STEALTHSTATION SYSTEM

K974161 · Surgical Navigation Technologies, Inc. · HAW · Nov 21, 1997 · Neurology

Device Facts

• Record ID: K974161
• Device Name: STEALTHSTATION SYSTEM
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: HAW · Neurology
• Decision Date: Nov 21, 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™ Drill Attachment is an accessory for the StealthStation™ System; enables tracking of powered surgical drills during stereotactic procedures. Device attaches to drill; allows system to track drill bit of known length using optical tracking technology. Used in OR by surgeons to precisely locate anatomical structures relative to pre-operative CT or MR images. Output provides real-time visualization of drill position relative to patient anatomy; assists surgeon in navigation during open or percutaneous surgery. Benefits include improved precision in surgical targeting.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established through demonstration of tracking accuracy for drill bits compared to existing optical probes.

Technological Characteristics

Optical tracking system; drill attachment hardware; compatible with powered surgical drills. Utilizes known drill bit length for spatial registration. System operates via optical sensors tracking markers on the drill attachment.

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 models.

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™ (K954276)

Submission Summary (Full Text)

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K974161

NOV 2 1 1997

Summary of Safety and Effectiveness

## K954276 Addendum - August 14, 1997 StealthStation™ Drill Attachment

Surgical Navigation Technologies, Inc. I. Company: 530 Compton Street Broomfield, CO 80020

- Product Name: StealthStation™ Drill Attachment II.
- This submission is an addendum to K954276 which allows the III. StealthStation™ to track a powered surgical drill.
- The StealthStation™ Drill Attachment's ability to track a drill bit of known IV. length was shown to be substantially equivalent to the method used to track other optical probes specified in 510(k) No. K954276.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 symbol, which is a stylized representation of a human figure. The symbol is composed of three curved lines that form the shape of a person's head and shoulders. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

NOV 21 1997

Mr. David A. Mire Clinical and Regulatory Affairs Associate Surgical Navigation Technologies, Incorporated 530 Compton Street Broomfield, Colorado 80020

Re : K974161 StealthStation™ System Trade Name: Requlatory Class: II Product Code: HAW Dated: August 26, 1997 Received: August 27, 1997

Dear Mr. Mire:

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, Druq, 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, labelinq, and prohibitions aqainst 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 Requlations, 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 Requlation (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Mire

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 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 requlation (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, MD Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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## 510(k) Number (if known): K 9741 C /

Device Name: _________________________________________________________________________________________________________________________________________________________________

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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Coneurrence of CDRH, Office Of Device Evaluation (ODE)

(Division Sign-Off)

on Control Division of Dental, Into and General Hospita 510(k) Number _

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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