# Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A05-19510 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** September 29, 2005 - **Citation:** 70 FR 56911 ## Text 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 --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A05-19510. Public record. Not legal advice.