STEALTHSTATION SYSTEM

K983670 · Surgical Navigation Technologies, Inc. · HAW · Jan 14, 1999 · Neurology

Device Facts

• Record ID: K983670
• Device Name: STEALTHSTATION SYSTEM
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jan 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The StealthStation™ System with the Universal Attachment 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.

Device Story

Universal Attachment for StealthStation® System; utilizes infrared markers to enable image-guided surgery for rigid surgical instruments. Device attaches to instruments to allow tracking within the StealthStation® navigation environment. Used in open or percutaneous procedures; operated by surgeons. System inputs include CT or MR-based anatomical models; tracks instrument position relative to rigid anatomical structures (skull, long bone, vertebra). Provides real-time visualization of instrument location relative to patient anatomy; aids in precise anatomical localization during stereotactic procedures. Benefits include enhanced surgical accuracy and guidance.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Universal attachment featuring infrared markers for optical tracking. Designed for integration with existing StealthStation® infrared navigation hardware. Mechanical attachment mechanism for rigid surgical instruments. No specific materials, software algorithms, or connectivity standards detailed in the provided documentation.

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; includes intranasal or sinus procedures. No specific contraindications listed.

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 (K983670)
• BrainLAB VectorVision™ System

Submission Summary (Full Text)

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JAN 1 4 1999

K983670

## 510(k) Summary

## Universal Attachment for the StealthStation® System

- I. Company: Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 [phone]
- Universal Attachment II. Product Name:
- This submission describes a Universal Attachment with infrared markers that III. allows a StealthStation® System user to image guide rigid surgical instruments.
- The StealthStation® System with the Universal Attachment is intended as an aid IV. 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.
- V. The Universal Attachment for the StealthStation@ System was shown to be substantially equivalent to the previously cleared StealthStation® System and the BrainLAB VectorVision™ System.

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JAN 1 4 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K983670

> Trade Name: StealthStation™ System Universal Attachment Regulatory Class:II Product Code: HAW Dated: October 15, 1998 Received: October 19, 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 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.

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Page 2 - Mr. Roger 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,

Celia M. Witten, Ph.D., M.D.
Director

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: __ Universal Attachment

Indications For Use:

The StealthStation™ System with the Universal Attachment 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.

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Concurrence of CDRH, Office Of Device Evaluation (ODE)

(Divisign St
Division of General Restorative Devices 12983670
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)