IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM

K030552 · Medtronic Surgical Navigation Technologies · HAW · Mar 19, 2003 · Neurology

Device Facts

• Record ID: K030552
• Device Name: IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM
• Applicant: Medtronic Surgical Navigation Technologies
• Product Code: HAW · Neurology
• Decision Date: Mar 19, 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

The Imageless Knee Module is a software update for the StealthStation® System. It enables stereotactic navigation without preoperative or intra-operative image datasets. The system uses software algorithms to establish stereotactic coordinates based on anatomical landmarks. It is used in orthopedic procedures, specifically knee arthroplasty, by surgeons in the operating room. The system provides real-time navigation data to assist the surgeon in precisely locating anatomical structures during surgery, potentially improving surgical accuracy and patient outcomes.

Clinical Evidence

Bench testing only. Verification and validation activities were performed to demonstrate substantial equivalence.

Technological Characteristics

Software module for the StealthStation System; enables image-free stereotactic navigation; utilizes software algorithms for coordinate calculation; operates within the existing StealthStation hardware platform.

Indications for Use

Indicated for patients requiring stereotactic surgery for cranial, spinal, ENT, or orthopedic procedures (e.g., tumor resection, pedicle screw placement, total knee/hip arthroplasty) where rigid anatomical structures can be referenced via CT, MR, or fluoroscopy.

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 (K030552)

Submission Summary (Full Text)

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K0305-52

## Summary of Safety and Effectiveness Imageless Knee Module for the StealthStation® System

#### I. Manufacture:

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

MAR 1 9 2003

## II. Contact:

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

## Product Name/ Classification Name: III.

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

#### Date Summary Submitted IV.

February 19, 2003

#### V. Description of Device Modification:

This submission describes updates made to the StealthStation® System to include software algorithms that enable the establishment of stereotactic coordinates without the use of preoperative or intra-operative image datasets.

#### VI. Substantial Equivalence:

The Imageless Knee Module for the StealthStation® System 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.

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K030552

# VII. Indications For Use:

The indications for use for the Imageless Knee Module for the StealthStation® System 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 | | |

Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary Antrostomies, Sphenoidotomies/Sphenoidotomies/Sphenoid

Explorations, Turbinate Resections, and Frontal Sinusotomies

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text, which is arranged in a circular pattern around the seal. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 1 9 2003

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

Re: K030552

Trade/Device Name: Imageless Knee Module for the StealthStation® System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: February 19, 2003 Received: February 21, 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. Iisting 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), 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" (21CFR Part 807.97) you may obtain. 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.

Mark H. Milkenon

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: Imageless Knee Module for the StealthStation® System

Indications for Use:

The indications for use for the StealthStation® System Imageless Knee 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: Cranial Biopsies Tumor Resections Craniotomies/ Craniectomies Skull Base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair Pediatric Catheter Shunt Placement General Catheter Shunt Placement

ENT Procedures: Transphenoidal Procedures Intranasal Procedures Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures

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

Ko30552

Orthopedic Procedures:

Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopedic Procedures Total Hip Replacement (Primary and Revision) Tumor Resection and Bone/Joint Reconstruction Femoral Revision Placement of Hiosacral Screws Stabilization and Repair of Pelvic Fractures (Including but not Limited to Acetabular Fractures)

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

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Concurrence of CDRH, Office Of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR<br>(Optional Format 1-2006) |
|------------------------------------------|--------------------------------|
|------------------------------------------|--------------------------------|

| | Over-The-Counter Use<br>(Division of n-Off) |
|--|--------------------------------------------------------------|
| | Division of General, Restorative<br>and Neurological Devices |

| §10(k) Number | K0 30552<br>06469 |
|---------------|-------------------|
|---------------|-------------------|