Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0161] (formerly Docket No. 03N-0161)

Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is adding noncompression heart stabilizers to the list of critical reprocessed single-use devices (SUDs) whose exemption from premarket notification requirements has been terminated and for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a premarket notification (510(k)). The agency is also adding laparoscopic and endoscopic electrosurgical accessories to the list of reprocessed SUDs currently subject to premarket notification requirements that will now require submission of supplemental validation data. FDA is requiring submission of these data to ensure that reprocessed single-use noncompression heart stabilizers and laparoscopic and endoscopic electrosurgical accessories are substantially equivalent to predicate devices, in accordance with MDUFMA.

DATES:

These actions are effective September 29, 2005. Manufacturers of reprocessed single-use noncompression heart stabilizers must submit 510(k)s for these devices by December 29, 2006, or their devices may no longer be legally marketed. Manufacturers of reprocessed single-use laparoscopic and endoscopic electrosurgical accessories who already have 510(k) clearance for these devices must submit supplemental validation data for the devices by June 29, 2006, or their devices may no longer be legally marketed.

ADDRESSES:

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to

http://www.fda.gov/dockets/ecomments

. Comments should be identified with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Barbara A. Zimmerman, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8320, ext. 158.

SUPPLEMENTARY INFORMATION:

I. Background

On October 26, 2002, MDUFMA (Public Law 107-250), amended the Federal Food, Drug, and Cosmetic Act (the act) by adding section 510(o) (21 U.S.C. 360(o)), which provided new regulatory requirements for reprocessed SUDs. According to this new provision, in order to ensure that reprocessed SUDs are substantially equivalent to predicate devices, 510(k)s for certain reprocessed SUDs identified by FDA must include validation data. These required validation data include cleaning and sterilization data, and functional performance data demonstrating that each SUD will remain substantially equivalent to its predicate device after the maximum number of times the device is reprocessed as intended by the person submitting the premarket notification.

Before enactment of the new law, a manufacturer of a reprocessed SUD was required to obtain premarket approval or premarket clearance for the device, unless the device was exempt from premarket submission requirements. Under MDUFMA, some previously exempt reprocessed SUDs are no longer exempt from premarket notification requirements. Manufacturers of these identified devices were required to submit 510(k)s that included validation data specified by FDA. Reprocessors of certain SUDs already subject to cleared 510(k)s were also required to submit the validation data specified by the agency.

The reprocessed SUDs subject to these new requirements were listed in the

Federal Register

as required by MDUFMA. In accordance with section 510(o) of the act, FDA shall revise the lists as appropriate. This notice adds two types of reprocessed SUDs to the lists of devices subject to MDUFMA's data submission requirements. Noncompression heart stabilizers are being added to the list of previously exempt reprocessed SUDs that now require the submission of 510(k)s containing validation data. Laparoscopic and endoscopic electrosurgical accessories are being added to the list of reprocessed SUDs, already subject to premarket notification requirements, for which supplemental validation data are required.

A. Definitions

Under section 302(b) of MDUFMA, a reprocessed SUD is defined as an “original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. The subsequent processing and manufacture of a reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition.”

Reprocessed SUDs are divided into three groups: (1) critical, (2) semicritical, and (3) noncritical. The first two categories reflect definitions set forth in MDUFMA, and all three reflect a classification scheme recognized in the industry.

1

These categories of devices are defined as follows:

1

Spaulding, E.H., “The Role of Chemical Disinfection in the Prevention of Nonsocomial Infections,” P.S. Brachman and T.C. Eickof (ed), Proceedings of International Conference on Nonsocomial Infections, 1970, American Hospital Association, Chicago, 254-274, 1971.

(1)

A critical reprocessed SUD

is intended to contact normally sterile tissue or body spaces during use.

(2)

A semicritical reprocessed SUD

is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body.

(3)

A noncritical reprocessed SUD

is intended to make topical contact and not penetrate intact skin.

B. Critical and Semicritical Reprocessed SUDs Previously Exempt From Premarket Notification

MDUFMA required FDA to review the critical and semicritical reprocessed SUDs that were previously exempt from premarket notification requirements and determine which of these devices required premarket notification to ensure their substantial equivalence to predicate devices. By April 26, 2003, FDA was required to identify in a

Federal Register

notice those critical reprocessed SUDs whose exemption from premarket notification would be terminated and for which FDA determined that validation data, as specified under MDUFMA, was necessary in a 510(k). According to the law, manufacturers of the devices whose exemptions from premarket notification were terminated were required to submit 510(k)s that included validation data regarding cleaning, sterilization, and functional performance, in addition to all the other required elements of a 510(k) identified in § 807.87 (21 CFR 807.87), within 15 months of

publication of the notice or no longer market their devices.

In accordance with section 510(o) of the act, FDA must revise the list of devices subject to this requirement as appropriate. On June 26, 2003 (68 FR 38071), FDA recategorized nine device types from semicritical to critical, and added nonelectric gastroenterology-urology biopsy forceps to the list of critical devices whose exemption from premarket notification requirements was being terminated.

By April 26, 2004, FDA was required to identify in a

Federal Register

notice those semicritical reprocessed SUDs whose exemption from premarket notification would be terminated and for which FDA determined that validation data, as specified under MDUFMA, was necessary in a 510(k). As discussed above, manufacturers of the devices whose exemptions from premarket notification were terminated were required to submit 510(k)s that included validation data regarding cleaning, sterilization, and functional performance, in addition to all the other required elements of a 510(k) identified in § 807.87, within 15 months of publication of the notice or no longer market their devices. In accordance with section 510(o) of the act, FDA must revise the list of devices subject to this requirement as appropriate.

C. Reprocessed SUDs Already Subject to Premarket Notification Requirements

MDUFMA also required FDA to review the types of reprocessed SUDs already subject to premarket notification requirements and to identify which of these devices required the submission of validation data to ensure their substantial equivalence to predicate devices. FDA published a list of these devices in the

Federal Register

on April 30, 2003 (68 FR 23139). As described above, FDA must revise the list of devices subject to this requirement as appropriate.

For devices identified on this list that had already been cleared through the 510(k) process, manufacturers were required to submit validation data regarding cleaning, sterilization, and functional performance within 9 months of publication of the list or no longer market their devices.

For devices on this list that were not yet cleared through the 510(k) process, manufacturers were required to submit 510(k)s including validation data regarding cleaning, sterilization, and functional performance, in addition to all the other required elements identified in 21 CFR 807.87, in order to market these devices.

II. FDA's Implementation of New Section 510(o) of the Act

In the

Federal Register

of April 30, 2003 (68 FR 23139), FDA described the methodology and criteria used to identify the reprocessed SUDs that were included in the lists required by MDUFMA. First, FDA described how it identified the types of SUDs currently being reprocessed and how the Spaulding definitions (see footnote 1) were used to categorize these devices as critical, semicritical, or noncritical. (See Attachment 1.) Next, the agency described its use of the Risk Prioritization Scheme (RPS)

2

that was used to evaluate the potential risk (high, moderate, or low) associated with an SUD based on the following factors: (1) Risk of infection and (2) risk of inadequate performance following reprocessing. FDA identified its final criterion as those reprocessed SUDs intended to come in contact with tissue at high risk of being infected with the causative agents of Creutzfeldt-Jakob Disease (CJD). (These are generally devices intended for use in neurosurgery and ophthalmology.)

2

This scheme is described in the February 2000 draft guidance document entitled, “Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme.”

http://www.fda.gov/cdrh/reuse/1156.html

.

Using this methodology and these criteria, the devices included on List I (Critical and Semicritical Reprocessed SUDs Previously Exempt from Premarket Notification Requirements that Now Require 510(k)s with Validation Data) of the April 30, 2003, June 26, 2003, and April 13, 2004,

Federal Register

notices are those critical and semicritical reprocessed SUDs that were either high risk according to the RPS or intended to come in contact with tissue at high risk of being infected with CJD. The devices included on List II (Reprocessed SUDs Subject to Premarket Notification Requirements that Now Require the Submission of Validation Data) of the April 30, 2003,

Federal Register

notice are those reprocessed SUDs already subject to premarket notification requirements that were either high risk according to the RPS or intended to come in contact with tissue at high risk of being infected with CJD.

III. Revisions to Attachment 1, List I, and List II

A. Revisions to Attachment 1 (List of SUDs Known To Be Reprocessed or Considered for Reprocessing)

FDA has evaluated the comments received regarding section 510(o) of the act. In doing so, the agency has determined that all noncompression heart stabilizers and endoscopic and laparoscopic electrosurgical accessories should be considered high risk devices when reprocessed.

Noncompression heart stabilizers are intended to move, lift, and position the heart while maintaining hemodynamic stability during cardiovascular surgery. The agency has determined that noncompression heart stabilizers are high risk devices when reprocessed because they include features, such as narrow tubing, interlocking parts, and small crevices that could impede cleaning and sterilization and because these devices contain materials, coatings, or components that may be damaged or altered by reprocessing. Therefore, these devices have the potential for a high risk of infection and/or inadequate performance when reprocessed. This includes noncompression heart stabilizers (device 21 in Attachment 1) classified under § 870.4500 (21 CFR 870.4500). In determining that noncompression heart stabilizers are high risk devices when reprocessed, a new product code has been created to identify these devices within regulation § 870.4500. The new product code is NQG. This new product code has been added to device 21 in Attachment 1 of this document.

Endoscopic and laparoscopic electrosurgical accessories are surgical instruments used during minimally invasive surgery, including vein harvesting. The agency has determined that these devices should be considered high risk devices when reprocessed because they include features, such as narrow lumens, that could impede thorough cleaning and sterilization and because these devices contain materials, coatings, or components that may be damaged or altered by reprocessing. Therefore, these devices have the potential for a high risk of infection or inadequate performance when reprocessed. This includes endoscopic and laparoscopic electrosurgical accessories (device 162 in Attachment 1) classified under § 878.4400 (21 CFR 878.4400). In determining that endoscopic and laparoscopic electrosurgical accessories are potentially high risk devices when reprocessed, a new product code has been created to identify these devices within regulation § 878.4400. The new product code is NUJ. This new product code has been added to device 162 in Attachment 1.

These changes are reflected in a revised version of Attachment 1 included in this

Federal Register

notice.

B. Revisions to List I (Critical and Semicritical Reprocessed Single-Use Devices Previously Exempt from Premarket Notification Requirements that Now Require 510(k)s with Validation Data)

Using the RPS, FDA has recategorized noncompression heart stabilizers from moderate risk to high risk when reprocessed, and the agency has therefore added noncompression heart stabilizers to List I. Manufacturers of noncompression heart stabilizers will be required to submit 510(k)s with validation data by December 29, 2006, which is 15 months following this revision of the list.

To help reprocessors be able to easily identify those critical and semicritical reprocessed SUDs that have been categorized into List I in this notice and previous

Federal Register

notices, FDA is re-issuing a complete listing of these devices. Therefore, List 1 now identifies all critical and semicritical reprocessed SUDs previously exempt from premarket notification requirements that now require 510(k)s with validation data.

C. Revisions to List II (Reprocessed Single-Use Devices Subject to Premarket Notification Requirements that Now Require the Submission of Validation Data)

Using the RPS, FDA has recategorized endoscopic and laparoscopic electrosurgical accessories under regulation § 878.4400 from moderate risk to high risk when reprocessed. Therefore, endoscopic and laparoscopic electrosurgical accessories have been added to List II. Under MDUFMA, manufacturers of these devices who have already obtained clearance through the 510(k) process must submit validation data regarding cleaning, sterilization, and functional performance by June 29, 2006, which is 9 months following this revision of the list. Upon publication of this notice, manufacturers who have not yet obtained clearance through the 510(k) process must submit 510(k)s including validation data regarding cleaning, sterilization, and functional performance, in addition to all the other required elements of a 510(k) identified in 21 CFR 807.87, in order to market these devices.

List I.—Critical and Semicritical Reprocessed Single-Use Devices Previously Exempt From Premarket Notification Requirements that Now Require 510(k)s With Validation Data [Manufacturers of noncompression heart stabilizers will need to submit 510(k)s with validation data by 15 months following the publication of this revised list.]

21 CFR No.

Classification name

Product code for nonreprocessed

device

Product code for reprocessed

device

Product code name for

reprocessed device

868.6810

Tracheobronchial suction catheter

BSY

NQV

Tracheobronchial suction catheter

870.4500

Cardiovascular surgical instruments

MWS

NQG

Noncompression heart stabilizer

872.3240

Dental bur

Diamond coated

NME

Dental diamond coated bur

872.4535

Dental diamond instrument

DZP

NLD

Dental diamond instrument

872.4730

Dental injection needle

DZM

NMW

Dental needle

872.5410

Orthodontic appliance and accessories

EJF

NQS

Orthodontic metal bracket

874.4140

Ear, nose, and throat bur

Microdebrider

NLY

ENT high speed microdebrider

874.4140

Ear, nose, and throat bur

Diamond coated

NLZ

ENT diamond coated bur

874.4420

Ear, nose, throat manual surgical ..

KAB, KBG, KCI

NLB

Laryngeal, sinus, tracheal trocar

876.1075

Gastroenterology-urology biopsy instrument

FCL

NON

Nonelectric biopsy forceps

876.4680

Ureteral stone dislodger

FGO, FFL

NQT, NQU

Flexible and basket stone dislodger

878.4200

Introduction/drainage catheter and accessories

GCB

NMT

Catheter needle

878.4800

Manual surgical instrument

MJG

NNA

Percutaneous biopsy device

878.4800

Manual surgical instrument

FHR

NMU

Gastro-Urology needle

878.4800

Manual surgical instrument for ... ....

DWO

NLK

Cardiovascular biopsy needle

878.4800

Manual surgical instrument for...

GAA

NNC

Aspiration and injection needle

882.4190

Forming/cutting clip instrument

HBS

NMN

Forming/cutting clip instrument

884.1730

Laparoscopic insufflator, ..

HIF

NMI

Laparoscopic insufflator and accessories

884.4530

OB/GYN specialized manual instrument

HFB

NMG

Gynecological biopsy forceps

886.4350

Manual ophthalmic surgical instrument

HNN

NLA

Ophthalmic knife

List II.—Reprocessed Single-Use Devices Subject to Premarket Notification Requirements That Now Require the Submission of Validation Data

1

[Manufacturers of endoscopic and laparoscopic electrosurgical accessories who already have 510(k) clearance for these devices must submit validation data by June 29, 2006. Any new 510(k) for this device type will require validation data upon publication of this document.]

21 CFR No.

Classification name

Product code for nonreprocessed

device

Product code for reprocessed

device

Product code name for

reprocessed device

Unclassified

Oocyte aspiration needles

MHK

NMO

Oocyte aspiration needles

Unclassified

Percutaneous transluminal angioplasty catheter

LIT

NMM

Transluminal peripheral angioplasty catheter

Unclassified

Ultrasonic surgical instrument

LFL

NLQ

Ultrasonic scalpel

868.5150

Anesthesia conduction needle

BSP

NNH

Anesthetic conduction needle (with/without introducer)

868.5150

Anesthesia conduction needle

MIA

NMR

Short term spinal needle

868.5730

Tracheal tube

BTR

NMA

Tracheal tube (with/without connector)

868.5905

Noncontinuous ventilator (IPPB)

BZD

NMC

Noncontinuous ventilator (respirator) mask

870.1200

Diagnostic intravascular catheter

DQO

NLI

Angiography catheter

870.1220

Electrode Recording Catheter

DRF

NLH

Electrode recording catheter

870.1220

Electrode Recording Catheter

MTD

NLG

Intracardiac mapping catheter

870.1230

Fiberoptic oximeter catheter

DQE

NMB

Fiberoptic oximeter catheter

870.1280

Steerable Catheter

DRA

NKS

Steerable Catheter

870.1290

Steerable catheter control system

DXX

NKR

Steerable catheter control system

870.1330

Catheter guide wire

DQX

NKQ

Catheter guide wire

870.1390

Trocar

DRC

NMK

Cardiovascular trocar

870.1650

Angiographic injector and syringe

DXT

NKT

Angiographic injector and syringe

870.1670

Syringe actuator for injector

DQF

NKW

Injector for actuator syringe

870.2700

Oximeter

MUD

NMD

Tissue saturation oximeter

870.2700

Oximeter

DQA

NLF

Oximeter

870.3535

Intra-aortic balloon and control system

DSP

NKO

Intra-aortic balloon and control system

870.4450

Vascular clamp

DXC

NMF

Vascular clamp

870.4885

External vein stripper

DWQ

NLJ

External vein stripper

872.5470

Orthodontic Plastic Bracket

DYW

NLC

Orthodontic Plastic Bracket

874.4680

Bronchoscope (flexible or rigid) and accessories

BWH

NLE

Bronchoscope (nonrigid) biopsy forceps

876.1075

Gastro-Urology biopsy instrument

FCG

NMX

G-U biopsy needle and needle set

876.1075

Gastroenterology-urology biopsy instrument

KNW

NLS

Biopsy instrument

876.1500

Endoscope and accessories

FBK, FHP

NMY

Endoscopic needle

876.1500

Endoscope and accessories

MPA

NKZ

Endoilluminator

876.1500

Endoscope and accessories

GCJ

NLM

General and plastic surgery laparoscope

876.1500

Endoscope and accessories

FHO

NLX

Spring-loaded pneumoperitoneum needle

876.4300

Endoscopic electrosurgical unit and accessories

FAS

NLW

Active Urological electrosurgical electrode

876.4300

Endoscopic electrosurgical unit and accessories

FEH

NLV

Flexible suction coagulator electrode

876.4300

Endoscopic electrosurgical unit and accessories

KGE

NLU

Electric biopsy forceps

876.4300

Endoscopic electrosurgical unit and accessories

FDI

NLT

Flexible snare

876.4300

Endoscopic electrosurgical unit and accessories

KNS

NLR

Endoscopic (with or without accessories) Electrosurgical unit

876.5010

Biliary catheter and accessories

FGE

NML

Biliary catheter

876.5540

Blood access device and accessories

LBW

NNF

Single needle dialysis set (co-axial flow)

876.5540

Blood access device and accessories

FIE

NNE

Fistula needle

876.5820

Hemodialysis systems and accessories

FIF

NNG

Single needle dialysis set with uni-directional pump

878.4300

Implantable clip

FZP

NMJ

Implantable clip

878.4400

Electrosurgical Cutting and Coagulation Device and Accessories

GEI

NUJ

Endoscopic and laparoscopic electrosurgical accessories

878.4750

Implantable staple

GDW

NLL

Implantable staple

880.5570

Hypodermic single lumen needle

FMI

NKK

Hypodermic single lumen needle

880.5860

Piston Syringe

FMF

NKN

Piston Syringe

882.4300

Manual cranial drills, burrs, trephines and accessories

HBG

NLO

(Manual) drills, burrs, trephines and accessories

882.4305

Powered compound cranial drills, burrs, trephines .

HBF

NLP

(Powered, compound) drills, burrs, trephines and accessories

882.4310

Powered simple cranial drills, burrs, trephines .

HBE

NLN

(Simple, powered) drills, burrs, trephines and accessories

884.1720

Gynecologic laparoscope and accessories

HET

NMH

Gynecologic laparoscope (and accessories)

884.6100

Assisted reproduction needle

MQE

NNB

Assisted reproduction needle

886.4370

Keratome

HMY, HNO

NKY

Keratome blade

886.4670

Phacofragmentation system

HQC

NKX

Phacoemulsification needle

892.5730

Radionuclide brachytherapy source

IWF

NMP

Isotope needle

1

Hemodialyzers have been excluded from this list because the reuse of hemodialyzers is addressed in “Draft Guidance for Hemodialyzer Reuse Labeling” October 6, 1995. An archived copy may be obtained from CDRH's Division of Small Manufacturers, International, and Consumer Assistance, please contact

dsmica@cdrh.fda.gov

.

IV. Stakeholder Input

In the

Federal Register

of February 4, 2003 (68 FR 5643), FDA invited interested persons to provide information and share views on the implementation of MDUFMA. Since that time, the agency has received comments on various MDUFMA provisions, including several on its implementation of section 510(o) of the act. As discussed above, one comment recommended that heart stabilizers should be considered high risk because of the risk of cross contamination and deterioration of the mechanical properties of the device. FDA agrees that noncompression heart stabilizers, a subset of all heart stabilizers, should be added to the list of critical reprocessed SUDs previously exempt from premarket notification requirements that will now require 510(k)s with validation data. Therefore, FDA has added noncompression heart stabilizers to List I.

Another comment recommended that FDA recategorize endoscopic vessel harvesting devices as high risk to be consistent with the categorization of other endoscopic accessories under 21 CFR 876.1500 (Endoscope and accessories). FDA agrees that endoscopic vessel harvesting devices should be considered high risk and subject to the submission of validation data. As discussed previously, in reviewing this comment, the agency also determined that laparoscopic electrosurgical accessories should be similarly categorized. Therefore, FDA has added laparoscopic and endoscopic electrosurgical accessories to List II.

Other additional comments requested that specific reprocessed SUDs be added to either List I or II. Each of these comments was carefully considered. However, FDA does not believe, based on the risk-based approach described in the April 30, 2003,

Federal Register

notice, that SUDs other than those identified in this notice should be added to the Lists at this time.

Another comment requested the FDA to call for the immediate submission and review of validation data regarding cleaning, sterilization, and functional performance for all reprocessed SUDs. The comment further stated that this request was based on the significant number of reprocessed devices which were withdrawn or were deemed to be insufficiently supported by validation data as of February 8, 2005.

Section 510(o) of the act required FDA to identify those reprocessed SUDs for which validation data must be submitted in order to ensure that those SUDs remain substantially equivalent to predicate devices after reprocessing. Because the agency has found that some reprocessed SUDs do not require the submission and review of validation data in order to demonstrate substantial equivalence, the agency identified the types of devices requiring the submission of validation data by implementing a risk-based approach. This risk-based approach, described in the April 30, 2003,

Federal Register

notice, identified a significant number of reprocessed SUDs that can no longer be legally marketed without agency review and clearance of validation data. The failure of some manufacturers to submit this validation data and the agency's review of submitted data resulted in a determination that a significant number of reprocessed SUDs could no longer be legally marketed. However, the process also identified a significant number of reprocessed SUDs that could continue to be marketed because: (1) they were found not to require the submission of additional validation data in order to ensure substantial equivalence to legally marketed predicate devices; or (2) after a review of submitted validation data, they were found to be substantially equivalent to legally marketed predicate devices. Therefore, FDA does not intend to expand the list of reprocessed SUDs subject to the submission and review of validation data to all reprocessed SUDs as requested in the comment. The agency believes it has implemented section 510(o) of the act by identifying the types of devices that require the submission of validation data and determining which of those devices can no longer be legally marketed.

V. Comments

You may submit written or electronic comments on the designation of reprocessed noncompression heart stabilizers and laparoscopic and endoscopic electrosurgical devices requiring the submission of premarket notifications with validation data to the Division of Dockets Management (see

ADDRESSES

). Submit electronic comments to

http://www.fda.gov/dockets/ecomments

. Submit two copies of mailed comments, but individuals may submit one copy. You should identify your comments with the docket number found in brackets in the heading of this document. You may see any comments FDA receives in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing

Medical

Specialty

Device Type

Regulation

Number

Class

Product

Code

Risk

A

Critical/Semicritical/Noncritical

Premarket

Exempt

1

Cardio

Cardiopulmonary Bypass Marker

Unclassified

MAB

1

C

N

2

Cardio

Percutaneous & Operative Transluminal Coronary Angioplasty Catheter (PTCA)

Post-amendment

III

LOX

3

C

N

3

Cardio

Percutaneous Ablation Electrode

Post-amendment

III

LPB

3

C

N

4

Cardio

Peripheral Transluminal Angioplasty (PTA) Catheter

870.1250

II

LIT

3

C

N

5

Cardio

Blood-Pressure Cuff

870.1120

II

DXQ

1

N

N

6

Cardio

Angiography Catheter

870.1200

II

DQO

3

C

N

7

Cardio

Electrode Recording Catheter

870.1220

II

DRF

3

C

N

8

Cardio

High-Density Array Catheter

870.1220

II

MTD

3

C

N

9

Cardio

Fiberoptic Oximeter Catheter

870.1230

II

DQE

3

C

N

10

Cardio

Steerable Catheter

870.1280

II

DRA

3

C

N

11

Cardio

Steerable Catheter Control System

870.1290

II

DXX

3

C

N

12

Cardio

Guide Wire

870.1330

II

DQX

3

C

N

13

Cardio

Angiographic Needle

870.1390

II

DRC

3

C

N

14

Cardio

Trocar

870.1390

II

DRC

3

C

N

15

Cardio

Syringes

870.1650

II

DXT

3

C

N

16

Cardio

Injector Type Syringe Actuator

870.1670

II

DQF

3

C

N

17

Cardio

Oximeter

870.2700

II

DQA

3

N

N

18

Cardio

Tissue Saturation Oximeter

870.2700

II

MUD

3

C

N

19

Cardio

Intra-Aortic Balloon System

870.3535

III

DSP

3

C

N

20

Cardio

Vascular Clamp

870.4450

II

DXC

3

C

N

21

Cardio

Heart Stabilizer

870.4500

I

MWS

2

C

Y

22

Cardio

Noncompression Heart Stabilizer

870.4500

I

MWS

3

C

Y

23

Cardio

External Vein Stripper

870.4885

II

DWQ

3

C

N

24

Cardio

Compressible Limb Sleeve

870.5800

II

JOW

1

N

N

25

Dental

Bur

872.3240

I

EJL

1

C

Y

26

Dental

Diamond Coated Bur

872.3240

I

EJL

3

C

Y

27

Dental

Diamond Instrument

872.4535

I

DZP

3

C

Y

28

Dental

AC-Powered Bone Saw

872.4120

II

DZH

2

C

N

29

Dental

Manual Bone Drill and Wire Driver

872.4120

II

DZJ

2

C

N

30

Dental

Powered Bone Drill

872.4120

II

DZI

2

C

N

31

Dental

Intraoral Drill

872.4130

I

DZA

1

C

Y

32

Dental

Injection needle

872.4730

I

DZM

3

C

Y

33

Dental

Metal Orthodontic Bracket

872.5410

I

EJF

3

S

Y

34

Dental

Plastic Orthodontic Bracket

872.5470

II

DYW

3

S

N

35

ENT

Bur

874.4140

I

EQJ

1

C

Y

36

ENT

Diamond Coated Bur

874.4140

I

EQJ

3

C

Y

37

ENT

Microdebrider

874.4140

I

EQJ

3

C

Y

38

ENT

Microsurgical Argon Fiber Optic Laser Cable, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology

874.4490

II

LMS

1

S

N

39

ENT

Microsurgical Argon Fiber Optic Laser Cable, For Use In Otology

874.4490

II

LXR

1

S

N

40

ENT

Microsurgical Carbon-Dioxide Fiber Optic Laser Cable

874.4500

II

EWG

1

S

N

41

ENT

Bronchoscope Biopsy Forceps (Nonrigid)

874.4680

II

BWH

3

C

N

42

ENT

Bronchoscope Biopsy Forceps (Rigid)

874.4680

II

JEK

1

C

N

43

Gastro/ Urology

Biopsy Forceps Cover

876.1075

I

FFF

1

C

Y

44

Gastro/ Urology

Biopsy Instrument

876.1075

II

KNW

3

C

N

45

Gastro/ Urology

Biopsy Needle Set

876.1075

II

FCG

3

C

N

46

Gastro/ Urology

Biopsy Punch

876.1075

II

FCI

2

C

N

47

Gastro/ Urology

Mechanical Biopsy Instrument

876.1075

II

FCF

2

C

N

48

Gastro/ Urology

Nonelectric Biopsy Forceps

876.1075

I

FCL

3

C

Y

49

Gastro/ Urology

Cytology Brush For Endoscope

876.1500

II

FDX

2

S

N

50

Gastro/ Urology

Endoscope accessories

876.1500

II

KOG

2

S

N

51

Gastro/ Urology

Extraction Balloons/Baskets

876.1500

II

KOG

2

S

N

52

Gastro/Urology

Endoscopic needle

876.1500

II

FBK

3

C

N

53

Gastro/ Urology

Simple Pneumoperitoneum Needle

876.1500

II

FHP

3

C

N

54

Gastro/ Urology

Spring Loaded Pneumoperitoneum Needle

876.1500

II

FHO

3

C

N

55

Gastro/ Urology

Active Electrosurgical Electrode

876.4300

II

FAS

3

S

N

56

Gastro/ Urology

Biliary Sphincterotomes

876.5010, 876.1500

II

FGE

3

C

N

57

Gastro/ Urology

Electric Biopsy Forceps

876.4300

II

KGE

3

C

N

58

Gastro/ Urology

Electrosurgical Endoscopic Unit (With Or Without Accessories)

876.4300

II

KNS

3

S

N

59

Gastro/ Urology

Flexible Snare

876.4300

II

FDI

3

S

N

60

Gastro/ Urology

Flexible Suction Coagulator Electrode

876.4300

II

FEH

3

S

N

61

Gastro/ Urology

Flexible Stone Dislodger

876.4680

II

FGO

3

S

Y

62

Gastro/ Urology

Metal Stone Dislodger

876.4680

II

FFL

3

S

Y

63

Gastro/ Urology

Needle Holder

876.4730

I

FHQ

1

C

Y

64

Gastro/ Urology

Nonelectrical Snare

876.4730

I

FGX

1

S

Y

65

Gastro/ Urology

Urological Catheter

876.5130

II

KOD

2

S

N

66

Gastro/Urology

Single needle dialysis set

876.5540

II

LBW, FIE

3

C

N

67

Gastro/ Urology

Hemodialysis Blood Circuit Accessories

876.5820

II

KOC

2

S

N

68

Gastro/Urology

Single needle dialysis set

876.5820

II

FIF

3

C

N

69

Gastro/Urology

Hemorrhoidal Ligator

876.4400

II

FHN

2

C

N

70

General Hospital

Implanted, Programmable Infusion Pump

Post-amendment

III

LKK

3

C

N

71

General Hospital

Needle Destruction Device

Post-amendment

III

MTV

1

N

N

72

General Hospital

Nonpowered Flotation Therapy Mattress

880.5150

I

IKY

2

N

Y

73

General Hospital

NonAC-Powered Patient Lift

880.5510

I

FSA

2

N

Y

74

General Hospital

Alternating Pressure Air Flotation Mattress

880.5550

II

FNM

1

N

Y

75

General Hospital

Temperature Regulated Water Mattress

880.5560

I

FOH

2

N

Y

76

General Hospital

Hypodermic Single Lumen Needle

880.5570

II

FMI

3

C

N

77

General Hospital

Piston Syringe

880.5860

II

FMF

3

C

N

78

General Hospital

Mattress Cover (Medical Purposes)

880.6190

I

FMW

2

N

Y

79

General Hospital

Disposable Medical Scissors

880.6820

I

JOK

1

N

Y

80

General Hospital

Irrigating Syringe

880.6960

I

KYZ, KYY

1

C

Y

81

Infection Control

Surgical Gowns

878.4040

II

FYA

1

C

N

82

Lab

Blood Lancet

878.4800

I

FMK

1

C

Y

83

Neurology

Clip Forming/Cutting Instrument,

882.4190

I

HBS

3*

C

Y

84

Neurology

Drills, Burrs, Trephines &Accessories (Manual)

882.4300

II

HBG

3*

C

N

85

Neurology

Drills, Burrs, Trephines &Accessories (Compound, Powered)

882.4305

II

HBF

3*

C

N

86

Neurology

Drills, Burrs, Trephines &Accessories (Simple, Powered)

882.4310

II

HBE

3*

C

N

87

OB/GYN

Oocyte aspiration needle

III

MHK

3

C

N

88

OB/GYN

Laparoscope accessories

884.1720

I

HET

2

C

Y

89

OB/GYN

Laparoscope Accessories

884.1720

II

HET

3

C

N

90

OB/GYN

Laparoscopic Dissectors

884.1720

I

HET

2

C

Y

91

OB/GYN

Laparoscopic Graspers

884.1720

I

HET

2

C

Y

92

OB/GYN

Laparoscopic Scissors

884.1720

I

HET

2

C

Y

93

OB/GYN

Insufflator accessories (tubing, Verres needle, kits)

884.1730

II

HIF

3

C

Y

94

OB/GYN

Laparoscopic Insufflator

884.1730

II

HIF

2

N

N

95

OB/GYN

Endoscopic Electrocautery and Accessories

884.4100

II

HIM

2

N

N

96

OB/GYN

Gynecologic Electrocautery (and Accessories)

884.4120

II

HGI

2

N

N

97

OB/GYN

Endoscopic Bipolar Coagulator-Cutter (and Accessories)

884.4150

II

HIN

2

N

N

98

OB/GYN

Culdoscopic Coagulator (and Accessories)

884.4160

II

HFI

2

N

N

99

OB/GYN

Endoscopic Unipolar Coagulator-Cutter (and Accessories)

884.4160

II

KNF

2

N

N

100

OB/GYN

Hysteroscopic Coagulator (and Accessories)

884.4160

II

HFH

2

N

N

101

OB/GYN

Unipolar Laparoscopic Coagulator (and Accessories)

884.4160

II

HFG

2

N

N

102

OB/GYN

Episiotomy Scissors

884.4520

I

HDK

1

C

Y

103

OB/GYN

Umbilical Scissors

884.4520

I

HDJ

1

C

Y

104

OB/GYN

Biopsy Forceps

884.4530

I

HFB

3

C

Y

105

OB/GYN

Assisted reproduction needle

884.6100

II

MQE

3

C

N

106

Ophthalmic

Endoilluminator

876.1500

II

MPA

3*

C

N

107

Ophthalmic

Surgical Drapes

878.4370

II

KKX

2

C

N

108

Ophthalmic

Ophthalmic Knife

886.4350

I

HNN

3

C

Y

109

Ophthalmic

Keratome Blade

886.4370

I

HMY, HNO

3

C

N

110

Ophthalmic

Phacoemulsification Needle

886.4670

II

HQC

3

C

N

111

Ophthalmic

Phacoemulsification/ Phacofragmentation Fluidic

886.4670

II

MUS

2

C

N

112

Ophthalmic

Phacofragmentation Unit

886.4670

II

HQC

1

N

N

113

Orthopedic

Saw Blades

878.4820

I

GFA, DWH, GEY, GET

1

C

Y

114

Orthopedic

Surgical Drills

878.4820

I

GEY, GET

1

C

Y

115

Orthopedic

Arthroscope accessories

888.1100

II

HRX

2

C

Y

116

Orthopedic

Bone Tap

888.4540

I

HWX

1

C

Y

117

Orthopedic

Burr

888.4540

I

HTT

1

C

Y

118

Orthopedic

Carpal Tunnel Blade

888.4540

I

LXH

2

C

Y

119

Orthopedic

Countersink

888.4540

I

HWW

1

C

Y

120

Orthopedic

Drill Bit

888.4540

I

HTW

1

C

Y

121

Orthopedic

Knife

888.4540

I

HTS

1

C

Y

122

Orthopedic

Manual Surgical Instrument

888.4540

I

LXH

1

C

Y

123

Orthopedic

Needle Holder

888.4540

I

HXK

1

C

Y

124

Orthopedic

Reamer

888.4540

I

HTO

1

C

Y

125

Orthopedic

Rongeur

888.4540

I

HTX

1

C

Y

126

Orthopedic

Scissors

888.4540

I

HRR

1

C

Y

127

Orthopedic

Staple Driver

888.4540

I

HXJ

1

C

Y

128

Orthopedic

Trephine

888.4540

I

HWK

1

C

Y

129

Orthopedic

Flexible Reamers/Drills

886.4070 878.4820

I

GEY, HRG

1

C

Y

130

Orthopedic

External Fixation Frame

888.3040 888.3030

II

JEC KTW KTT

2

N

N

131

Physical Medicine

Nonheating Lamp for Adjunctive Use Inpatient Therapy

890.5500

II

NHN

1

N

N

132

Physical Medicine

Electrode Cable,

890.1175

II

IKD

1

N

Y

133

Physical Medicine

External Limb Component, Hip Joint

890.3420

I

ISL

2

N

Y

134

Physical Medicine

External Limb Component, Knee Joint

890.3420

I

ISY

2

N

Y

135

Physical Medicine

External Limb Component, Mechanical Wrist

890.3420

I

ISZ

2

N

Y

136

Physical Medicine

External Limb Component, Shoulder Joint

890.3420

I

IQQ

2

N

Y

137

Plastic Surgery

Stapler

878.4800

I

GAG, GEF, FHM, HBT

2

C

Y

138

Radiology

Isotope Needle

892.5730

II

IWF

3

C

N

139

Respiratory

Endotracheal Tube Changer

Unclassified

III

LNZ

3

C

N

140

Respiratory

Anesthesia conduction needle

868.5150

II

BSP

3

C

N

141

Respiratory

Short term spinal needle

868.5150

II

MIA

3

C

N

142

Respiratory

Respiratory Therapy and Anesthesia Breathing Circuits

868.5240

I

CAI

2

S

Y

143

Respiratory

Oral and Nasal Catheters

868.5350

I

BZB

1

C

Y

144

Respiratory

Gas Masks

868.5550

I

BSJ

1

S

Y

145

Respiratory

Breathing Mouthpiece

868.5620

I

BYP

1

N

Y

146

Respiratory

Tracheal Tube

868.5730

II

BTR

3

C

N

147

Respiratory

Airway Connector

868.5810

I

BZA

2

S

Y

148

Respiratory

CPAP Mask

868.5905

II

BZD

3

S

N

149

Respiratory

Emergency Manual Resuscitator

868.5915

II

BTM

2

S

N

150

Respiratory

Tracheobronchial Suction Catheter

868.6810

I

BSY

3

S

Y

151

Surgery

AC-powered Orthopedic Instrument and accessories

878.4820

I

HWE

2

C

N

152

Surgery

Breast Implant Mammary Sizer

Unclassified

MRD

1

C

N

153

Surgery

Ultrasonic Surgical Instrument

Unclassified

LFL

3

C

N

154

Surgery

Trocar

874.4420

I

KAB, KBG, KCI

3

C

Y

155

Surgery

Endoscopic Blades

876.1500

II

GCP, GCR

2

C

N

156

Surgery

Endoscopic Guidewires

876.1500

II

GCP, GCR

1

C

N

157

Surgery

Inflatable External Extremity Splint

878.3900

I

FZF

1

N

Y

158

Surgery

Noninflatable External Extremity Splint

878.3910

I

FYH

1

N

Y

159

Surgery

Catheter needle

878.4200

I

GCB

3

C

Y

160

Surgery

Implantable Clip

878.4300

II

FZP

3

C

N

161

Surgery

Electrosurgical and Coagulation Unit With Accessories

878.4400

II

BWA

2

C

N

162

Surgery

Electrosurgical Apparatus

878.4400

II

HAM

2

C

N

163

Surgery

Electrosurgical Cutting & Coagulation Device & Accessories

878.4400

II

GEI

NUJ

2

3

C

N

164

Surgery

Electrosurgical Device

878.4400

II

DWG

2

C

N

165

Surgery

Electrosurgical Electrode

878.4400

II

JOS

2

C

N

166

Surgery

Implantable Staple, Clamp, Clip for Suturing Apparatus

878.4750

II

GDW

3

C

N

167

Surgery

Percutaneous biopsy device

878.4800

I

MJG

3

C

Y

168

Surgery

Gastro-Urology needle

878.4800

I

FHR

3

C

Y

169

Surgery

Aspiration and injection needle

878.4800

I

GAA

3

C

Y

170

Surgery

Biopsy Brush

878.4800

I

GEE

1

C

Y

171

Surgery

Blood Lancet

878.4800

I

FMK

1

C

Y

172

Surgery

Bone Hook

878.4800

I

KIK

1

C

Y

173

Surgery

Cardiovascular Biopsy Needle

878.4800

I

DWO

3

C

Y

174

Surgery

Clamp

878.4800

I

GDJ

1

C

Y

175

Surgery

Clamp

878.4800

I

HXD

1

C

Y

176

Surgery

Curette

878.4800

I

HTF

1

C

Y

177

Surgery

Disposable Surgical Instrument

878.4800

I

KDC

1

C

Y

178

Surgery

Disposable Vein Stripper

878.4800

I

GAJ

1

C

Y

179

Surgery

Dissector

878.4800

I

GDI

1

C

Y

180

Surgery

Forceps

878.4800

I

GEN

2

C

Y

181

Surgery

Forceps

878.4800

I

HTD

2

C

Y

182

Surgery

Gouge

878.4800

I

GDH

1

C

Y

183

Surgery

Hemostatic Clip Applier

878.4800

I

HBT

2

C

Y

184

Surgery

Hook

878.4800

I

GDG

1

C

Y

185

Surgery

Manual Instrument

878.4800

I

MDM, MDW

1

C

Y

186

Surgery

Manual Retractor

878.4800

I

GZW

1

C

Y

187

Surgery

Manual Saw and Accessories

878.4800

I

GDR HAC

1

C

Y

188

Surgery

Manual Saw and Accessories

878.4800

I

HAC

1

C

Y

189

Surgery

Manual Surgical Chisel

878.4800

I

FZO

1

C

Y

190

Surgery

Mastoid Chisel

878.4800

I

JYD

1

C

Y

191

Surgery

Orthopedic Cutting Instrument

878.4800

I

HTZ

1

C

Y

192

Surgery

Orthopedic Spatula

878.4800

I

HXR

1

C

Y

193

Surgery

Osteotome

878.4800

I

HWM

1

C

Y

194

Surgery

Rasp

878.4800

I

GAC

1

C

Y

195

Surgery

Rasp

878.4800

I

HTR

1

C

Y

196

Surgery

Retractor

878.4800

I

GAD

1

C

Y

197

Surgery

Retractor

878.4800

I

HXM

1

C

Y

198

Surgery

Saw

878.4800

I

HSO

1

C

Y

199

Surgery

Scalpel Blade

878.4800

I

GES

1

C

Y

200

Surgery

Scalpel Handle

878.4800

I

GDZ

1

C

Y

201

Surgery

Scissors

878.4800

I

LRW

1

C

Y

202

Surgery

Snare

878.4800

I

GAE

1

C

Y

203

Surgery

Spatula

878.4800

I

GAF

1

C

Y

204

Surgery

Staple Applier

878.4800

I

GEF

2

C

Y

205

Surgery

Stapler

878.4800

I

GAG

2

C

Y

206

Surgery

Stomach and Intestinal Suturing Apparatus

878.4800

I

FHM

2

C

Y

207

Surgery

Surgical Curette

878.4800

I

FZS

1

C

Y

208

Surgery

Surgical Cutter

878.4800

I

FZT

1

C

Y

209

Surgery

Surgical Knife

878.4800

I

EMF

1

S

Y

210

Surgery

Laser Powered Instrument

878.4810

II

GEX

2

C

N

211

Surgery

AC-Powered Motor

878.4820

I

GEY

2

C

Y

212

Surgery

Bit

878.4820

I

GFG

1

C

Y

213

Surgery

Bur

878.4820

I

GFF, GEY

1

C

Y

214

Surgery

Cardiovascular Surgical Saw Blade

878.4820

I

DWH

1

C

Y

215

Surgery

Chisel (Osteotome)

878.4820

I

KDG

1

C

Y

216

Surgery

Dermatome

878.4820

I

GFD

1

C

Y

217

Surgery

Electrically Powered Saw

878.4820

I

DWI

2

C

Y

218

Surgery

Pneumatic Powered Motor

878.4820

I

GET

2

C

Y

219

Surgery

Pneumatically Powered Saw

878.4820

I

KFK

2

C

Y

220

Surgery

Powered Saw and Accessories

878.4820

I

HAB

2

C

Y

221

Surgery

Saw Blade

878.4820

I

GFA

1

C

Y

222

Surgery

Nonpneumatic Tourniquet

878.5900

I

GAX

1

N

Y

223

Surgery

Pneumatic Tourniquet

878.5910

I

KCY

1

N

Y

224

Surgery

Endoscopic Staplers

888.4540

I

HXJ

2

C

Y

225

Surgery

Trocar

876.1500 870.1390

II

GCJ, DRC

3

C

N

226

Surgery

Surgical Cutting Accessories

878.4800, 874.4420

I

GDZ, GDX, GES, KBQ, KAS

2

C

Y

227

Surgery

Electrosurgical Electrodes/Handles/Pencils

876.4300 878.4400

II

HAM, GEI, FAS

2

C

N

228

Surgery

Scissor Tips

878.4800, 884.4520, 874.4420

I

LRW, HDK, HDJ, JZB, KBD

2

C

Y

229

Surgery

Laser Fiber Delivery Systems

878.4810 874.4500 886.4390 884.4550 886.4690

II

GEX EWG LLW HQF HHR HQB

1

C

N

A

Risk categorization may be either:

1 = low risk according to RPS

2 = moderate risk according to RPS

3 = high risk according to RPS

3* = high risk due to neurological use

See section II of this document, “FDA's Implementation of New Section 510(o) of the Act” for methodology and criteria used to identify the risk.

Dated: September 22, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05-19510 Filed 9-28-05; 8:45 am]

BILLING CODE 4160-01-S