STEALTHSTATION SYSTEM DIGITIZER CHANGE

K981686 · Surgical Navigation Technologies, Inc. · HAW · Aug 7, 1998 · Neurology

Device Facts

• Record ID: K981686
• Device Name: STEALTHSTATION SYSTEM DIGITIZER CHANGE
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: HAW · Neurology
• Decision Date: Aug 7, 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 perculaneous 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 for open or percutaneous procedures. Device uses camera array to track anatomical locations relative to pre-operative CT or MR image models. Modification involves replacing original three 3D-camera array with two 2D-camera array. System used in OR by surgeons to guide instruments; provides real-time visualization of instrument position relative to patient anatomy. Benefits include increased precision in stereotactic surgical procedures.

Clinical Evidence

Bench testing only. Performance data provided to support substantial equivalence of the modified camera array to the predicate system.

Technological Characteristics

Surgical navigation system utilizing optical tracking. Modification: camera array changed from three 3D-cameras to two 2D-cameras. System integrates with CT/MR imaging data for anatomical registration. Class II device.

Indications for Use

Indicated for patients requiring stereotactic surgery where rigid anatomical structures (skull, long bone, vertebra) can be referenced to CT/MR models; includes intranasal or sinus use with ENT option. No specific age or gender 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 (K954276)

Submission Summary (Full Text)

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AUG - 7 1998

K981686

## Summary of Safety and Effectiveness

## StealthStation® System - Digitizer Change

## K981686

- Surgical Navigation Technologies I. Company: 530 Compton St. Broomfield, CO 80020 [phone]
- Product Name: StealthStation™ System Digitizer Change II.
- III. This submission describes changes made to the StealthStation™ System to include the use of a camera array utilizing two 2-dimensional cameras as an alternative to the originally cleared camera array utilizing three 3-dimensional cameras.
- 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 perculaneous 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 StealthStation™ System - Digitizer Change was shown to be substantially equivalent to the original StealthStation™ System cleared in K954276. Performance data was provided to support the claim of substantial equivalence.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 1998

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

Re: K981686 Trade Name: StealthStation® System Digitizer Change Regulatory Class: II Product Code: HAW Dated: June 25, 1997 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 (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 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): K981686 --------------------------------------------------------------------------------------------------------------------------------------------

Device Name: StealthStation® System Digitizer Change

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) |
| Division of General Restorative Devices |
| K981686 |

5100k) Number .

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)