STEALTHSTATION TREATMENT GUIDANCE PLATFORM

K981768 · Surgical Navigation Technologies, Inc. · HAW · Nov 23, 1998 · Neurology

Device Facts

• Record ID: K981768
• Device Name: STEALTHSTATION TREATMENT GUIDANCE PLATFORM
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: HAW · Neurology
• Decision Date: Nov 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The StealthStation™ System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate, and where a 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 of the anatomy. The Stealth Station™ System is also indicated for intranasal or sinus use. The Ultrasonic Probe Option provides the user with supplemental real time imaging information to be used to monitor soft tissue locations relative to the CT or MR based model of the anatomy.

Device Story

StealthStation™ System is a surgical navigation platform; uses optical tracking to monitor surgical instruments. Ultrasonic Probe Attachment adds capability to track an ultrasonic probe and its associated image plane. System inputs include CT or MR-based anatomical models and real-time optical tracking data. Device transforms these inputs to provide supplemental real-time imaging information for monitoring soft tissue locations relative to pre-operative models. Used in OR by surgeons to aid in precise anatomical localization during open or percutaneous procedures. Output displayed to surgeon to assist in intraoperative decision-making; enhances surgical accuracy by correlating real-time soft tissue imaging with rigid anatomical reference structures.

Clinical Evidence

Bench testing only. Performance data provided to support substantial equivalence of the optical tracking of the ultrasonic probe to the tracking of general surgical instruments in the predicate system.

Technological Characteristics

Optical tracking system for surgical instruments; includes ultrasonic probe attachment. Integrates real-time ultrasonic imaging with pre-operative CT/MR anatomical models. System operates as an aid for stereotactic surgical navigation.

Indications for Use

Indicated for patients undergoing stereotactic surgery where rigid anatomical structures (skull, long bone, vertebra) can be referenced to CT/MR models; includes intranasal or sinus procedures. Provides supplemental real-time soft tissue monitoring.

Regulatory Classification

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.

Predicate Devices

• StealthStation™ System (original tracking of general surgical instruments)

Submission Summary (Full Text)

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## Nov 23 jggs

K981768

## Summary of Safety and Effectiveness

## StealthStation™ System - Ultrasonic Probe Attachment

- 」。 Company: Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 [phone]
- Product Name: StealthStation™ System Ultrasonic Probe Attachment II.
- This submission describes updates made to the StealthStation™ System to provide III. for optical tracking of an ultrasonic probe and its associated image plane.
- IV. The indications for use for the StealthStation™ System have not changed and are as follows:

The StealthStation™ System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate, and where a 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 of the anatomy. The Stealth Station™ System is also indicated for intranasal or sinus use.

The Ultrasonic Probe Option provides the user with supplemental real time imaging information to be used to monitor soft tissue locations relative to the CT or MR based model of the anatomy.

- V. The StealthStation™ System - Ultrasonic Probe Attachment was shown to be substantially equivalent to the tracking of general surgical instruments in 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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 23 1998

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

Re: K981768

Trade Name: StealthStation™ System- Ultrasonic Probe Attachment Regulatory Class: II Product Code: HAW Dated: September 17, 1998 Received: September 18, 1998

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 legally marketed predicate 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 requirements, 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 [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/dsma/dsmamain.html".

Sincerely yours,

pcwelly

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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510(k) Number (if known): K981768

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StealthStation™ System - Ultrasonic Probe Attachment Device Name:

Indications For Use:

11/10/1330 | 11.01

The StealthStation™ System is intended as an aid for precisely locating anatomical locations 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 a 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 of the anatomy. The StealthStation™ System is also indicated for intranasal or sinus use.

The Ultrasonic Probe Option provides the user with supplemental real time imaging information to be used to monitor soft tissue locations relative to the CT or MR based model of the anatomy.

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

| Concurrence of CDRH, Office Of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

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


| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K981768 |