REPROCESSED ARTHROSCOPIC SHAPERS

K012667 · Surgical Instruments Service and Savings, Inc. · HRX · Jun 3, 2002 · Orthopedic

Device Facts

• Record ID: K012667
• Device Name: REPROCESSED ARTHROSCOPIC SHAPERS
• Applicant: Surgical Instruments Service and Savings, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jun 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The reprocessed arthroscopic shapers are accessories intended for use in arthroscopic procedures.

Device Story

Reprocessed arthroscopic shapers (shavers, burs, trimmers) function as accessories to arthroscopes for bone and soft tissue cutting. Devices are originally manufactured as single-use items; SISS reprocesses these by cleaning, refurbishing, testing, and re-sterilizing to enable multiple uses. Used in clinical arthroscopic procedures by surgeons. Output is mechanical tissue/bone removal via shaper geometry. Benefit is extended device utility through reprocessing.

Clinical Evidence

No clinical data. Bench testing only, consisting of functionality testing and validation of the sterility protocol.

Technological Characteristics

Materials, dimensions, and geometry are identical to original single-use devices. Mechanical cutting principle. Provided sterile. No software or electronic components.

Indications for Use

Indicated for use as accessories in arthroscopic procedures for cutting bone or soft tissue, depending on the specific geometry of the shaper.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Same single use shaper as provided by the original manufacturer

Submission Summary (Full Text)

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K012667

# 510(k) SUMMARY

Surgical Instruments Servicing & Savings, Inc. Submitter's name: 723 Curtis Court Sisters. OR 97759 [phone]

Date summary prepared: August 10, 2001

Device name:

| Proprietary name: | Reprocessed Arthroscopic Shapers |
|-----------------------|--------------------------------------------------------------------|
| Common or usual name: | Various arthroscopic shapers, such as shavers, burs, and trimmers. |
| Classification name: | Arthroscope (888.1100). Arthroscope and accessories (87 HRX). |

Legally marketed device for substantial equivalence comparison:

The predicate device for each reprocessed arthroscopic shaper is the same single use shaper as provided by the original manufacturer.

Description of the device:

The devices that are the subject of this submission are used as accessories for shaping bone and soft tissue during arthroscopic procedures. They have a variety of names, such as shavers, burs, or trimmers, are made of a variety of materials, and come in many shapes and sizes. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning, refurbishing, testing, packaging, and sterilization. It allows the shapers to be used several times rather than just once.

Intended use of device:

The reprocessed arthroscopic shapers are accessories intended for use in arthroscopic procedures.

Technological characteristics:

The device features of the reprocessed arthroscopic shapers and the single use shapers are very similar. The materials, dimensions, and geometry of individual shapers are identical. Both products are provided sterile. The technical characteristics, method of use, and compatibility with arthroscopic systems are also identical. The only difference is that the original products are sold for single use, while the reprocessed products can be used several times.

Testing conducted:

Each arthroscopic shaper is tested for functionality as part of the reprocessing procedures. Validation of the sterility protocol was also included in the submission.

Performance testing:

Comparative performance testing and clinical evaluations were not included as part of this 510(k).

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K012667

# SECTION 3- INTENDED USE

Intended use of device:

Reprocessed arthroscopic shapers are accessories intended for use in arthroscopic procedures. Each shaper can accomplish certain kinds of cutting based on its geometry and the intended uses of the arthroscope for which it is an accessory. Some are used on bone and others on soft tissue. The shapers that are the subject of this submission are single use items that will be reprocessed, sterilized, and then reused.

Intended use of predicate device:

The predicate devices are arthroscopic shapers that are accessories to arthroscopes and are used in the procedures for which the arthroscope is cleared. Each shaper can do certain types of cutting depending on its geometry. Some are used on bone and others are used on soft tissue. The predicate devices are single use devices that are used and then discarded.

Comparison:

The general intended use for arthroscopic shapers and reprocessed arthroscopic shapers is the same. In addition, the specific uses are the same for each shaper, whether it is single use or reprocessed, because these uses are dictated by the geometry of the shaper. The single use and reprocessed shapers have the same geometry.

Labeling:

Both sets of products are generically called "Arthroscopic shapers" thereby describing their use. The Surgical Instruments Servicing & Savings, Inc. (SISS) products state clearly on the label that they have been reprocessed. Sample SISS labels can be found in Appendix III. Labeling for the predicate devices is not included in this submission.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Surgical Instruments Servicing & Savings, Inc. c/o Mr. Robert S. McQuate R.S. McQuate & Associates, Inc. 3636 E. Columbine Drive Phoenix, AZ 85032

JUN 0 3 2002

Re: K012667

Trade/Device Name: Reprocessed Arthroscopic Shapers Regulation Number: 888.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: March 4, 2002 Received: March 5, 2002

Dear Mr. McQuate:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Robert S. McQuate .

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

s Slipt Rhodes

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Reprocessed Arthroscopic Shapers 510(k) Notification Page 3 .

# Indications for Use Statement

510(k) Number (if known):

Device name: Reprocessed Arthroscopic Shapers

Indications for Use: The reprocessed arthroscopic shapers are accessories intended for use in arthroscopic procedures.

(Please do not write below this line)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-----------------------------------------------------------|----------------------|
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K012667 |
| Prescription Use | |
| OR | Over-The-Counter Use |

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