METRX SYSTEM

K993021 · Surgical Navigation Technologies, Inc. · HRX · Nov 10, 1999 · Orthopedic

Device Facts

• Record ID: K993021
• Device Name: METRX SYSTEM
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Nov 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The METRx™ Endoscope is Indicated for visualization of herniated disc material, visualization of the circumferential decompression of the nerve roots, and aiding in the search and removal of nucleus material. It is intended for use in the lumbar spine. The endoscope is also indicated for use in the knee, shoulder, wrist and temporomandibular joint (TMJ).

Device Story

METRx™ Endoscope is an arthroscopic device used for visualization and surgical assistance. Input: optical visualization of anatomical structures. Operation: provides direct visual access to surgical sites; aids in herniated disc material removal and nerve root decompression. Used in clinical/surgical settings by physicians. Output: visual feedback to the surgeon to guide instrumentation and tissue removal. Benefits: enables minimally invasive access to lumbar spine and joints (knee, shoulder, wrist, TMJ).

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and literature references.

Technological Characteristics

Arthroscope; design and materials are similar to predicate endoscopes. Device is intended for visualization and surgical assistance in orthopedic and spinal procedures.

Indications for Use

Indicated for visualization of herniated disc material, circumferential decompression of nerve roots, and aiding in search/removal of nucleus material in the lumbar spine. Also indicated for use in knee, shoulder, wrist, and temporomandibular joint (TMJ).

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

• Endoscopes (K943356)
• Endoscopes (K946087)
• Endoscopes (K955471)

Submission Summary (Full Text)

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

## 510(k) Summary

## StealthStation® System - Indications Modification

## Date Summary Prepared: October 26, 1999

- Contact: Roger N. White Company: 1. Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 [phone]
- Product Trade Name: METRx™ System ll. Common or usual name: Arthroscope Classification name: Arthroscope and Accessories (HRX per 21 CFR 888.1100)
- The above device is substantially equivalent to the Endoscopes cleared in III. K943356, K946087, and K955471. This submission describes a change to the indications for use and minor design changes.
- This submission describes a modification to the METRx™ System indications for IV. use to provide for use of the endoscope in the cervical spine.
- The indications for use for the METRx™ System arc as follows: V.

The METRx TM Endoscope is Indicated for visualization of herniated disc material, visualization of the circumferential decompression of the nerve roots, and aiding in the search and removal of nucleus material. It is intended for use in the lumbar spine. The endoscope is also indicated for use in the knee, shoulder, wrist and temporomandibular joint (TMJ).

- The technological characteristics of the device are the same as or similar to those VI. for the predicate devices. A comparison of technological characteristics and literature references support the claim of substantial equivalence.

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

Image /page/1/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 1999

Mr. Roger N. White Group Director, Quality Systems and Regulatory Affairs Surgical Navigation Technologies 530 Compton Street Broomfield, Colorado 80020

K993021 Re:

> Trade Name: METRx™ Endoscope Regulatory Class: II Product Code: HRX Dated: September 3, 1999 Received: September 8, 1999

Dear Mr. White:

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.

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

## Page 2 - Mr. Roger N. White

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,

Colin M. Wittwer, 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

{3}------------------------------------------------

510(k) Number (if known): K993021

Device Name: METRx™ Endoscope - Indications Modification

Indications For Usc:

The METRx™ Endoscope is Indicated for visualization of herniated disc material, visualization of the circumferential decompression of the nerve roots, and aiding in the scarch and removal of nucleus material. It is intended for use in the lumbar spinc. The endoscope is also indicated for use in the knec, shoulder, wrist and temporomandibular joint (TMJ).

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

| Concurrence of CDRH, Office Of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K993021 |

Prescription Use_X
OR
Over-The-Counter Usc_

(Pcr 21 CFR 801.109)

(Optional Format 1-2-96)