STEALTHSTATION TREATMENT GUIDANCE PLATFORM

K981684 · Surgical Navigation Technologies, Inc. · HAW · Aug 6, 1998 · Neurology

Device Facts

• Record ID: K981684
• Device Name: STEALTHSTATION TREATMENT GUIDANCE PLATFORM
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: HAW · Neurology
• Decision Date: Aug 6, 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 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. The StealthStation™ System with the ENT option is also indicated for intranasal or sinus use.

Device Story

StealthStation™ System provides surgical navigation; aids in precise localization of anatomical structures during open or percutaneous procedures. System utilizes CT or MR-based anatomical models as reference. Subject submission introduces pre-sterilized passive markers for use with system instruments. Markers serve as tracking points for navigation; system tracks markers to correlate physical anatomy with imaging data. Used in clinical settings (OR); operated by surgeons. Output allows visualization of instrument position relative to patient anatomy; assists in surgical guidance; potentially improves procedural accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use comparison to predicate.

Technological Characteristics

Passive markers for optical/electromagnetic tracking; pre-sterilized. System integrates with CT/MR imaging data for stereotactic navigation. No changes to core system energy source or sensing principles compared to predicate.

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 via ENT option.

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

• Passive Marker Option for the StealthStation™ System (K972398)

Submission Summary (Full Text)

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K981684

## 510(k) Summary

## Sterile Passive Markers for the StealthStation™ System

I. Company: Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 [phone]

Sterile Passive Markers for the StealthStation™ System II. Product Name:

- This submission describes updates made to the StealthStation™ System to provide III. the option for providing pre-sterilized passive markers for the StealthStation™ instruments.
- The indications for use for the StealthStation™ System have not changed and are as IV. 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. The StealthStation™ System with the ENT option is also indicated for intranasal or sinus use.

- V. The Sterile Passive Marker for the StealthStation™ System was shown to be substantially equivalent to the Passive Marker Option for the StealthStation™ System that was cleared in K972398.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 6 1998

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

Re: K981684 Trade Name: StealthStation™ System - Battery Powered Marker Option Regulatory Class: II Product Code: HAW Dated: May 12, 1998 Received: May 13, 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 (OS) 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/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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510(k) Number (if known): 9871684

Device Name: StealthStation™ System - Battery Powered Marker 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. The StealthStation™ System with the ENT option is also indicated for intranasal or sinus use.

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(Division Sign-Off)
Division of General Restorative Devices K981684
510(k) Number

Prescription Use U (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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