STRYKER POWER TOOL NAVIGATOR ATTACHMENT

K080450 · Stryker Corp. · HAW · Jul 17, 2008 · Neurology

Device Facts

• Record ID: K080450
• Device Name: STRYKER POWER TOOL NAVIGATOR ATTACHMENT
• Applicant: Stryker Corp.
• Product Code: HAW · Neurology
• Decision Date: Jul 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Stryker® Power Tool Navigator attachment is intended to enable spatial localization and identification of Stryker Power Tools by the Stryker® Navigation System.

Device Story

Stryker Power Tool Navigator (PTN) is an optical surgical navigation tracker attachment for Stryker surgical power tools. Device utilizes array of optical IR LEDs and IR communications link to interface with Stryker Navigation System. System tracks tool position in 3D space during surgical procedures. Output allows surgeon to visualize tool location relative to patient anatomy on navigation system display. Facilitates precise surgical instrument guidance; assists in spatial localization during procedures. Used in clinical/surgical settings by trained medical professionals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Optical surgical navigation tracker; utilizes IR LED array and IR communications link. Designed for integration with Stryker Navigation System. Manufactured per QSR 21CFR 820.

Indications for Use

Indicated for spatial localization and identification of Stryker Power Tools within the Stryker Navigation System environment. No specific patient population, age, or disease state contraindications provided.

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

• Stryker® Navigation System - Neuro Module (K993239)
• Stryker® Navigation System - KneeTrack Module (K010204)
• Stryker® Navigation System - Hip Module (K022365)

Submission Summary (Full Text)

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4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 269 324 5412
www.stryker.com

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## stryker

14080450

| 510(k) Summary | |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Sponsor: | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>(p) 269-323-7700<br>(f) 269-324-5412 |
| Registration No .: | 1811755 |
| Trade Name: | Stryker® Power Tool Navigator |
| Common Name: | Power Tool Navigator |
| Classification Name: | Stereotaxic Instruments |
| Equivalent to: | K993239 Stryker® Navigation System - Neuro Module<br>K010204 Stryker® Navigation System - KneeTrack Module<br>K022365 Stryker® Navigation System - Hip Module |
| Device Description: | The Stryker® Power Tool Navigator (PTN) attachment is a tracking device designed<br>for use with Stryker Surgical Power Tools. The PTN attachment is an optical surgical<br>navigation tracker that attaches to a power tool, allowing that tool to be tracked by a<br>Stryker Navigation System. The device employs an array of optical IR LEDs and an IR<br>communications link to interface with the Navigation System. |
| Indications for Use: | Stryker® Power Tool Navigator attachment is intended to enable spatial localization<br>and identification of Stryker Power Tools by the Stryker® Navigation System |
| Substantial Equivalence<br>(SE) Rational: | Stryker® Power Tool Navigator attachment is equivalent in intended use, safety, and<br>effectiveness to existing devices being marketed by Stryker. |
| Safety and Effectiveness: | The Stryker® Power Tool Navigator attachment does not raise any new safety and<br>efficacy concerns when compared to a similar device already legally marketed. The<br>Stryker® Power Tool Navigator attachment is, therefore, substantially equivalent to the<br>existing device. Stryker® Power Tool Navigator attachment is designed and<br>manufactured in accordance with Stryker Instrument's Quality Management System<br>covered by QSR 21CFR 820. |
| Submitted by: | Becky Ditty<br>Senior Regulatory Affairs Representative |

Signature
2/15/18Date Submitted:

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Public Health Service

JUL 1 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Corporation % Ms. Becky Ditty Regulatory Analyst 4100 E. Milham Avenue Kalamazoo, Michigan 49001

Re: K080450

Trade/Device Name: Stryker® Power Tool Navigation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: June 16, 2008 Received: June 19, 2008

Dear Ms. Ditty:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Becky Ditty

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems ম্ম [phone]. You may otuain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mullein

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

:

Device Name: Stryker® Power Tool Navigator

Indications for Use

The Stryker® Power Tool Navigator attachment is intended to enable spatial localization and identification of Stryker Power Tools by the Stryker® Navigation System.

| Prescription Use | X | and/or | Over-The-Counter Use | |
|-----------------------------|---|--------|------------------------|--|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) | |

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

(Division Sign-Off)

Division of General Restorative Device Evaluation (ODE)

and Neurological Devices

| 510(k) Number | L080480 |
|---------------|---------|
|---------------|---------|