REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES

K012536 · Sterilmed, Inc. · HRX · Nov 2, 2001 · Orthopedic

Device Facts

• Record ID: K012536
• Device Name: REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
• Applicant: Sterilmed, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Nov 2, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Reprocessed powered arthroscopic accessories are intended for use in operative large and small joint arthroscopic procedures and Functional Endoscopic Sinus Surgery (FESS). These accessories are indicated for resection of soft, osseous and cartilaginous tissue, and bone in large and small articular cavities and FESS.

Device Story

SterilMed reprocessed powered arthroscopic accessories are surgical instruments used for cutting soft tissue, cartilage, and bone. The devices consist of straight or angled rotating blades, burrs, and cutters with diameters ranging from 2.0 to 6.0 mm. They are designed to operate in conjunction with a control console, motor drive unit, foot or hand switch, and suction/irrigation system under endoscopic/video visualization. The accessories are used by surgeons in clinical settings during arthroscopic procedures and FESS. The device functions by mechanical rotation to resect tissue, with the surgeon controlling the procedure via the console and visualization system. Reprocessing restores the devices to a functional state for reuse, providing a clinical alternative to new disposable accessories.

Clinical Evidence

No clinical data. Evidence consists of bench testing to demonstrate functional equivalence and process validation for cleaning, sterilization, and packaging. Manufacturing includes visual and functional testing of all produced units.

Technological Characteristics

Powered surgical accessories (burr, shaver, cutter designs) with rotating blades. Diameters 2.0-6.0 mm. Materials and functional design are identical to original manufacturer counterparts. Energy source: external motor drive unit. Connectivity: mechanical interface to motor drive and suction/irrigation systems. Sterilization: validated reprocessing procedures.

Indications for Use

Indicated for resection of soft, osseous, and cartilaginous tissue and bone during large and small joint arthroscopic procedures and Functional Endoscopic Sinus Surgery (FESS).

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

• Linvatec Universal Drive System (K971059)
• Smith & Nephew Dyonics Disposable Endoscopic Surgery Blades (K970511)
• Smith & Nephew Dyonics Disposable Arthroscopic Blades (K953695)

Submission Summary (Full Text)

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# SECTION 2. SUMMARY AND CERTIFICATION

#### 510(k) Summary A.

| Submitter: | NOV 0 2 2001<br>SterilMed, Inc. |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patrick Fleischhacker<br>11400 73 ^rd Avenue North<br>Minneapolis, MN 55369<br>Ph: 888-856-4870<br>Fax: [phone] |
| Date Prepared: | August 6, 2001 |
| Trade Name: | SterilMed Reprocessed Powered Arthroscopic Accessories |
| Classification Name<br>and Number: | Arthroscope, Class II, 21 CFR 888.1100 |
| Product Code: | HRX |
| Predicate Device(s): | The reprocessed powered arthroscopic accessories are<br>substantially equivalent to:<br><ul><li>The powered arthroscopic accessories included in the<br/> Linvatec Universal Drive System (K971059);</li><li>The Smith &amp; Nephew Dyonics Disposable Endoscopic<br/> Surgery Blades (K970511);</li><li>The Smith &amp; Nephew Dyonics Disposable<br/> Arthroscopic Blades (K953695); and</li><li>Their counterparts from the original manufacturers.</li></ul> |
| Device Description: | SterilMed's reprocessed powered arthroscopic accessories<br>consist of surgical instruments which run at variable speeds<br>and are used for cutting soft tissue, cartilage and bone.<br>These accessories are straight or angled, and have rotating<br>blades that are used with irrigation and suction. Their<br>diameters range from 2.0 to 6.0 mm and come in burr,<br>shaver, and cutter designs. These accessories are designed<br>to run in conjunction with a control console, motor drive<br>unit, foot or hand switch, and a suction /irrigation system<br>under endoscopic/video visualization. However, this<br>submission only pertains to the accessories and not the<br>other system components, such as the control console or<br>motor drive unit. |

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K012536

Reprocessed powered arthroscopic accessories are intended Intended Use: for use in operative large and small joint arthroscopic procedures and Functional Endoscopic Sinus Surgery (FESS). These accessories are indicated for resection of soft, osseous and cartilaginous tissue, and bone in large and small articular cavities and FESS.

Representative samples of reprocessed powered Safety Testing: arthroscopic accessories underwent bench testing to demonstrate substantially equivalent functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.

The powered arthroscopic accessories reprocessed by Conclusion: SterilMed are substantially equivalent to the powered arthroscopic accessories included in the Linvatec Universal Drive System (K971059), the Smith & Nephew Dyonics Disposable Endoscopic Surgery Blades (K970511), the Smith & Nephew Dyonics Disposable Arthroscopic Blades (K953695), and their counterparts from the original manufacturers. This conclusion is based upon the fact that these devices' are essentially identical to their predicate devices in terms of functional design, materials, indications for use, and principles of operation.

Functional and

Premarket Notification

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 2 2001

Mr. Patrick Fleischhacker Vice President Regulatory and Quality Control SterilMed, Inc. 11400 73rd Avenue North Minneapolis, Minnesota 55369

Re: K012536

K012530
Trade/Device Name: SterilMed Reprocessed Powered Arthroscopic Accessories Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: August 6, 2001 Received: August 7, 2001

Dear Mr. Fleischhacker:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section >10(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars manned to the Medical Device Amendments, or to commerce prior to May 26, 1776, the enacenture with the provisions of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosment Act (Act) that to hot require subject to the general controls provisions of the Act. The Act. The You may, therefore, market the dovice, belyer to the most
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the 110 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 ( If your device is classified (see above) the exist on a consequentions affecting your device can
may be subject to such additional controls. Existing major and the collected this be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the Code of Poderal Regarities in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuation of a backed complies with other requirements of the Act
that FDA has made a determination that your device complies with on anyat that I DA has made a determination administered by other Federal agencies. You must or any regeral statutes and regulations annualing, but not limited to: registration and listing (21 Comply with an the 71et 31equirements, and manufacturing practice requirements as set CFK Part 807), labeling (21 CFRT art 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Patrick Fleischhacker

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin mainting of substantial equivalence of your device to a legally prematicated 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 IT you desire specific authoritor for your witto diagnostic devices), please contact the Office of additionally 21 CHT Fur 007.10 for questions on the promotion and advertising of Compination at [phone] - 1854 - 15 - 15 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - 1 - - - - - - - - - - - - - - - - - - - - - - - - your do roo, prodo combronding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general information on your responsional 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,

Susan Walker, m

Image /page/3/Picture/5 description: The image shows a close-up of a handwritten letter. The letter is written in black ink on white paper. The handwriting is cursive and appears to be a signature. The signature is illegible.

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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NOV 0 2 2001

K012536

## Indications for use Page

Device Name: Reprocessed Powered Arthroscopic Accessories

### Indications for Use:

Reprocessed powered arthroscopic accessories are intended for use in operative large and Reprocessed powered antinoscopic accessors and Functional Endoscopic Sinus Surgery (FESS). small Joint arthroscopic procedures and I and Laster in
These accessories are indicated for resection of soft, osseous and cartilaginous tissue, and These accessorres are large and articular cavities and FESS.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Walker

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

510(k) Number K012536

Premarket Notification