ARTHROSCOPE / MEDIFIX INC.

K992474 · Medifix, Inc. · HRX · Sep 23, 1999 · Orthopedic

Device Facts

• Record ID: K992474
• Device Name: ARTHROSCOPE / MEDIFIX INC.
• Applicant: Medifix, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Sep 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

Operative and Diagnostic Arthroscopy for visual imaging and light transmission to the operative area. The Arthroscopes are limited in their use to: Wrist, Knee, Shoulder and Ankle Surgery.

Device Story

Arthroscope provides visual imaging and light transmission for surgical and diagnostic procedures. Used in wrist, knee, shoulder, and ankle surgery. Operated by surgeons in clinical or OR settings. Device transmits light to the operative site and captures visual images for the clinician to view, facilitating minimally invasive surgical visualization and decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid endoscope for visual imaging and light transmission. Intended for use in wrist, knee, shoulder, and ankle surgery.

Indications for Use

Indicated for patients undergoing operative or diagnostic arthroscopy of the wrist, knee, shoulder, or ankle for visual imaging and light transmission.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person with their arms raised, or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1999

Mr. George Albulescu President Medifix. Inc. 8727 Narragansett Morton Grove, Illinois 60053

Re: K992474 Trade Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: July 23, 1999 Received: July 26, 1999

## Dear Mr. Albulescu:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{1}------------------------------------------------

## Page 2 - Mr. George Albulescu

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

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

Enclosure

{2}------------------------------------------------

510(k) Number (if Known): Device Name: Arthroscope / MEDIFIX Inc. Page 1 of 1

K992474/

Indications for Use:

Operative and Diagnostic Arthroscopy for visual imaging and light transmission to the operative area.

The Arthroscopes are limited in their use to: Wrist, Knee, Shoulder and Ankle Surgery.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrance of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|----------------------------------------------------|
| | |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K992474 |
| Prescription Use (Per 21 CFR 801.1091 | <span style="text-decoration: underline;">✓</span> |
| | OR |
| | Over-The-Counter Use ______ |
| | (Optional Format 1-2-96) |