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

Spinal Procedures: Spinal Implant, such as pedicle screw procedures

ENT Procedures: Transphenoidal procedures Intranasal procedures Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies Orbital Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures

Orthopedic Indications: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

Device Description

This submission describes updates made to the StealthStation® System to include an optional software package that enables a user to merge a patient's pre-operative dataset with a patient's intra-operative dataset.

AI/ML Overview

The provided text is a 510(k) summary for the StealthStation® with FluoroMerge™ Software. It describes updates to an existing device, focusing on substantial equivalence rather than presenting new clinical study data with specific acceptance criteria and performance metrics against them.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, and adjudication methods cannot be extracted from this document, as it falls outside the scope of a 510(k) summary for a device modification establishing substantial equivalence to a predicate. The document states:

"As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence." This implies internal testing was done, but specific details or results are not provided for public review in this summary.
The focus is on the "Description of Device Modification" and "Substantial Equivalence" to previously cleared StealthStation Systems. This suggests that the primary method of demonstrating safety and effectiveness was by showing that the modified device performs as intended and is no less safe or effective than the predicate.

Without specific performance studies and acceptance criteria detailed in the document, it's impossible to fill out the table and answer the subsequent questions.

Summary

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K02033d

FEB 2 7 2002

Summary of Safety and Effectiveness StealthStation® with FluoroMerge™ Software

I. Manufacture:

Medtronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, CO 80027 USA Telephone Number: (720) 890-3200 Fax Number: (720) 890-3500

II. Contact:

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

Product Name/ Classification Name: III.

Product Name: StealthStation® with FluoroMerge™ Software Classification Name: Stereotaxic Instrument (21 CFR 882.4560) Classification Panel: 84 HAW

IV. Date Summary Submitted

January 30, 2002

V. Description of Device Modification:

VI. Substantial Equivalence:

The StealthStation® with the FluoroMerge™ 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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VII. Indications For Use:

The indications for use for the FluoroMerge™ Software are identical to the StealthStation® System indications for use. The indications for use are as follows:

Example procedures include, but are not limited to:

Cranial Procedures: Cranial biopsies Craniotomies/Craniectomies Skull base procedures Thalamotomies/Pallidotomies Pituitary tumor removal CSF Leak Repair

Spinal Procedures: Spinal implant procedures, such as pedicle screw procedures

ENT Procedures: Transphenoidal procedures Intranasal procedures Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies /Sphenoid explorations, Turbinate resections, and Frontal sinusotomies Orbital Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures

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

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird or eagle with its wings spread, with three human faces incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2002

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

Re: K020338

Trade/Device Name: StealthStation® with FluoroMerge™ Software Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 30, 2002 Received: February 1, 2002

Dear Ms. Rendon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalled is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) is regists of the Medical Device Amendments, or to conninered prices to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de necs that have been received require approval of a premarket approval application (PMA). and Cosmetic rece (1101) that to nevice, subject to the general controls provisions of the Act. The I ou may, therefore, marres of the Act include requirements for annual registration, listing of general condon profiseturing 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 II your device is classinod toonal 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 or unly I valuates and 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 er it rate 607); accems (21 (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) This icter will anow you to ocgin maisog of substantial equivalence of your device to a legally premarket notincation. The Pro Primating of Eastification 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 If you desire specific advice for your avitro diagnostic devices), please contact the Office of additionally 21 CFR Furt 607.10 for his nally, for questions on the promotion and advertising of Compliance at (301) 594-1057. Ticalizense at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation cirities, "Ninorananing oresponsibilities under the Act may be obtained from the Other general information of your respational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Marla n Milleess

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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Page 1 of 1

510(k) Number (if known): K020338

Device Name: StealthStation® with FluoroMerge™ Software

Indications for Use:

Indications for OSC.
The StealthStation® System is intended as an aid for precisely locating anatomical structures in The StealthStation® Dystem is mentors. The StealthStation® System is indicated for any medical enner open of perodianoods probodated is surgery may be appropriate, and where reference to a condition in which and use of sters outs 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

Spinal Procedures: Spinal Implant, such as pedicle screw procedures

Orthopedic Indications: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)
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Prescription Use (Per 21 CFR 801.109)	☑
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Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

510(k) Number	K020338
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510(k) Number -

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
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.(b)
Classification. Class II (performance standards).