AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM

K061248 · Medtronic Navigation, Inc. · HAW · Aug 31, 2006 · Neurology

Device Facts

• Record ID: K061248
• Device Name: AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
• Applicant: Medtronic Navigation, Inc.
• Product Code: HAW · Neurology
• Decision Date: Aug 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or perculaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The AxiEM™ Imageless Hip Module for the StealthStation® is intended to precisely position instruments and implants in example procedures such as but not limited to: Orthopedic Procedures: Minimally Invasive Orthopedic Procedures Total Hip Replacement (Primary and Revision)

Device Story

AxiEM™ Imageless Hip Module is an accessory for the StealthStation® System; provides stereotactic navigation for orthopedic hip procedures. Unlike optical tracking predecessors, this module utilizes electromagnetic (EM) navigation technology. System tracks surgical instruments relative to patient anatomy using digitized landmarks; eliminates need for pre-operative or intra-operative imaging. Used in clinical settings by surgeons to guide instrument and implant positioning during total hip replacement (primary/revision) and minimally invasive orthopedic procedures. Output provides real-time spatial visualization of instruments on the StealthStation display; assists surgeon in precise anatomical alignment; potentially improves surgical accuracy and patient outcomes.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Stereotaxic instrument (Class II, Product Code HAW). Utilizes electromagnetic (EM) navigation technology for tracking. Replaces optical tracking components found in predicate. System is designed for integration with the existing StealthStation® platform.

Indications for Use

Indicated for patients undergoing orthopedic procedures, including minimally invasive procedures and primary or revision total hip replacement, where stereotactic surgery is appropriate and anatomical structures can be referenced via digitized landmarks.

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

• Imageless Hip Module for the StealthStation® System (K052623)

Reference Devices

• AxiEM™ Imageless Knee Module for the StealthStation® System

Submission Summary (Full Text)

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# KOG1248

## Summary of Safety and Effectiveness AxiEM™ Imageless Hip Module for the StealthStation® System

#### l. Manufacturer

Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number [phone] Fax Number: [phone]

#### II. Contact

Tina Dreiling Associate Requlatory Affairs Specialist Medtronic Navigation, Inc.

#### 111. Product Name / Classification

Common Name: Stereotaxic instrument Classification Name: Instrument, Stereotaxic Trade Name: Imageless Hip Module for the StealthStation® System Stereotaxic instrument - Class II as described in 21 CFR § 882 4560 Product Code: HAW

### IV. Date Summary Submitted April 28, 2006

#### V. Description of Device Modification

The AxiEM™ Imageless Hip Module for the StealthStation® System provides a mechanism for the establishment of stereotactic coordinates without the use of a pre-operative or intra-operative image using electromagnetic navigation

#### VI. Substantial Equivalence

The primary difference between the Imageless Hip Module for the StealthStation® System and the AxiEM™ Imageless Hip Module for the StealthStation® System is that the AxiEM™ Imageless Hip Module utilizes electromagnetic navigation technology rather than optical tracking.

The primary difference between the AxiEM™ Imageless Knee Module for the StealthStation® System and the AxiEM ™ Imageless Hip Module for the StealthStation® System is that the subject device navigates instruments for use in hip procedures and the AxIEM™ Imageless Knee application navigates instruments for use in knee procedures.

As required by risk analysis, all verfication and validation activities will be performed by designated individuals and will demonstrate the safety and effectiveness of the device.

The information provided in this 510(k) application supports that the AxiEM™ Imageless Hip Module for the StealthStation® System is substantially equivalent to the Imageless Hip Module for the StealthStation® System (K052623).

#### VII. Indications for Use

The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The AxiEM™ Imageless Hip Module for the StealthStation® is intended to precisely position instruments and implants in example procedures such as but not limited to:

## Orthopedic Procedures:

Minimally Invasive Orthopedic Procedures Total Hip Replacement (Primary and Revision)

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2006

Medtronic Navigation, Inc. % Ms. Tina Dreiling Associate RA Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K061248

Trade/Device Name: AxiEM™ Imageless Hip Module for the StealthStation® System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: August 9, 2006 Received: August 10, 2006

Dear Ms. Dreiling:

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. Tina Dreiling

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain 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 N. Melkerson

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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## Indications for Use

510(k) Number (if known): 7700) 978

Device Name: AxiEM ™ Imageless Hip Module for the StealthStation® System

Indications for Use:

-

The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or perculaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The AxiEM™ Imageless Hip Module for the StealthStation® is intended to precisely position instruments and implants in example procedures such as but not limited to:

Orthopedic Procedures: Minimally Invasive Orthopedic Procedures Total Hip Replacement (Primary and Revision)

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

| (Division Sign-Off) | |
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| Division of General, Restorative, and Neurological Devices | Page 1 of 1 |

Number F06/244

Medtronic

CONFIDENTIAL

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