SNT STEREOTACTIC LOCALIZATION SYSTEM

K971675 · Surgical Navigation Technologies, Inc. · HAW · Jul 14, 1997 · Neurology

Device Facts

• Record ID: K971675
• Device Name: SNT STEREOTACTIC LOCALIZATION SYSTEM
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The SNT Stereotactic Localization System is indicated for providing a precise stereotactic coordinate system in either CT or Radiographic images for the purpose of planning and performing stereotactic cranial procedures.

Device Story

SNT Stereotactic Localization System provides precise coordinate mapping for cranial surgery planning. System components include headring, CT localizer, X-ray localizer, and film holder. Used in clinical settings by neurosurgeons to establish stereotactic coordinates on CT or radiographic images. Facilitates surgical planning and execution of cranial procedures. Benefits include improved spatial accuracy for targeting during stereotactic interventions.

Clinical Evidence

No clinical data provided; substantial equivalence based on comparison to existing commercially available stereotactic localization systems.

Technological Characteristics

System includes mechanical components: headring, CT localizer, X-ray localizer, and film holder. Provides stereotactic coordinate system for imaging modalities (CT/Radiographic).

Indications for Use

Indicated for patients undergoing stereotactic cranial procedures requiring precise coordinate mapping via CT or Radiographic imaging.

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.

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

## SNT Stereotactic Localization System JUL 1 4 1997

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

- Product Name: SNT Stereotactic Localization System II.
- III. The SNT Stereotactic Localization System is indicated for providing a precise stereotactic coordinate system in either CT or Radiographic images for the purpose of planning and performing stereotactic cranial procedures.

The system includes:

- a headring .
- a CT localizer ●
- an X-ray localizer ●
- a film holder ●
- I V. The SNT Stereotactic Localization System was shown to be substantially equivalent to other commercially available stereotactic localization systems.

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Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Roger N. White Surgical Navigation Technologies, Inc. 530.Compton Street JUL 1 4 1997 Broomfield, Colorado 80020

Re: K971675 Trade Name: SNT Stereotactic Localization System Regulatory Class: II Product Code: 84HAW Dated: May 5, 1997 Received: May 7, 1997

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 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 Pood and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): K971475

Device Name: ________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The SNT Stereotactic Localization System is indicated for providing a precise stereotactic coordinate system in either CT or Radiographic images for the purpose of planning and performing stereotactic cranial procedures.

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Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

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Division of Cardiovascular, Respiratory, Division of Size of Sical Devices 510(k) Number