(13 days)
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Not Found
No
The provided 510(k) summary does not mention AI, ML, or any related concepts like image processing, deep neural networks (DNN), or training/test sets, which are typically associated with AI/ML-powered devices.
No
The device is designed to conduct tests (Nerve Conduction Studies and Evoked Potentials), which are diagnostic in nature, not therapeutic.
Yes
The device is intended for Nerve Conduction Studies (NCS) and Evoked Potentials (EP), which are diagnostic tests used to assess nerve function and brain responses to stimuli.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the VT 3000 is a software-only medical device. The intended use describes performing tests that typically require hardware components (electrodes, stimulators, amplifiers) to acquire physiological signals.
Based on the provided information, it is highly unlikely that the VT 3000 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is described as conducting "Nerve Conduction Studies (NCS) and Evoked Potentials (EP)". These are tests performed directly on a patient to assess the function of their nervous system.
- Nature of IVDs: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. They are used outside of the body (in vitro).
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting specific substances or markers in samples.
- Providing diagnostic information based on laboratory analysis.
The VT 3000 appears to be a device used for in vivo (within the living body) physiological testing.
Therefore, based on the provided text, the VT 3000 is not an IVD.
N/A
Intended Use / Indications for Use
The VT 3000 is designed to conduct a range of tests including Nerve Conduction Studies (NCS) and Evoked Potentials (EP).
Product codes
JXF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1550 Nerve conduction velocity measurement device.
(a)
Identification. A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black. The overall design is simple and recognizable, representing the department's focus on health and human welfare.
Public Health Service
OCT 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Scientific Imaging, Inc. c/o Neil E. Devine, Jr. Responsible Third Party Official Intetek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K052904
Trade/Device Name: Virtual Medical Systems VT 3000 Regulation Number: 21 CFR 882.1550 Regulation Name: Nerve conduction velocity measurement device Regulatory Class: II Product Code: JXF Dated: October 13, 2005 Received: October 14, 2005
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 gettoral conable and would be and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2-Neil E. Devine, Jr.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin manceing your and equivalence of your device to a legally premarket notification. The PDA maing of castion 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), please If you desire specific advice for Jour ac (240) 276-0115. Also, please note the regulation entitled, Colliact the Office of Complanes in (21CFR Part 807.97). You may obtain Misolanding by reference to premainters with the Act from the Division of Small other general information on your responsionation with toll-free number (800) 638-2041 or Manufacturers, International and Conson http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
1.7.1 – Indications for Use
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Device Name: Virtual Medical Systems VT 3000
Indications: The VT 3000 is designed to conduct a range of tests including Nerve Conduction Studies (NCS) and Evoked Potentials (EP).
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________ Page 1 of 1