SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION

K994421 · Surgical Navigation Specialists, Inc. · HAW · Feb 23, 2000 · Neurology

Device Facts

• Record ID: K994421
• Device Name: SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION
• Applicant: Surgical Navigation Specialists, Inc.
• Product Code: HAW · Neurology
• Decision Date: Feb 23, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The SNN Stereotactic Planning Application module is intended to be used as an accessory for planning stereotactic frame-based procedures such as biopsies, functional stereotaxy, tumor resections, vascular malformation surgeries, thalamotomies and pallidotomies.

Device Story

SNN Stereotactic Planning Application is a software module within the SNN System; functions as an accessory to stereotaxic instruments. Input consists of medical scan images. Software registers these images with stereotactic frame space; calculates frame and arc system coordinates for surgical planning. Used by clinicians in surgical settings to facilitate frame-based procedures. Output provides spatial coordinates to guide surgical instruments; assists in planning biopsies, resections, and functional neurosurgical interventions. Benefits include improved precision in targeting anatomical structures during stereotactic surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software module for stereotactic frame-based surgical planning. Functions as an accessory to stereotaxic instruments. Operates by registering medical scan images to stereotactic frame space and calculating coordinate outputs. Connectivity and specific software architecture details are not provided.

Indications for Use

Indicated for patients undergoing stereotactic frame-based surgical procedures, including biopsies, functional stereotaxy, tumor resections, vascular malformation surgeries, thalamotomies, and pallidotomies.

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

• StereoPlan (Radionics)
• AtlasPlan (Radionics)
• @Target (Brainlab)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 a cursor pointing towards the logo.

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FEB 2 3 2000

SIO(K) Premarket Notification
Submitter Siteroolactic Planning Application
Submitter: Surgical Navigation Siceliation Inc.
Submitter: Surgical Navigation Inc. And

## 510(k) Summary of Safety and Effectiveness

K99442|

| Submitter: | Surgical Navigation Specialists Inc. |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 6509 Airport Road<br>Mississauga, Ontario<br>Canada LAV 1S7 |
| Contact: | Carol Nakagawa. |
| Telephone: | [phone]. |
| Date: | February 18, 2000. |
| Trade Names: | SNN Stereotactic Planning Application; SNN Stereotactic<br>Application. |
| Common Name: | Stereotactic Head Frame software accessory. |
| Classification Name: | Accessory to Stereotaxic Instrument. |
| Predicate Devices: | StereoPlan and AtlasPlan software from Radionics, and @Target<br>software from Brainlab. |
| Device Description: | The SNN Stereotactic Planning Application software is an optional<br>module of the SNN System software. The SNN Stereotactic<br>Planning Application module registers medical scan images with<br>stereotactic frame space and calculates frame and arc system<br>coordinates. |
| Intended Use: | The SNN Stereotactic Planning Application module is intended to<br>be used as an accessory for planning stereotactic frame-based<br>procedures such as biopsies, functional stereotaxy, tumor<br>resections, vascular malformation surgeries, thalamotomies and<br>pallidotomies. |
| Comparison to<br>Predicate: | The intended use and technological characteristics of the SNN<br>image-guided surgical device including the SNN Stereotactic<br>Planning Application software module is substantially equivalent,<br>in the opinion of Surgical Navigation Specialists Inc., to those of<br>the predicate devices and do not pose any new issues of safety and<br>effectiveness. |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines above a shape resembling an eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2000

Surgical Navigation Specialists, Inc. c/o Ms. Carol Nakagawa Regulatory Scientist Cedara Software Corporation 6509 Airport Road Mississauga, Ontario Canada L4V 1S7 T

K994421 Re:

> Trade Name: SNN Stereotaxic Planning Application Regulatory Class: II Product Code: HAW Dated: December 28, 1999 Received: December 29, 1999

Dear Ms. Nakagawa:

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.

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Page 2 – Ms. Carol Nakagawa

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,

Stipt Plurle

1 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): K994421

SNN Stereotactic Planning Application Device Name:

Indications For Use :

The SNN Stereotactic Planning Application module is intended to be used as an accessory for planning stereotactic frame-based procedures such as biopsies, functional stereotaxy, turnor resections, vascular malformation surgeries, thalamotomies and pallidotomies.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use d (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K994421