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 Department of Health and Human Services Food and Drug Administration [Docket No. 2003N-0161] (formerly Docket No. 03N-0161)
 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) 
                    *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 
                    ( print page 56912)
                    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.) 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 device868.6810
Tracheobronchial suction catheter
BSY
NQV
Tracheobronchial suction catheter870.4500
Cardiovascular surgical instruments
MWS
NQG
Noncompression heart stabilizer872.3240
Dental bur
Diamond coated
NME
Dental diamond coated bur872.4535
Dental diamond instrument
DZP
NLD
Dental diamond instrument872.4730
Dental injection needle
DZM
NMW
Dental needle872.5410
Orthodontic appliance and accessories
EJF
NQS
Orthodontic metal bracket874.4140
Ear, nose, and throat bur
Microdebrider
NLY
ENT high speed microdebrider874.4140
Ear, nose, and throat bur
Diamond coated
NLZ
ENT diamond coated bur874.4420
Ear, nose, throat manual surgical ..
KAB, KBG, KCI
NLB
Laryngeal, sinus, tracheal trocar876.1075
Gastroenterology-urology biopsy instrument
FCL
NON
Nonelectric biopsy forceps876.4680
Ureteral stone dislodger
FGO, FFL
NQT, NQU
Flexible and basket stone dislodger878.4200
Introduction/drainage catheter and accessories
GCB
NMT
Catheter needle878.4800
Manual surgical instrument
MJG
NNA
Percutaneous biopsy device878.4800
Manual surgical instrument
FHR
NMU
Gastro-Urology needle878.4800
Manual surgical instrument for ... ....
DWO
NLK
Cardiovascular biopsy needle878.4800
Manual surgical instrument for...
GAA
NNC
Aspiration and injection needle882.4190
Forming/cutting clip instrument
HBS
NMN
Forming/cutting clip instrument884.1730
Laparoscopic insufflator, ..
HIF
NMI
Laparoscopic insufflator and accessories884.4530
OB/GYN specialized manual instrument
HFB
NMG
Gynecological biopsy forceps886.4350
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 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 name
Product code for nonreprocessed 
                             device
Product code for reprocessed 
                             device
Product code name for 
                             reprocessed deviceUnclassified
Oocyte aspiration needles
MHK
NMO
Oocyte aspiration needlesUnclassified
Percutaneous transluminal angioplasty catheter
LIT
NMM
Transluminal peripheral angioplasty catheterUnclassified
Ultrasonic surgical instrument
LFL
NLQ
Ultrasonic scalpel868.5150
Anesthesia conduction needle
BSP
NNH
Anesthetic conduction needle (with/without introducer)868.5150
Anesthesia conduction needle
MIA
NMR
Short term spinal needle868.5730
Tracheal tube
BTR
NMA
Tracheal tube (with/without connector)868.5905
Noncontinuous ventilator (IPPB)
BZD
NMC
Noncontinuous ventilator (respirator) mask870.1200
Diagnostic intravascular catheter
DQO
NLI
Angiography catheter870.1220
Electrode Recording Catheter
DRF
NLH
Electrode recording catheter870.1220
Electrode Recording Catheter
MTD
NLG
Intracardiac mapping catheter870.1230
Fiberoptic oximeter catheter
DQE
NMB
Fiberoptic oximeter catheter870.1280
Steerable Catheter
DRA
NKS
Steerable Catheter870.1290
Steerable catheter control system
DXX
NKR
Steerable catheter control system870.1330
Catheter guide wire
DQX
NKQ
Catheter guide wire870.1390
Trocar
DRC
NMK
Cardiovascular trocar870.1650
Angiographic injector and syringe
DXT
NKT
Angiographic injector and syringe870.1670
Syringe actuator for injector
DQF
NKW
Injector for actuator syringe870.2700
Oximeter
MUD
NMD
Tissue saturation oximeter870.2700
Oximeter
DQA
NLF
Oximeter870.3535
Intra-aortic balloon and control system
DSP
NKO
Intra-aortic balloon and control system870.4450
Vascular clamp
DXC
NMF
Vascular clamp870.4885
External vein stripper
DWQ
NLJ
External vein stripper872.5470
Orthodontic Plastic Bracket
DYW
NLC
Orthodontic Plastic Bracket874.4680
Bronchoscope (flexible or rigid) and accessories
BWH
NLE
Bronchoscope (nonrigid) biopsy forceps876.1075
Gastro-Urology biopsy instrument
FCG
NMX
G-U biopsy needle and needle set876.1075
Gastroenterology-urology biopsy instrument
KNW
NLS
Biopsy instrument876.1500
Endoscope and accessories
FBK, FHP
NMY
Endoscopic needle876.1500
Endoscope and accessories
MPA
NKZ
Endoilluminator876.1500
Endoscope and accessories
GCJ
NLM
General and plastic surgery laparoscope( print page 56915)876.1500
Endoscope and accessories
FHO
NLX
Spring-loaded pneumoperitoneum needle876.4300
Endoscopic electrosurgical unit and accessories
FAS
NLW
Active Urological electrosurgical electrode876.4300
Endoscopic electrosurgical unit and accessories
FEH
NLV
Flexible suction coagulator electrode876.4300
Endoscopic electrosurgical unit and accessories
KGE
NLU
Electric biopsy forceps876.4300
Endoscopic electrosurgical unit and accessories
FDI
NLT
Flexible snare876.4300
Endoscopic electrosurgical unit and accessories
KNS
NLR
Endoscopic (with or without accessories) Electrosurgical unit876.5010
Biliary catheter and accessories
FGE
NML
Biliary  catheter876.5540
Blood access device and accessories
LBW
NNF
Single needle dialysis set (co-axial flow)876.5540
Blood access device and accessories
FIE
NNE
Fistula needle876.5820
Hemodialysis systems and accessories
FIF
NNG
Single needle dialysis set with uni-directional pump878.4300
Implantable clip
FZP
NMJ
Implantable clip878.4400
Electrosurgical Cutting and Coagulation Device and Accessories
GEI
NUJ
Endoscopic and laparoscopic electrosurgical accessories878.4750
Implantable staple
GDW
NLL
Implantable staple880.5570
Hypodermic single lumen needle
FMI
NKK
Hypodermic single lumen needle880.5860
Piston Syringe
FMF
NKN
Piston Syringe882.4300
Manual cranial drills, burrs, trephines and accessories
HBG
NLO
(Manual) drills, burrs, trephines and accessories882.4305
Powered compound cranial drills, burrs, trephines .
HBF
NLP
(Powered, compound) drills, burrs, trephines and accessories882.4310
Powered simple cranial drills, burrs, trephines .
HBE
NLN
(Simple, powered) drills, burrs, trephines and accessories884.1720
Gynecologic laparoscope and accessories
HET
NMH
Gynecologic laparoscope (and accessories)884.6100
Assisted reproduction needle
MQE
NNB
Assisted reproduction needle886.4370
Keratome
HMY, HNO
NKY
Keratome blade886.4670
Phacofragmentation system
HQC
NKX
Phacoemulsification needle892.5730
Radionuclide brachytherapy source
IWF
NMP
Isotope needle1
                        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
RiskA
Critical/Semicritical/Noncritical
Premarket 
                             Exempt1
Cardio
Cardiopulmonary Bypass Marker
Unclassified

MAB
1
C
N2
Cardio
Percutaneous & Operative Transluminal Coronary Angioplasty Catheter (PTCA)
Post-amendment
III
LOX
3
C
N3
Cardio
Percutaneous Ablation Electrode
Post-amendment
III
LPB
3
C
N4
Cardio
Peripheral Transluminal Angioplasty (PTA) Catheter
870.1250
II
LIT
3
C
N5
Cardio
Blood-Pressure Cuff
870.1120
II
DXQ
1
N
N6
Cardio
Angiography Catheter
870.1200
II
DQO
3
C
N( print page 56917)7
Cardio
Electrode Recording Catheter
870.1220
II
DRF
3
C
N8
Cardio
High-Density Array Catheter
870.1220
II
MTD
3
C
N9
Cardio
Fiberoptic Oximeter Catheter
870.1230
II
DQE
3
C
N10
Cardio
Steerable Catheter
870.1280
II
DRA
3
C
N11
Cardio
Steerable Catheter Control System
870.1290
II
DXX
3
C
N12
Cardio
Guide Wire
870.1330
II
DQX
3
C
N13
Cardio
Angiographic Needle
870.1390
II
DRC
3
C
N14
Cardio
Trocar
870.1390
II
DRC
3
C
N15
Cardio
Syringes
870.1650
II
DXT
3
C
N16
Cardio
Injector Type Syringe Actuator
870.1670
II
DQF
3
C
N17
Cardio
Oximeter
870.2700
II
DQA
3
N
N18
Cardio
Tissue Saturation Oximeter
870.2700
II
MUD
3
C
N19
Cardio
Intra-Aortic Balloon System
870.3535
III
DSP
3
C
N20
Cardio
Vascular Clamp
870.4450
II
DXC
3
C
N21
Cardio
Heart Stabilizer
870.4500
I
MWS
2
C
Y22
Cardio
Noncompression Heart Stabilizer
870.4500
I
MWS
3
C
Y23
Cardio
External Vein Stripper
870.4885
II
DWQ
3
C
N24
Cardio
Compressible Limb Sleeve
870.5800
II
JOW
1
N
N25
Dental
Bur
872.3240
I
EJL
1
C
Y26
Dental
Diamond Coated Bur
872.3240
I
EJL
3
C
Y27
Dental
Diamond Instrument
872.4535
I
DZP
3
C
Y28
Dental
AC-Powered Bone Saw
872.4120
II
DZH
2
C
N29
Dental
Manual Bone Drill and Wire Driver
872.4120
II
DZJ
2
C
N30
Dental
Powered Bone Drill
872.4120
II
DZI
2
C
N31
Dental
Intraoral Drill
872.4130
I
DZA
1
C
Y32
Dental
Injection needle
872.4730
I
DZM
3
C
Y33
Dental
Metal Orthodontic Bracket
872.5410
I
EJF
3
S
Y34
Dental
Plastic Orthodontic Bracket
872.5470
II
DYW
3
S
N35
ENT
Bur
874.4140
I
EQJ
1
C
Y36
ENT
Diamond Coated Bur
874.4140
I
EQJ
3
C
Y37
ENT
Microdebrider
874.4140
I
EQJ
3
C
Y( print page 56918)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
N39
ENT
Microsurgical Argon Fiber Optic Laser Cable, For Use In Otology
874.4490
II
LXR
1
S
N40
ENT
Microsurgical Carbon-Dioxide Fiber Optic Laser Cable
874.4500
II
EWG
1
S
N41
ENT
Bronchoscope Biopsy Forceps (Nonrigid)
874.4680
II
BWH
3
C
N42
ENT
Bronchoscope Biopsy Forceps (Rigid)
874.4680
II
JEK
1
C
N43
Gastro/ Urology
Biopsy Forceps Cover
876.1075
I
FFF
1
C
Y44
Gastro/ Urology
Biopsy Instrument
876.1075
II
KNW
3
C
N45
Gastro/ Urology
Biopsy Needle Set
876.1075
II
FCG
3
C
N46
Gastro/ Urology
Biopsy Punch
876.1075
II
FCI
2
C
N47
Gastro/ Urology
Mechanical Biopsy Instrument
876.1075
II
FCF
2
C
N48
Gastro/ Urology
Nonelectric Biopsy Forceps
876.1075
I
FCL
3
C
Y49
Gastro/ Urology
Cytology Brush For Endoscope
876.1500
II
FDX
2
S
N50
Gastro/ Urology
Endoscope accessories
876.1500
II
KOG
2
S
N51
Gastro/ Urology
Extraction Balloons/Baskets
876.1500
II
KOG
2
S
N52
Gastro/Urology
Endoscopic needle
876.1500
II
FBK
3
C
N53
Gastro/ Urology
Simple Pneumoperitoneum Needle
876.1500
II
FHP
3
C
N54
Gastro/ Urology
Spring Loaded Pneumoperitoneum Needle
876.1500
II
FHO
3
C
N55
Gastro/ Urology
Active Electrosurgical Electrode
876.4300
II
FAS
3
S
N56
Gastro/ Urology
Biliary Sphincterotomes
876.5010, 876.1500
II
FGE
3
C
N57
Gastro/ Urology
Electric Biopsy Forceps
876.4300
II
KGE
3
C
N58
Gastro/ Urology
Electrosurgical Endoscopic Unit (With Or Without Accessories)
876.4300
II
KNS
3
S
N( print page 56919)59
Gastro/ Urology
Flexible Snare
876.4300
II
FDI
3
S
N60
Gastro/ Urology
Flexible Suction Coagulator Electrode
876.4300
II
FEH
3
S
N61
Gastro/ Urology
Flexible Stone Dislodger
876.4680
II
FGO
3
S
Y62
Gastro/ Urology
Metal Stone Dislodger
876.4680
II
FFL
3
S
Y63
Gastro/ Urology
Needle Holder
876.4730
I
FHQ
1
C
Y64
Gastro/ Urology
Nonelectrical Snare
876.4730
I
FGX
1
S
Y65
Gastro/ Urology
Urological Catheter
876.5130
II
KOD
2
S
N66
Gastro/Urology
Single needle dialysis set
876.5540
II
LBW, FIE
3
C
N67
Gastro/ Urology
Hemodialysis Blood Circuit Accessories
876.5820
II
KOC
2
S
N68
Gastro/Urology
Single needle dialysis set
876.5820
II
FIF
3
C
N69
Gastro/Urology
Hemorrhoidal Ligator
876.4400
II
FHN
2
C
N70
General Hospital
Implanted, Programmable Infusion Pump
Post-amendment
III
LKK
3
C
N71
General Hospital
Needle Destruction Device
Post-amendment
III
MTV
1
N
N72
General Hospital
Nonpowered Flotation Therapy Mattress
880.5150
I
IKY
2
N
Y73
General Hospital
NonAC-Powered Patient Lift
880.5510
I
FSA
2
N
Y74
General Hospital
Alternating Pressure Air Flotation Mattress
880.5550
II
FNM
1
N
Y75
General Hospital
Temperature Regulated Water Mattress
880.5560
I
FOH
2
N
Y76
General Hospital
Hypodermic Single Lumen Needle
880.5570
II
FMI
3
C
N77
General Hospital
Piston Syringe
880.5860
II
FMF
3
C
N78
General Hospital
Mattress Cover (Medical Purposes)
880.6190
I
FMW
2
N
Y79
General Hospital
Disposable Medical Scissors
880.6820
I
JOK
1
N
Y80
General Hospital
Irrigating Syringe
880.6960
I
KYZ, KYY
1
C
Y81
Infection Control
Surgical Gowns
878.4040
II
FYA
1
C
N82
Lab
Blood Lancet
878.4800
I
FMK
1
C
Y( print page 56920)83
Neurology
Clip Forming/Cutting Instrument,
882.4190
I
HBS
3*
C
Y84
Neurology
Drills, Burrs, Trephines &Accessories (Manual)
882.4300
II
HBG
3*
C
N85
Neurology
Drills, Burrs, Trephines &Accessories (Compound, Powered)
882.4305
II
HBF
3*
C
N86
Neurology
Drills, Burrs, Trephines &Accessories (Simple, Powered)
882.4310
II
HBE
3*
C
N87
OB/GYN
Oocyte aspiration needle

III
MHK
3
C
N88
OB/GYN
Laparoscope accessories
884.1720
I
HET
2
C
Y89
OB/GYN
Laparoscope Accessories
884.1720
II
HET
3
C
N90
OB/GYN
Laparoscopic Dissectors
884.1720
I
HET
2
C
Y91
OB/GYN
Laparoscopic Graspers
884.1720
I
HET
2
C
Y92
OB/GYN
Laparoscopic Scissors
884.1720
I
HET
2
C
Y93
OB/GYN
Insufflator accessories (tubing, Verres needle, kits)
884.1730
II
HIF
3
C
Y94
OB/GYN
Laparoscopic Insufflator
884.1730
II
HIF
2
N
N95
OB/GYN
Endoscopic Electrocautery and Accessories
884.4100
II
HIM
2
N
N96
OB/GYN
Gynecologic Electrocautery (and Accessories)
884.4120
II
HGI
2
N
N97
OB/GYN
Endoscopic Bipolar Coagulator-Cutter (and Accessories)
884.4150
II
HIN
2
N
N98
OB/GYN
Culdoscopic Coagulator (and Accessories)
884.4160
II
HFI
2
N
N99
OB/GYN
Endoscopic Unipolar Coagulator-Cutter (and Accessories)
884.4160
II
KNF
2
N
N100
OB/GYN
Hysteroscopic Coagulator (and Accessories)
884.4160
II
HFH
2
N
N101
OB/GYN
Unipolar Laparoscopic Coagulator (and Accessories)
884.4160
II
HFG
2
N
N102
OB/GYN
Episiotomy Scissors
884.4520
I
HDK
1
C
Y103
OB/GYN
Umbilical Scissors
884.4520
I
HDJ
1
C
Y104
OB/GYN
Biopsy Forceps
884.4530
I
HFB
3
C
Y105
OB/GYN
Assisted reproduction needle
884.6100
II
MQE
3
C
N106
Ophthalmic
Endoilluminator
876.1500
II
MPA
3*
C
N107
Ophthalmic
Surgical Drapes
878.4370
II
KKX
2
C
N108
Ophthalmic
Ophthalmic Knife
886.4350
I
HNN
3
C
Y( print page 56921)109
Ophthalmic
Keratome Blade
886.4370
I
HMY, HNO
3
C
N110
Ophthalmic
Phacoemulsification Needle
886.4670
II
HQC
3
C
N111
Ophthalmic
Phacoemulsification/   Phacofragmentation Fluidic
886.4670
II
MUS
2
C
N112
Ophthalmic
Phacofragmentation Unit
886.4670
II
HQC
1
N
N113
Orthopedic
Saw Blades
878.4820
I
GFA, DWH,   GEY, GET
1
C
Y114
Orthopedic
Surgical Drills
878.4820
I
GEY, GET
1
C
Y115
Orthopedic
Arthroscope accessories
888.1100
II
HRX
2
C
Y116
Orthopedic
Bone Tap
888.4540
I
HWX
1
C
Y117
Orthopedic
Burr
888.4540
I
HTT
1
C
Y118
Orthopedic
Carpal Tunnel Blade
888.4540
I
LXH
2
C
Y119
Orthopedic
Countersink
888.4540
I
HWW
1
C
Y120
Orthopedic
Drill Bit
888.4540
I
HTW
1
C
Y121
Orthopedic
Knife
888.4540
I
HTS
1
C
Y122
Orthopedic
Manual Surgical Instrument
888.4540
I
LXH
1
C
Y123
Orthopedic
Needle Holder
888.4540
I
HXK
1
C
Y124
Orthopedic
Reamer
888.4540
I
HTO
1
C
Y125
Orthopedic
Rongeur
888.4540
I
HTX
1
C
Y126
Orthopedic
Scissors
888.4540
I
HRR
1
C
Y127
Orthopedic
Staple Driver
888.4540
I
HXJ
1
C
Y128
Orthopedic
Trephine
888.4540
I
HWK
1
C
Y129
Orthopedic
Flexible Reamers/Drills
886.4070 878.4820
I
GEY, HRG
1
C
Y130
Orthopedic
External Fixation Frame
888.3040 888.3030
II
JEC KTW KTT
2
N
N131
Physical Medicine
Nonheating Lamp for Adjunctive Use Inpatient Therapy
890.5500
II
NHN
1
N
N132
Physical Medicine
Electrode Cable,
890.1175
II
IKD
1
N
Y133
Physical Medicine
External Limb Component, Hip Joint
890.3420
I
ISL
2
N
Y134
Physical Medicine
External Limb Component, Knee Joint
890.3420
I
ISY
2
N
Y135
Physical Medicine
External Limb Component, Mechanical Wrist
890.3420
I
ISZ
2
N
Y136
Physical Medicine
External Limb Component, Shoulder Joint
890.3420
I
IQQ
2
N
Y( print page 56922)137
Plastic Surgery
Stapler
878.4800
I
GAG, GEF, FHM, HBT
2
C
Y138
Radiology
Isotope Needle
892.5730
II
IWF
3
C
N139
Respiratory
Endotracheal Tube Changer
Unclassified
III
LNZ
3
C
N140
Respiratory
Anesthesia conduction needle
868.5150
II
BSP
3
C
N141
Respiratory
Short term spinal needle
868.5150
II
MIA
3
C
N142
Respiratory
Respiratory Therapy and Anesthesia Breathing Circuits
868.5240
I
CAI
2
S
Y143
Respiratory
Oral and Nasal Catheters
868.5350
I
BZB
1
C
Y144
Respiratory
Gas Masks
868.5550
I
BSJ
1
S
Y145
Respiratory
Breathing Mouthpiece
868.5620
I
BYP
1
N
Y146
Respiratory
Tracheal Tube
868.5730
II
BTR
3
C
N147
Respiratory
Airway Connector
868.5810
I
BZA
2
S
Y148
Respiratory
CPAP Mask
868.5905
II
BZD
3
S
N149
Respiratory
Emergency Manual Resuscitator
868.5915
II
BTM
2
S
N150
Respiratory
Tracheobronchial Suction Catheter
868.6810
I
BSY
3
S
Y151
Surgery
AC-powered Orthopedic Instrument and accessories
878.4820
I
HWE
2
C
N152
Surgery
Breast Implant Mammary Sizer
Unclassified

MRD
1
C
N153
Surgery
Ultrasonic Surgical Instrument
Unclassified

LFL
3
C
N154
Surgery
Trocar
874.4420
I
KAB, KBG, KCI
3
C
Y155
Surgery
Endoscopic Blades
876.1500
II
GCP, GCR
2
C
N156
Surgery
Endoscopic Guidewires
876.1500
II
GCP, GCR
1
C
N157
Surgery
Inflatable External Extremity Splint
878.3900
I
FZF
1
N
Y158
Surgery
Noninflatable External Extremity Splint
878.3910
I
FYH
1
N
Y159
Surgery
Catheter needle
878.4200
I
GCB
3
C
Y160
Surgery
Implantable Clip
878.4300
II
FZP
3
C
N161
Surgery
Electrosurgical and Coagulation Unit With Accessories
878.4400
II
BWA
2
C
N162
Surgery
Electrosurgical Apparatus
878.4400
II
HAM
2
C
N( print page 56923)163
Surgery
Electrosurgical Cutting & Coagulation Device & Accessories
878.4400
II
GEI
                             NUJ
2
                             3
C
N164
Surgery
Electrosurgical Device
878.4400
II
DWG
2
C
N165
Surgery
Electrosurgical Electrode
878.4400
II
JOS
2
C
N166
Surgery
Implantable Staple, Clamp, Clip for Suturing Apparatus
878.4750
II
GDW
3
C
N167
Surgery
Percutaneous biopsy device
878.4800
I
MJG
3
C
Y168
Surgery
Gastro-Urology needle
878.4800
I
FHR
3
C
Y169
Surgery
Aspiration and injection needle
878.4800
I
GAA
3
C
Y170
Surgery
Biopsy Brush
878.4800
I
GEE
1
C
Y171
Surgery
Blood Lancet
878.4800
I
FMK
1
C
Y172
Surgery
Bone Hook
878.4800
I
KIK
1
C
Y173
Surgery
Cardiovascular Biopsy Needle
878.4800
I
DWO
3
C
Y174
Surgery
Clamp
878.4800
I
GDJ
1
C
Y175
Surgery
Clamp
878.4800
I
HXD
1
C
Y176
Surgery
Curette
878.4800
I
HTF
1
C
Y177
Surgery
Disposable Surgical Instrument
878.4800
I
KDC
1
C
Y178
Surgery
Disposable Vein Stripper
878.4800
I
GAJ
1
C
Y179
Surgery
Dissector
878.4800
I
GDI
1
C
Y180
Surgery
Forceps
878.4800
I
GEN
2
C
Y181
Surgery
Forceps
878.4800
I
HTD
2
C
Y182
Surgery
Gouge
878.4800
I
GDH
1
C
Y183
Surgery
Hemostatic Clip Applier
878.4800
I
HBT
2
C
Y184
Surgery
Hook
878.4800
I
GDG
1
C
Y185
Surgery
Manual Instrument
878.4800
I
MDM, MDW
1
C
Y186
Surgery
Manual Retractor
878.4800
I
GZW
1
C
Y187
Surgery
Manual Saw and Accessories
878.4800
I
GDR HAC
1
C
Y188
Surgery
Manual Saw and Accessories
878.4800
I
HAC
1
C
Y189
Surgery
Manual Surgical Chisel
878.4800
I
FZO
1
C
Y190
Surgery
Mastoid Chisel
878.4800
I
JYD
1
C
Y191
Surgery
Orthopedic Cutting Instrument
878.4800
I
HTZ
1
C
Y192
Surgery
Orthopedic Spatula
878.4800
I
HXR
1
C
Y( print page 56924)193
Surgery
Osteotome
878.4800
I
HWM
1
C
Y194
Surgery
Rasp
878.4800
I
GAC
1
C
Y195
Surgery
Rasp
878.4800
I
HTR
1
C
Y196
Surgery
Retractor
878.4800
I
GAD
1
C
Y197
Surgery
Retractor
878.4800
I
HXM
1
C
Y198
Surgery
Saw
878.4800
I
HSO
1
C
Y199
Surgery
Scalpel Blade
878.4800
I
GES
1
C
Y200
Surgery
Scalpel Handle
878.4800
I
GDZ
1
C
Y201
Surgery
Scissors
878.4800
I
LRW
1
C
Y202
Surgery
Snare
878.4800
I
GAE
1
C
Y203
Surgery
Spatula
878.4800
I
GAF
1
C
Y204
Surgery
Staple Applier
878.4800
I
GEF
2
C
Y205
Surgery
Stapler
878.4800
I
GAG
2
C
Y206
Surgery
Stomach and Intestinal Suturing Apparatus
878.4800
I
FHM
2
C
Y207
Surgery
Surgical Curette
878.4800
I
FZS
1
C
Y208
Surgery
Surgical Cutter
878.4800
I
FZT
1
C
Y209
Surgery
Surgical Knife
878.4800
I
EMF
1
S
Y210
Surgery
Laser Powered Instrument
878.4810
II
GEX
2
C
N211
Surgery
AC-Powered Motor
878.4820
I
GEY
2
C
Y212
Surgery
Bit
878.4820
I
GFG
1
C
Y213
Surgery
Bur
878.4820
I
GFF, GEY
1
C
Y214
Surgery
Cardiovascular Surgical Saw Blade
878.4820
I
DWH
1
C
Y215
Surgery
Chisel (Osteotome)
878.4820
I
KDG
1
C
Y216
Surgery
Dermatome
878.4820
I
GFD
1
C
Y217
Surgery
Electrically Powered Saw
878.4820
I
DWI
2
C
Y218
Surgery
Pneumatic Powered Motor
878.4820
I
GET
2
C
Y219
Surgery
Pneumatically Powered Saw
878.4820
I
KFK
2
C
Y220
Surgery
Powered Saw and Accessories
878.4820
I
HAB
2
C
Y221
Surgery
Saw Blade
878.4820
I
GFA
1
C
Y222
Surgery
Nonpneumatic Tourniquet
878.5900
I
GAX
1
N
Y223
Surgery
Pneumatic Tourniquet
878.5910
I
KCY
1
N
Y224
Surgery
Endoscopic Staplers
888.4540
I
HXJ
2
C
Y225
Surgery
Trocar
876.1500 870.1390
II
GCJ, DRC
3
C
N( print page 56925)226
Surgery
Surgical Cutting Accessories
878.4800, 874.4420
I
GDZ, GDX, GES, KBQ, KAS
2
C
Y227
Surgery
Electrosurgical Electrodes/Handles/Pencils
876.4300 878.4400
II
HAM, GEI, FAS
2
C
N228
Surgery
Scissor Tips
878.4800, 884.4520, 874.4420
I
LRW, HDK, HDJ, JZB, KBD
2
C
Y229
Surgery
Laser Fiber Delivery Systems
878.4810 874.4500  886.4390  884.4550  886.4690
II
GEX  EWG LLW HQF HHR HQB
1
C
NA
                        Risk categorization may be either:1 = low risk according to RPS2 = moderate risk according to RPS3 = high risk according to RPS3* = high risk due to neurological useSee 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.


# 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. Back to Citation
 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*. Back to Citation


[FR Doc. 05-19510 Filed 9-28-05; 8:45 am] BILLING CODE 4160-01-S