STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX

K993239 · Stryker Corp. · HAW · Jan 18, 2000 · Neurology

Device Facts

• Record ID: K993239
• Device Name: STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
• Applicant: Stryker Corp.
• Product Code: HAW · Neurology
• Decision Date: Jan 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Stryker Navigation System - Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any neurological medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure can be identified relative to medical images.

Device Story

System provides planning and intraoperative guidance for open or percutaneous neurological surgery. Inputs: diagnostic medical images. Operation: computer calculates stereotactic coordinates from images; measures coordinates within surgical field; displays high-resolution images with overlaid stereotactic coordinates. Used in clinical/surgical settings by physicians. Output: visual guidance on display to assist surgical navigation. Benefit: precise stereotactic determination of surgical targets; facilitates accurate instrument positioning relative to patient anatomy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises hardware and software components for stereotactic coordinate calculation and image display. Utilizes diagnostic imaging data for navigation. No specific materials, connectivity, or software architecture details provided.

Indications for Use

Indicated for patients with neurological conditions requiring image-guided surgery where rigid anatomical structures can be referenced to medical images.

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.

Reference Devices

• Sofamor Danek image guided surgery systems
• Zeiss image guided surgery systems
• BrainLab image guided surgery systems

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are closely spaced together, creating a solid block of text. The word appears to be a logo or brand name.

4100 East Mitham Avenue
Kalamazoo. Mi 49001
Phone [phone]
[phone]

993239

## Device Name:

| Trade Name: | Stryker Navigation System Neuro Module |
|----------------------|---------------------------------------------------|
| Common Name: | Image Guided Surgery System |
| Classification Name: | Instrument, Stereotaxic: 21 CFR 882.4560, Class I |

## Device Sponsor:

| Manufacturer: | Stryker Corporation<br>Stryker Leibinger GmbH and Co. KG<br>Boetzinger Straße 41<br>D-79111 Freiburg Germany<br>Registration No.: 8010177 |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Distributor: | Stryker Corporation<br>Stryker Leibinger<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>Registration No.: 1811755 |
| Regulatory Class: | Class II |

## Summary of Safety and Effectiveness:

The Stryker Navigation System - Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any neurological medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure can be identified relative to medical images.

The Stryker Navigation System - Neuro Module is equivalent in intended use, safety, and effectiveness to existing image guided surgery systems begin marketed by companies such as Sofamor Danek, Zeiss, and BrainLab.

The Stryker Navigation System - Neuro Module provides precise stereotactic determiniation of surgical targets using a stereotactic methdology. The three principle features include computer calculation of stereotactic coordinates from the diagnostic images, measurement of stereotactic coordinates within the surgical field, high-

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K99 3239

resolution computer display of diagnostic images with stereotactic coordinates indicated. The system is comprised of hardware and software components.

The Stryker Navigation System - Neuro Module does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Navigation System - Neuro Module is substantially equivalent to these existing devices.

By: Nicole Petty

Regulatory Affairs Analyst Stryker Leibinger

Dated: _

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

JAN 18 2000

Ms. Nicole Petty Regulatory Affairs Analyst Stryker Leibinger 4100 East Milham Avenue Kalamazoo. Michigan 49001

K993239 Re:

> Trade Name: Stryker Navigation System - Neuro Module Regulatory Class: II Product Code: HAW Dated: November 15, 1999 Received: November 16, 1999

Dear Ms. Petty:

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. Nicole Petty

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 vour 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.

Stupt Rhodes
James H. Dillard III

James R. Dillard Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__1_______________________________________________________________________________________________________________________________________________________________________

| 510(k) Number: | K993239 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Stryker Navigation System - Neuro Module |
| Indications For Use: | The Stryker Navigation System - Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any neurological medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure can be identified relative to medical images. |

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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K993239 |

| Prescription Use | <img alt="Prescription Use" src="prescription_use.png"/> | OR | Over-The-Counter Use |
|----------------------|----------------------------------------------------------|----|----------------------|
| (Per 21 CFR 801.109) | | | |