STEALTHSTATION TREATMENT GUIDANCE PLATFORM by SURGICAL NAVIGATION TECHNOLOGIES, INC.

The StealthStation™ System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a 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 of the anatomy. The StealthStation™ System with the ENT option is also indicated for intranasal or sinus use.

Device Description

This submission describes updates made to the StealthStation™ System to provide the option for providing pre-sterilized passive markers for the StealthStation™ instruments.

AI/ML Overview

This 510(k) submission (K981684) is for "Sterile Passive Markers for the StealthStation™ System" and primarily describes updates to provide pre-sterilized passive markers for the StealthStation™ instruments. It states that the indications for use for the StealthStation™ System have not changed. The submission declares substantial equivalence to the "Passive Marker Option for the StealthStation™ System" cleared in K972398.

Based on the provided text, the document focuses on the regulatory aspects of introducing pre-sterilized markers and does not contain detailed information about a study proving device performance against specific acceptance criteria for the navigation system's overall accuracy or clinical effectiveness.

Therefore, most of the requested information cannot be extracted directly from this document. However, I can still address the relevant points based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given 510(k) summary. The document does not specify performance acceptance criteria for the sterile passive markers or the StealthStation™ System concerning, for example, accuracy specifications. It focuses on the substantial equivalence of the new pre-sterilized markers to previously cleared markers.

2. Sample size used for the test set and the data provenance

This information is not provided in the given 510(k) summary. The document does not describe a performance study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the given 510(k) summary. No test set or ground truth establishment process is described.

4. Adjudication method for the test set

This information is not provided in the given 510(k) summary. No test set or adjudication method 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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided 510(k) summary. This document is related to an image-guided surgery system's markers, not an AI-assisted diagnostic or interpretative system that would typically involve human readers.

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

A standalone performance study for an algorithm is not mentioned in the provided 510(k) summary. The device is a surgical navigation system, which inherently involves human interaction, and the submission is about passive markers for this system.

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

This information is not provided in the given 510(k) summary. No ground truth is described as the document does not detail a performance study.

8. The sample size for the training set

This information is not provided in the given 510(k) summary. The document does not describe an algorithm development process that would involve a training set.

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

This information is not provided in the given 510(k) summary. No training set or ground truth establishment is described.

Summary of what the document does provide:

Device: Sterile Passive Markers for the StealthStation™ System.
Purpose: To offer pre-sterilized passive markers for the StealthStation™ instruments.
Indications for Use: The StealthStation™ System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures, where a reference to a rigid anatomical structure can be identified relative to a CT or MR based model of the anatomy. The ENT option is also indicated for intranasal or sinus use. These indications are unchanged from the predicate device.
Predicate Device: Passive Marker Option for the StealthStation™ System (cleared in K972398).
Basis for Clearance: Substantial equivalence to the predicate device. The 510(k) process for this device relies on demonstrating that the new sterile markers are as safe and effective as the previously cleared non-sterile markers, typically through material biocompatibility, sterility validation, and ensuring unchanged functionality in tracking performance. The document implies that these updated markers maintain the established performance of the StealthStation™ System.

Summary

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K981684

510(k) Summary

Sterile Passive Markers for the StealthStation™ System

I. Company: Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709

Sterile Passive Markers for the StealthStation™ System II. Product Name:

This submission describes updates made to the StealthStation™ System to provide III. the option for providing pre-sterilized passive markers for the StealthStation™ instruments.
The indications for use for the StealthStation™ System have not changed and are as IV. follows:

V. The Sterile Passive Marker for the StealthStation™ System was shown to be substantially equivalent to the Passive Marker Option for the StealthStation™ System that was cleared in K972398.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUM. SERVICES USA" are written around the eagle in a circular pattern. The eagle is a symbol of the United States, and the seal represents the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 6 1998

Mr. Roger N. White Group Director, Quality Systems and Regulatory Affairs Surgical Navigation Technologies, Inc. 530 Compton Street Broomfield, Colorado 80020

Re: K981684 Trade Name: StealthStation™ System - Battery Powered Marker Option Regulatory Class: II Product Code: HAW Dated: May 12, 1998 Received: May 13, 1998

Dear Mr. White:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Roger N. White

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 9871684

Device Name: StealthStation™ System - Battery Powered Marker Option

Indications For Use:

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

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(Division Sign-Off)
Division of General Restorative Devices K981684
510(k) Number

Prescription Use U (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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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).