STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM by SURGICAL NAVIGATION TECHNOLOGIES, INC.

The StealthSERVER™ Image Storage and Communication System is used to store and provide remote viewing access to diagnostic images via a LAN, the internet or modem. In addition, the system can be used to remotely set surgical plans for stereotactic surgery that are compatible with and can be accessed by the StealthStation® Treatment Guidance Platform.

Device Description

This submission describes a network server system that provides remote access to digital image sets for the purpose of reviewing the images and, optionally, for developing and storing a stereotactic surgical plan that is compatible with the StealthStation® Image Guided Treatment Platform. The submission includes the capability of the StealthStation® System to retrieve the surgical plans and image sets from the network server.

AI/ML Overview

This 510(k) submission for the StealthSERVER™ Image Storage and Communication System does not contain the information requested regarding acceptance criteria or a study proving the device meets said criteria.

The provided document is a summary and an FDA clearance letter, which focuses on:

Device identification: StealthSERVER™ Image Storage and Communication System.
Intended Use: Storing and providing remote viewing access to diagnostic images, and remotely setting surgical plans compatible with the StealthStation® Treatment Guidance Platform.
Substantial Equivalence: Stating that the device was shown to be substantially equivalent to other commercially available medical image storage, review, and communication systems. The FDA clearance letter confirms this finding.

There is no mention of the following in the provided text:

A table of acceptance criteria or reported device performance.
Details about a study, including sample sizes, data provenance, ground truth establishment, or expert involvement.
MRMC comparative effectiveness studies or standalone performance.

Therefore, I cannot provide the requested information based on the given input.

Summary

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JAN 12 1999

510(k) Summary

StealthSERVER™ Image Storage and Communication System

I. Company: Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709
Product Name: StealthSERVER™ Image Storage and Communication System II.
This submission describes a network server system that provides remote access to III. digital image sets for the purpose of reviewing the images and, optionally, for developing and storing a stereotactic surgical plan that is compatible with the StealthStation® Image Guided Treatment Platform. The submission includes the capability of the StealthStation® System to retrieve the surgical plans and image sets from the network server.
The StealthSERVER™ Image Storage and Communication System was shown to be IV. substantially equivalent to other commercially available medical image storage, review and communication systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 1999

Roger N. White Group Director, Regulatory Affairs Surgical Navigation Technologies, Inc. 530 Compton Street Broomfield. CO 80020

Re:

K984000 StealthSERVER Dated: November 6, 1998 Received: November 10, 1998 Regulatory class: I 21 CFR 892.2020/Procode: 90 LMD

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 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). 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 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requiration may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to vour 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.

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 800.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director. Division of Reproductive. Abdominal. Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/1/Picture/15 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with three lines representing its wings.

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Page 1 of 1

K984000 510(k) Number (if known):

Device Name: StealthSERVER™ Image Storage and Communication System

Indications For Use:

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Eunice A. Seger

(Division Sign-Off) (Division of Reproductive, Abdominal, El and Radiological 510(k) Number

হ --.

Prescription Use
(Per 21 CFR 801.109) X

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.2020 Medical image communications device.

(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.