SNT IMAGE ANALYSIS SYSTEM

K992354 · Surgical Navigation Technologies, Inc. · LLZ · Oct 12, 1999 · Radiology

Device Facts

• Record ID: K992354
• Device Name: SNT IMAGE ANALYSIS SYSTEM
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Oct 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The Image Analysis System is intended to provide a method of storing and providing remote viewing and analyzing access to diagnostic images via a LAN, the internet, or a modem. The system is also intended to provide the display of segmented anatomical structures based on the correlation of the image sets to atlas information. Examples of structures that may be segmented include but are not limited to: vertebral bodies, prostate, hippocampus, and the basal ganglia.

Device Story

System stores, transfers, displays, and analyzes diagnostic image sets; enables segmentation of anatomical structures (e.g., vertebral bodies, prostate, hippocampus, basal ganglia) by correlating image data with atlas information. Used in clinical settings for remote viewing and analysis via LAN, internet, or modem. Healthcare providers use the system to visualize segmented structures, aiding in clinical assessment and diagnostic workflows. Benefits include improved access to diagnostic data and automated anatomical visualization.

Clinical Evidence

No clinical data provided; substantial equivalence based on functional and feature comparison.

Technological Characteristics

Image processing system for display, transfer, storage, and analysis of diagnostic images. Features include anatomical structure segmentation via atlas correlation. Connectivity via LAN, internet, or modem.

Indications for Use

Indicated for the storage, remote viewing, analysis, and processing of diagnostic images, including the display of segmented anatomical structures (e.g., vertebral bodies, prostate, hippocampus, basal ganglia) via correlation with atlas information.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• MR Workstations (K961637)
• AccuImage Image Display Processor (K961023)

Submission Summary (Full Text)

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1992354

OCT 1 2 1999

## Image Analysis System 510(k) Summary

## Date Prepared: July 13, 1999

I. Submitter Information: Contact: Roger N. White Group Director, Quality Systems and Regulatory Affairs Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 [phone] [phone] (fax)

- Trade name: Image Analysis System II. Common or usual name: Image Processing System Classification name: Image Processing System (per 21 CFR section 892.2050)
- The above device is substantially equivalent to the MR Workstations manufactured III. by Picker International, Inc. (K961637) and the Acculmage Image Display Processor manufactured by AccuImage, Inc. (K961023). The substantial equivalence was established by comparison of functions and features.
- This submission describes a system to display, transfer, store, analyze and process IV. patient image sets. The processing of image data includes the ability to segment anatomical structures.
- The Image Analysis System is intended to provide a method of storing and providing V. remote viewing and analyzing access to diagnostic images via a LAN, the internet, or a modem. The system is also intended to provide the display of segmented anatomical structures based on the correlation of the image sets to atlas information. Examples of structures that may be segmented include but are not limited to: vertebral bodies, prostate, hippocampus, and the basal ganglia.
- The technological characteristics are the same as or similar to those found with the VI. predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 2 1999

Roger N. White Group Director Ouality Assurance and Regulatory Affairs Surgical Navigation Technologies, Inc. 530 Compton St. Broomfield. CO 80020

Re:

K992354

SNT Image Analysis System Dated: July 13, 1999 Received: July 14, 1999 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

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 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation may result in a regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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 809.10 for in vitro diagnostic devices), 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"(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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

S. Patel, M.D.

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

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510(k) Number (if known): __ K 99 2354

Device Name:

Indications For Use:

The Image Analysis System is intended to provide a method of storing and providing remote viewing and analyzing access to diagnostic images via a LAN, the internet, or a modem. The system is also intended to provide the display of segmented anatomical structures based on the correlation of the image sets to atlas information. Examples of structures that may be segmented include but are not limited to: vertebral bodies, prostate, hippocampus, and the basal ganglia.

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Concurrence of CDRH, Office Of Device Evaluation (ODE)


(Division Sign-Off)

Division of Reproductive, Abdominal, El and Radiological De 510(k) Number

Prescription Use
(Per 21 CFR 801.109)
✓

OR

Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)