STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE

K030106 · Medtronic Surgical Navigation Technologies · HAW · Feb 12, 2003 · Neurology

Device Facts

• Record ID: K030106
• Device Name: STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE
• Applicant: Medtronic Surgical Navigation Technologies
• Product Code: HAW · Neurology
• Decision Date: Feb 12, 2003
• 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. 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.

Device Story

StealthStation® System Advanced Contour Registration Software Module updates existing surgical navigation software; provides new registration method for aligning patient anatomy with pre-operative CT/MR or intra-operative fluoroscopy images. Used in OR by surgeons to precisely locate anatomical structures during open or percutaneous procedures. Software processes anatomical data to facilitate registration; output displayed to surgeon to guide surgical instruments relative to patient anatomy. Enhances surgical accuracy; aids in complex procedures like tumor resection, spinal implant placement, and joint arthroplasty.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and verification/validation activities.

Technological Characteristics

Software module for surgical navigation system. Implements contour registration algorithms. Operates on existing StealthStation hardware platform. No specific materials or energy sources defined for the software module itself.

Indications for Use

Indicated for patients requiring stereotactic surgery for cranial, spinal, orthopedic, or ENT procedures where rigid anatomical structures (skull, long bone, vertebra) can be registered to CT, MR, or fluoroscopic images. Includes tumor resection, biopsies, joint arthroplasty, and sinus 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.

Predicate Devices

• StealthStation System (K030106)

Submission Summary (Full Text)

{0}------------------------------------------------

K030/06

# Summary of Safety and Effectiveness StealthStation® System Advanced Contour Registration Software Module

## I. Manufacture:

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

FEB 1 2 2003

# II. Contact:

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

### III. Product Name/ Classification Name:

Product Name: StealthStation® System Advanced Contour Registration Software Module Classification Name: Stereotaxic Instrument (21 CFR 882.4560)

Classification Panel: 84 HAW

# Date Summary Submitted IV.

January 10, 2003

### Description of Device Modification: V.

This submission describes updates made to the StealthStation® System to include software algorithms that facilitates a different registration method.

### VI. Substantial Equivalence:

The StealthStation® System Advanced Contour Registration Software Module was shown to be substantially equivalent to the StealthStation System cleared in previous 510(k)'s. As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence.

{1}------------------------------------------------

# VII. Indications For Use:

Encephalocele Procedures

The indications for use for the StealthStation® System Advanced Contour Registration Software Module are identical to the StealthStation® System indications for use. 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.

Example procedures include, but are not limited to:

| Cranial Procedures: | Spinal Procedures: | Orthopedic Procedures: |
|----------------------------------------|--------------------------------------------|--------------------------------------------------------|
| Cranial Biopsies | Spinal Implant Procedures, such as Pedicle | Total Knee Arthroplasty (Primary and Revision) |
| Tumor Resections | Screw Placement | Unicompartmental Knee Arthroplasty |
| Craniotomies/ Craniectomies | | Minimally Invasive Orthopedic Procedures |
| Skull Base procedures | | Total Hip Replacement (Primary and Revision) |
| Thalamotomies/Pallidotomies | | Tumor Resection and Bone/Joint Reconstruction |
| Pituitary Tumor Removal | | Femoral Revision |
| CSF Leak Repair | | Placement of Iliosacral Screws |
| Pediatric Catheter Shunt Placement | | Stabilization and Repair of Pelvic Fractures |
| General Catheter Shunt Placement | | (Including but not Limited to Acetabular<br>Fractures) |
| ENT Procedures: | | |
| Transphenoidal Procedures | | |
| Intranasal Procedures | | |
| Orbital Nerve Decompression Procedures | | |
| Optic Nerve Decompression Procedures | | |
| Polyposis Procedures | | |
| Endoscopic Dacryocystorhinostomy | | |

Sinus procedures, such as Maxillary Antrostomies, Sphenoidotomies/Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies

{2}------------------------------------------------

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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

FFB 1 2 2003

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: K030106

Trade/Device Name: StealthStation System Advanced Contour Registration Software Module

Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: January 10, 2003 Received: January 13, 2003

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.

{3}------------------------------------------------

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 vours.

Miriam C. Provost

for 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

{4}------------------------------------------------

Page 1 of of l

# 510(k) Number (if known): ≤030 l o 6

Device Name: StealthStation® System Advanced Contour Registration Software Module

Indications for Use:

The indications for use for the StealthStation® System Advanced Contour Registration Software Module is identical to the StealthStation® System indications for use. 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.

Example procedures include, but are not limited to:

| Cranial Procedures: | Spinal Procedures: | Orthopedic Procedures: |
|------------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------|
| Cranial Biopsies | Spinal Implant Procedures, such as Pedicle | Total Knee Arthroplasty (Primary and Revision) |
| Tumor Resections | Screw Placement | Unicompartmental Knee Arthroplasty |
| Craniotomies/ Craniectomies | | Minimally Invasive Orthopedic Procedures |
| Skull Base procedures | | Total Hip Replacement (Primary and Revision) |
| Thalamotomies/Pallidotomies | | Tumor Resection and Bone/Joint Reconstruction |
| Pituitary Tumor Removal | | Femoral Revision |
| CSF Leak Repair | | Placement of Iliosacral Screws |
| Pediatric Catheter Shunt Placement | | Stabilization and Repair of Pelvic Fractures<br>(Including but not Limited to Acetabular |
| General Catheter Shunt Placement | | |
| ENT Procedures: | | |
| Transphenoidal Procedures | | |
| Intranasal Procedures | | |

Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures

Fractures)

Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use
Miriam C. Provost
(Optional Format 1-2-96)

K030106

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510/k) Niimker

0469