REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS

K022744 · Medical Device Services · HWE · Sep 18, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022744
• Device Name: REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
• Applicant: Medical Device Services
• Product Code: HWE · General, Plastic Surgery
• Decision Date: Sep 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

MDS Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades/Burs are single use surgical devices used for resection of tissue within joint spaces under arthroscopic control.

Device Story

Reprocessed arthroscopic blades and burs; originally manufactured by Stryker or Dyonics. Device consists of inner rotating blade driven by motor; used for tissue resection within joint spaces. Reprocessing involves cleaning and sterilization of contaminated single-use devices to render them patient-ready. Operated by surgeons in arthroscopic procedures. Benefit: provides functional surgical instrument for tissue resection while extending utility of disposable components through validated reprocessing protocols.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing demonstrating that the devices can withstand cleaning and sterilization processes without compromising physical characteristics or quality.

Technological Characteristics

Powered surgical accessory; consists of tubes and designs for tissue resection. Materials are identical to original Stryker and Dyonics blades/burs. Device is reprocessed via cleaning and sterilization. No software or electronic components integral to the blade/bur itself; driven by external motor system.

Indications for Use

Indicated for resection of tissue within joint spaces under arthroscopic control. Intended for use as single-use surgical instruments.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• Smith & Nephew Dyonics disposable arthroscopic blades/burs (K953695)

Submission Summary (Full Text)

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SEP 1 8 2002

K022744

Medical Device Services, Inc

West Brigham Road, Bldg. E St. George, UT 84790

*Tel:* [phone]

*Fax:* [phone]

## 510(k) SUMMARY

Medical Device Services Re: 501(K) Notification: Reprocessed Used Disposable Arthroscopic Blades and Burs 87HWE Powered Surgical Instruments & Accessories/Attachments. Classification Name: Disposable Arthroscopic Bone Shavers Common/Usual Name: Proprietary Name: Reprocessed Used Disposable Arthoscopic Blades and Burs Establishment Reg. No .: 1724309 Class I per 21 CFR 878.482 - Powered Surgical Accessories. Device Classifications:

Medical Device Services (MDS), intends to market Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades Burs that have been reprocessed. Reprocessing Stryker and Dyonics Disposable Arthroscopic Blades/Burs is performed by MDS protocols. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals).

MDS believes that reprocessed single-use Stryker and Dyonics Arthroscopic Blades/Burs can be considered "reusable" as defined in the Food and Drug Administration Compliance Policy Guide #7124.16; they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use.

MDS Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades/Burs are single use surgical devices used for resection of tissue within joint spaces under arthroscopic control.

MDS Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades Burs are composed of the same materials as currently marketed hand-manipulated Stryker and Dyonics Disposable Arthroscopic Blades/Burs sold new

MDS Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades/Burs are substantially equivalent to disposable arthroscopic blades/burs marketed by Smith & Nephew Dyonics under 510(k) Number K953695.

MDS claims that Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades/Burs are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SFP 1 8 2002

Medical Device Services c/o Mark Aldana Adven Medical, Inc. 1001 Slaton Highway Lubbock, Texas 79404

Re: K022744

Trade/Device Name: Reprocessed Used Disposable Arthroscopic Blades and Burs Regulation Number: 878.4820 Regulation Name: Powered surgical instruments & accessories/attachments Regulatory Class: Class I Product Code: HWE Dated: August 9, 2002 Received: August 19, 2002

Dear Mr. Aldana:

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. Iisting 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. Mark Aldana

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 you 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" (21 CFR 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 yours

Sincerely yours,

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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K022744 510)k) Number:

Reprocessed Used, Disposable Arthroscopic Blades and Burrs Device Name:

Indications For Use:

Arthroscopic blades and burs are single use instruments consisting of several tubes and designs. The inner blade rotation is driven by a motor.

Arthroscopy blades and burs are indicated for resection of tissue within joint spaces under arthroscopic control.

Medical Device Services intends to reprocess arthroscopy blades and burs. Reprocessing includes all the steps performed to make a contaminated single use device patient ready.

Only disposable, non angled arthroscopy blades and burs manufactured by Dyonics and Stryker, that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) will be reprocessed by Medical Device Services.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Hert Purle

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use / (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)