(90 days)
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.
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.
This is a 510(k) summary for the "Image Analysis System" and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. The provided documents are primarily for regulatory clearance based on substantial equivalence to predicate devices, rather than a performance study report.
Therefore, I cannot fulfill your request with the information provided. The document states that "The substantial equivalence was established by comparison of functions and features" with predicate devices, but it does not describe a performance study with acceptance criteria, sample sizes, or ground truth establishment.
To answer your questions accurately, a different type of document, such as a validation study report or a more detailed technical submission, would be required.
{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:
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
{2}------------------------------------------------
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)
(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)
§ 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).