VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW

K030096 · Arthrex, Inc. · HRX · Mar 18, 2003 · Orthopedic

Device Facts

• Record ID: K030096
• Device Name: VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW
• Applicant: Arthrex, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Mar 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Arthroscopes are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the shoulder, knee, elbow, ankle, wrist, and jaw, and also to provide illumination and visualization during arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

Device Story

Arthrex Arthroscopes are rigid, fixed-angle (30 or 70 degree) arthroscopes; surgical stainless steel shafts and lens housings; sealed optical components for focusing. Device connects to video camera for visualization. Used in OR by surgeons for diagnostic and operative arthroscopic procedures in various joints (shoulder, knee, elbow, ankle, wrist, jaw, hip). Provides illumination and internal visualization to assist in surgical decision-making and tissue removal/repair. Benefits include minimally invasive access to joint spaces.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid arthroscope; surgical stainless steel construction; 30 or 70 degree angle of view; wide-angle optics; sealed focusing mechanism; various diameters and lengths; non-powered (optical illumination).

Indications for Use

Indicated for diagnostic and operative arthroscopic procedures in the shoulder, knee, elbow, ankle, wrist, and jaw. Also indicated for hip joint diagnostic procedures (including staging of avascular necrosis, chondral injuries, joint sepsis, synovial chondromatosis, unresolved hip pain, labral tears) and removal of loose bodies and soft tissue, as size/length appropriate.

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

• Smith & Nephew arthroscope (unspecified 510(k))

Submission Summary (Full Text)

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K030096

MAR 1 8 2003

### PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Arthrex Arthroscopes

| NAME OF SPONSOR: | Arthrex, Inc.<br>2885 S. Horseshoe Drive<br>Naples, Florida 34104 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Sally Foust, RAC<br>Regulatory Affairs Specialist<br>Arthrex, Inc.<br>Telephone: [phone] extension 1251<br>FAX: [phone] |
| TRADE NAME: | Arthrex Arthroscopes |
| COMMON NAME: | Arthroscope |
| CLASSIFICATION: | Arthroscope<br>21 CFR 888.1100 |
| DEVICE PRODUCT CODE: | HRX |

#### DEVICE DESCRIPTION AND INTENDED USE:

Arthrex Arthroscopes are rigid, fixed arthroscopes with a wide-angle view. Arthrex Arthroscopes have surgical stainless steel shafts and lens housings for durability and are available with a 30 or 70 degree angle view. The optical components are sealed to provide a durable focusing mechanism. The arthroscopes may be attached to a video camera and are available in various sizes, diameters and lengths, to provide for differences in arthroscopic surqical site and surgeon preference.

The Arthrex Arthroscopes are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the shoulder, knee, elbow, ankle, wrist, and jaw, and also to provide illumination and visualization during arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

### SAFETY AND EFFECTIVENESS

The Arthrex, Inc. Arthroscopes are similar to the predicate devices in design, materials, and intended use and as such are considered by Arthrex, Inc. to be substantially equivalent to devices currently available in U.S. distribution. The expansion of the indications of the Arthrex, Inc. Arthroscopes to include elbow and hip, those of the Smith & Nephew predicate device, does not raise new issues of safety and effectiveness.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 1 8 2003

Ms. Sally Foust, RAC Regulatory Affairs Specialist Arthrex, Inc. 2885 S. Horsehoe Drive Naples, Florida 34104

Re: K030096

Trade/Device Name: Arthrex Arthroscopes Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscopes and accessories Regulatory Class: II Product Code: HRX Dated: January 9, 2003 Received: January 10, 2003

Dear Ms. Foust:

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 - Ms. Sally Foust, RAC

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), 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) you may obtain. 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,

uriam C. Provost

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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510(k) Number (if known)

INDICATIONS FOR USE:

The Arthrex Arthroscopes are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the shoulder, knee, elbow, ankle, wrist, and jaw, and also to provide illumination and visualization during arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

Hip diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondromatosis Unresolved hip pain Labral tears

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Prescription Use

_ OR

Over-The-Counter

Use

(Per 21 CFR 801.109)

iriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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