is a

device used to detect, measure, and record in graphic form (by means of

one or more electrodes placed transcervically on the fetal scalp during

labor) the rhythmically varying electrical skin potentials produced by

the fetal brain.

(2) Summary of data. The Panel based its recommendation on the fact

that fetal electroencephalographic monitoring was a relatively new

method of brain function evaluation during birth. Its sensitivity and

applicability in the field of the fetal brain research remained to be

established because clinical experience was too limited to ascertain

its safe and effective use. Rosen and Peltzman, who were performing the

major research on this device, were continuing with further controlled

studies (Refs. 39 and 40).

(3) Risks to health.

Electrical shock--Malfunction of the device could result

in electrical shock to the patient.

Misdiagnosis--Inadequate design of the device can lead to

the generation of inaccurate diagnostic data. If inaccurate diagnostic

data are used in managing the patient, the physician may prescribe a

course of treatment that places the fetus and patient at risk

unnecessarily.

Adverse tissue reaction--Material in the device could

result in a systemic or local tissue reaction when the device comes in

contact with the patient.

Infection--If the device is not properly sterilized, it

may introduce microorganisms that could cause infection.

Fetal Scalp Clip Electrode and Applicator (Sec. 884.2685)

(1) Identification. A fetal scalp clip electrode and applicator is

a device designed to establish electrical contact between fetal skin

and an external monitoring device by means of pinching skin tissue with

a nonreusable clip. This device is used to obtain a fetal

electrocardiogram. This generic type of device may include a clip

electrode applicator.

(2) Summary of data. The Panel based its recommendation on personal

knowledge of, and experience with, the device. Information presented to

the Panel indicated a 1 to 2 percent infection rate for newborns on

whom fetal scalp clip electrodes were used (Ref. 41). The Panel noted

that this device is in limited use in the United States because the

circular (spiral) electrode, preferred because it is easier to apply

and remove, is available.

(3) Risks to health.

Adverse tissue reaction--Material in the device could

cause a local tissue or systemic reaction when the device comes in

contact with the fetus.

Infection--If the device is not properly sterilized, it

may introduce microorganisms that could cause infection.

Tissue damage--Poor design or incorrect application could

result in scalp injury when the device pinches the fetal scalp.

Expandable Cervical Dilator (Sec. 884.4250)

(1) Identification. An expandable cervical dilator is an instrument

with two handles and two opposing blades used manually to dilate

(stretch open) the cervix.

(2) Summary of data. The Panel based its recommendation on personal

knowledge of, and experience with, the device. The Panel members'

experience with the expandable cervical dilator had been that its

leverage is very difficult to control in such a way that the cervix is

dilated evenly.

(3) Risks to health.

Laceration of the cervix--Appropriate design and materials

are necessary to prevent trauma to the cervix and possible subsequent

infertility.

Adverse tissue reaction--Material in the device could

cause a local tissue or systematic reaction when the device comes in

contact with the patient.

Infection--If the device is not properly sterilized, it

may introduce microorganisms that could cause infection.

Vibratory Cervical Dilator (Sec. 884.4270)

(1) Identification. A vibratory cervical dilator is a device

designed to dilate the cervical os by stretching it with a power-driven

vibrating probe head. The device is used to gain access to the uterus

or to induce abortion, but is not to be used during labor when a viable

fetus is desired or anticipated.

(2) Summary of data. The Panel based its recommendation on

experience with, and personal knowledge of, the device. The Panel

reviewed the literature on the device and in a typical study of 50

patients, there were 3 failures to dilate and 3 patients with cervical

tears (Ref. 42). The Panel believed that more data concerning these

types of dilators were necessary before standards could be written.

(3) Risks to health.

Laceration of the cervix--Appropriate design and material

are necessary to prevent trauma to the cervix and possible subsequent

infertility.

Electrical shock--Malfunction of the device could result

in electrical shock to the patient.

Adverse tissue reaction--Material in the device could

cause a systemic or local tissue reaction when the device comes in

contact with the patient.

Infection--If the device is not properly sterilized, it

may introduce microorganisms that could cause infection.

[[Page 46725]]

Metreurynter-Balloon Abortion System (Sec. 884.5050)

(1) Identification. A metreurynter-balloon abortion system is a

device used to induce abortion. The device is inserted into the uterine

cavity, inflated, and slowly extracted. The extraction of the balloon

from the uterus causes dilation of the cervical os. This generic type

of device may include pressure sources and pressure controls.

(2) Summary of data. The Panel based its recommendation on the

Panel members' familiarity with the device and a review of the

literature on this device. Although journal articles discussing the use

of this device in Japan indicate that it may be safe and effective

(Refs. 43 and 44), the Panel believed that these data were inconclusive

and that more studies needed to be performed to establish the

performance characteristics of the device. A standard textbook

mentioned that the device is rarely used because of potential trauma or

infection, unpredictability, and the risk of a live-born fetus (Ref.

45).

(3) Risks to health.

Infection--If the device is not properly sterilized, it

may introduce microorganisms that could cause infection.

Trauma, laceration, hemorrhage, and perforation--Poor

design of the device could cause uneven dilation of the cervix causing

injury to the patient.

Adverse tissue reaction--Material or substances in the

device could cause a systemic or local tissue reaction when the device

comes in contact with the patient's cervix.

Unnecessary medical procedures--Loss of the device could

result in an otherwise unnecessary medical procedure to recover the

device from the uterus.

Abdominal Decompression Chamber (Sec. 884.5225)

(1) Identification. An abdominal decompression chamber is a

hoodlike device used to reduce pressure on the pregnant patient's

abdomen for the relief of abdominal pain during pregnancy or labor.

(2) Summary of data. The Panel based its recommendation on personal

knowledge of, and experience with, this device. The Panel considered

this device to be ineffective. Additionally, the Panel found no

literature available to supply adequate clinical data supporting any

claim of effectiveness. The consensus of the Panel was that any data

that might be developed would support an action to ban the device

because its risks outweigh its benefits.

(3) Risks to health.

Difficult patient management--The device is cumbersome and

covers the abdominal area of the patient, thus blocking the physician

from examining the patient.

Supine hypotension--Because the patient is required to lie

on her back, the possibility of induced low blood pressure and

consequent complications exists.

9. Orthopedic Devices

Ankle Joint Metal/Polymer Non-Constrained Cemented Prosthesis

(Sec. 888.3120)

(1) Identification. An ankle joint metal/polymer non-constrained

cemented prosthesis is a device intended to be implanted to replace an

ankle joint. The device limits minimally (less than normal anatomic

constraints) translation in one or more planes. It has no linkage

across-the-joint. This generic type of device includes prostheses that

have a tibial component made of alloys, such as cobalt-chromium-

molybdenum, and a talar component made of ultra-high molecular weight

polyethylene, and is limited to those prostheses intended for use with

bone cement (Sec. 888.3027).

(2) Summary of data. The members of the Orthopedic Devices

Classification Panel based their recommendation on the Panel members'

personal knowledge of the device and on the available medical

literature. According to Freeman (Ref. 47), ``It is still too early to

say whether this operation (total ankle joint replacement) offers any

advantages over arthrodesis * * *. It would appear a comfortable mobile

ankle can be produced but how reliably this can be done and how long

the results will last is impossible to say.'' The only available

clinical study on the device at the time of the Panel meeting had been

done by Newton (Ref. 48). From 1973 to 1978, 50 patients had this

prosthesis implanted. There have been 20 (40 percent) reported

failures. FDA believed these data are insufficient to establish the

safety and effectiveness of ankle joint metal/polymer non-constrained

prostheses.

(3) Risks to health.

Loss or reduction of joint function--Improper design or

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear, may result in a loss or reduction of

joint function due to excessive wear, fracture, deformation of the

device, or loosening of the device in the surgical cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to dissolution or wearing away from the surfaces of

the device and the release of materials from the device to the

surrounding tissues and systemic circulation. -

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

Elbow Joint Humeral (Hemi-Elbow) Metallic Uncemented Prosthesis

(Sec. 888.3180)

(1) Identification. An elbow joint humeral (hemi-elbow) metallic

uncemented prosthesis is a device intended to be implanted, made of

alloys such as cobalt-chromium-molybdenum, that is used to replace the

distal end of the humerus formed by the trochlea humeri and the

capitulum humeri. The generic type of device is limited to prostheses

intended for use without bone cement (Sec. 888.3027).

(2) Summary of data. The Panel based its recommendation on the

Panel members' personal knowledge of, and clinical experience with, the

device. The only available clinical data at the time of the Panel

meeting were the results of 2 surgeons who had implanted 18 devices

over a 10-year period (Ref. 49). An earlier publication (Ref. 50)

discussed the clinical results in what appeared to be the first 10 of

these 18 implantations. The devices had been implanted in nine patients

(one patient had prostheses implanted bilaterally). These patients were

evaluated 1 to 7 years later and only four patients (44 percent) had

stable, pain-free elbows with a functional range of motion. New bone

growth restricted or totally blocked elbow joint motion in three

patients. The device was removed in two other patients; because of

joint pain and swelling in one; and because the device had dislocated

and was eroding through the skin in the other.

(3) Risks to health.

Loss or reduction of joint function--Improper design or

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear, may result in the loss or reduction of

joint function due to excessive wear, fracture, deformation of the

device, or loosening of the device in the surgical cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to dissolution or wearing away from the surfaces of

the device and release of materials from the device to the

[[Page 46726]]

surrounding tissues and systemic circulation.

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

Finger Joint Metal/Metal Constrained Uncemented Prosthesis

(Sec. 888.3200)

(1) Identification. A finger joint metal/metal constrained

uncemented prosthesis is a device intended to be implanted to replace a

metacarpophalangeal (MCP) or proximal interphalangeal (finger) joint.

The device prevents dislocation in more than one anatomic plane and

consists of two components which are linked together. This generic type

of device includes prostheses made of alloys, such as cobalt-chromium-

molybdenum, or protheses made from alloys and ultra-high molecular

weight polyethylene. This generic type of device is limited to

prostheses intended for use without bone cement (Sec. 888.3027).

(2) Summary of data. The only finger joint metal/metal constrained

uncemented prosthesis discussed in the literature at the time of the

Panel meeting was a two-pronged stainless steel hinged prostheses that

was developed by Flatt for use in the MCP and the proximal

interphalangeal (PIP) joints of the fingers.

Flatt presented clinical results with the Flatt finger prosthesis

in a series of publications over a 12-year period (Refs. 51 through

56). Thirty-one prostheses had been implanted for 6 months or more (6

months to 34 months); 23 in the PIP joint and 8 in the MCP joint. In

the earliest of these reports, Flatt noted that despite early

encouraging clinical results, the long-term outlook for the device did

not look favorable. In particular, Flatt noted that the bone absorption

that occurs around the neck of the prosthesis may possibly lead to

obstruction of flexion. Flatt also noted that possible complications

from use of the device might be: (a) Bone erosion in patients in whom

the intramedullary prongs have been forced together in the medullary

canal, and (b) metal fatigue and fracture of the intramedullary prongs.

Subsequent publications by Flatt (Refs. 55 and 56) showed that the

predicted complications did, in fact, occur. Flatt and Ellison (Ref.

55) reported on the implantation of 242 prostheses (167 in the MCP

joint and 75 in the PIP joint) with an average followup of 6.2 years

(range 1 to 12 years). Twenty-six (10.7 percent) of the prostheses (15

MCP and 11 PIP) had to be removed for the following reasons:

Periarticular fibrosis (bone resorption) and settling, 14; failure

(i.e., fracture) of both intramedullary prongs, 2; failure of the screw

holding the hinge together, 2; breakdown of the skin over the

prosthesis, 5; and infection, 3. The authors reported that of the

prostheses that required removal, more than half were removed because

of settling within the recipient bones. Bone absorption around the

intramedullary prongs, scarring, or heterotrophic bone formation around

the hinge caused sufficient mechanical difficulties to necessitate

removal of the prosthesis. Flatt and Ellison noted that the gradually

progressing periarticular fibrosis (bone resorption) resulted in a

decreased range of joint motion and was related to very active use of

the hand.

Girzados and Clayton (Ref. 57) reported on the implantation of 23

Flatt finger prostheses in 11 patients with an average followup of 44

months (range 24 to 73 months). Of the 23 prostheses implanted, 11 were

in the MCP joints of the fingers, 8 were in the PIP joints of the

thumb. Bone absorption around the neck and stems of the prosthesis

occurred in 16 of the 23 (69 percent) joints. Six prostheses (26

percent) were rated as poor results: Three had no motion

postoperatively; one was grossly unstable; and two were implanted in a

patient with active rheumatoid disease who, over a period of 64 months,

had intermittent swelling and pain over the joints that had been

replaced with the prostheses. The authors reported that ``good'' or

``fair'' results were obtained in 13 (56 percent) of the joints.

However, the number of patients having pain-free stable joints with a

useful range of motion (defined as ``good'') as opposed to those with

limited motion, minimal pain, and instability (defined as ``fair'')

could not be determined.

Problems associated with the Flatt finger prosthesis have been

recognized by many authors (Refs. 58 through 63). Several authors

(Refs. 58 and 59) reported that these prostheses have not been

generally accepted because of the accompanying bone resorption.

McFarland (Ref. 60) reported that the Flatt prosthesis had been only

moderately successful, that complications were frequent and included

bone overgrowth with loss of motion, migration of the prosthesis due to

bone erosion, and metal failures (i.e., device fractures). Goldner and

Urbaniak (Ref. 62) and Smith and Broudy (Ref. 63) noted that the bone

resorption and subsequent migration of the devices was caused by the

use of a rigid material in osteoporotic bone. Smith and Broudy (Ref.

63) also noted that the intramedullary prongs frequently migrate

through the cortex and occasionally the hinge would break or the

overlying skin would ulcerate, causing tendon rupture and infection.

(3) Risks to health.

Loss or reduction of joint function--Improper design or

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear, may result in a loss or reduction of

joint function due to excessive wear, fracture, deformation of the

device, or loosening of the device in the surgical cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to dissolution or wearing away from the surfaces of

the device and the release of materials from the device to the

surrounding tissues and systemic circulation.

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

Finger Joint Metal/Metal Constrained Cemented Prosthesis

(Sec. 888.3210)

(1) Identification. A finger joint metal/metal constrained cemented

prosthesis is a device intended to be implanted to replace a MCP

(finger) joint. This device prevents dislocation in more than one

anatomic plane and has components which are linked together. This

generic type of device include prosthesis that are made of alloys, such

as cobalt-chromium-molybdenum, and is limited to those prosthesis

intended for use with bone cement (Sec. 888.3027).

(2) Summary of data. Two types of these prostheses were discussed

in the literature: (a) The Link prostheses, a metallic hinge intended

to replace the MCP joint of a finger or thumb; and (b) the Biomedical

Laboratories of the University of Cincinnati (BLUC) prostheses, a

hinged metallic prostheses intended to replace the MCP joint of the

thumb.

Devas and Shah (Refs. 64 and 65) reported on the implementation of

51 Link prostheses in 25 patients with an average postoperative

followup of 4 years (range 2 to 6 years). In 15 (30 percent) of these

implantations, the patient had persistent pain in the joint and what

was described as a useless finger. The authors believed that the

proportion of patients with pain was far too large to make the

treatment method freely available. They noted that the main cause of

failure was due to loosening of the prostheses with disruption

(erosion) of the bone. They also noted that in most of the joints with

good and fair results the prosthesis had become loose but that the

patients were free from symptoms at the time of

[[Page 46727]]

evaluation. The authors believed that prosthesis loosening may have

been caused by fixation of the components by injecting the cement into

the metacarpal and phalangeal bone shafts, and it was noted that a

modified prosthesis with a different technique of insertion was being

considered (Ref. 65). Two papers (Refs. 66 and 67) described the design

and testing of the BLUC thumb prostheses. Clinical results, however,

were not presented. FDA believed that the data available on the

devices, the clinical results of the use of the devices in 25 patients

with a reported failure rate of 30 percent, and the recommendation by

the authors that the procedure not be made freely available, did not

establish the long-term safety and effectiveness of finger joint metal/

metal constrained prostheses.

(3) Risks to health

Loss or reduction of joint function--Improper design or

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear, may result in a loss or reduction of

joint function due to excessive wear, fracture, deformation of the

device, or loosening of the device in the surgical cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to dissolution or wearing away from the surfaces of

the device and the release of materials from the device to the

surrounding tissues and systemic circulation.

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

Finger Joint Metal/Polymer Constrained Cemented Prosthesis

(Sec. 888.3220)

(1) Identification. A finger joint metal/polymer constrained

cemented prosthesis is a device intended to be implanted to replace a

MCP or proximal interphalangeal (finger) joint. The device prevents

dislocation in more than one anatomic plane, and consists of two

components which are linked together. This generic type of device

includes prostheses that are made of alloys, such as cobalt-chromium-

molybdenum, and ultra-high molecular weight polyethylene, and is

limited to those prostheses intended for use with bone cement

(Sec. 888.3027).

(2) Summary of data. Clinical results on three designs of finger

joint polymer constrained prostheses were presented in the literature:

The Calnan-Nicolle prosthesis, intended for use in the MCP and PIP

joints for the fingers; the Niebauer prosthesis also intended for use

in the MCP and PIP joints of the fingers; and the Swanson prosthesis

intended for use in the MCP and PIP joints of the fingers and for the

MCP joint of the thumb.

a. Calnan-Nicolle prosthesis. This device has two components: An

across-the-joint component having intramedullary stems and a flexible

hinge made of polypropylene, and a silicone rubber sleeve which

encapsulates the flexible hinge portion of the device (Ref. 72).

Griffiths and Nicolle (Ref. 73) reported on the clinical results 8 to

37 months (average of 20 months) after implantation of the Calnan-

Nicolle device in 112 MCP joints in 31 patients. Complete relief from

pain was obtained in four (13 percent) patients. There was much

improvement over preoperative pain status in 13 (42 percent), moderate

pain relief in 10 (32 percent), and little pain relief in 4 (13

percent) patients. These authors reported that a deterioration in the

performance of the prosthesis occurred in up to half of the patients

between 1 and 2 years after insertion of the prosthesis; and that part

of the deterioration in function was due directly to mechanical failure

of the prosthesis. The range of joint motion had deteriorated over time

in 33 of the 40 (82.5 percent) hands on which surgery was performed.

Joint deformity was ``corrected and held'' in 10 to 31 hands (32

percent), was corrected initially but recurred in 14 of 31 (45 percent)

hands, and worsened in 7 of 31 (23 percent) hands. The silicone capsule

(sleeve) had fractured in 31 of the 112 prostheses (28 percent). The

polypropylene stems had fractured in five joints (5 percent). Nicolle

(Ref. 71) noted that time and experience had shown that the

polypropylene hinge of the Calnan-Nicolle prosthesis does not appear to

be strong enough to withstand fully the compression and torsional

stresses that may occur in the use of the hand.

b. Niebauer prosthesis. This device consists of a single, flexible,

across-the-joint component. The intramedullary stems and the flexible

hinge portion of the device are made of silicone to allow tissue

penetration and fixation of the stems. Beckenbaugh et al. (Ref. 75)

reported on the clinical results 12 to 65 months (average 32 months)

after implantation in the MCP joints of 68 Niebauer prostheses and

found a fracture rate of the device of 38.2 percent (26 devices),

recurrence of clinical deformity in 44.1 percent (30 devices) and

recurrence of pain in 2 percent. Goldner et al. (Ref. 76) reported a

fracture rate of 29.7 percent in 37 prostheses implanted for 6.5 years

and 17.5 percent fracture rate in 143 prostheses implanted 4 to 6

years. These authors believe that the silicone-polyester material used

in the device may absorb lipids and become brittle, and that eventual

fracture of the prosthesis is a possibility, but that fracture does not

preclude a good functional result. Goldner and Urbaniak (Ref. 77)

evaluated 103 patients over a 4-year period. Pain was relieved or

greatly diminished postoperatively in all but 8 of the 103 patients.

The average active range of motion in these patients was 51 degrees.

The range of motion was noted to increase up to about 1 year

postoperatively; and then thought to decrease slightly, possibly due to

enlarged bony outgrowths from the surface of the bone and impingement

of peripheral bone on the hinge of the device. In two (2 percent) of

patients, the device had fractured, which was accompanied by deformity

and a moderate amount of pain.

Hagert (Ref. 78) conducted X-ray examinations on 41 joints with

Niebauer implants. This author reported that of the 41 prostheses

studied, 26 (63.4 percent) were found to be damaged (i.e., cracked

within the implant midsection, fragmented at the midsection, or

fractured at the hinge), 1 to 36 months postoperatively. This author

believed that the Niebauer implant might be too weak to withstand

forces in the MCP joints, and that a possible contributing factor was

the use of materials (polyester fiber and silicone rubber) with

differing elasticity. This author noted that the Niebauer implant was

reported to have withstood 100 million flexions during mechanical tests

bending it around a fixed axis, but not exposing it simultaneously to

shearing type forces which are present in the MCP joint. These shearing

forces were reportedly most probably responsible for the deformation of

the implant and the subsequent damage observed. Niebauer and Landry

(Ref. 79) reported that destruction of the bone around the hinge of the

device had occurred in a few cases and that this atrophy may be the

result of pressure from the prosthesis. In an evaluation by X-ray of

the 41 Niebauer prostheses, Hagert (Ref. 78) observed bone resorption

in 23 of the 41 joints (56 percent). The cortex of the bone was

penetrated in 13 (32 percent) of these joints. It was reported that the

observed erosion of the bone is most likely caused by motion of the

intramedullary stems within the medullary cavity, and is exaggerated by

the rough polyester surface of the device.

c. Swanson prosthesis. This device is made entirely of silicone

rubber and is

[[Page 46728]]

designed to act as an internal mold, maintaining joint alignment,

becoming encapsulated and stabilized by fibrous tissue, and gliding or

moving within the medullary cavity rather than being fixed to the bone

(Ref. 80). A number of reports (Refs. 75 and 80 through 86) were found

describing the use of the Swanson prostheses in the MCP joints of the

fingers, but few reports (Refs. 87 through 90) were available

describing the use of this device in the MCP joint of the thumb, or the

PIP joints of the fingers. In 1976, it was reported that a new ``high

performance'' silicone elastomer material had been developed for use in

the Swanson prosthesis. With the exception of one report (Ref. 90), the

available clinical data were obtained using prostheses made from the

``conventional'' silicone elastomer. Fracture of implants made of the

``conventional'' silicone elastomer appears to be the most frequently

reported failure. Beckenbaugh et al. (Ref. 75) reported that of 186

Swanson prostheses implanted in the MCP joint for an average of 32

months (range 12 months to 65 months), 26.3 percent (49) had fractured.

Hagert et al. (Ref. 82) reported that of 104 Swanson implants

evaluated, 25 percent (26) had failed, either by cracking or

fragmenting and fracturing within the followup period of 1.5 to 5

years. Mannerfelt and Anderson (Ref. 83) reported a fracture rate of

2.8 percent in 144 joints evaluated 1.5 to 3.5 years (average 2.5

years) after implantation. Ferlic et al. (Ref. 84) reported a fracture

rate of 9 months (average 2.3 years) after implantation. Swanson (Ref.

80) reported the lowest rate of fracture, 0.88 percent, in a field

clinic series involving over 3,000 implants with a followup of from 6

to 30 months.

The effects of fracture of the device on the clinical results were

evaluated by several authors. Aptekar et al. (Ref. 85) described the

occurrence of detritic synovitis (inflammation of the synovial tissue)

due to shards of silicone rubber found in relation to a broken

prosthesis. Beckenbaugh et al. (Ref. 75) noted that recurrence of

deformity was associated with implant fracture, i.e., ulnar drift, in

14 percent; weakness or instability in 21 percent; hyperextension in 11

percent; and some clinical deformities in 43 percent; but that while

the recurrence of deformity implied that soft tissue balance was not

present after the implant fractured, it was not clear whether the

imbalance caused the fracture or developed because of it.

Hagert (Ref. 86) believed that the increased displacement, i.e.,

ulnar deviation, noted in some joints with fractured implants, may

indicate insufficiency of the fibrous capsule surrounding the implant

to restrain the forces occurring at the MCP joint. This pressure,

combined with movement of the implant within the medullary canal was

reportedly found to cause a moderately progressive bone resorption

throughout the followup period in all of the 36 joints examined.

Resorption was observed around the midsection of the prosthesis where

the implant was in close contact with bone and around the

intramedullary stems of the device. Erosion of bone around the

midsection of the device led to various degrees of migration of the

device in 28 out of 36 (78 percent) of the joints examined. The author

found that decreased joint flexion was observed due either to the

distal migration of the implant or a growing volar bony spur in 13 out

of the 39 (33 percent) joints examined. He concluded that the design of

the device may be insufficient to fully restrain the volarly and

proximally directed forces in the MCP joint and the serious decrease of

flexion. Hagert et al. (Ref. 82) reported that although it is generally

accepted that silicone rubber absorbs lipids and other substances, the

effects on material changes and degradation is not adequately known.

Weightman et al. (Ref. 87) noted that lipid absorption could contribute

to mechanical failure of the prostheses, as chemical deterioration is

known to be a prime initiator of fatigue failures of polymers. Other

clinical results have been reported in the literature (Refs. 80, 81,

87, and 89) on the use of this prosthesis in large numbers of patients.

These results were very similar to those summarized previously.

(3) Risks to health.

Loss or reduction of joint function--Improper design of

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear, may result in a loss or reduction of

joint function due to excessive wear, fracture, deformation of the

device, or loosening of the device in the surgical cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to dissolution or wearing away from the surfaces of

the device and the release of materials from the device to the

surrounding tissues and systemic circulation. -

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

Hip Joint Metal Constrained Cemented or Uncemented Prosthesis

(Sec. 888.3300)

(1) Identification. A hip joint metal constrained cemented or

uncemented prosthesis is a device intended to be implanted to replace a

hip joint. The device prevents dislocation in more than one anatomic

plane and has components that are linked together. This generic type of

device includes prostheses that have components made of alloys, such as

cobalt-chromium-molybdenum, and is intended for use with or without

bone cement (Sec. 888.3027). This device is not intended for biological

fixation.

(2) Summary of data. The agency has obtained data and information

describing the use of hip joint metal constrained prostheses. Sivash

(Ref. 91) reported on implantation in 164 patients; followup time was 1

to 9 years. Breakage of the prosthesis was reported in 13 (8 percent)

of the patients. Because of the lack of adequate data to demonstrate

the safety and effectiveness of these implanted devices, FDA believed

that use of the hip joint metal constrained prosthesis presents an

unreasonable risk of illness or injury.

(3) Risks to health.

Loss or reduction of joint function--Improper design or

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear, may result in a loss or reduction of

joint function due to excessive wear, fracture, deformation of the

device, or loosening of the device, or loosening of the device in the

surgical cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to a dissolution or wearing away from the surfaces

of the device and the release of material from the device to the

surrounding tissues and systemic circulation. -

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis

(Sec. 888.3310)

(1) Identification. A hip joint metal/polymer constrained cemented

or uncemented prosthesis is a device intended to be implanted to

replace a hip joint. The device prevents dislocation in more than one

anatomic plane and has components that are linked together. This

generic type of device includes prostheses that have a femoral

component made of alloys, such

[[Page 46729]]

as cobalt-chromium-molybdenum, and an acetabular component made of

ultra-high molecular weight polyethylene. This generic type of device

is intended for use with or without bone cement (Sec. 888.3027). This

device is not intended for biological fixation.

(2) Summary of data. The Panel based its recommendation on the

Panel members' personal knowledge of, and clinical experience with, the

device.

(3) Risks to health.

Loss or reduction of joint function--Improper design or

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear, may result in a loss or reduction of

joint function due to excessive wear, fracture, deformation of the

device, or loosening of the device in the surgical cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to dissolution or wearing away from the surfaces of

the device and the release of materials from the device to the

surrounding tissues and systemic circulation.

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

Hip Joint (Hemi-Hip) Acetabular Metal Cemented Prosthesis

(Sec. 888.3370)

(1) Identification. A hip joint (hemi-hip) acetabular metal

cemented prosthesis is a device intended to be implanted to replace a

portion of the hip joint. This generic type of device includes

prostheses that have an acetabular component made of alloys, such as

cobalt-chromium-molybdenum. This generic type of device is limited to

those prostheses intended for use with bone cement (Sec. 888.3027).

(2) Summary of data. The Panel based its recommendation on the

Panel members' personal knowledge of, and clinical experience with, the

device.

(3) Risks to health.

Loss or reduction of joint function--Improper design or

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear, may result in a loss or reduction of

joint function due to excessive wear, fracture, deformation of the

device, or loosening of the device in the surgical cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to dissolution or wearing away from the surfaces of

the device and the release of materials from the device to the

surrounding tissues and systemic circulation. -

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

Hip Joint Femoral (Hemi-Hip) Trunnion-Bearing Metal/Polyacetal Cemented

Prosthesis (Sec. 888.3380)

(1) Identification. A hip joint femoral (hemi-hip) trunnion-bearing

metal/polyacetal cemented prosthesis is a two-part device intended to

be implanted to replace the head and neck of the femur. This generic

type of device includes prostheses that consist of a metallic stem made

of alloys, such as cobalt-chromium-molybdenum, with an integrated

cylindrical trunnion bearing at the upper end of the stem that fits

into a recess in the head of the device. The head of the device is made

of polyacetal (polyoxymethylene) and it is covered by a metallic alloy,

such as cobalt-chromium-molybdenum. The trunnion bearing allows the

head of the device to rotate on its stem. The prosthesis is intended

for use with bone cement (Sec. 888.3027).

(2) Summary of data. The Panel based its recommendation on the

Panel members' personal knowledge of, and clinical experience with, the

device and on a presentation to the Panel. Dr. Ian Goldie (University

of Goteborg) presented the results of several Norwegian studies with

these prostheses. Dr. Goldie referred to Christiansen's series of 241

hips in which excellent results were obtained in 57 percent of the

cases and good results in 33 percent. In this series, there were five

infections, seven cases of loosening of the acetabular cup, two

dislocations shortly after operation, two cases of femoral perforation,

and three cases of heterotopic ossification. Dr. Goldie then presented

the results of his own series of 61 patients. In the 19 patients with 2

years followup, and in the 28 patients with 6 months followup, there

were no complications. However, in the remaining 14 patients with a

followup of 1 year, there were the following complications: 2

dislocations between the head and the cup, 2 cases of heterotopic

ossification, and 2 patients with inexplicable pain.

FDA sought additional data and information on the safety and

effectiveness of these devices. A review of the medical literature

revealed a disagreement regarding the resistance to wear of polyacetal

materials. McKellop et al. (Ref. 92) reported that laboratory wear

rates for polyacetal ranged from 70 percent lower than polyethylene to

540 percent higher. Dumbleton (Ref. 93) reported wear in the trunnion

sleeve of the device and that polyacetal exhibits a low resistance to

wear. Because of the potential problems involving its resistance to

wear, the long-term effectiveness of this device is questionable. The

initial investigator and his associates have been the primary users of

this device. Long-term followup data are available only from the

initial investigator. Clinical cases documenting effectiveness and

safety of the device involve usage of less than 3 years.

(3) Risks to health.

Loss or reduction of joint function--Improper design or

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear, may result in a loss or reduction in

joint function due to excessive wear, fracture, deformation of the

device components, or loosening of the device in the surgical cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility or resistance to wear, may result in an adverse tissue

reaction due to dissolution or wearing away of the surfaces of the

device and the release of materials from the device to the surrounding

tissues and systemic circulation. -

Infection--The presence of a prosthesis within the body

may lead to an increased risk of infection.

Knee Joint Femorotibial Metallic Constrained Cemented Prosthesis

(Sec. 888.3480)

(1) Identification. A knee joint femorotibial metallic constrained

cemented prosthesis is a device intended to be implanted to replace

part of a knee joint. The device prevents dislocation in more than one

anatomic plane and has components that are linked together. The only

knee joint movement allowed by the device is in the sagittal plane.

This generic type of device includes prostheses that have an

intramedullary stem at both the proximal and distal locations. The

upper and lower components may be joined either by a solid bolt or pin,

an internally threaded bolt with locking screw, or a bolt retained by

circlip. The components of the device are made of alloys, such as

cobalt-chromium-molybdenum. The stems of the device may be perforated,

but are intended to be implanted with a polymethylmethacrylate luting

agent (bone cement).

(2) Summary of data. The Panel based its recommendation on the

Panel members' personal knowledge of, and experience with, the device,

and its

[[Page 46730]]

review of the medical literature. Results from using the device in more

than 720 cases have been reported in the medical literature in the

United States during the past 3 years (Refs. 94, 100, and 103). Reports

in the medical literature exist that document use of the device in

several thousand cases worldwide during the past 10 years. The Panel

believed that this extensive clinical use has revealed the usual

mechanical problems, implant loosening and settling. The Panel

determined that the overall risks resulting from use of the prosthesis

were no worse than the risks associated with major knee surgery without

implantation of a prosthesis.

Of the 957 patients reviewed by the Panel who have had this

prosthesis implanted and who were discussed in the worldwide medical

literature (Refs. 94 through 105), 108 (11 percent) suffered implant

failure, 233 (24 percent) of the cases had complications, and 104 (11

percent) had loosening of the prosthesis.

FDA sought additional data on the safety and effectiveness of this

device. Kettelkamp (Ref. 105) reported that the failure rate for the

device ranges from 5 percent to 24 percent for the hinged metal knee

prosthesis, with a short followup time. Kettlekamp (Ref. 105) and Chand

(Ref. 106) both believe that excessive forces may be applied to the

intramedullary stem bone cement interface because the constrained

prosthesis hinge prevents medial/lateral joint movement. Kettlekamp

believes that if the stem loosens, the cement may rub away and destroy

the surrounding bone, causing a larger cavity and making revision

difficult or impossible.

Kettlekamp reviewed reports in the medical literature on use of 576

Walldius hinged knee prostheses. In one group of 144 implantations,

complications occurred in 29 cases (13 percent). In the remaining 432

cases, 89 (20 percent) were classified as failures, 33 (7 percent)

required reoperations, and 53 (12 percent) had loosening. Fractures

occurred in 11 cases (2 percent) and deep infection was reported in 35

knees (8 percent). Kettlekamp reported that the incidence of

complication increased with the length of reported followup. Brady and

Garber (Ref. 103) reviewed results of implanting the Shiers design of

this device in 288 knees. He reported poor results in 71 knees (24

percent), reoperation was required in 33 knees (11 percent), and

loosening observed in 56 knees (19 percent). Brady stated that the

major problems involved with use of these prosthesis are the absence of

axial (medial) rotation, the necessary resection of large amounts of

bone, and the creation of physiologic dead space.

Kettlekamp (Ref. 105) and Deburge et al. (Ref. 107) reported that

the major problem with the Shiers design prosthesis is loosening.

Deburge reported a loosening rate of 15 percent (22 patients) during a

5-year followup of the request of implanting the Guepar constrained

knee prosthesis in 152 patients. However, less than half of these

instances of device loosening were symptomatic (10 of 22 patients).

Reoperations were performed on the 10 patients. Other authors (Ref.

100) believed that the rate of loosening of the prosthesis is higher,

possibly around 80 percent, but that only a small percentage of those

patients with device loosening are symptomatic.

Arden and Kamdar (Ref. 108) reported followup for 7 years on

implantation of 193 Shiers design prostheses. They reported that 11

percent of the patients had aseptic loosening. Kaushal et al. (Ref.

109) reported followup examination of a series of 30 knees about 42

months following implantation of the prosthesis. The examination

revealed that 13 knees (46 percent) had phlebothrombosis, 8 knees (11

percent) had asymptomatic loosening, 4 knees (5.4 percent) had deep

infections, and 3 knees (4.3 percent) had symptomatic loosening. The

major problems with use of the prosthesis were settling, loosening, and

limitation on the range of joint motion allowed. In preliminary data,

Van Camp et al. (Ref. 110) showed that stress loading appeared to cause

mechanical loosening of the device.

Walker (Ref. 111) stated that the valgus angle of the knee was

ignored in the older designs of this prosthesis. Walker said this

design problem resulted in lateral stress on the intramedullary stems

of the device. This theory was verified experimentally by Wagner and

Bourgois (Ref. 112). Wagner and Bourgois also showed that, in both the

Walldius and Shiers designs of the prosthesis, the prosthesis' axis of

rotation was not equivalent to the axis of the anatomic joint it

replaced. These researchers said the pin in the Shiers prosthesis was

turned down on the axis and that it might loosen if the prosthesis were

overstressed. Because the axle pin of the Walldius prosthesis is

clamped on one side, the location of the axis causes localized wear.

Although infection immediately following implantation of a

prosthesis is primarily a result of surgical technique, Swanson et al.

(Ref. 113) stated that the design of the prosthesis may minimize the

rate of infection associated with implantation. Swanson found that the

infection rate was lower when less bone was removed for insertion of

the device. Phillips and Taylor (Ref. 98) reported that most groups of

patients who have received this prosthesis have suffered about a 10

percent higher incidence of infection than patients in whom other

generic types of knee prostheses have been implanted.

In cases of total failure of implantation of a joint prosthesis,

the prosthesis may be removed and the joint fused (arthrodesis). The

rate of success in performing arthrodesis is related to the amount of

bone that was removed to implant the device. Arthrodesis is difficult

following implantation of a constrained joint replacement device.

(3) Risks to health.

Loss or reduction of joint function--Improper design or

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear, may result in a loss or reduction of

joint function due to excessive wear, fracture, deformation of the

device, or loosening of the device in the surgical cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to dissolution or wearing away from the surfaces of

the device and the release of materials from the device to the

surrounding tissues and systemic circulation. -

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

Knee Joint Patellofemoral Polymer/Metal Semi-Constrained Cemented

Prothesis (Sec. 888.3540)

(1) Identification. A knee joint patellofemoral polymer/metal semi-

constrained cemented prosthesis is a two-part device intended to be

implanted to replace part of a knee joint in the treatment of primary

patellofemoral arthritis or chondromalacia. The device limits

translation and rotation in one or more planes via the geometry of its

articulating surfaces. It has no linkage across-the-joint. This generic

type of device includes a component made of alloys, such as cobalt-

chromium-molybdenum or austenitic steel, for resurfacing the

intercondylar groove (femoral sulcus) on the anterior aspect of the

distal femur, and a patellar component made of ultra-high molecular

weight polyethylene. This generic type of device is limited to those

devices intended for use with bone cement (Sec. 888.3027). The patellar

component is designed to be implanted only with its femoral component.

[[Page 46731]]

(2) Summary of data. The Panel based its recommendation on the

Panel members' personal knowledge of, and experience with, similar

devices and a presentation made to the Panel. Fox reported on his

clinical experience with this generic type of device. Fox stated that

patellofemoral joint replacement was performed in more than 60 knees,

with the followup since 1974. He reported that he, as well as his

patients, were pleased with the results.

Other than the presentation to the Panel made by Fox, FDA was not

aware of any clinical data for this device. Moreover, because Fox

provided no details regarding the device or its implantation procedure,

FDA was not certain that the devices Fox implanted belong to this

generic class.

(3) Risks to health.

Loss or reduction of joint function--Improper design or

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear, may result in a loss or reduction of

joint function due to excessive wear, fracture, deformation of the

device, or loosening of the device in the surgical cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to dissolution of wearing away from the surfaces of

the device and the release of materials from the device to the

surrounding tissues and systemic circulation. -

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

Knee Joint Patellofemorotibial Polymer/Metal/Metal Constrained Cemented

Prosthesis (Sec. 888.3550)

(1) Identification. A knee joint patellofemorotibial polymer/metal/

metal constrained cemented prosthesis is a device intended to be

implanted to replace a knee joint. The device prevents dislocation in

more than one anatomic plane and has components that are linked

together. This generic type of device includes prostheses that have a

femoral component, a tibial component, a cylindrical bolt and

accompanying locking hardware that are all made of alloys, such as

cobalt-chromium-molybdenum, and a retropatellar resurfacing component

made of ultra-high molecular weight polyethylene. The retropatellar

surfacing component may be attached to the resected patella either with

a metallic screw or luting agent. All stemmed metallic components

within this generic class are intended to be implanted with a

polymethylmethacrylate luting agent (bone cement).

(2) Summary of data. The Panel based its recommendation on the

Panel members' knowledge of, and experience with, the device and a

presentation made to the Panel. Pritchard and Fox described their

experiences with various patellofemoral joint replacing devices

including this generic type of device. Pritchard has implanted

patellofemorotibial joint prostheses in at least 100 patients during

the 3 years prior to the Panel meeting. Also, Fox reported that he has

achieved good results in over 60 cases since 1974. In May 1962, Young

(Ref. 116) reported on a series of 16 patients ranging in age from 31

to 70 years who had a Young design prosthesis implanted (2 were

bilateral implantations). With a followup time between 9 and 61 months

(median of 20 months), 7 of these 16 experienced a clinical failure

(43.8 percent) with a mean time of about 9 months before prosthesis

removal and arthrodesis (joint fusion). In a later report in 1971,

Young (Ref. 120) stratified results by indication: At least 3 of 19

osteoarthritic knees were failures (15.8 percent incidence); at least

17 of 45 rheumatoid knees failed (37.8 percent incidence); of 4

replacements for giant-cell tumor, 2 failed (50 percent incidence); and

at least 6 of 10 traumatic arthritic knees failed (60 percent

incidence).

Young noted that nine knees examined sometime after initial

implantation demonstrated darkening in tissue adjacent to metallic

components. Young believed that the darkening of tissue was caused by

tissue contamination from corrosion products. Young also believed that

similar tissue darkening was noted by Girzadas et al. (Ref. 117). Young

believed that the darkening was caused by the bolts used in his design

that were made from a cobalt-based alloy, whereas the other components

were made from a casting alloy. Young stated that, as a result of his

survey of the clinical results for 85 physicians who had implanted the

Young-design prosthesis, he was not optimistic about use of the hinged

metal/metal knee prostheses and their future for replacement

arthroplasty.

In 1973, Hanslik (Ref. 121) reported results of using the device in

50 patients (two bilaterally implanted), principally for the indication

of stereoarthrosis. Minimum followup was not given, while maximum

followup was possibly 4 years. The patients ranged in age from 56 to 76

years. At least four failures (8 percent) were associated with

restricted gliding of the patellofemoral articulation: One of these was

attributed to polymethylmethacrylate-induced bony necrosis. Hanslik

used the Young (Ref. 116) design of prosthesis and had made major

modifications in implantation technique as recommended by Friedebold

and Radloff (Refs. 115, 118, and 120). Hanslik performed partial

resection of the patella rather than total excision and used a

polymethylmethacrylate luting agent to grout the medullary stems

(presumably in addition to the cancellous bone screws recommended by

Young). Friedebold and Radloff (Ref. 119) reported on use of the

prosthesis in femorotibial replacement in 11 patients ranging in age

from 50 to 80 years, with between 6 months and 5 years of followup.

There were three failures (27.3 percent).

(3) Risks to health.

Loss or reduction of joint function--Improper design or

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear, may result in a loss or reduction of

joint function due to excessive wear, fracture, deformation of the

device, or loosening of the device in the surgical cavity.

Adverse tissue reactions--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to dissolution or wearing away from the surface of

the device and the release of materials from the device to the

surrounding tissues and systemic circulation. -

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

Knee Joint Femoral (Hemi-Knee) Metallic Uncemented Prosthesis

(Sec. 888.3570)

(1) Identification. A knee joint femoral (hemi-knee) metallic

uncemented prosthesis is a device made of alloys, such as cobalt-

chromium-molybdenum, intended to be implanted to replace part of a knee

joint. The device limits translation and rotation in one or more planes

via the geometry of its articulating surfaces. It has no linkage

across-the-joint. This generic type of device includes prostheses that

consist of a femoral component with or without protuberance(s) for the

enhancement of fixation and is limited to those prostheses intended for

use without bone cement (Sec. 888.3027).

(2) Summary of data. FDA was concerned about both the severity of

the clinical complications resulting from use of the device and the

rate at which these complications occur. The agency

[[Page 46732]]

used the complication classification scheme developed by Fox (Ref. 122)

and grouped complications by time periods following surgical

implantation; immediate postoperative complications, within 2 weeks;

short term, within 24 months; and long term, more than 24 months. Platt

and Pepler reported in 1969 their clinical results on 55 patients who

had this prosthesis implanted with up to 10 years followup (Ref. 123).

Their reported incidence of complications ranged from: General--none

reported; systemic--none reported; and remote--1 late (2 years

postoperatively) paranoid schizophrenia (1.8 percent); and (4) local--

at least 45 percent. The most frequent complication was immediate

postoperative infection with a presumed incidence of 25.5 percent. The

reoperation rate for this series of patients was reported as 20 out of

62 knees or 32.4 percent; assuming only 1 reoperation per patient, a

36.4 percent revision rate will result.

Aufranc and Jones et al. (Refs. 124 and 125) made extensive

modifications to M. Smith-Peterson's original ``keeled'' femoral

condylar mold (Ref. 126) and commenced a series of device implantations

employing a noncemented stemmed implant in 1952. Clinical results on 64

patients with a minimum of 1-year followup showed that the incidence of

complications were: Zero for general and remote categories; 3.1 percent

for systemic (2 thrombophlebitic episodes); and a minimum of 25 percent

for cumulated local complications. Matching Platt and Pepler's

experience (Ref. 124), the most frequent complication observed was

immediate postoperative infection with a presumed incidence of 20.3

percent. This series of patients, as of mid-1969, displayed a

reoperation rate of 14 out of 79 knees (17.7 percent), assuming only 1

reoperation per patient. Considering this result, with their report of

16 clinical results rated at less than ``fair,'' the failure rate is

calculated as 38 percent with an average followup time of 87 months.

Aufranc and Jones (Ref. 124) noted that 6 of their initial 14

implantations were failures (42.9 percent) with a maximum followup of 5

years; apparently 10 more years of surgical experience reduced the

overall failure rate by 5 percent, without altering the principal

reported failure modes: Infection and ``poor'' clinical result.

Further review of available literature (Refs. 108 and 127 through

136), failed to disclose device experience that would significantly

alter the trends described above.

(3) Risks to health.

Loss or reduction of joint or limb function--Improper

design or inadequate mechanical properties of the device, such as its

lack of strength and resistance to wear, may result in the loss or

reduction of joint function due to excessive wear, fracture,

deformation of the device, or loosening of the device in the surgical

cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to dissolution of wearing away from the surfaces of

the device and the release of materials from the device to the

surrounding tissues and the systemic circulation. -

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

Death--Death may result from lipoembolic sequelae or

thromboembolic complications during or immediately following

implantation.

Knee Joint Patellar (Hemi-Knee) Metallic Resurfacing Uncemented

Prosthesis (Sec. 888.3580)

(1) Identification. A knee joint patellar (hemi-knee) metallic

resurfacing uncemented prosthesis is a device made of alloys, such as

cobalt-chromium-molybdenum, intended to be implanted to replace the

retropatellar articular surface of the patellofemoral joint. The device

limits minimally (less than normal anatomic constraints) translation in

one or more planes. It has no linkage across-the-joint. This generic

type of device includes prostheses that have a retropatellar

resurfacing component and an orthopedic screw to transfix the patellar

remnant. This generic type of device is limited to those prostheses

intended for use without bone cement (Sec. 888.3027). This device is in

class III when intended for uses other than treatment of degenerative

and posttraumatic patellar arthritis; when intended for those uses, it

is in class II.

(2) Summary of data. FDA was not aware of any valid scientific

evidence supporting the safety and effectiveness of this device when

intended for uses other than the treatment of degenerative and

posttraumatic patellar arthritis.

3. Risks to health.

Loss or reduction of joint function--Improper design or

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear, may result in a loss or reduction of

joint function due to excessive wear, fracture, deformation of the

device, or loosening of the device in the surgical cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to dissolution or wearing away from the surfaces of

the device and the release of materials from the device to the

surrounding tissues and systemic circulation. -

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

Shoulder Joint Metal/Metal or Metal/Polymer Constrained Cemented

Prosthesis (Sec. 888.3640)

(1) Identification. A shoulder joint metal/metal or metal/polymer

constrained cemented prosthesis is a device intended to be implanted to

replace a shoulder joint. The device prevents dislocation in more than

one anatomic plane and has components that are linked together. This

generic type of device includes prostheses that have a humeral

component made of alloys, such as cobalt-chromium-molybdenum, and a

glenoid component made of this alloy or a combination of this alloy and

ultra-high molecular weight polyethylene. This generic type of device

is limited to those prostheses intended for use with bone cement

(Sec. 888.3027).

(2) Summary of data. The Panel based its recommendation on the

Panel members' personal knowledge of the device and on their knowledge

of the medical literature (Refs. 136 through 139). Two of these

references (Refs. 136 and 137) described a shoulder joint constrained

prosthesis (Fenlin and Zippel designs) and report that implantation of

the device relieved pain in 16 of 17 patients. In the patient with the

painful prosthesis, the authors believed that the device had loosen.

The times of implantation were not reported.

Fenlin (Ref. 138) reported that the Fenlin design prosthesis had

been implanted in five patients. The results in three of these patients

were discussed. One patient was described as being free of pain, and

able to use the operated shoulder for all normal activities, except

those requiring elevation of the arm above 80 deg.. The length of

followup in this patient was 20 months. Complications were reported in

the other two patients. In one patient, the device had loosened at 3

months postoperatively, due to abnormal anatomy of the glenoid. The

second patient suffered partial nerve palsy due to damage of the

axillary nerve during surgery. Linscheid and Cofield (Ref. 139)

reported on the implantation of 13 constrained shoulder joint

prostheses (6

[[Page 46733]]

of the Stanmore design, and 7 of the Bickel design). The average time

of followup was reported as 13 months and ranged from 2 to 26 months.

There were two cases of dislocations of the Stanmore design prosthesis

and one case of dislocation of the Bickel design prosthesis. There were

two additional complications reported with the Bickel design device;

one case of fracture of the humeral component and one case of loosening

of the glenoid component.

FDA sought additional information on the safety and effectiveness

of these devices. Cofield (Ref. 140) reported that prosthetic

replacement of the shoulder joint was in 1971, an experimental,

investigational procedure. This author noted that basic knowledge about

shoulder biomechanics was limited and that current knowledge of

shoulder prostheses was not sufficient to establish the requirements of

a prosthetic replacement. Buechel et al. (Ref. 141) noted that

complications with current shoulder prostheses have been associated

with the designs of the devices: (1) The Bickel design shoulder joint

prosthesis was reported to dislocate and loosen due to the limited

motion of the prosthesis; and (2) the prosthesis design used by Lettin

and Scales (presumably the Stanmore design shoulder prosthesis) was

reported to significantly limit joint motion, then sublux, and

eventually dislocate at the extremes of normal joint motion. Clinical

results with several prosthesis designs were reported by Cofield (Ref.

140, 142, and 143). Eleven persons in whom Bickel design prostheses had

been implanted were evaluated 18 months to 39 months postoperatively

(Ref. 142). Three (27 percent) were experiencing significant pain. The

components of the Bickel device had dislocated in two cases. The

glenoid component had dislodged from the scapula in two cases and

loosened in one. The humeral component had fractured in two other

cases. Reoperation was required in four patients and was needed in two

or three others. Cofield reported that further clinical and mechanical

deterioration in these patients was anticipated due to progressive

loosening of the glenoid components and fatigue fracture of the neck of

the humeral component, which was not believed to be strong enough.

These authors concluded that this type of shoulder joint replacement

(i.e., the Bickel design) is not justified. Cofield (Refs. 140 and 143)

also reported clinical results in nine patients who had received

Stanmore prostheses. After an average postoperative time of 1 year

(ranging between 4 and 18 months), six patients had satisfactory relief

of pain and three had significant pain. The glenoid component had

loosened in two patients. FDA concurred with the Panel that the

reported clinical experience with these devices did not establish their

long-term safety and effectiveness.

(3) Risks to health.

Loss or reduction of joint function--Improper design or

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear may result in a loss or reduction of

joint function due to excessive wear, fracture, deformation of the

device, or loosening of the device in the surgical cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to dissolution or wearing away from the surfaces of

the device and the release of materials from the device to the

surrounding tissues and systemic circulation. - -

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

Shoulder Joint Glenoid (Hemi-Shoulder) Metallic Cemented

(Sec. 888.3680) Prosthesis

(1) Identification. A shoulder joint glenoid (hemi-shoulder)

metallic cemented prosthesis is a device that has a glenoid (socket)

component made of alloys, such as cobalt-chromium-molybdenum, or alloys

with ultra-high molecular weight polyethylene and intended to be

implanted to replace part of a shoulder joint. This generic type of

device is limited to those prostheses intended for use with bone cement

(Sec. 888.3027).

(2) Summary of the data. The Panel based its recommendation on the

Panel members' personal knowledge of, and clinical experience with, the

device.

(3) Risks to health.

Loss or reduction of joint function--Improper design or

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear, may result in a loss or reduction of

joint function due to excessive wear, fracture, deformation of the

device, or loosening of the device in the surgical cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to dissolution or wearing away from the surfaces of

the device and the release of materials from the device to the

surrounding tissues and systemic circulation. -

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

Wrist Joint Metal Constrained Cemented Prosthesis (Sec. 888.3790)

(1) Identification. A wrist joint metal constrained cemented

prosthesis is a device intended to be implanted to replace a wrist

joint. The device prevents dislocation in more than one anatomic plane

and consists of either a single flexible across-the-joint component or

two components linked together. This generic type of device is limited

to a device which is made of alloys, such as cobalt-chromium-

molybdenum, and is limited to those prostheses intended for use with

bone cement (Sec. 888.3027).

(2) Summary of data. The Panel based its recommendation on the

Panel members' personal knowledge of the device and on the available

medical literature. Gschwend et al. (Ref. 144) used this prosthesis in

15 cases from 1971 through 1975. Fixation was reported to be inadequate

and not correlated to loads imposed on the wrist joint. In three cases

(20 percent), the distal stem became loose. The stem fractured in two

cases (13 percent). On one occasion (6.6 percent) the metacarpal bone

broke. In another case, as a result of a disturbance of muscle balance,

the investigators observed a fixed ulnar deviation of the wrist joint

with a tendency toward radial penetration of the medullary canal of the

third metacarpal bone. The investigators also described three cases (20

percent) of a sinking of the prosthesis into the capitate through the

third metacarpal.

(3) Risks to health.

Loss or reduction of joint function--Improper design or

inadequate mechanical properties of the device, such as its lack of

strength and resistance to wear, may result in a loss or reduction of

joint function due to excessive wear, fracture, deformation of the

device, or loosening of the device in the surgical cavity.

Adverse tissue reaction--Inadequate biological or

mechanical properties of the device, such as its lack of

biocompatibility and resistance to wear, may result in an adverse

tissue reaction due to dissolution or wearing away from the surfaces of

the device and release of materials from the device to the surrounding

tissues and systemic circulation.

Infection--The presence of the prosthesis within the body

may lead to an increased risk of infection.

[[Page 46734]]

10. Physical Medicine Devices

Rigid Pneumatic Structure Orthosis (Sec. 890.3610)

(1) Identification. A rigid pneumatic structure orthosis is a

device intended for medical purposes to provide whole body support by

means of a pressurized suit to help thoracic paraplegics walk.

(2) Summary of data. The Panel based its recommendation on the

literature concerning the device (Refs. 145 and 146). The literature

evaluation did not demonstrate that the device was safe or effective

(Ref. 146). The rigid pneumatic structure orthosis was also evaluated

as requested by the Veterans' Administration and the Rehabilitation

Services Administration, Department of Health, Education, and Welfare

(Ref. 146), and did not meet adequate performance standards for safety

and effectiveness.

(3) Risks to health.

Bodily injury--The device could collapse and the patient

could fall, resulting in bodily injury, if inflation is lost or the

zippers fail.

Tissue trauma and/or pressure sores--Tissue trauma and/or

pressure sores could result if the support beams overinflate and cause

excessive pressure on the skin of the patient.

II. PMA Requirements

A PMA for these devices must include the information required by

section 515(c)(1) of the act. Such a PMA should also include a detailed

discussion of the risks identified above, as well as a discussion of

the effectiveness of the device for which premarket approval is sought.

In addition, a PMA must include all data and information on: (1) Any

risks known, or that should be reasonably known, to the applicant that

have not been identified in this document; (2) the effectiveness of the

device that is the subject of the application; and (3) full reports of

all preclinical and clinical information from investigations on the

safety and effectiveness of the device for which premarket approval is

sought.

A PMA should include valid scientific evidence obtained from well-

controlled clinical studies, with detailed data, in order to provide

reasonable assurance of the safety and effectiveness of the device for

its intended use.

Applicants should submit any PMA in accordance with FDA's

``Premarket Approval (PMA) Manual.'' This manual is available upon

request from FDA, Center for Devices and Radiological Health, Division

of Small Manufacturers Assistance (HFZ-220), 1350 Piccard Dr.,

Rockville, MD 20850.

III. Request for Comments with Data

Interested persons may, on or before January 5, 1996, submit to the

Dockets Management Branch (address above) written comments regarding

this proposal. Two copies of any comments are to be submitted, except

that individuals may submit one copy. Comments are to be identified

with the docket number found in brackets in the heading of this

document. Received comments may be seen in the office above between 9

a.m. and 4 p.m., Monday through Friday.

IV. Opportunity to Request a Change in Classification

Before requiring the filing of a PMA or a notice of completion of a

PDP for a device, FDA is required by section 515(b)(2)(A)(i) through

(b)(2)(A)(iv) of the act and Sec. 860.132 (21 CFR 860.132) to provide

an opportunity for interested persons to request a change in the

classification of the device based on new information relevant to its

classification. Any proceeding to reclassify the device will be under

the authority of section 513(e) of the act.

A request for a change in the classification of these devices is to

be in the form of a reclassification petition containing the

information required by Sec. 860.123 (21 CFR 860.123), including new

information relevant to the classification of the device, and shall,

under section 515(b)(2)(B) of the act, be submitted by September 22,

1995.

The agency advises that, to ensure timely filing of any such

petition, any request should be submitted to the Dockets Management

Branch (address above) and not to the address provided in

Sec. 860.123(b)(1). If a timely request for a change in the

classification of these devices is submitted, the agency will, by

November 6, 1995, after consultation with the appropriate FDA advisory

committee and by an order published in the Federal Register, either

deny the request or give notice of its intent to initiate a change in

the classification of the device in accordance with section 513(e) of

the act and Sec. 860.130 (21 CFR 860.130) of the regulations.

V. Environmental Impact

The agency has determined under 21 CFR 25.24(a)(8) that this action

is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

VI. Analysis of Impacts

FDA has examined the impacts of the proposed rule under Executive

Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).

Executive Order 12866 directs agencies to assess all costs and benefits

of available regulatory alternatives and, when regulation is necessary,

to select regulatory approaches that maximize net benefits (including

potential economic, environmental, public health and safety, and other

advantages; distributive impacts; and equity). The agency believes that

this proposed rule is consistent with the regulatory philosophy and

principles identified in the Executive Order. In addition, the proposed

rule is not a significant regulatory action as defined by the Executive

Order and so is not subject to review under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. Because FDA believes that there is little or no

interest in marketing these devices, the agency certifies that the

proposed rule will not have a significant economic impact on a

substantial number of small entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is required.

VII. References

The following information has been placed on display in the Dockets

Management Branch (address above) and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday through Friday.

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3. Cairns, J. W. et al., ``Evaluation of the Homolog

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30:997-1004, 1977.

4. Egan, J. J. et al., ``Evaluation of an Automated Differential

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5. Christoper, E. A. et al., ``Automated Detection of Abnormal

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6. ``An Evaluation of Electroanesthesia and Electrosleep,''

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7. Stephenson, H. E., ``Cardiac Arrest and Resuscitation,'' C.

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8. Levy, M. N. et al., ``Factorial Analysis of the

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9. Schwartz, S. I. et al., ``Chronic Carotid Sinus Nerve

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12. Tacker, W. A., Jr., L. A. Geddes, and J. P. Rosborough,

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Trapezoidal Current Waveforms,'' Journal of Electrocardiology,

8(3):237-240, 1975.

13. Gold, J. H. et al., ``Transthoracic Ventricular

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14. Anderson, G. J., and J. Suelzer, ``The Efficacy of

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15. Ewy, G. A., D. Taren, and P. W. Kohnen, ``Comparison of

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16. Tacker, W. A., Jr. et al., ``The Effect of Tilt on the

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Defibrillation: Role of Paddle Electrode Size: II,'' American Heart

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18. Thomas, E. D. et al., ``Effectiveness of Direct Current

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19. Dahl, C. F. et al., ``Myocardial Necrosis from Direct

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Between Discharges,'' Circulation, 50:956-961, 1974.

20. Connell, P. N. et al., ``Transthoracic Impedance to

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317, 1973.

21. Geddes, L. A. et al., ``The Thoracic Windows for Electrical

Ventricular Defibrillation Current,'' American Heart Journal,

94(1):67-72, 1977.

22. Report of the Intersociety Commission on Heart Disease

Resources, ``Electronic Equipment in Critical Care Areas Part I:

Status of Devices Currently in Use,'' Circulation, 43:5-26, 1971.

23. Report of the Intersociety Commission on Heart Disease

Resources, ``Electronic Equipment in Critical Care Areas Part III:

Selection and Maintenance Program,'' Circulation, 44:A247-A261,

1971.

24. Report of the American Heart Association Target Activity

Group: Cardiopulmonary Resuscitation in the Young, ``Guidelines for

Defibrillation in Infants and Children,'' Circulation, 56(3):502-

503A, 1977.

25. Standard for Cardiac Defibrillator Devices, Sixth Draft,

Utah Biomedical Test Laboratories, FDA Contract-MDS-021-0001, May

1990.

26. ``Summary Report on Denture Aids and Plaque Disclosants

Transferred to the Bureau of Medical Devices,'' by the OTC Panel on

Dentifrices and Dental Care Agents, March 11-12, 1978.

27. Blacow, N. W., ``Martindale: The Extra Pharmacopeia,'' The

Pharmaceutical Press, London, pp. 1084-1085, 1972.

28. ``GRAS (generally recognized as safe) Food Ingredients-

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29. Halverstadt, D. B., and W. L. Parry, ``Electronic

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Urology, 13:341-344, 1975.

30. Clement, J. F., and R. G. Pietrusko, ``Pit Viper Snakebite

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1977.

32. Watt, C. H., Jr., ``Poisonous Snakebite Treatment in the

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240(7):654-656, August 1978.

33. Jarzembski, W. B., ``Pathological Implications of

Transcranial Impedance Change,'' (prepublication draft).

34. Jarzembski, W. B., ``Evaluation of Specific Cerebral

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Academy of Sciences, 170:476-490, 1970.

35. Geddes, L. A., and H. E. Hoff, ``The Measurement of

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Medical Electronics, 3:16-27, 1964.

36. Hill, R. V. et al., ``Electrical Impedance Plethysmography:

A Critical Analysis,'' Journal of Applied Physiology, 22:161-168,

1967.

37. Nashold, B. S. et al., ``Operative Stimulation of the

Neurogenic Bladder,'' Proceedings of the Symposium on the Safety and

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Neurosurgery, 1:218-220, 1977.

38. Sureau, C., ``The Clinical Use of Computers in Fetal Heart

Rate Monitoring,'' in ``Perinatal Medicine,'' 4th European Congress

of Perinatal Medicine, Prague, August 1974; edited by Stembera, Z.

K., K. Pollacek, V. Sabata, and G. Thieme, Stuttgart, Avicenum,

Prague, 1975:44-48.

39. Peltzman, P., P. J. Goldstein, and R. Battagin, ``Optical

Analysis of the Fetal Electroencephalogram,'' Journal of Obstetrics

and Gynecology, 116(7):957-962, 1973.

40. Rosen, M. G., J. J. Scibetta, and C. J. Hochberg, ``Fetal

Electroencephalograph: IV. The FEEG During Spontaneous and Forceps

Births,'' Obstetrics and Gynecology, 42(2):283-289, 1973.

41. Borgstedt, A. D. et al., ``Fetal Electroencephalography,''

American Journal of Diseased Children, 129:35-38, January 1975.

42. Ng, A. Y. H., ``Use of the Vibro Dilator in Outpatient

Termination of Pregnancy,'' Australia and New Zealand Journal of

Obstetrics and Gynecology, 13:228-230, 1973.

43. Manabe, Y., and A. Nakajima, ``Laminaria Metreurynter Method

of Midterm Abortion in Japan,'' Obstetrics and Gynecology, 40:612-

615, 1972.

44. Manabe, Y. et al., ``Uterine Contractility and Placental

Histology in Abortion by Laminaria and Metreurynter,'' Obstetrics

and Gynecology, 41:753-759, 1973.

45. Benson, R. C., ``Current Obstetric and Gynecologic Diagnosis

and Treatment,'' Lange Medical Publications, Los Altos, CA, pp. 840-

841, 1976.

46. Population Reports, ``Pregnancy Termination,'' Series F,

Nos. 5 and 6, The George Washington University Medical Center,

Washington, DC, 1976-1977.

47. Freeman, M. A. R., ``Current State of Joint Replacement,''

British Medical Journal, (6047):1301-1304, 1976.

48. Newton, S. E., ``Total Ankle Arthroplasty,'' Journal of Bone

and Joint Surgery, 64:104-111, 1982.

49. Stevens, P. S., ``Distal Humeral Prosthesis for the Elbow,''

in ``Joint Replacement in the Upper Limb: Institution of Mechanical

Engineers Conference Publications 1977-1985,'' Mechanical

Engineering Publications, Ltd., Great Britain, pp. 69-76, 1977.

50. Street, D. M., T. Stevens, and P. S. Stevens, ``A Humeral

Replacement Prosthesis for the Elbow,'' The Journal of Bone and

Joint Surgery, 56A:1147-1158, 1974.

51. Flatt, A. E., ``Restoration of Rheumatoid Finger-Joint

Function,'' Journal of Bone and Joint Surgery, 43A:753-774, 1961.

52. Flatt, A. E., ``Restoration of Rheumatoid Finger-Joint

Function, II,'' Journal of Bone and Joint Surgery, 45A:1101-1103,

1963.

53. Flatt, A. E., ``Prosthetic Substitution for Rheumatoid

Finger Joints,'' Plastic and Reconstructive Surgery, 40:565-570,

1967.

54. Flatt, A. E., and G. W. Fischer, ``Biomechanical Factors in

the Replacement of Rheumatoid Finger Joints,'' Annals of Rheumatic

Diseases, 28:36-41, 1969.

55. Flatt, A. E., and M. R. Ellison, ``Restoration of Rheumatoid

Finger-Joint Function, III,'' Journal of Bone and Joint Surgery,

54:1317-1333, 1972.

56. Flatt, A. E., ``Studies in Finger Joint Replacement: A

Review of the Present Position,'' Archives of Surgery, 107:437-443,

1973.

57. Girzados, D. V., and M. L. Clayton, ``Limitations of the Use

of Metallic Prosthesis in the Rheumatoid Hand,'' Clinical

Orthopedics and Related Research, 67:127-132, 1969.

58. Calenoff, L., and W. B. Stromberg, ``Silicone Rubber

Arthroplasties of the Hand,'' Radiology, 107:29-34, 1973.

59. Millender, L. H., and E. A. Nalebuff, ``Metacarpophalangeal

Joint Arthroplasty Utilizing the Silicone Rubber Prosthesis,''

Orthopedic Clinics of North America, 4(2):349-371, 1973.

60. McFarland, G. B., Jr., ``Early Experience with the Silicone

Rubber Prosthesis (Swanson) in the Reconstruction Surgery of the

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61. Walker, P. S., and L. R. Straub, ``Development and

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[[Page 46736]]

Mechanical Finger Prosthesis,'' in ``Joint Replacement in the Upper

Limb: Institution of Mechanical Engineers Conference Publications,

1977-1985,'' Mechanical Engineering Publications Ltd., Great

Britain, pp. 168-173, 1977.

62. Goldner, J. L., and J. R. Urbaniak, ``The Clinical

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Research, 4:137-163, 1973.

63. Smith, R. J., and A. S. Broudy, ``Advances in Surgery of the

Rheumatoid Hand,'' Current Practices in Orthopedic Surgery, 7:1-35,

1977.

64. Devas, M., and V. Shah, ``Link Arthroplasty of the

Metacarpophalangeal Joints,'' Journal of Bone and Joint Surgery,

57:72-77, 1975.

65. Devas, M., and V. Shah, ``Arthroplasty of the Upper Limb.

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1977-1985,'' Mechanical Engineering Publications, Ltd., Great

Britain, pp. 154-161, 1977.

66. Hirsch, D. et al., ``A Biomechanical Analysis of the

Metacarpophalangeal Joint of the Thumb,'' Journal of Biomechanics,

7:343-348, 1973.

67. Page, D., J. H. Dumbleton, and E. H. Miller, ``A Study of

the Wear Resistance of a Prosthesis for the Metacarpophalangeal

Joint of the Thumb,'' Clinical Orthopedics and Related Research,

100:301-308, 1974.

68. Walker, P. S. et al., ``Development and Evaluation of a

Mechanical Finger Prosthesis,'' in ``Joint Replacement in the Upper

Limb: Institution of Mechanical Engineers Conference Publications,

Ltd.,'' Great Britain, pp. 127-132, 1977.

69. Walker P. S., and M. J. Erkman, ``Laboratory Evaluation of a

Metal-Plastic Type of Metacarpophalangeal Joint Prosthesis,''

Clinical Orthopedics and Related Research, 112:349-356, 1975.

70. Walker, P. S., ``Human Joints and their Artificial

Replacements,'' C. C. Thomas, Publisher, Springfield, IL, pp. 270-

272, 337-351, 1977.

71. Nicolle, F., ``Modified Design of Encapsulated

Metacarpophalangeal Joint Prosthesis for the Rheumatoid Hand,'' in

``Joint Replacement in the Upper Limb: Institution of Mechanical

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135, 1977.

72. Nicolle, F. V., and J. S. Calnan, ``A New Design of Finger

Joint Prosthesis for the Rheumatoid Hand,'' The Hand, 4(2):135-146,

1972.

73. Griffiths, R. W., and F. V. Nicolle, ``Three Years'

Experience of Metacarpophalangeal Joint Replacement in the

Rheumatoid Hand,'' The Hand, 7(3):275-283, 1975.

74. Burton, D. S., and D. J. Schurman, ``Hematogenous Infection

in Bilateral Total Hip Arthroplasty,'' Journal of Bone and Joint

Surgery, 57A:1004-1005, 1975.

75. Beckenbaugh, R. D. et al., ``Review and Analysis of

Silicone-Rubber Metacarpophalangeal Implants,'' Journal of Bone and

Joint Surgery, 58A:483-487, 1976.

76. Goldner, J. L. et al., ``Metacarpophalangeal Joint

Arthroplasty with Silicone-Dacron Prostheses (Niebauer type): Six

and a Half Years' Experience,'' Journal of Hand Surgery, 2:200-211,

1977.

77. Goldner, J. L., and J. R. Urbaniak, ``The Clinical

Experience with Silicone-Dacron Metacarpophalangeal and

Interphalangeal Joint Prostheses,'' Journal of Biomedical Materials,

4:137-163, 1973.

78. Hagert, C. G., ``Metacarpophalangeal Joint Implants II:

Roentgenographic Study of the Niebauer-Cutter Metacarpophalangeal

Joint Prosthesis,'' Scandinavian Journal of Plastic and

Reconstructive Surgery, 9:158-164, 1975.

79. Niebauer, J. J., and R. M. Landry, ``Dacron-Silicone

Prosthesis for the Metacarpophalangeal and Interphalangeal Joints,''

The Hand, 3:55-61, 1971.

80. Swanson, B., ``Flexible Implant Arthroplasty for Arthritic

Finger Joints: Rationale, Technique and Results of Treatment,''

Journal of Bone and Joint Surgery, 54A:435-455, 1972.

81. Swanson, A. B., ``Flexible Implant Arthroplasty in the

Hand,'' Clinical and Plastic Surgery, 3:141-157, 1976.

82. Hagert, C. G. et al., ``Metacarpophalangeal Joint

Implants,'' Scandinavian Journal of Plastic and Reconstructive

Surgery, 19:147-157, 1975.

83. Mannerfelt, L., and K. Anderson, ``Silastic Arthroplasty of

the Metacarpophalangeal Joints in Rheumatoid Arthritis,'' Journal of

Bone and Joint Surgery, 57A:484-489, 1975.

84. Ferlic, D. C., M. L. Clayton, and M. Holloway,

``Complications of Silicone Implant Surgery in the

Metacarpophalangeal Joint,''Journal of Bone and Joint Surgery,

57A:991-994, 1975.

85. Aptekar, R. G., J. M. Davie, and H. S. Cattell, ``Foreign

Body Reaction to Silicone Rubber, Complication of a Finger Joint

Implant,'' Clinical Orthopaedics and Related Research, 231-232.

86. Hagert, C. G., ``Metacarpophalangeal Joint Implants,''

Scandinavian Journal of Plastic and Reconstructive Surgery, 9:216-

226, 1975.

87. Weightman, S. S. et al., ``Environmental Fatigue Testing of

Silastic Joint Prostheses,'' Journal of Biomedical Materials

Research, Symposium, 3:15-24, 1972.

88. Swanson, A. B., and J. H. Herndon, ``Flexible (Silicone)

Implant Arthroplasty of the Metacarpophalangeal Joint of the

Thumb,'' Journal of Bone and Joint Surgery, 59A:362-368, 1977.

89. Swanson, A. B., ``Implant Resection Arthroplasty of the

Proximal Interphalangeal Joint,'' Orthopedic Clinics of North

America, 4(4):1007-1209, 1973.

90. Braun, R. M., and J. Chandler, ``Quantitative Results

Following Implant Arthroplasty of the Proximal Finger Joints in the

Arthritic Hand,'' Clinical Orthopaedics and Related Research,

83:135-143, 1972.

91. Sivash, K. M., ``The Development of a Total Metal Prosthesis

for the Hip Joint from a Partial Joint Replacement,'' Reconstructive

Surgery and Traumatology, 11:53-62, 1969.

92. McKellop, H. A. et al., ``Wear Properties of Sialon Ceramics

and Delrin 150 Homopolymer Under Physiological Conditions,''

Transaction of the 4th Annual Meeting of the Society for

Biomaterials, April 29-May 2, 1978.

93. Dumbleton, J. H., ``Delrin as a Material for Joint

Prostheses--A Review,'' ``Corrosion and Degradation of Implant

Material, ASTM STP684,'' American Society for Testing Materials, pp.

41-60, 1978.

94. Insall, J. N. et al., ``A Comparison of 4 Models of Total

Knee Replacement Prostheses,'' Journal of Bone and Joint Surgery,

58A:754-765, September 1976.

95. Deburge, A., ``GUEPAR Hinge Prosthesis,'' Clinical

Orthopedics, 120:47-53, October 1976.

96. Engelbrecht, E. et al., ``Statistics of Total Knee

Replacement: Partial and Total Knee Replacement,'' Clinical

Orthopedics, 120:54-64, October 1976.

97. Freeman, P. A., ``Walldius Arthroplasty,'' Clinical

Orthopedics, 94:85-91, July-August 1973.

98. Phillips, H., and J. G. Taylor, ``The Walldius Hinge

Arthroplasty,'' Journal of Bone and Joint Surgery, 57B:51-62, 1975.

99. Habermann, E. T., S. D. Deutsch, and G. D. Rovere, ``Knee

Arthroplasty with the Use of the Walldius Total Knee Prosthesis,''

Clinical Orthopedics, 94:72-84, July-August 1973.

100. Wilson, F. C., and G. L. Venters, ``Results of Knee

Replacement with the Walldius Prosthesis,'' Clinical Orthopedics,

20:39-46, October 1976.

101. Blundell-Jones, G., ``Total Knee Replacement--The Walldius

Hinge,'' Clinical Orthopedics, 94:50:57, July-August 1973.

102. Bain, A. M., ``Replacement of the Knee Joint with the

Walldius Prosthesis Using Cement Fixation,'' Clinical Orthopedics,

94:65-71, July-August 1973.

103. Brady, T. A., and J. N. Garber, ``Knee Joint Replacement

Using Shiers Knee Hinge,'' Journal of Bone and Joint Surgery,

56A:1610-1614, December 1974.

104. Watson, J. R., H. Wood, and R. C. J. Hill, ``The Shiers

Arthroplasty of the Knee,'' Journal of Bone and Joint Surgery,

58B:300-304, August 1976.

105. Kettlekamp, D. B., ``Total Joint Replacement,''

``Proceedings of the Workshop: Mechanical Failure of Total Joint

Replacement, Atlanta, June 1978,'' The Sterring Committee, American

Academy of Orthopaedic Surgeons, Chicago, 1978.

106. Chand, K., ``The Knee Joint in Rheumatoid Arthritis III.

Treatment by Hinged Total Knee Prosthetic Replacement,''

International Surgery, 59:600-607, November-December 1974.

107. Deburge, A., J. H. Aubriot, and J. P. Genet, ``Current

Status of a Hinge Prosthesis (GUEPAR),'' Clinical Orthopedics and

Related Research, 145:91-93, November-December 1979.

108. Arden, G. P., and B. A. Kamdar, ``Complications of

Arthroplasty of the Knee,'' in ``Total Knee Replacement,'' chaired

by L. G. P. Shiers, Mechanical Engineering Publications, Ltd.,

London, pp. 118-122, 1975.

109. Kaushal, S. P. et al., ``Complications Following Total Knee

Replacements,'' Clinical Orthopedics and Related Research, 121:181-

187, November-December 1976.

110. Van Camp, D. H., H. W. Croon, and J. Lindwer, ``Influence

of Cyclic Loading on

[[Page 46737]]

Mechanical Loosening of Hinged Knee Prostheses,'' Engineering in

Medicine, 4:235-239, 1978.

111. Walker, P. S., ``Human Joints and Their Artificial

Replacements,'' Charles C. Thomas, publisher, Springfield, IL, p.

321, 1977.

112. Wagner, J., and R. Bourgois, ``Biomedical Study of the

Hinged Knee Prosthesis,'' Clinical Orthopedics and Related Research,

102:188-193, July-August 1974.

113. Swanson, S. A. V., M. A. R. Freeman, and J. C. Health,

``Laboratory Tests on Total Joint Replacement Prostheses,'' Journal

of Bone and Joint Surgery, 55B:759-773, November 1973.

114. Brodersen, M. P. et al., ``Arthrodesis of the Knee

Following Failed Total Knee Arthroplasty,'' Journal of Bone and

Joint Surgery, 61A:181-185, March 1979.

115. Hanslik, L., ``Das patellofemorale Gleitlagerbeim total

kniegelenkersatz. Vorlaeufige Mitteilung ueber die implantation

einer modifizierten McKeever-Endoprothese in Kombination mit der

Alloarthroplastik nach Young,'' Zeitschrift fuer Orthopaedic and

Ihre Gremzgebicte, 109:435-440, 1971.

116. Young, H. H., ``Use of Hinged Vitallium Prosthesis for

Arthroplasty of the Knee. A Preliminary Report,'' Journal of Bone

and Joint Surgery, 45A:1627-1641, 1963.

117. Girzadas, D. V. et al., ``Performance of a Hinged Metal

Knee Prosthesis: A Case Report With a Followup of 3.5 years and

Histological and Metallurgical Data,'' Journal of Bone and Joint

Surgery, 50A:355-364, 1968.

118. Friedebold, G., ``First Experiences With the Young Knee in

Synovectomy and Arthroplasty in Rheumatoid Arthritis,'' edited by

Chapchal, G., G. Thieme, Verlag, Stuttgart, pp. 85-86, 1967.

119. Friedebold, G., and H. Radloff, ``Alloarthroplasties of the

Knee Joint. Indications and Results,'' Reconstructive Surgery and

Traumatology, 12:181-196, 1971.

120. Young, H. H., ``Reconstruction of Knee Joint With Young-

Type Hinged Vitallium Prosthesis,'' Reconstructive Surgery and

Traumatology, 12:176-180, 1971.

121. Hanslik, L., ``First Experience on Knee Joint Replacement

Using the Young Hinged Prosthesis Combined with a Modification on

the McKeever Patella Prosthesis,'' Clinical Orthopedics, 94:115-121,

1973.

122. Fox, K. W., ``Geometric Total Knee Arthroplasty: Local

Complications,'' Texas Medicine, 72:92-97, 1976.

123. Platt, G., and C. Pepler, ``Mould Arthroplasty of the Knee.

A Ten-Year Followup Study,'' Journal of Bone and Joint Surgery,

51B:76-87, 1969.

124. Aufranc, O. E., and W. N. Jones, ``Mold Arthroplasty of the

Knee,'' Journal of Bone and Joint Surgery, 40A:1431, 1958.

125. Jones, W. N., ``Mold Arthroplasty of the Knee Joint,''

Clinical Orthopedics, 66:82-89, 1969.

126. Riley, L. H., Jr., ``The Evolution of Total Knee

Arthroplasty,'' Clinical Orthopedics, 120:7-10, 1976.

127. Kitridou, R. C. et al., ``Recurrent Hemarthrosis After

Prosthetic Knee Arthroplasty,'' Arthritis and Rheumatism, 12(5):520-

528, 1969.

128. Turner, R. H., and O. E. Aufranc, ``Femoral Stem

Replacement Arthroplasty of the Knee,'' Surgical Clinics of North

America, 49(4):917-927, 1969.

129. Friedebold, G., and H. Radloff, ``Alloarthroplasties of the

Knee Joint. Indications and Results,'' Reconstructive Surgery and

Traumatology, 12:181-196, 1971.

130. Yeoman, P. M., ``Arthroplasty of the Knee: A Comparative

Study of Platt's Mold and McKee Arthroplasties,'' Journal of Bone

and Joint Surgery, 53B(1):150, 1971.

131. Turner, R. A. et al., ``Arthroplasty of the Knee With

Tibial and/or Femoral Metallic Implants in Rheumatoid Arthritis,''

Arthritis and Rheumatism, 15:1-15, 1972.

132. Groeneveld, H. B., ``Combined Femorotibial-Patellar

Endoprosthesis of the Knee Joint Preserving the Ligaments,'' Acta

Orthopaedica Belgica, 39:210-215, 1973.

133. Kettelkamp, D. B., ``Functional Analysis of the Knee,'' in

``Workshop on Fundamental Studies for Internal Structural

Prostheses,'' chaired by F. W. Clippinger, Jr., National Academy of

Sciences, Washington, DC pp., 19-23, 1973.

134. Sbarbaro, J. L., Jr., ``Femoral Condylar Mold Arthroplasty

in 150 Rheumatoid Knees,'' Acta Orthopaedica Belgica, 39:138-147,

1973.

135. Wilde, A. H. et al., ``Current Use of Geometric Knee

Replacement Arthroplasty,'' Orthopedic Review, 3(3):25-31, 1974.

136. Romero, R. L., and E. M. Burgess, ``Total Shoulder

Replacement,'' Journal of Bone and Joint Surgery, 57A:1033, 1975.

137. Fenlin, J. M., Jr., ``Total Shoulder Prosthesis,'' Journal

of Bone and Joint Surgery, 58A:735, 1976.

138. Fenlin, J. M., Jr., ``Total Glenohumeral Joint

Replacement,'' Orthopedic Clinics of North America, 6:565-583, 1975.

139. Linscheid, R. L., and R. H. Cofield, ``Total Shoulder

Arthroplasty: Experimental but Promising,'' Geriatrics, 64-69, April

1976.

140. Cofield, R. H., ``Status of Total Shoulder Arthroplasty,''

Archives of Surgery, 12:1088-1091, 1971.

141. Buechel, F. F., M. J. Pappas, and A. F. DePalma,

``'Floating Socket' Total Shoulder Replacement: Anatomical,

Biomechanical and Surgical Rationale,'' Journal of Biomedical

Materials Research, 12:89-144, 1978.

142. Cofield, R. H., and R. N. Stauffer, ``The Bickel

Glenohumeral Arthroplasty,'' in ``Joint Replacement in the Upper

Limb: Institution of Mechanical Engineers, 1977-1985,'' Mechanical

Engineering Publications Ltd., Great Britain, pp. 15-20, 1977.

143. Cofield, R. H., ``Total Shoulder Arthroplasty: The Current

State of Development,'' in ``DHEW/RSA Workshop on Internal Joint

Replacement,'' edited by C. L. Compere and J. L. Lewis, Chicago, pp.

33-37, 1977.

144. Gschwend, N., H. Scheier, and A. Bahler, ``GSB Elbow,

Wrist, MP and PIP Joints,'' in ``Proceedings of Joint Replacement in

the Upper Limb Conference,'' sponsored by the Institute of

Mechanical Engineering, April 18-20, pp. 107-116, 1977.

145. Peizer, E., ``Special Programs: VA Prosthetics Center

Research, Development, and Evaluation Program,'' Bulletin of

Prosthetics Research, 10-22:469-477, Fall 1974.

146. ``Evaluation of the Ortho-Walk Type B Pneumatic Orthosis on

Thirty-Seven Paraplegic Patients,'' Report by the Committee on

Prosthetics Research and Development/Committee on Prosthetic-

Orthotic Education, National Academy of Sciences, Washington, DC,

1976. Supported by the Veterans' Administration and the Social

Rehabilitation Service, Department of Health, Education, and

Welfare.

List of Subjects

21 CFR Part 864

Blood, Medical devices, Packaging and containers.

21 CFR Parts 868, 870, 872, 876, 880, 882, 884, 888, and 890

Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR parts 864, 868, 870, 872, 876, 880, 882, 884, 888,

and 890 be amended as follows:

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

1. The authority citation for 21 CFR part 864 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

2. Section 864.5220 is amended by revising paragraph (c) to read as

follows:

Sec. 864.5220 Automated differential cell counter.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

notice of completion of a PDP is required to be filed with the Food and

Drug Administration on or before (date 90 days after date of

publication of the final rule based on this proposed rule). For any

automated differential cell counter described in paragraph (b)(2) of

this section that was in commercial distribution before May 28, 1976,

or that has, on or before (date 90 days after date of publication of

the final rule based on this proposed rule), been found to be

substantially equivalent to an automated differential cell counter

described in paragraph (b)(2) of this section that was in commercial

distribution before May 28, 1976. Any other automated differential cell

counter described in paragraph (b)(2) of this section shall have an

approved PMA or declared

[[Page 46738]]

completed PDP in effect before being placed in commercial distribution.

PART 868--ANESTHESIOLOGY DEVICES

3. The authority citation for 21 CFR part 868 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

4. Section 868.5400 is amended by revising paragraph (c) to read as

follows:

Sec. 868.5400 Electroanesthesia apparatus.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

notice of completion of a PDP is required to be filed with the Food and

Drug Administration on or before (date 90 days after date of

publication of the final rule based on this proposed rule) for any

electroanesthesia apparatus that was in commercial distribution before

May 28, 1976, or that has, on or before (date 90 days after date of

publication of the final rule), been found to be substantially

equivalent to a electroanesthesia apparatus that was in commercial

distribution before May 28, 1976. Any other electroanesthesia apparatus

shall have an approved PMA or a declared completed PDP in effect before

being placed in commercial distribution.

PART--870 CARDIOVASCULAR DEVICES

5. The authority citation for 21 CFR part 870 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

6. Section 870.1350 is amended by revising paragraph (c) to read as

follows:

Sec. 870.1350 Catheter balloon repair kit.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

notice of completion of a PDP is required to be filed with the Food and

Drug Administration on or before (date 90 days after date of

publication of the final rule). For any catheter balloon repair kit

that was in commercial distribution before May 28, 1976, or that has,

on or before (date 90 days after date of publication of the final

rule), been found to be substantially equivalent to a catheter balloon

repair kit that was in commercial distribution before May 28, 1976. Any

other catheter balloon repair kit shall have an approved PMA or a

declared completed PDP in effect before being placed in commercial

distribution.

7. Section 870.1360 is amended by revising paragraph (c) to read as

follows:

Sec. 870.1360 Trace microsphere.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

notice of completion of a PDP is required to be filed with the Food and

Drug Administration on or before (date 90 days after date of

publication of the final rule). For any trace microsphere that was in

commercial distribution before May 28, 1976, or that has, on or before

(date 90 days after date of publication of the final rule), been found

to be substantially equivalent to a trace microsphere that was in

commercial distribution before May 28, 1976. Any other trace

microsphere shall have an approved PMA or a declared completed PDP in

effect before being placed in commercial distribution.

8. Section 870.3850 is amended by revising paragraph (c) to read as

follows:

Sec. 870.3850 Carotid sinus nerve stimulator.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before (date 90 days after date of

publication of the final rule) for any carotid sinus nerve stimulator

that was in commercial distribution before May 28, 1976, or that has,

on or before (date 90 days after date of publication of the final

rule), been found to be substantially equivalent to a carotid sinus

nerve stimulator that was in commercial distribution before May 28,

1976. Any other carotid sinus nerve stimulator shall have an approved

PMA or a declared completed PDP in effect before being placed in

commercial distribution.

9. Section 870.5300 is amended by revising paragraph (c) to read as

follows:

Sec. 870.5300 DC-defibrillator (including paddles).

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before (date 90 days after date of

publication of the final rule). For any DC-defibrillator (including

paddles) described in paragraph (b)(1) of this section that was in

commercial distribution before May 28, 1976, or that has, on or before

(date 90 days after date of publication of the final rule), been found

to be substantially equivalent to a DC-defibrillator (including

paddles) described in paragraph (b)(1) of this section that was in

commercial distribution before May 28, 1976. Any other DC-defibrillator

(including paddles) described in paragraph (b)(1) of this section shall

have an approved PMA or declared completed PDP in effect before being

placed in commercial distribution.

PART 872--DENTAL DEVICES

10. The authority citation for 21 CFR part 872 continues to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

11. Section 872.3400 is amended by revising paragraph (c) to read

as follows:

Sec. 872.3400 Karaya and sodium borate with or without acacia denture

adhesive.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before (date 90 days after date of

publication of the final rule) for any karaya and sodium borate with or

without acacia denture adhesive that was in commercial distribution

before May 28, 1976, or that has, on or before (date 90 days after date

of publication of the final rule), been found to be substantially

equivalent to a karaya and sodium borate with or without acacia denture

adhesive that was in commercial distribution before May 28, 1976. Any

other karaya and sodium borate with or without acacia denture adhesive

shall have an approved PMA or a declared completed PDP in effect before

being placed in commercial distribution.

12. Section 872.3420 is amended by revising paragraph (c) to read

as follows:

Sec. 872.3420 Carboxymethylcellulose sodium and cationic

polyacrylamide polymer denture adhesive.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before (date 90 days after date of

publication of the final rule) for any carboxymethylcellulose sodium

and cationic polyacrylamide polymer denture adhesive that was in

commercial distribution before May 28, 1976, or that has, on or before

(date 90 days after date of publication of the final rule), been found

to be substantially equivalent to a carboxymethylcellulose sodium and

cationic polyacrylamide polymer denture adhesive that was in

[[Page 46739]]

commercial distribution before May 28, 1976. Any other

carboxymethylcellulose sodium and cationic polyacrylamide polymer

denture adhesive shall have an approved PMA or a declared completed PDP

in effect before being placed in commercial distribution.

13. Section 872.3480 is amended by revising paragraph (c) to read

as follows:

Sec. 872.3480 Polyacrylamide polymer (modified cationic) denture

adhesive.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before (date 90 days after date of

publication of the final rule) for any polyacrylamide polymer (modified

cationic) denture adhesive that was in commercial distribution before

May 28, 1976, or that has, on or before (date 90 days after date of

publication of the final rule), been found to be substantially

equivalent to a polyacrylamide polymer (modified cationic) denture

adhesive that was in commercial distribution before May 28, 1976. Any

other polyacrylamide polymer (modified cationic) denture adhesive shall

have an approved PMA or a declared completed PDP in effect before being

placed in commercial distribution.

14. Section 872.3500 is amended by revising paragraph (c) to read

as follows:

Sec. 872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid

copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before (date 90 days after date of

publication of the final rule) for any polyvinylmethylether maleic

anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium

(NACMC) denture adhesive that was in commercial distribution before May

28, 1976, or that has, on or before (date 90 days after date of

publication of the final rule), been found to be substantially

equivalent to a polyvinylmethylether maleic anhydride (PVM-MA), acid

copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive

that was in commercial distribution before May 28, 1976. Any other

polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and

carboxymethylcellulose sodium (NACMC) denture adhesive shall have an

approved PMA or a declared completed PDP in effect before being placed

in commercial distribution.

15. Section 872.3560 is amended by revising paragraph (c) to read

as follows:

Sec. 872.3560 OTC denture reliner.

* * * * *

(c) Date PMA or notice of completion of a PDP is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and

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