STEALTHSTATION PASSIVE INSTRUMENT OPTION

K972398 · Surgical Navigation Technologies, Inc. · HAW · Sep 16, 1997 · Neurology

Device Facts

• Record ID: K972398
• Device Name: STEALTHSTATION PASSIVE INSTRUMENT OPTION
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: HAW · Neurology
• Decision Date: Sep 16, 1997
• 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 safe and effective, 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.

Device Story

StealthStation® System is a surgical navigation platform. This update introduces a passive instrument tracking option. System uses infrared light reflection off reflective spheres attached to surgical instruments to track their position. Inputs consist of infrared signals from passive markers; these are processed to determine instrument location relative to patient anatomy. Output is real-time visualization of instrument position overlaid on pre-operative CT or MR image models. Used in OR by surgeons to guide surgical instruments during open or percutaneous procedures. Provides precise anatomical localization; assists in stereotactic surgical planning and execution; improves surgical accuracy by referencing rigid structures.

Clinical Evidence

Bench testing only. No clinical data provided. Performance data was submitted to support the claim of substantial equivalence regarding the accuracy and reliability of the passive infrared tracking system compared to active probe systems.

Technological Characteristics

Optical tracking system utilizing infrared light reflection. Passive instruments equipped with reflective spheres. System integrates with pre-operative CT or MR imaging data. Operates as a stereotactic surgical navigation platform. Connectivity involves tracking hardware interface with the navigation workstation.

Indications for Use

Indicated for patients requiring stereotactic surgery where rigid anatomical structures (skull, long bone, vertebra) can be referenced to CT or MR imaging. Applicable to any medical condition where stereotactic surgery is considered safe and effective for open or percutaneous procedures.

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 active probe version)
• BrainLAB VectorVision System

Submission Summary (Full Text)

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K972398

SEP 1 6 1997

## Summary of Safety and Effectiveness

## StealthStation® System - Passive Instrument Option

| I. | Company: Surgical Navigation Technologies<br>530 Compton St.<br>Broomfield, CO 80020<br>[phone] |
|----|--------------------------------------------------------------------------------------------------------|
|----|--------------------------------------------------------------------------------------------------------|

- StealthStation® System Passive Instrument Option Product Name: II.
- III. This submission describes updates made to the StealthStation® System to provide for optical tracking of instruments via the use of reflection of infrared light off of reflective spheres on the instruments.
- 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 safe and effective, 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.

- v. The StealthStation® System - Passive Instrument Option was shown to be substantially equivalent to the original StealthStation® System with active probes. Performance data was provided to support the claim of substantial equivalence. In addition, the StealthStation System with the Passive Instrument Option was shown to be substantially equivalent to the BrainLAB VectorVision System.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 6 1997

Mr. Roger N. White Surgical Navigation Technologies, Inc. 530 Compton Street Broomfield, Colorado 80020

Re: K972398 StealthStation® Treatment Guidance Platform Trade Name: Requlatory Class: II Product Code: 84HAW Dated: June 25, 1997 Received: June 26, 1997

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, qood 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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

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Page 2 - Mr. Roger N. White

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 requlations.

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 requlation 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 at [phone].

Sincerely yours,

Thomas J. Callahan

Thomas J. Callawan, Ph.D Director Division of Cardiovascular, Respiratory, and Neurological 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 - Passive Instrument Option ______________________________________________________________________________________________________________

Indications For 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 safe and effective, 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.

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| Concurrence of CDRH, Office Of Device Evaluation (ODE) | |
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| (Division Sign-Off) | |
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| Division of Cardiovascular, Respiratory,<br>and Neurological Devices | |
| 510(k) Number | K972398 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
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| | | (Optional Format 1-2-96) |