K Number
K992354
Device Name
SNT IMAGE ANALYSIS SYSTEM
Date Cleared
1999-10-12

(90 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 Description
This submission describes a system to display, transfer, store, analyze and process patient image sets. The processing of image data includes the ability to segment anatomical structures.
More Information

Not Found

Unknown
The description mentions "segmenting anatomical structures based on the correlation of the image sets to atlas information," which could potentially involve AI/ML techniques for image registration and segmentation, but it doesn't explicitly state the use of AI/ML. The lack of information on training/test sets and performance studies also makes it difficult to confirm.

No
The device is described as an "Image Analysis System" intended for storing, viewing, analyzing, and processing diagnostic images, including segmentation of anatomical structures. It does not perform any therapeutic function.

Yes
The device is intended to provide "analyzing access to diagnostic images" and "process patient image sets," which are functions of a diagnostic device. It also explicitly states its intention to display segmented anatomical structures, which supports medical analysis.

Unknown

The summary describes a system that processes and displays images, including segmentation. While it focuses on software functionalities, it doesn't explicitly state that it is only software and doesn't include any associated hardware components necessary for its operation or image acquisition. The predicate devices are workstations and image processors, which could be hardware or software systems.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device's function: The described device is an Image Analysis System that deals with diagnostic images (like MRI, CT, etc.) and processes them for viewing, storage, and analysis, including anatomical segmentation. This is image processing and analysis, not testing biological samples.
  • No mention of biological samples: The description focuses entirely on image data and its manipulation. There is no mention of analyzing blood, urine, tissue, or any other biological specimen.

Therefore, the device falls under the category of medical imaging software or systems, not in vitro diagnostics.

N/A

Intended Use / 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.

Product codes

90 LLZ

Device Description

This submission describes a system to display, transfer, store, analyze and process patient image sets. The processing of image data includes the ability to segment anatomical structures.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Vertebral bodies, prostate, hippocampus, and the basal ganglia

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K961637, K961023

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).

0

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 (303) 439-9709 (303) 439-9711 (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.

1

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

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 (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,

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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Page 1 of 1

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.

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

image

(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)