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

Spinal Procedures:
Spinal Implant Procedures, such as Pedicle Screw

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

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

Device Description

This submission allows a surgeon an image guided instrument to place catheter shunts. The Catheter Introducer for the StealthStation® System is technically equivalent to the StealthStation® System. All systems use either active(LED's), passive reflective markers or electromagnetic coils to track surgical instruments in relation to an image guided reference frame. This information is correlated to the patient's CT, MR or fluoroscopic images of the anatomy.

AI/ML Overview

The provided text is a 510(k) summary for a Catheter Introducer for the StealthStation® System. It describes the device, its indications for use, and a determination of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, specific device performance metrics, or details of a study demonstrating fulfillment of such criteria.

The document primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study with defined acceptance criteria. Therefore, most of the requested information cannot be extracted from this text.

Here's a breakdown of what can and cannot be answered based on the provided input:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not define specific acceptance criteria (e.g., accuracy thresholds, failure rates) or report detailed device performance metrics from a study against such criteria. The "verification and validation activities" mentioned generally indicate testing was done but no specific results or targets are shared.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not describe a clinical study or a test set, hence no sample size, data provenance, or study design (retrospective/prospective) is available.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. No information about ground truth establishment or experts involved is present, as no specific test set is detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No adjudication method is mentioned, as no test set or expert review process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. This document is for a surgical navigation system, not an AI diagnostic tool. No MRMC study is mentioned, nor is there any AI component that would involve human readers improving with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be provided. This device is an instrument for a surgical navigation system, which inherently involves human interaction (a surgeon using the instrument). The concept of "standalone" algorithm performance without human-in-the-loop is not applicable in this context.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Cannot be provided. No ground truth type is mentioned as no specific performance study is detailed.

8. The sample size for the training set

Cannot be provided. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in the context of this submission. "Verification and validation activities" were performed, but these are typically engineering tests, not machine learning model training.

9. How the ground truth for the training set was established

Cannot be provided. As there is no training set for a machine learning model, this question is not applicable.

Summary

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Summary of Safety and Effectiveness Catheter Introducer for the StealthStation® System

I. Manufacture:

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

JAN 0 3 2003

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II. Contact:

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

III. Product Name/ Classification Name:

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

Date Summary Submitted IV.

June 28, 2002

V. Description of Device Modification:

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

VI. Substantial Equivalence:

The Catheter Introducer for the StealthStation® System was substantially equivalent to the StealthStation® System cleared in previous 510(k)'s. Additionally, the Catheter Introducer was determined to be substantially equivalent to the Radionics Optical Tracking System. 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:

Example procedures include, but are not limited to:

(Including but not Limited to Acetabular Fractures)

Cranial Procedures:	Spinal Procedures:	ENT Procedures:	Orthopedic Procedures:
Cranial Biopsies	Spinal Implant Procedures, such as Pedicle Screw	Transphenoidal Procedures	Total Knee Arthroplasty (Primary and Revision)
Placement		Intranasal Procedures	Unicompartmental Knee Arthroplasty
Tumor Resections		Orbital Nerve Decompression Procedures	Minimally Invasive Orthopedic Procedures
Craniotomies/ Craniectomies		Optic Nerve Decompression Procedures	Pediatric Orthopedics
Skull Base procedures		Polyposis Procedures	Total Hip Replacement (Primary and Revision)
Thalamotomies/Pallidotomies		Endoscopic Dacryocystorhinostomy	Periacetabular Osteotomies
Pituitary Tumor Removal		Encephalocele Procedures	Tumor Resection and Bone/Joint Reconstruction
CSF Leak Repair		Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies	Femoral Revision
Pediatric Catheter Shunt Placement			Stabilization and Repair of Pelvic Fractures
General Catheter Shunt Placement

0459

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized eagle symbol. The eagle is depicted with three lines forming its body and wings, representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

JAN 0 3 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: K022126

Trade/Device Name: Catheter Introducer for the StealthStation® System Regulation Number: 882.4560 Regulation Name: Stereotactic system and accessories Regulatory Class: Class II Product Code: HAW Dated: October 4, 2002 Received: October 7, 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

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Page 2 - Ms. Victoria G. Rendon

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.

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milken

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): 1(022126

Device Name: Catheter Introducer for the StealthStation® System

Indications For Use:

Example procedures include, but are not limited to:

Cranial Procedures:

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

Orthopedic Procedures:

Total Knee Arthroplasty (Primary and Revision) Ethmoidectomies, Sphenoidotomies/Sphenoid Unicompartmental Knee Arthroplasty Minimally Invasive Orthopedic Procedures Pediatric Orthopedics Total Hip Replacement (Primary and Revision) Periacetabular Osteotomies Tumor Resection and Bone/Joint Reconstruction Femoral Revision Stabilization and Repair of Pelvic Fractures (Including but not Limited to Acetabular Fractures)

Spinal Procedures:

Spinal Implant Procedures, such as Pedicle Screw

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, Explorations, Turbinate Resections.and Frontal Sinusotomies

Mark N Melleuson

Division of General, Restorative and Neurological Devices

510(k) Number _

K022126

(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

(Optional Format 1-2-96)

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).