(525 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description and intended use do not inherently suggest the use of such technologies.
No
The device is designed for the evaluation of visuo-motor performance disturbances, not for treating them.
Yes
The device is described as being "designed for the evaluation of visuo-motor performance disturbances," which indicates its use in identifying or assessing a medical condition.
Unknown
The provided 510(k) summary does not explicitly state whether the VMT™ System is software-only. While it describes the system and its intended use, it doesn't detail the components or how the "Ataxiagraph" functions, making it impossible to definitively determine if it's purely software. The predicate devices listed (Equitest System, Pro & Smart Balance Master Systems) are typically hardware-based systems for balance assessment, which further complicates the determination without more information about the VMT™ System itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "evaluation of visuo-motor performance disturbances." This describes a functional assessment of a patient's physical abilities, not the analysis of biological samples (like blood, urine, tissue) to diagnose a disease or condition.
- Device Description: The common name "Ataxiagraph" further suggests a device that measures and records movement or balance, which aligns with a functional assessment rather than an in vitro test.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on biological sample analysis.
The device appears to be a system for assessing a patient's physical performance related to balance and coordination, similar to the predicate devices listed (Equitest System, Balance Master Systems), which are also not IVDs.
N/A
Intended Use / Indications for Use
The VMT™ System is designed for the evaluation of visuo-motor performance disturbances.
Product codes
LXV
Device Description
The VMT™ System is provided as follows:
- Trade Name VMT™ System a.
- b. Common and Descriptive Name - Ataxiagraph
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Clinical studies have been performed and have concluded that the device was safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
G.N.P. Holdings LTD 37 Shvedia St., Danya, Haifa-Israel
ಿಗೆ ಸ
VMT™ System -Ataxiagraph 510(k) Premarket Notification Dated: April 3, 1997
12. 510(k) Summary
THE VMT™ SYSTEM FOR THE EVALUATION OF VISUO-MOTOR PERFORMANCE
Contact: Target Health, Inc. 310 Madison Avenue, 22nd Floor New York, NY 10017
Tel: 212 681 2100 Fax: 212 682 0151
Sponsor: Taly Hocherman G.N.P. Holdings LTD 37 Shvedia Street, Danya, Haifa-Israel
Tel: ++972-4-8262293/4 Fax: ++972-4-8242088
15 015
:13
1
12.1 Device Name
The VMT™ System is provided as follows:
- Trade Name VMT™ System a.
- b. Common and Descriptive Name - Ataxiagraph
12.2 Predicate Devices/ Company Names and Addresses
The predicate devices are listed below with their 510(K) clearance numbers.
The Equitest System - (K851744) NuroCom International, Inc. 9570 SE Lawnfield Road, Clackamas, Oregon 97015-96 USA
The Pro & Smart Balance Master Systems - (K946229) NeuroCom International, Inc. 9570 SE Lawnfield Road, Clackamas, Oregon 97015-96 USA
12.3 Clinical Experience
Clinical studies have been performed and have concluded that the device was safe and effective for its intended use.
Image /page/1/Picture/12 description: The image shows a white background with several small, dark spots scattered across it. The spots vary in size and shape, with some appearing as single dots and others as clusters of dots. The distribution of the spots is uneven, with a higher concentration in the upper-left corner and fewer spots in the rest of the image.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird figure. The text is in all capital letters.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1698
Jules T. Mitchel, M.D. President Target Health, Inc. 310 Madison Avenue 22nd Floor New York, New York 10017
K971549/S004 Re : Trade Name: VMT System Regulatory Class: Unclassified Product Code: LXV Dated: July 23, 1998 Received: July 24, 1998
Dear Dr. Mitchel:
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. ಕ 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 (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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.
3
Page 2 - Dr. Jules T. Mitchel
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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
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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VMT™ System -Ataxiagraph 510(k) Premarket Notification Dated: April 3, 1997
ે. જિલ્લા
8. Indication for use
The VMT™ System is designed for the evaluation of visuo-motor performance disturbances.
Prescription Use
(Per 21 CFR 801.109)
ារ តាម
ses
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971549
009