SNN FLUORO NAVIGATION SYSTEM

K993673 · I.S.G. Technologies, Inc. · HAW · Dec 21, 1999 · Neurology

Device Facts

• Record ID: K993673
• Device Name: SNN FLUORO NAVIGATION SYSTEM
• Applicant: I.S.G. Technologies, Inc.
• Product Code: HAW · Neurology
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The SNN Fluoro Navigation System, comprised of a medical workstation and an integrated position-sensing instrument, is intended to be used intra-operatively for localization and navigation.

Device Story

SNN Fluoro Navigation System is an image-guided surgery module for the SNN System; utilizes intra-operative fluoroscopic images to provide real-time localization and navigation of surgical instruments relative to patient anatomy. System consists of a medical workstation and integrated position-sensing instruments. Used intra-operatively by surgeons to navigate surgical tools during procedures involving the head or spine. By mapping physical instruments to fluoroscopic images, the system assists in precise surgical targeting and navigation, potentially improving surgical accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to predicate devices.

Technological Characteristics

System comprises a medical workstation and integrated position-sensing instruments. Operates as a module of the SNN System to provide image-guided surgery based on intra-operative fluoroscopic imaging. Connectivity involves integration with fluoroscopic imaging equipment.

Indications for Use

Indicated for patients with space-occupying lesions or malformations (soft tissue or osseous) in the head, or patients requiring decompressive or reconstructive spine surgery. Also indicated for procedures where rigid anatomical structures (skull, long bone, vertebra) can be identified relative to intra-operative fluoroscopic images. Contraindicated for patients suspected of Creutzfeld-Jacob's disease if instrument sterilization cannot be assured.

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

• SNN System (K982570)
• Stealth Station with FluoroNav Module by Surgical Navigation Technologies (K990214)

Submission Summary (Full Text)

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K993673

## DEC 2 1 1996

Image /page/0/Picture/2 description: The image shows a logo with the letters SNN in a stylized font. Below the letters, the text "THE NETWORK FOR IMAGE GUIDED SURGERY" is written in a smaller font. To the right of the letters, there is an image of a cursor.

510(k)_Premarket Notification
SNN Fluoro Navigation System Submitter Surgical Navigation Specialists Inc.
October26, 1999

## 510(k) Summary of Safety and Effectiveness

| Submitter: | Surgical Navigation Specialists Inc. |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 6509 Airport Road<br>Mississauga, Ontario<br>Canada L4V 1S7 |
| Contact: | Dolores McGirr, Regulatory Scientist |
| Telephone: | [phone] |
| Date: | October 26, 1999 |
| Trade Name: | SNN Fluoro Navigation System |
| Common Name: | Image-Guided Surgical System. |
| Classification Name: | Stereotaxic Device. |
| Predicate Devices: | SNN System K982570; the Stealth Station with FluoroNav<br>Module by Surgical Navigation Technologies K990214. |
| Device Description: | The SNN Fluoro Navigation System is a module of the SNN<br>System to provide image-guided surgery based on an intra-<br>operative fluoroscopic image of the patient anatomy. |
| Intended Use: | The SNN Fluoro Navigation System, comprised of a medical<br>workstation and an integrated position-sensing instrument, is<br>intended to be used intra-operatively for localization and<br>navigation. |
| Comparison to<br>Predicates: | The intended use and technological characteristics of the SNN<br>Fluoro Navigation system are substantially equivalent, in the<br>opinion of SNS Inc., to those of the predicate devices and do not<br>pose any new issues of safety and effectiveness. |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a traditional symbol of medicine, with three lines representing the branches of government. The seal is black and white.

Public Health Service

DEC 2 1 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mrs. Dolores McGirr Regulatory Scientist Quality Engineering Support Team I.S.G. Technologies, Inc. 6509 Airport Road Mississauga, Ontario Canada L4V 1S7

Re: K993673

Trade Name: SNN Fluoro Navigation System Regulatory Class: II Product Code: HAW Dated: October 26, 1999 Received: November 1, 1999

Dear Mrs. McGirr:

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 (OS) 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.

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

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Page 2 - Mrs. Dolores McGirr

predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If vou 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.

Stephen Rhodes

James E. Dillard III Acting 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): _ _ 99 ≤ 6 7 3

Device Name: The SNN Fluoro Navigation System

Indications For Use :

The SNN System is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or The SNN System is contraindicated for malformations of the spine. patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured.

The SNN Fluoro Navigation Module is also indicated for situations where reference to a rigid anatomical structure such as the skull, a long bone or vertebra can be identified relative to a fluoroscopic image of the anatomy.

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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)
Het Eluolu

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K995673