AED ARTHROSCOPE

K991656 · National Advanced Endoscopy Devices, Inc. · HRX · Dec 2, 1999 · Orthopedic

Device Facts

• Record ID: K991656
• Device Name: AED ARTHROSCOPE
• Applicant: National Advanced Endoscopy Devices, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Dec 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AED line of rigid Arthroscopes is indicated to provide illumination and visualization in: · Diagnostic and operative arthroscope procedures.

Device Story

AED Arthroscope is a rigid endoscope used for visualization and illumination of joint cavities during arthroscopic surgery. Device transmits light to the surgical site and captures optical images for display on a monitor. Operated by surgeons in an operating room or clinical setting. Provides direct visualization to assist in diagnostic assessment and surgical intervention. Benefits include minimally invasive access to joint structures, facilitating surgical precision and reducing patient trauma.

Clinical Evidence

Bench testing only.

Technological Characteristics

Rigid arthroscope; optical visualization and illumination system. Materials and sterilization methods are consistent with standard surgical endoscope requirements for reusable medical devices.

Indications for Use

Indicated for patients undergoing diagnostic and operative arthroscopic procedures requiring illumination and visualization of joint spaces.

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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 2 1999

Ms. Gayle M. Butler Compliance Office National Advanced Endoscopy Devices, Inc. 10801 National Boulevard, Suite 603 Los Angeles, California 90064

Re: K991656 Trade Name: AED Arthroscope Regulatory Class: II Product Code: HRX Dated: September 1, 1999 Received: September 7, 1999

Dear Ms. Butler:

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 - Ms. Gayle M. Butler

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.

Mark M. Milkersm

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## 510(k) Number (if known): _K991626_ Device Name: AED Arthroscope

## INDICATIONS FOR USE:

The AED line of rigid Arthroscopes is indicated to provide illumination and visualization in:

· Diagnostic and operative arthroscope procedures.

.. . . . . .

・・・

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

:: : :

: : : . . . . . . .

.

| | Concurrence of CDHR, Office of Device Evaluation (ODE) | |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | <div><span style="text-decoration: overline;">Mark N. Mikkelsen</span> for BD</div> <div>(Division Sign-Off)</div> <div>Division of General Restorative Devices</div> <div>510(k) Number K991656</div> | |
| Prescription Use | X | Over-The-Counter Use _ |