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Notice

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

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Information about this document as published in the Federal Register.

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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.

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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, 301-443-8320, ext. 158.

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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 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) 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 Start Printed Page 56912publication 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.)

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.

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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 nameProduct code for nonreprocessed deviceProduct code for reprocessed deviceProduct code name for reprocessed device
868.6810Tracheobronchial suction catheterBSYNQVTracheobronchial suction catheter
870.4500Cardiovascular surgical instrumentsMWSNQGNoncompression heart stabilizer
872.3240Dental burDiamond coatedNMEDental diamond coated bur
872.4535Dental diamond instrumentDZPNLDDental diamond instrument
872.4730Dental injection needleDZMNMWDental needle
872.5410Orthodontic appliance and accessoriesEJFNQSOrthodontic metal bracket
874.4140Ear, nose, and throat burMicrodebriderNLYENT high speed microdebrider
874.4140Ear, nose, and throat burDiamond coatedNLZENT diamond coated bur
874.4420Ear, nose, throat manual surgical ..KAB, KBG, KCINLBLaryngeal, sinus, tracheal trocar
876.1075Gastroenterology-urology biopsy instrumentFCLNONNonelectric biopsy forceps
876.4680Ureteral stone dislodgerFGO, FFLNQT, NQUFlexible and basket stone dislodger
878.4200Introduction/drainage catheter and accessoriesGCBNMTCatheter needle
878.4800Manual surgical instrumentMJGNNAPercutaneous biopsy device
878.4800Manual surgical instrumentFHRNMUGastro-Urology needle
878.4800Manual surgical instrument for ... ....DWONLKCardiovascular biopsy needle
878.4800Manual surgical instrument for...GAANNCAspiration and injection needle
882.4190Forming/cutting clip instrumentHBSNMNForming/cutting clip instrument
884.1730Laparoscopic insufflator, ..HIFNMILaparoscopic insufflator and accessories
884.4530OB/GYN specialized manual instrumentHFBNMGGynecological biopsy forceps
886.4350Manual ophthalmic surgical instrumentHNNNLAOphthalmic knife
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List II.—Reprocessed Single-Use Devices Subject to Premarket Notification Requirements That Now Require the Submission of Validation Data1 [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 nameProduct code for nonreprocessed 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/without introducer)
868.5150Anesthesia conduction needleMIANMRShort term spinal needle
868.5730Tracheal tubeBTRNMATracheal tube (with/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
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876.1500Endoscope and accessoriesFHONLXSpring-loaded pneumoperitoneum needle
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
878.4400Electrosurgical Cutting and Coagulation Device and AccessoriesGEINUJEndoscopic and laparoscopic electrosurgical accessories
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 .HBFNLP(Powered, compound) drills, burrs, trephines and accessories
882.4310Powered simple cranial drills, burrs, trephines .HBENLN(Simple, powered) drills, burrs, trephines and accessories
884.1720Gynecologic laparoscope and accessoriesHETNMHGynecologic laparoscope (and accessories)
884.6100Assisted reproduction needleMQENNBAssisted reproduction needle
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 “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.
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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 SpecialtyDevice TypeRegulation NumberClassProduct CodeRiskACritical/Semicritical/NoncriticalPremarket Exempt
1CardioCardiopulmonary Bypass MarkerUnclassifiedMAB1CN
2CardioPercutaneous & Operative Transluminal Coronary Angioplasty Catheter (PTCA)Post-amendmentIIILOX3CN
3CardioPercutaneous Ablation ElectrodePost-amendmentIIILPB3CN
4CardioPeripheral Transluminal Angioplasty (PTA) Catheter870.1250IILIT3CN
5CardioBlood-Pressure Cuff870.1120IIDXQ1NN
6CardioAngiography Catheter870.1200IIDQO3CN
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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
21CardioHeart Stabilizer870.4500IMWS2CY
22CardioNoncompression Heart Stabilizer870.4500IMWS3CY
23CardioExternal Vein Stripper870.4885IIDWQ3CN
24CardioCompressible Limb Sleeve870.5800IIJOW1NN
25DentalBur872.3240IEJL1CY
26DentalDiamond Coated Bur872.3240IEJL3CY
27DentalDiamond Instrument872.4535IDZP3CY
28DentalAC-Powered Bone Saw872.4120IIDZH2CN
29DentalManual Bone Drill and Wire Driver872.4120IIDZJ2CN
30DentalPowered Bone Drill872.4120IIDZI2CN
31DentalIntraoral Drill872.4130IDZA1CY
32DentalInjection needle872.4730IDZM3CY
33DentalMetal Orthodontic Bracket872.5410IEJF3SY
34DentalPlastic Orthodontic Bracket872.5470IIDYW3SN
35ENTBur874.4140IEQJ1CY
36ENTDiamond Coated Bur874.4140IEQJ3CY
37ENTMicrodebrider874.4140IEQJ3CY
Start Printed Page 56918
38ENTMicrosurgical Argon Fiber Optic Laser Cable, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology874.4490IILMS1SN
39ENTMicrosurgical Argon Fiber Optic Laser Cable, For Use In Otology874.4490IILXR1SN
40ENTMicrosurgical Carbon-Dioxide Fiber Optic Laser Cable874.4500IIEWG1SN
41ENTBronchoscope Biopsy Forceps (Nonrigid)874.4680IIBWH3CN
42ENTBronchoscope Biopsy Forceps (Rigid)874.4680IIJEK1CN
43Gastro/ UrologyBiopsy Forceps Cover876.1075IFFF1CY
44Gastro/ UrologyBiopsy Instrument876.1075IIKNW3CN
45Gastro/ UrologyBiopsy Needle Set876.1075IIFCG3CN
46Gastro/ UrologyBiopsy Punch876.1075IIFCI2CN
47Gastro/ UrologyMechanical Biopsy Instrument876.1075IIFCF2CN
48Gastro/ UrologyNonelectric Biopsy Forceps876.1075IFCL3CY
49Gastro/ UrologyCytology Brush For Endoscope876.1500IIFDX2SN
50Gastro/ UrologyEndoscope accessories876.1500IIKOG2SN
51Gastro/ UrologyExtraction Balloons/Baskets876.1500IIKOG2SN
52Gastro/UrologyEndoscopic needle876.1500IIFBK3CN
53Gastro/ UrologySimple Pneumoperitoneum Needle876.1500IIFHP3CN
54Gastro/ UrologySpring Loaded Pneumoperitoneum Needle876.1500IIFHO3CN
55Gastro/ UrologyActive Electrosurgical Electrode876.4300IIFAS3SN
56Gastro/ UrologyBiliary Sphincterotomes876.5010, 876.1500IIFGE3CN
57Gastro/ UrologyElectric Biopsy Forceps876.4300IIKGE3CN
58Gastro/ UrologyElectrosurgical Endoscopic Unit (With Or Without Accessories)876.4300IIKNS3SN
Start Printed Page 56919
59Gastro/ UrologyFlexible Snare876.4300IIFDI3SN
60Gastro/ UrologyFlexible Suction Coagulator Electrode876.4300IIFEH3SN
61Gastro/ UrologyFlexible Stone Dislodger876.4680IIFGO3SY
62Gastro/ UrologyMetal Stone Dislodger876.4680IIFFL3SY
63Gastro/ UrologyNeedle Holder876.4730IFHQ1CY
64Gastro/ UrologyNonelectrical Snare876.4730IFGX1SY
65Gastro/ UrologyUrological Catheter876.5130IIKOD2SN
66Gastro/UrologySingle needle dialysis set876.5540IILBW, FIE3CN
67Gastro/ UrologyHemodialysis Blood Circuit Accessories876.5820IIKOC2SN
68Gastro/UrologySingle needle dialysis set876.5820IIFIF3CN
69Gastro/UrologyHemorrhoidal Ligator876.4400IIFHN2CN
70General HospitalImplanted, Programmable Infusion PumpPost-amendmentIIILKK3CN
71General HospitalNeedle Destruction DevicePost-amendmentIIIMTV1NN
72General HospitalNonpowered Flotation Therapy Mattress880.5150IIKY2NY
73General HospitalNonAC-Powered Patient Lift880.5510IFSA2NY
74General HospitalAlternating Pressure Air Flotation Mattress880.5550IIFNM1NY
75General HospitalTemperature Regulated Water Mattress880.5560IFOH2NY
76General HospitalHypodermic Single Lumen Needle880.5570IIFMI3CN
77General HospitalPiston Syringe880.5860IIFMF3CN
78General HospitalMattress Cover (Medical Purposes)880.6190IFMW2NY
79General HospitalDisposable Medical Scissors880.6820IJOK1NY
80General HospitalIrrigating Syringe880.6960IKYZ, KYY1CY
81Infection ControlSurgical Gowns878.4040IIFYA1CN
82LabBlood Lancet878.4800IFMK1CY
Start Printed Page 56920
83NeurologyClip Forming/Cutting Instrument,882.4190IHBS3*CY
84NeurologyDrills, Burrs, Trephines &Accessories (Manual)882.4300IIHBG3*CN
85NeurologyDrills, Burrs, Trephines &Accessories (Compound, Powered)882.4305IIHBF3*CN
86NeurologyDrills, Burrs, Trephines &Accessories (Simple, Powered)882.4310IIHBE3*CN
87OB/GYNOocyte aspiration needleIIIMHK3CN
88OB/GYNLaparoscope accessories884.1720IHET2CY
89OB/GYNLaparoscope Accessories884.1720IIHET3CN
90OB/GYNLaparoscopic Dissectors884.1720IHET2CY
91OB/GYNLaparoscopic Graspers884.1720IHET2CY
92OB/GYNLaparoscopic Scissors884.1720IHET2CY
93OB/GYNInsufflator accessories (tubing, Verres needle, kits)884.1730IIHIF3CY
94OB/GYNLaparoscopic Insufflator884.1730IIHIF2NN
95OB/GYNEndoscopic Electrocautery and Accessories884.4100IIHIM2NN
96OB/GYNGynecologic Electrocautery (and Accessories)884.4120IIHGI2NN
97OB/GYNEndoscopic Bipolar Coagulator-Cutter (and Accessories)884.4150IIHIN2NN
98OB/GYNCuldoscopic Coagulator (and Accessories)884.4160IIHFI2NN
99OB/GYNEndoscopic Unipolar Coagulator-Cutter (and Accessories)884.4160IIKNF2NN
100OB/GYNHysteroscopic Coagulator (and Accessories)884.4160IIHFH2NN
101OB/GYNUnipolar Laparoscopic Coagulator (and Accessories)884.4160IIHFG2NN
102OB/GYNEpisiotomy Scissors884.4520IHDK1CY
103OB/GYNUmbilical Scissors884.4520IHDJ1CY
104OB/GYNBiopsy Forceps884.4530IHFB3CY
105OB/GYNAssisted reproduction needle884.6100IIMQE3CN
106OphthalmicEndoilluminator876.1500IIMPA3*CN
107OphthalmicSurgical Drapes878.4370IIKKX2CN
108OphthalmicOphthalmic Knife886.4350IHNN3CY
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109OphthalmicKeratome Blade886.4370IHMY, HNO3CN
110OphthalmicPhacoemulsification Needle886.4670IIHQC3CN
111OphthalmicPhacoemulsification/ Phacofragmentation Fluidic886.4670IIMUS2CN
112OphthalmicPhacofragmentation Unit886.4670IIHQC1NN
113OrthopedicSaw Blades878.4820IGFA, DWH, GEY, GET1CY
114OrthopedicSurgical Drills878.4820IGEY, GET1CY
115OrthopedicArthroscope accessories888.1100IIHRX2CY
116OrthopedicBone Tap888.4540IHWX1CY
117OrthopedicBurr888.4540IHTT1CY
118OrthopedicCarpal Tunnel Blade888.4540ILXH2CY
119OrthopedicCountersink888.4540IHWW1CY
120OrthopedicDrill Bit888.4540IHTW1CY
121OrthopedicKnife888.4540IHTS1CY
122OrthopedicManual Surgical Instrument888.4540ILXH1CY
123OrthopedicNeedle Holder888.4540IHXK1CY
124OrthopedicReamer888.4540IHTO1CY
125OrthopedicRongeur888.4540IHTX1CY
126OrthopedicScissors888.4540IHRR1CY
127OrthopedicStaple Driver888.4540IHXJ1CY
128OrthopedicTrephine888.4540IHWK1CY
129OrthopedicFlexible Reamers/Drills886.4070 878.4820IGEY, HRG1CY
130OrthopedicExternal Fixation Frame888.3040 888.3030IIJEC KTW KTT2NN
131Physical MedicineNonheating Lamp for Adjunctive Use Inpatient Therapy890.5500IINHN1NN
132Physical MedicineElectrode Cable,890.1175IIIKD1NY
133Physical MedicineExternal Limb Component, Hip Joint890.3420IISL2NY
134Physical MedicineExternal Limb Component, Knee Joint890.3420IISY2NY
135Physical MedicineExternal Limb Component, Mechanical Wrist890.3420IISZ2NY
136Physical MedicineExternal Limb Component, Shoulder Joint890.3420IIQQ2NY
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137Plastic SurgeryStapler878.4800IGAG, GEF, FHM, HBT2CY
138RadiologyIsotope Needle892.5730IIIWF3CN
139RespiratoryEndotracheal Tube ChangerUnclassifiedIIILNZ3CN
140RespiratoryAnesthesia conduction needle868.5150IIBSP3CN
141RespiratoryShort term spinal needle868.5150IIMIA3CN
142RespiratoryRespiratory Therapy and Anesthesia Breathing Circuits868.5240ICAI2SY
143RespiratoryOral and Nasal Catheters868.5350IBZB1CY
144RespiratoryGas Masks868.5550IBSJ1SY
145RespiratoryBreathing Mouthpiece868.5620IBYP1NY
146RespiratoryTracheal Tube868.5730IIBTR3CN
147RespiratoryAirway Connector868.5810IBZA2SY
148RespiratoryCPAP Mask868.5905IIBZD3SN
149RespiratoryEmergency Manual Resuscitator868.5915IIBTM2SN
150RespiratoryTracheobronchial Suction Catheter868.6810IBSY3SY
151SurgeryAC-powered Orthopedic Instrument and accessories878.4820IHWE2CN
152SurgeryBreast Implant Mammary SizerUnclassifiedMRD1CN
153SurgeryUltrasonic Surgical InstrumentUnclassifiedLFL3CN
154SurgeryTrocar874.4420IKAB, KBG, KCI3CY
155SurgeryEndoscopic Blades876.1500IIGCP, GCR2CN
156SurgeryEndoscopic Guidewires876.1500IIGCP, GCR1CN
157SurgeryInflatable External Extremity Splint878.3900IFZF1NY
158SurgeryNoninflatable External Extremity Splint878.3910IFYH1NY
159SurgeryCatheter needle878.4200IGCB3CY
160SurgeryImplantable Clip878.4300IIFZP3CN
161SurgeryElectrosurgical and Coagulation Unit With Accessories878.4400IIBWA2CN
162SurgeryElectrosurgical Apparatus878.4400IIHAM2CN
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163SurgeryElectrosurgical Cutting & Coagulation Device & Accessories878.4400IIGEI NUJ2 3CN
164SurgeryElectrosurgical Device878.4400IIDWG2CN
165SurgeryElectrosurgical Electrode878.4400IIJOS2CN
166SurgeryImplantable Staple, Clamp, Clip for Suturing Apparatus878.4750IIGDW3CN
167SurgeryPercutaneous biopsy device878.4800IMJG3CY
168SurgeryGastro-Urology needle878.4800IFHR3CY
169SurgeryAspiration and injection needle878.4800IGAA3CY
170SurgeryBiopsy Brush878.4800IGEE1CY
171SurgeryBlood Lancet878.4800IFMK1CY
172SurgeryBone Hook878.4800IKIK1CY
173SurgeryCardiovascular Biopsy Needle878.4800IDWO3CY
174SurgeryClamp878.4800IGDJ1CY
175SurgeryClamp878.4800IHXD1CY
176SurgeryCurette878.4800IHTF1CY
177SurgeryDisposable Surgical Instrument878.4800IKDC1CY
178SurgeryDisposable Vein Stripper878.4800IGAJ1CY
179SurgeryDissector878.4800IGDI1CY
180SurgeryForceps878.4800IGEN2CY
181SurgeryForceps878.4800IHTD2CY
182SurgeryGouge878.4800IGDH1CY
183SurgeryHemostatic Clip Applier878.4800IHBT2CY
184SurgeryHook878.4800IGDG1CY
185SurgeryManual Instrument878.4800IMDM, MDW1CY
186SurgeryManual Retractor878.4800IGZW1CY
187SurgeryManual Saw and Accessories878.4800IGDR HAC1CY
188SurgeryManual Saw and Accessories878.4800IHAC1CY
189SurgeryManual Surgical Chisel878.4800IFZO1CY
190SurgeryMastoid Chisel878.4800IJYD1CY
191SurgeryOrthopedic Cutting Instrument878.4800IHTZ1CY
192SurgeryOrthopedic Spatula878.4800IHXR1CY
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193SurgeryOsteotome878.4800IHWM1CY
194SurgeryRasp878.4800IGAC1CY
195SurgeryRasp878.4800IHTR1CY
196SurgeryRetractor878.4800IGAD1CY
197SurgeryRetractor878.4800IHXM1CY
198SurgerySaw878.4800IHSO1CY
199SurgeryScalpel Blade878.4800IGES1CY
200SurgeryScalpel Handle878.4800IGDZ1CY
201SurgeryScissors878.4800ILRW1CY
202SurgerySnare878.4800IGAE1CY
203SurgerySpatula878.4800IGAF1CY
204SurgeryStaple Applier878.4800IGEF2CY
205SurgeryStapler878.4800IGAG2CY
206SurgeryStomach and Intestinal Suturing Apparatus878.4800IFHM2CY
207SurgerySurgical Curette878.4800IFZS1CY
208SurgerySurgical Cutter878.4800IFZT1CY
209SurgerySurgical Knife878.4800IEMF1SY
210SurgeryLaser Powered Instrument878.4810IIGEX2CN
211SurgeryAC-Powered Motor878.4820IGEY2CY
212SurgeryBit878.4820IGFG1CY
213SurgeryBur878.4820IGFF, GEY1CY
214SurgeryCardiovascular Surgical Saw Blade878.4820IDWH1CY
215SurgeryChisel (Osteotome)878.4820IKDG1CY
216SurgeryDermatome878.4820IGFD1CY
217SurgeryElectrically Powered Saw878.4820IDWI2CY
218SurgeryPneumatic Powered Motor878.4820IGET2CY
219SurgeryPneumatically Powered Saw878.4820IKFK2CY
220SurgeryPowered Saw and Accessories878.4820IHAB2CY
221SurgerySaw Blade878.4820IGFA1CY
222SurgeryNonpneumatic Tourniquet878.5900IGAX1NY
223SurgeryPneumatic Tourniquet878.5910IKCY1NY
224SurgeryEndoscopic Staplers888.4540IHXJ2CY
225SurgeryTrocar876.1500 870.1390IIGCJ, DRC3CN
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226SurgerySurgical Cutting Accessories878.4800, 874.4420IGDZ, GDX, GES, KBQ, KAS2CY
227SurgeryElectrosurgical Electrodes/Handles/Pencils876.4300 878.4400IIHAM, GEI, FAS2CN
228SurgeryScissor Tips878.4800, 884.4520, 874.4420ILRW, HDK, HDJ, JZB, KBD2CY
229SurgeryLaser Fiber Delivery Systems878.4810 874.4500 886.4390 884.4550 886.4690IIGEX EWG LLW HQF HHR HQB1CN
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.
Start Signature

Dated: September 22, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

Footnotes

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.

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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.

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

BILLING CODE 4160-01-S