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Notice

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

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is adding nonelectric biopsy forceps (classified in 21 CFR 876.1075, Gastroenterology-urology biopsy instrument) to the list of critical reprocessed single-use devices (SUDs) whose exemption from premarket notification requirements is being terminated and for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), is necessary in a premarket notification (510(k)). FDA is requiring submission of these data to ensure that reprocessed single-use nonelectric biopsy forceps are substantially equivalent to predicate devices, in accordance with MDUFMA.

DATES:

These actions are effective June 26, 2003. Manufacturers of reprocessed Start Printed Page 38072single-use biopsy forceps must submit 510(k)s for these devices by September 27, 2004, or their devices may no longer be 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.

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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.

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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 will no longer be exempt from premarket notification requirements. Manufacturers of these identified devices will need to submit 510(k)s that include validation data to be specified by FDA. Reprocessors of certain SUDs that currently have cleared 510(k)s also will need to submit the validation data specified by the agency.

A. Definitions

Under section 302(d) 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.”

B. Reprocessed SUDs Exempt From Premarket Notification

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 by the industry.[1] These categories of devices are defined as follows:

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.

C. Requirements for Critical Reprocessed SUDs

MDUFMA requires FDA to review the critical reprocessed SUDs that are currently exempt from premarket notification requirements and determine which of these devices require 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 requirements will be terminated and for which FDA has determined that validation data, as specified under MDUFMA, is necessary in a 510(k). According to the new law, manufacturers of the devices whose exemption from premarket notification requirements is terminated must submit 510(k)s that include 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, within 15 months of publication of the list or no longer market their 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 it used to determine which previously exempt critical reprocessed SUDs are now subject to 510(k) submission requirements, including the submission of validation data. First, FDA described how it identified the types of SUDs being reprocessed and how the Spaulding definitions (see footnote 1) were used to categorize these devices as critical, semicritical, or noncritical. (This list, which was Attachment 1 to that Federal Register notice, is being reprinted as Attachment 1 to this notice.) Next, the agency described its use of the Risk Prioritization Scheme (RPS)[2] that it used to evaluate the risk (high, moderate, or low) associated with an SUD based on: (1) Risk of infection and (2) risk of inadequate performance following reprocessing. FDA identified its final risk 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.)

Using this methodology and criteria, the devices included in List I (“Critical Reprocessed Single-Use Devices Previously Exempt From Premarket Notification Requirements That Will Now Require 510(k)s With Validation Data”) of the April 30, 2003, Federal Register notice are those critical 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 the causative agents of CJD.

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

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

FDA has re-evaluated the list of reprocessed SUDs with regard to the critical and semicritical device designations. In doing so, the agency has determined that all gastroenterology-urology biopsy instruments should be considered critical devices rather than semicritical devices because these devices are intended to break the mucous membrane and come in contact with sterile tissue when taking a biopsy. This includes biopsy forceps covers, biopsy instruments, biopsy needle sets, biopsy punches, mechanical biopsy instruments, and nonelectric biopsy Start Printed Page 38073forceps (devices 42-47 in Attachment I). In addition, it was determined that rigid and nonrigid bronchoscope biopsy forceps and biliary sphincterotomes (devices 40, 41, and 55 in Attachment I) should also be considered critical devices rather than semicritical devices for the same reason as stated previously. These changes are reflected in a revised version of Attachment I included in this Federal Register notice.

B. Revisions to List I (Critical Reprocessed Single-Use Devices Previously Exempt From Premarket Notification Requirements That Will Now Require 510(k)s With Validation Data)

FDA recategorized nine device types from semicritical to critical. One of these nine device types, nonelectric gastroenterology-urology biopsy forceps, was also considered high risk under the RPS. Therefore, nonelectric gastroenterology-urology biopsy forceps have been added to List I. Under MDUFMA, manufacturers of these biopsy forceps will be required to submit 510(k)s with validation data by (see DATES), which is 15 months following the publication of this revised list.

In addition, FDA is taking this opportunity to clarify the date by which manufacturers of the other devices in List I are required to submit 510(k)s with validation data. The correct date is July 30, 2004, which is 15 months following the initial publication of the list (the April 30, 2003, Federal Register notice inadvertently identified two dates).

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

The only change to List II is to clarify the date by which 510(k) submissions are required by MDUFMA to be supplemented with validation data. The correct date is January 30, 2004, which is 9 months following the initial publication of the list (as noted previously, the April 30, 2003, Federal Register notice inadvertently identified two dates).

List I.—Critical Reprocessed Single-Use Devices Previously Exempt From Premarket Notification Requirements That Will Now Require 510(k)s With Validation Data (to be submitted by July 30, 2004, unless otherwise noted).

21 CFR sectionClassification nameProduct code for non-reprocessed deviceProduct code for reprocessed deviceProduct code name for reprocessed device
872.3240Dental burDiamond coatedNMEDental diamond coated bur
872.4535Dental diamond instrumentDZPNLDDental diamond instrument
872.4730Dental injection needleDZMNMWDental needle
874.4140Ear, nose, and throat (ENT) burMicrodebriderNLYENT high speed microdebrider
874.4140Ear, nose, and throat burDiamond coatedNLZENT diamond coated bur
874.4420Ear, nose, throat manual surgical instrumentKAB, KBG, KCINLBLaryngeal, sinus, tracheal trocar
876.10751Gastroenterology-urology biopsy instrumentFCLNONNonelectric biopsy forceps
878.4200Introduction/drainage catheter and accessoriesGCBNMTCatheter needle
878.4800Manual surgical instrumentMJGNNAPercutaneous biopsy device
878.4800Manual surgical instrumentFHRNMUGastro-urology needle
878.4800Manual surgical instrument for general useDWONLKCardiovascular biopsy needle
878.4800Manual surgical instrument for general useGAANNCAspiration and injection needle
882.4190Forming/cutting clip instrumentHBSNMNForming/cutting clip instrument
884.1730Laparoscopic insufflatorHIFNMILaparoscopic insufflator and accessories
884.4530OB/GYN specialized manual instrumentHFBNMGGynecological biopsy forceps
886.4350Manual ophthalmic surgical instrumentHNNNLAOphthalmic knife
1 510(k)s with validation data to be submitted by September 27, 2004.
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List II.—Reprocessed Single-Use Devices Subject to Premarket Notification Requirements That Will Now Require the Submission of Validation Data1 (Manufacturers who already have 510(k) clearance for these devices must submit validation data by January 30, 2004. Any new 510(k) submitted after publication of the April 30 list will require validation data.)

21 CFR sectionClassification nameProduct code for non-reprocessed deviceProduct code for reprocessed deviceProduct code name for reprocessed device
UnclassifiedOocyte aspiration needlesMHKNMOOocyte aspiration needles
UnclassifiedPercutaneous transluminal angioplasty catheterLITNMMTransluminal peripheral angioplasty catheter
UnclassifiedUltrasonic surgical instrumentLFLNLQUltrasonic scalpel
868.5150Anesthesia conduction needleBSPNNHAnesthetic conduction needle (with or without introducer)
868.5150Anesthesia conduction needleMIANMRShort term spinal needle
868.5730Tracheal tubeBTRNMATracheal tube (with or without connector)
868.5905Noncontinuous ventilator (IPPB)BZDNMCNoncontinuous ventilator (respirator) mask
870.1200Diagnostic intravascular catheterDQONLIAngiography catheter
870.1220Electrode recording catheterDRFNLHElectrode recording catheter
870.1220Electrode recording catheterMTDNLGIntracardiac mapping catheter
870.1230Fiberoptic oximeter catheterDQENMBFiberoptic oximeter catheter
870.1280Steerable catheterDRANKSSteerable catheter
870.1290Steerable catheter control systemDXXNKRSteerable catheter control system
870.1330Catheter guide wireDQXNKQCatheter guide wire
870.1390TrocarDRCNMKCardiovascular trocar
870.1650Angiographic injector and syringeDXTNKTAngiographic injector and syringe
870.1670Syringe actuator for injectorDQFNKWInjector for actuator syringe
870.2700OximeterMUDNMDTissue saturation oximeter
870.2700OximeterDQANLFOximeter
870.3535Intra-aortic balloon and control systemDSPNKOIntra-aortic balloon and control system
870.4450Vascular clampDXCNMFVascular clamp
870.4885External vein stripperDWQNLJExternal vein stripper
872.5470Orthodontic plastic bracketDYWNLCOrthodontic plastic bracket
874.4680Bronchoscope (flexible or rigid) and accessoriesBWHNLEBronchoscope (nonrigid) biopsy forceps
876.1075Gastro-urology biopsy instrumentFCGNMXG-U biopsy needle and needle set
876.1075Gastroenterology-urology biopsy instrumentKNWNLSBiopsy instrument
876.1500Endoscope and accessoriesFBK, FHPNMYEndoscopic needle
876.1500Endoscope and accessoriesMPANKZEndoilluminator
876.1500Endoscope and accessoriesGCJNLMGeneral and plastic surgery laparoscope
876.1500Endoscope and accessoriesFHONLXSpring-loaded Pneumoperitoneum Needle
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876.4300Endoscopic electrosurgical unit and accessoriesFASNLWActive urological electrosurgical electrode
876.4300Endoscopic electrosurgical unit and accessoriesFEHNLVFlexible suction coagulator electrode
876.4300Endoscopic electrosurgical unit and accessoriesKGENLUElectric biopsy forceps
876.4300Endoscopic electrosurgical unit and accessoriesFDINLTFlexible snare
876.4300Endoscopic electrosurgical unit and accessoriesKNSNLREndoscopic (with or without accessories) Electrosurgical unit
876.5010Biliary catheter and accessoriesFGENMLBiliary catheter
876.5540Blood access device and accessoriesLBWNNFSingle needle dialysis set (co-axial flow)
876.5540Blood access device and accessoriesFIENNEFistula needle
876.5820Hemodialysis systems and accessoriesFIFNNGSingle needle dialysis set with uni-directional pump
878.4300Implantable clipFZPNMJImplantable clip
878.4750Implantable stapleGDWNLLImplantable staple
880.5570Hypodermic single lumen needleFMINKKHypodermic single lumen needle
880.5860Piston syringeFMFNKNPiston syringe
882.4300Manual cranial drills, burrs, trephines, and accessoriesHBGNLO(Manual) drills, burrs, trephines, and accessories
882.4305Powered compound cranial drills, burrs, trephines, and accessoriesHBFNLP(Powered, compound) drills, burrs, trephines, and accessories
882.4310Powered simple cranial drills, burrs, trephines, and accessoriesHBENLN(Simple, powered) drills, burrs, trephines, and accessories
884.1720Gynecologic laparoscope and accessoriesHETNMHGynecologic laparoscope (and accessories)
884.6100Assisted reproduction needlesMQENNBAssisted reproduction needles
886.4370KeratomeHMY, HNONKYKeratome blade
886.4670Phacofragmentation systemHQCNKXPhacoemulsification needle
892.5730Radionuclide brachytherapy sourceIWFNMPIsotope needle
1 Hemodialyzers have been excluded from this list because the reuse of hemodialyzers is addressed in FDA's “Guidance for Hemodialyzer Reuse Labeling” (final draft issued on October 6, 1995).

IV. Comments

You may submit written or electronic comments on this notice to the Division of Dockets Management (see ADDRESSES). You may submit a single copy of an electronic comment to http://www.fda.gov/​dockets/​ecomments. You should submit two paper copies of any mailed comments but individuals may submit one paper copy. You should identify your comment with the docket number found in brackets in the heading of this document. You may see any comments FDA receives in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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Attachment 1—List of SUDs Known To Be Reprocessed or Considered for Reprocessing June 26, 2003

Medical specialtyDevice type21 CFR sectionClassProduct codeRisk*Critical/semi-critical/noncriticalPremarket exempt
1CardioCardiopulmonary Bypass MarkerunclassifiedMAB1CN1
2CardioPercutaneous & Operative Transluminal Coronary Angioplasty Catheter (PTCA)post-amendmentIIILOX3CN
3CardioPercutaneous Ablation Electrodepost-amendmentIIILPB3CN
4CardioPeripheral Transluminal Angioplasty (PTA) CatheterunclassifiedLIT3CN
5CardioBlood-Pressure Cuff870.1120IIDXQ1NN
6CardioAngiography Catheter870.1200IIDQO3CN
7CardioElectrode Recording Catheter870.1220IIDRF3CN
8CardioHigh-Density Array Catheter870.1220IIMTD3CN
9CardioFiberoptic Oximeter Catheter870.1230IIDQE3CN
10CardioSteerable Catheter870.1280IIDRA3CN
11CardioSteerable Catheter Control System870.1290IIDXX3CN
12CardioGuide Wire870.1330IIDQX3CN
13CardioAngiographic Needle870.1390IIDRC3CN
14CardioTrocar870.1390IIDRC3CN
15CardioSyringes870.1650IIDXT3CN
16CardioInjector Type Syringe Actuator870.1670IIDQF3CN
17CardioOximeter870.2700IIDQA3NN
18CardioTissue Saturation Oximeter870.2700IIMUD3CN
19CardioIntra-Aortic Balloon System870.3535IIIDSP3CN
20CardioVascular Clamp870.4450IIDXC3CN
21CardioDevice, Stabilizer, Heart870.4500IMWS2CY2
22CardioExternal Vein Stripper870.4885IIDWQ3CN
23CardioCompressible Limb Sleeve870.5800IIJOW1NN
24DentalBur872.3240IEJL1CY
25DentalDiamond Coated Bur872.3240IEJL3CY
26DentalDiamond Instrument872.4535IDZP3CY
27DentalAC-Powered Bone Saw872.4120IIDZH2CN
28DentalManual Bone Drill and Wire Driver872.4120IIDZJ2CN
29DentalPowered Bone Drill872.4120IIDZI2CN
30DentalIntraoral Drill872.4130IDZA1CY
31DentalInjection needle872.4730IDZM3CY
32DentalMetal Orthodontic Bracket872.5410IEJF3SY
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33DentalPlastic Orthodontic Bracket872.5470IIDYW3SN
34ENTBur874.4140IEQJ1CY
35ENTDiamond Coated Bur874.4140IEQJ3CY
36ENTMicrodebrider874.4140IEQJ3CY
37ENTMicrosurgical Argon Fiber Optic Laser Cable, for Uses Other Than Otology, Including Laryngology and General Use in Otolaryngology874.4490IILMS1SN
38ENTMicrosurgical Argon Fiber Optic Laser Cable for Use in Otology874.4490IILXR1SN
39ENTMicrosurgical Carbon-Dioxide Fiber Optic Laser Cable874.4500IIEWG1SN
40 †ENTBronchoscope Biopsy Forceps (Nonrigid)874.4680IIBWH3CN
41 †ENTBronchoscope Biopsy Forceps (Rigid)874.4680IIJEK1CN
42 †Gastro/UrologyBiopsy Forceps Cover876.1075IFFF1CY
43 †Gastro/UrologyBiopsy Instrument876.1075IIKNW3CN
44 †Gastro/UrologyBiopsy Needle Set876.1075IIFCG3CN
45 †Gastro/UrologyBiopsy Punch876.1075IIFCI2CN
46 †Gastro/UrologyMechanical Biopsy Instrument876.1075IIFCF2CN
47 †Gastro/UrologyNonelectric Biopsy Forceps876.1075IFCL3CY
48Gastro/UrologyCytology Brush for Endoscope876.1500IIFDX2SN
49Gastro/UrologyEndoscope accessories876.1500IIKOG2SN
50Gastro/UrologyExtraction Balloons/Baskets876.1500IIKOG2SN
51Gastro/UrologyEndoscopic needle876.1500IIFBK3CN
52Gastro/UrologySimple Pneumoperitoneum Needle876.1500IIFHP3CN
53Gastro/UrologySpring Loaded Pneumoperitoneum Needle876.1500IIFHO3CN
54Gastro/UrologyActive Electrosurgical Electrode876.4300IIFAS3SN
55 †Gastro/UrologyBiliary Sphincterotomes876.5010, 876.1500IIFGE3CN
56Gastro/UrologyElectric Biopsy Forceps876.4300IIKGE3CN
57Gastro/UrologyElectrosurgical Endoscopic Unit (With or Without Accessories)876.4300IIKNS3SN
58Gastro/UrologyFlexible Snare876.4300IIFDI3SN
59Gastro/UrologyFlexible Suction Coagulator Electrode876.4300IIFEH3SN
Start Printed Page 38078
60Gastro/UrologyFlexible Stone Dislodger876.4680IIFGO3SY
61Gastro/UrologyMetal Stone Dislodger876.4680IIFFL3SY
62Gastro/UrologyNeedle Holder876.4730IFHQ1CY
63Gastro/UrologyNonelectrical Snare876.4730IFGX1SY
64Gastro/UrologyUrological Catheter876.5130IIKOD2SN
65Gastro/UrologySingle Needle Dialysis Set876.5540IILBW, FIE3CN
66Gastro/UrologyHemodialysis Blood Circuit Accessories876.5820IIKOC2SN
67Gastro/UrologySingle Needle Dialysis Set876.5820IIFIF3CN
68GE/UHemorrhoidal Ligator876.4400IIFHN2CN
69General HospitalImplanted, Programmable Infusion Pumppost-amendmentIIILKK3CN
70General HospitalNeedle Destruction Devicepost-amendmentIIIMTV1NN
71General HospitalNonpowered Flotation Therapy Mattress880.5150IIKY2NY
72General HospitalNon-AC-Powered Patient Lift880.5510IFSA2NY
73General HospitalAlternating Pressure Air Flotation Mattress880.5550IIFNM1NY
74General HospitalTemperature Regulated Water Mattress880.5560IFOH2NY
75General HospitalHypodermic Single Lumen Needle880.5570IIFMI3CN
76General HospitalPiston Syringe880.5860IIFMF3CN
77General HospitalMattress Cover (Medical Purposes)880.6190IFMW2NY
78General HospitalDisposable Medical Scissors880.6820IJOK1NY
79General HospitalIrrigating Syringe880.6960IKYZ, KYY1CY
80Infection ControlSurgical Gowns878.4040IIFYA1CN
81LabBlood Lancet878.4800IFMK1CY
82NeuroClip Forming/Cutting Instrument,882.4190IHBS3*CY
83NeuroDrills, Burrs, Trephines, and Accessories (Manual)882.4300IIHBG3*CN
84NeuroDrills, Burrs, Trephines, and Accessories (Compound, Powered)882.4305IIHBF3*CN
85NeuroDrills, Burrs, Trephines, and Accessories (Simple, Powered)882.4310IIHBE3*CN
86OB/GYNOocyte Aspiration NeedleUnclassifiedIIMHK3CN
87OB/GYNLaparoscope Accessories884.1720IHET2CY
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88OB/GYNLaparoscope Accessories884.1720IIHET3CN
89OB/GYNLaparoscopic Dissectors884.1720IHET2CY
90OB/GYNLaparoscopic Graspers884.1720IHET2CY
91OB/GYNLaparoscopic Scissors884.1720IHET2CY
92OB/GYNInsufflator Accessories (Tubing, Verres Needle, Kits)884.1730IIHIF3CY
93OB/GYNLaparoscopic Insufflator884.1730IIHIF2NN
94OB/GYNEndoscopic Electrocautery and Accessories884.4100IIHIM2NN
95OB/GYNGynecologic Electrocautery (and Accessories)884.4120IIHGI2NN
96OB/GYNEndoscopic Bipolar Coagulator-Cutter (and Accessories)884.4150IIHIN2NN
97OB/GYNCuldoscopic Coagulator (and Accessories)884.4160IIHFI2NN
98OB/GYNEndoscopic Unipolar Coagulator-Cutter (and Accessories)884.4160IIKNF2NN
99OB/GYNHysteroscopic Coagulator (and Accessories)884.4160IIHFH2NN
100OB/GYNUnipolar Laparoscopic Coagulator (and Accessories)884.4160IIHFG2NN
101OB/GYNEpisiotomy Scissors884.4520IHDK1CY
102OB/GYNUmbilical Scissors884.4520IHDJ1CY
103OB/GYNBiopsy Forceps884.4530IHFB3CY
104OB/GYNAssisted Reproduction Needles884.6100IIMQE3CN
105OphthalmicEndoilluminator876.1500IIMPA3*CN
106OphthalmicSurgical Drapes878.4370IIKKX2CN
107OphthalmicOphthalmic Knife886.4350IHNN3CY
108OphthalmicKeratome Blade886.4370I not exemptHMY, HNO3CN
109OphthalmicPhacoemulsification Needle886.4670IIHQC3CN
110OphthalmicPhacoemulsification/ Phacofragmentation Fluidic886.4670IIMUS2CN
111OphthalmicPhacofragmentation Unit886.4670IIHQC1NN
112OrthoSaw Blades878.4820IGFA, DWH, GEY, GET1CY
113OrthoSurgical Drills878.4820IGEY, GET1CY
114OrthoArthroscope accessories888.1100IIHRX2CY
Start Printed Page 38080
115OrthoBone Tap888.4540IHWX1CY
116OrthoBurr888.4540IHTT1CY
117OrthoCarpal Tunnel Blade888.4540ILXH2CY
118OrthoCountersink888.4540IHWW1CY
119OrthoDrill Bit888.4540IHTW1CY
120OrthoKnife888.4540IHTS1CY
121OrthoManual Surgical Instrument888.4540ILXH1CY
122OrthoNeedle Holder888.4540IHXK1CY
123OrthoReamer888.4540IHTO1CY
124OrthoRongeur888.4540IHTX1CY
125OrthoScissors888.4540IHRR1CY
126OrthoStaple Driver888.4540IHXJ1CY
127OrthoTrephine888.4540IHWK1CY
128OrthoFlexible Reamers/Drills886.4070 878.4820IGEY, HRG1CY
129OrthoExternal Fixation Frame888.3040 888.3030IIJEC, KTW, KTT2NN
130Physical MedicineNon-Heating Lamp for Adjunctive Use Inpatient TherapyunclassifiedNHN1NN
131Physical MedicineElectrode Cable890.1175IIIKD1NY
132Physical MedicineExternal Limb Component, Hip Joint890.3420IISL2NY
133Physical MedicineExternal Limb Component, Knee Joint890.3420IISY2NY
134Physical MedicineExternal Limb Component, Mechanical Wrist890.3420IISZ2NY
135Physical MedicineExternal Limb Component, Shoulder Joint890.3420IIQQ2NY
136Plastic SurgeryStapler878.4800IGAG, GEF, FHM, HBT2CY
137RadiologyIsotope Needle892.5730IIIWF3CN
138RespEndotracheal Tube ChangerunclassifiedIIILNZ3CN
139RespAnesthesia conduction needle868.5150IIBSP3CN
140RespShort term spinal needle868.5150IIMIA3CN
141RespRespiratory Therapy and Anesthesia Breathing Circuits868.5240ICAI2SY
142RespOral and Nasal Catheters868.5350IBZB1CY
143RespGas Masks868.5550IBSJ1SY
144RespBreathing Mouthpiece868.5620IBYP1NY
Start Printed Page 38081
145RespTracheal Tube868.5730IIBTR3CN
146RespAirway Connector868.5810IBZA2SY
147RespCPAP Mask868.5905IIBZD3SN
148RespEmergency Manual Resuscitator868.5915IIBTM2SN
149RespTracheobronchial Suction Catheter868.6810IBSY3SY
150SurgeryAC-Powered Orthopedic Instrument and AccessoriesunclassifiedHWE2CN
151SurgeryBreast Implant Mammary SizerunclassifiedMRD1CN
152SurgeryUltrasonic Surgical InstrumentunclassifiedLFL3CN
153SurgeryTrocar874.4420IKAB, KBG, KCI3CY
154SurgeryEndoscopic Blades876.1500IIGCP, GCR2CN
155SurgeryEndoscopic Guidewires876.1500IIGCP, GCR1CN
156SurgeryInflatable External Extremity Splint878.3900IFZF1NY
157SurgeryNoninflatable External Extremity Splint878.3910IFYH1NY
158SurgeryCatheter Needle878.4200IGCB3CY
159SurgeryImplantable Clip878.4300IIFZP3CN
160SurgeryElectrosurgical and Coagulation Unit With Accessories878.4400IIBWA2CN
161SurgeryElectrosurgical Apparatus878.4400IIHAM2CN
162SurgeryElectrosurgical Cutting and Coagulation Device and Accessories878.4400IIGEI2CN
163SurgeryElectrosurgical Device878.4400IIDWG2CN
164SurgeryElectrosurgical Electrode878.4400IIJOS2CN
165SurgeryImplantable Staple, Clamp, Clip for Suturing Apparatus878.4750IIGDW3CN
166SurgeryPercutaneous Biopsy Device878.4800IMJG3CY
167SurgeryGastro-Urology Needle878.4800IFHR3CY
168SurgeryAspiration and Injection Needle878.4800IGAA3CY
169SurgeryBiopsy Brush878.4800IGEE1CY
170SurgeryBlood Lancet878.4800IFMK1CY
171SurgeryBone Hook878.4800IKIK1CY
172SurgeryCardiovascular Biopsy Needle878.4800IDWO3CY
173SurgeryClamp878.4800IGDJ1CY
174SurgeryClamp878.4800IHXD1CY
Start Printed Page 38082
175SurgeryCurette878.4800IHTF1CY
176SurgeryDisposable Surgical Instrument878.4800IKDC1CY
177SurgeryDisposable Vein Stripper878.4800IGAJ1CY
178SurgeryDissector878.4800IGDI1CY
179SurgeryForceps878.4800IGEN2CY
180SurgeryForceps878.4800IHTD2CY
181SurgeryGouge878.4800IGDH1CY
182SurgeryHemostatic Clip Applier878.4800IHBT2CY
183SurgeryHook878.4800IGDG1CY
184SurgeryManual Instrument878.4800IMDM, MDW1CY
185SurgeryManual Retractor878.4800IGZW1CY
186SurgeryManual Saw and Accessories878.4800IGDR, HAC1CY
187SurgeryManual Saw and Accessories878.4800IHAC1CY
188SurgeryManual Surgical Chisel878.4800IFZO1CY
189SurgeryMastoid Chisel878.4800IJYD1CY
190SurgeryOrthopedic Cutting Instrument878.4800IHTZ1CY
191SurgeryOrthopedic Spatula878.4800IHXR1CY
192SurgeryOsteotome878.4800IHWM1CY
193SurgeryRasp878.4800IGAC1CY
194SurgeryRasp878.4800IHTR1CY
195SurgeryRetractor878.4800IGAD1CY
196SurgeryRetractor878.4800IHXM1CY
197SurgerySaw878.4800IHSO1CY
198SurgeryScalpel Blade878.4800IGES1CY
199SurgeryScalpel Handle878.4800IGDZ1CY
200SurgeryScissors878.4800ILRW1CY
201SurgerySnare878.4800IGAE1CY
202SurgerySpatula878.4800IGAF1CY
203SurgeryStaple Applier878.4800IGEF2CY
204SurgeryStapler878.4800IGAG2CY
205SurgeryStomach and Intestinal Suturing Apparatus878.4800IFHM2CY
206SurgerySurgical Curette878.4800IFZS1CY
207SurgerySurgical Cutter878.4800IFZT1CY
208SurgerySurgical Knife878.4800IEMF1SY
209SurgeryLaser Powered Instrument878.4810IIGEX2CN
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210SurgeryAc-Powered Motor878.4820IGEY2CY
211SurgeryBit878.4820IGFG1CY
212SurgeryBur878.4820IGFF, GEY1CY
213SurgeryCardiovascular Surgical Saw Blade878.4820IDWH1CY
214SurgeryChisel (Osteotome)878.4820IKDG1CY
215SurgeryDermatome878.4820IGFD1CY
216SurgeryElectrically Powered Saw878.4820IDWI2CY
217SurgeryPneumatic Powered Motor878.4820IGET2CY
218SurgeryPneumatically Powered Saw878.4820IKFK2CY
219SurgeryPowered Saw and Accessories878.4820IHAB2CY
220SurgerySaw Blade878.4820IGFA1CY
221SurgeryNonpneumatic Tourniquet878.5900IGAX1NY
222SurgeryPneumatic Tourniquet878.5910IKCY1NY
223SurgeryEndoscopic Staplers888.4540IHXJ2CY
224SurgeryTrocar876.1500 870.1390IIGCJ, DRC3CN
225SurgerySurgical Cutting Accessories878.4800 874.4420IGDZ, GDX, GES, KBQ, KAS2CY
226SurgeryElectrosurgical Electrodes/Handles/Pencils876.4300 878.4400IIHAM, GEI, FAS2CN
227SurgeryScissor Tips878.4800 884.4520 874.4420ILRW, HDK, HDJ, JZB, KBD2CY
228SurgeryLaser Fiber Delivery Systems878.4810 874.4500 886.4390 884.4550 886.4690IIGEX, EWG, LLW, HQF, HHR, HQB1CN
1 N means no.
2 Y means yes.
† Indicates a change since last publication.
Start Signature

Dated: June 20, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

Footnotes

1.  These are known in the industry as the Spaulding definitions, and are described in 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, IL 1971:254-274.

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2.  This scheme is described in the agency's February 2000 draft guidance document entitled “Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme.” The document is available on the Internet at http://www.fda.gov/​cdrh/​reuse/​1156.pdf.

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[FR Doc. 03-16109 Filed 6-25-03; 8:45 am]

BILLING CODE 4160-01-S