FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM by SURGICAL NAVIGATION TECHNOLOGIES, INC.

The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. The StealthStation® System with the ENT option is also indicated for intranasal or sinus use.

Device Description

This submission describes a modification to the StealthStation® System to provide for image guided surgery based on a fluoroscopy based model of the anatomy.

AI/ML Overview

The provided text for K990214, the "StealthStation® System - FluoroNav™ Module," is a 510(k) summary and FDA clearance letter. It states:

"The StealthStation® System with the FluoroNav™ Module was shown to be substantially equivalent to the original StealthStation® System."
"Performance data was provided to support the claim of substantial equivalence."

However, the provided document does not include the specific acceptance criteria, detailed results of performance studies, or information regarding sample sizes, ground truth establishment, or expert involvement.

In a 510(k) submission, the "Summary of Safety and Effectiveness" usually provides a high-level overview. Detailed performance data, acceptance criteria, and study methodologies (including statistical methods, sample sizes, ground truth, etc.) are typically found in the full 510(k) submission not included in this document.

Therefore,Based on the provided text, I cannot complete your request. The document only states that performance data was provided to support substantial equivalence but does not detail the acceptance criteria, the study itself, or its results.

To fulfill your request, I would need access to the detailed performance study report that was submitted as part of the K990214 510(k) application.

Summary

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K990214

Summary of Safety and Effectiveness

StealthStation® System - FluoroNav™ Module

I. Company: Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709
Product Name: StealthStation® System with FluoroNav™M Module II.
III. This submission describes a modification to the StealthStation® System to provide for image guided surgery based on a fluoroscopy based model of the anatomy.
The indications for use for the StealthStation® System are as follows: IV.

V. The StealthStation® System with the FluoroNav™ Module was shown to be substantially equivalent to the original StealthStation® System. Performance data was provided to support the claim of substantial equivalence.

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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 a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 1999

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

Re: K990214 Trade Name: StealthStation FluoroNavTM Module Regulatory Class: II Product Code: HAW Dated: January 21, 1999 Received: January 22, 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 (OS) 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.

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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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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Page 1 of 1

510(k) Number (if known):

Device Name: StealthStation® System - FluoroNav™ Module

Indications For Use:

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices K990214
510(k) Number

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).