STELTHSTATION WIRELESS SURGEON MOUSE

K051029 · Medtronic Surgical Navigation · HAW · Jun 8, 2005 · Neurology

Device Facts

• Record ID: K051029
• Device Name: STELTHSTATION WIRELESS SURGEON MOUSE
• Applicant: Medtronic Surgical Navigation
• Product Code: HAW · Neurology
• Decision Date: Jun 8, 2005
• Decision: SESE
• Submission Type: Special
• 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 in which the use of stereotactic surgery may be 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.

Device Story

The StealthStation® Wireless Surgeon Mouse is an accessory for the StealthStation® surgical navigation system. It functions as a wireless Bluetooth input device, allowing surgeons to interact with the navigation system's interface during procedures. By replacing or supplementing wired input methods, it enables sterile, remote control of the system's software, which displays anatomical models and navigation data. The device is used in the operating room by surgeons to manipulate navigation views, select targets, or adjust settings without breaking the sterile field. This interaction facilitates real-time surgical guidance, potentially improving the precision of instrument placement and anatomical localization during complex cranial, spinal, orthopaedic, and ENT surgeries.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing and verification/validation activities related to the integration of the wireless mouse component.

Technological Characteristics

Wireless Bluetooth input device; interfaces with existing StealthStation® navigation system; operates as a peripheral for system control; no changes to core navigation sensing or imaging technology.

Indications for Use

Indicated for patients undergoing stereotactic surgical procedures where anatomical structures (skull, long bone, vertebra) must be located relative to CT, MR, fluoroscopy, or digitized landmarks. Applicable to cranial, spinal, orthopaedic, and ENT procedures.

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.

Submission Summary (Full Text)

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## 221029

Summary of Safety and Effectiveness StealthStation® Wireless Surgeon Mouse

- Manufacturer l. Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: [phone] Fax Number: [phone]
- Contact 11. Tina Dreiling Associate Regulatory Affairs Specialist Medtronic Navigation, Inc.

## Product Name / Classification III.

| Common Name: | Stereotaxic instrument |
|----------------------|----------------------------------------|
| Classification Name: | Instrument, Stereotaxic |
| Trade Name: | StealthStation® Wireless Surgeon Mouse |

Stereotaxic instrument - Class II as described in 21 CFR § 882.4560 Product Code: HAW

- IV. Date Summary Submitted April 20, 2005
- Description of Device Modification V. Description of Device Modification® System to allow for the use of a wireless Bluetooth mouse.
- VI. Substantial Equivalence Substantial Lqurvalenoo The use of the StealthStation® Wirenton ourgressions 510(K) submissions. As equired by risk analysis, all verification and validation activities were performed by required by nok analyons, and the results demonstrated the substantial equivalence.

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## VII. Indications for Use

Indications for USE
This submission does not change the indications for use for the StealthStation System.

The StealthStation® System is intended as an aid for precisely locating anatomical The StealthStation® Oystem is Intended as an and an and StealthStation® System is structures in enner open of persulanced in which the use of stereotactic surgery may be Indicated for any medical condition in which the aconcel structure, such as the skull, a long appropriate, and where references to a nigra that based model, fluoroscopy images, or digitized landmarks of the anatomy.

For the optical-based and EM-based system, example procedures include, but are not limited to:

| Cranial Procedures: | Spinal |
|------------------------------------|---------|
| Cranial Biopsies | Spinal |
| Tumor Resections | Screw |
| Craniotomies/ Craniectomies | |
| Skull Base procedures | ENT P |
| Thalamotomies/Pallidotomies | Trans |
| Pituitary Tumor Removal | Intrana |
| CSF Leak Repair | Orbital |
| Pediatric Catheter Shunt Placement | Optic |
| General Catheter Shunt Placement | Polyp |
| | Endos |

Orthopaedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

Spinal Procedures: Implant Procedures, such as Pedicle Placement

rocedures: henoidal Procedures asal Procedures Nerve Decompression Procedures Nerve Decompression Procedures sis Procedures copic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies

Additional example procedures for the optical-based system include, but are not limited to:

Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopaedic Procedures Pediatric Orthopaedics Total Hip Replacement (Primary and Revision) Periacetabular Osteotomies Tumor Resection and Bone/Joint Reconstruction Femoral Revision Placement of Iliosacral Screws 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 features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

JUN 8 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tina Dreiling Associate Regulatory Affairs Specialist Medtronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, Colorado 80027

Re: K051029

Trade/Device Name: StealthStation® Wireless Surgeon Mouse Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: May 31, 2005 Received: June 1, 2005

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) remarket 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 other general mixernational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting 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): ____________________________________________________________________________________________________________________________________________________

Device Name: StealthStation® Wireless Surgeon Mouse

Indications for Use: This submission does not change the indications for use for the StealthStation System.

The StealthStation® System is intended as an aid for precisely locating anatomical structures in rite ofcalthorions operations of the StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a Condition in which the doe of etersetablications of vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

For the optical-based and EM-based system, example procedures include, but are not limited to:

Cranial Procedures: Cranial Biopsies Turnor Resections Craniotomies/ Craniectomies Skull Base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair Pediatric Catheter Shunt Placement General Catheter Shunt Placement

Orthopaedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

Spinal Procedures: Spinal Implant Procedures, such as Pedicle Screw Placement

ENT Procedures Transphenoidal Procedures Intranasal Procedures Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations. Turbinate Resections, and Frontal Sinusotomies

Additional example procedures for the optical-based system include, but are not limited to:

Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopaedic Procedures Pediatric Orthopaedics Total Hip Replacement (Primary and Revision) Periacetabular Osteotomies Tumor Resection and Bone/Joint Reconstruction Femoral Revision Piacement of Iliosacral Screws r labornent of Medarer of Pelvic Fractures (Including but not limited to Acetabular Fractures)

× Prescription Use (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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General, Restorative
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K05/029
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