STEALTHSTATION SYSTEM

K974187 · Surgical Navigation Technologies, Inc. · HAW · Jan 21, 1998 · Neurology

Device Facts

• Record ID: K974187
• Device Name: STEALTHSTATION SYSTEM
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jan 21, 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 is a surgical navigation platform; utilizes CT or MR image data to create anatomical models; enables precise localization of anatomical structures during open or percutaneous procedures. System tracks surgical instruments relative to patient anatomy; provides real-time visual feedback to surgeons in OR. Used by surgeons to guide instrumentation; improves accuracy in complex anatomical regions like sinus/intranasal spaces. Benefits include enhanced surgical precision and navigation in stereotactic procedures.

Clinical Evidence

Clinical data provided to support the claim of substantial equivalence for the ENT application.

Technological Characteristics

Stereotactic surgical navigation system; utilizes CT/MR image-based anatomical modeling; tracks rigid anatomical structures (skull, long bone, vertebra) for surgical guidance.

Indications for Use

Indicated for patients requiring stereotactic surgery where rigid anatomical structures (skull, long bone, vertebra) can be referenced to CT/MR models; specifically includes intranasal or sinus 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)

Submission Summary (Full Text)

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Ki 14,51

## JAN 2 1 1998

## 510(k) Summary

## StealthStation™ System - ENT Application

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

- Product Name: StealthStation System ENT Application II.
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- This submission describes a revised indications statement for the III. StealthStation System to provide specifically for the ENT application of intranasal or sinus use.
- The indications for use for the StealthStation System are as follows: IV.

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.

- The StealthStation System ENT Application was shown to be V. substantially equivalent to the original StealthStation System. Clinical data was provided to support the claim of substantial equivalence.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1998

Roger White Group Director Quality Systems and Regulatory Affaris Surgical Navigation Technologies 530 Compton Street Broomfield, CO 80020

Re:

K974187 StealthStation™ System - ENT Application Dated: December 15, 1997 Received: December 16, 1997 Regulatory class: II 21 CFR 882.4560/Procode: 84 HAW

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 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 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations. ... . . . . . . . . . .

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/cdrb/dsmamain.html":---------------------------------------------------------------------------------------------

Sincerely yours,

hìàu Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K974187 ____________________________________________________________________________________________________________________________________________

Device Name: StealthStation System - ENT Application

Indications For Use:

D

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.

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

| | <i>David C. Seymour</i> | |
|---------------|--------------------------------------------------------------------|--|
| | (Division Sign-Off) | |
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | <i>K974187</i> | |

| Prescription Use | X | OR | Over-The-Counter Use ______ |
|----------------------|---|----|-----------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |