ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES

K992621 · Advanced Diagnostics & Interventions · HRX · Nov 8, 1999 · Orthopedic

Device Facts

• Record ID: K992621
• Device Name: ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES
• Applicant: Advanced Diagnostics & Interventions
• Product Code: HRX · Orthopedic
• Decision Date: Nov 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The arthroscope and accessories are intended to be used by a licensed physician, for the purpose of joint arthroscopic procedures.

Device Story

The ADI 9000/9001 is an arthroscope and accessory system used by licensed physicians in clinical settings to perform joint arthroscopic procedures. The device provides visualization of the interior of a joint, allowing the physician to inspect, diagnose, and perform surgical interventions. It functions as a standard endoscopic tool, transmitting visual data to the clinician to guide surgical decision-making and improve patient outcomes by enabling minimally invasive joint surgery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Arthroscope and accessories for joint visualization. Mechanical/optical device. No software or electronic algorithm components described.

Indications for Use

Indicated for use by licensed physicians for joint arthroscopic procedures.

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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov - 8 1999

Mr. Antony R. H. Fender Official FDA correspondent Advanced Diagnostics & Interventions, Inc. 216 Via Linda Vista Redondo Beach, California 90277

Re: K992621 Trade Name: ADI 9000/9001 Arthroscope and Accessories Regulatory Class: II Product Code: HRX Dated: September 30, 1999 Received: October 13, 1999

Dear Mr. Fender:

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. Antony R. H. Fender

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.
Director
Division of General and

Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

K992621 510(k) Number (if known):

사

ADI 9000/9001 arthroscope and accessories. Device Name:

The arthroscope and accessories are intended to be used by a Indications For Use: licensed physician, for the purpose of joint arthroscopic procedures.

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

7

Concurrance of CDRH, Office of Device Evaluation (ODE)

510(k) Number

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)