HIP MODULE FOR THE STEALTHSTATION SYSTEM

K021980 · Medtronic Surgical Navigation Technologies · HAW · Nov 19, 2002 · Neurology

Device Facts

• Record ID: K021980
• Device Name: HIP MODULE FOR THE STEALTHSTATION SYSTEM
• Applicant: Medtronic Surgical Navigation Technologies
• Product Code: HAW · Neurology
• Decision Date: Nov 19, 2002
• 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 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 or fluoroscopy images of the anatomy. The 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) Tumor Resection and Bone/Joint Reconstruction Placement of Iliosacral Screws Femoral Revision Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)

Device Story

Hip Module for StealthStation® System; software extension for existing surgical navigation platform. Inputs: active/passive infrared markers tracking surgical instruments and patient anatomy; CT, MR, or fluoroscopic image data. Operation: correlates tracked instrument position with patient imaging to provide real-time visualization of instrument/implant placement relative to anatomy. Used in OR by surgeons for orthopedic procedures (e.g., hip replacement, pelvic fracture repair). Output: visual navigation guidance on system display. Benefit: enables precise instrument/implant positioning during minimally invasive or open orthopedic surgeries.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence established through verification and validation activities and comparison to predicate devices.

Technological Characteristics

Stereotaxic instrument; utilizes active or passive infrared markers for tracking. Integrates with CT, MR, or fluoroscopic imaging. Software-based navigation module for StealthStation® platform. Connectivity via system integration.

Indications for Use

Indicated for patients requiring stereotactic surgery for orthopedic procedures, including total hip replacement, tumor resection, bone/joint reconstruction, iliosacral screw placement, femoral revision, and pelvic fracture stabilization/repair, where anatomical structures can be referenced to CT, MR, or fluoroscopic 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.

Predicate Devices

• StealthStation® System (K021980 context)
• BrainLAB Vector Vision Hip
• Stryker Navigation System - Spine & Fluoroscopy Module

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness Hip Module Software for the StealthStation® System

### I. Manufacture:

Medtronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, CO 80027 USA Telephone Number: [phone] Fax Number: [phone]

NOV 1 9 2002

### II. Contact:

Victoria G. Rendon Clinical and Regulatory Affairs Associate Medtronic Surgical Navigation Technologies

#### III. Product Name/ Classification Name:

Product Name: Hip Module for the StealthStation® System Classification Name: Stereotaxic Instrument (21 CFR 882.4560) Classification Panel: 84 HAW

#### IV. Date Summary Submitted

June 13, 2002

#### V. Description of Device Modification:

This submission allows a surgeon to utilize a modified version of the FluoroNav™ Software to place hip implants and repair and/or stabilize trauma sustained to the pelvic area. The Hip Module for the StealthStation® System is technically equivalent to the StealthStation® System, and the FluoroNav™ Module for the StealthStation®. All systems use either active or passive infrared markers to track a reference frame attached to the anatomy and to track surgical instruments. This information is correlated to the patient's CT, MR or fluoroscopic images of the anatomy.

This submission provides new orthopedic indications that are substantially equivalent to the named predicate devices' indications statement.

### VI. Substantial Equivalence:

The Hip Module for the StealthStation® System was substantially equivalent to the StealthStation System cleared in previous 510(k)'s. Additionally, the Hip Module was determined to be substantially equivalent to the BrainLAB Vector Vision Hip, and the Stryker Navigation System -Spine & Fluoroscopy Module. As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence.

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### VII. Indications For Use:

The indications for use for the Hip Module for the StealthStation® Software are identical to the indications for use for the named predicate devices. The indications for use are as follows:

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 or fluoroscopy images of the anatomy.

The 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)

Tumor Resection and Bone/Joint Reconstruction

Placement of Iliosacral Screws

Femoral Revision

Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Surgical Navigation Technologies Victoria G. Rendon Clinical and Regulatory Affairs Associate 826 Coal Creek Circle Louisville, Colorado 80027

Re: K021980

Trade/Device Name: Hip Module for the Stealthstation System Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: October 25, 2002 Received: October 28, 2002

Dear Ms. Rendon:

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. Victoria G. Rendon

. .

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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Purvet

fol Celia M. Witten, Ph.D., M.D. 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: 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 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 or fluoroscopy images of the anatomy.

The 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)

Tumor Resection and Bone/Joint Reconstruction

Placement of Iliosacral Screws

Femoral Revision

Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription Use O (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Miriam C. Provost

Division Sign-Off Division of General. Restorative

Number __

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