(69 days)
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Not Found
No
The summary describes a basic physiological measurement device (Galvanic Skin Response) and explicitly states there are no claims regarding data usefulness or diagnostic capabilities. There are no mentions of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
No
The device measures galvanic skin response for physiological indications but makes no claims regarding the usefulness of the data or diagnostic capabilities, which are typical for therapeutic devices.
No
The "Intended Use / Indications for Use" explicitly states, "There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities." This indicates it does not diagnose.
Unknown
The provided text does not contain a device description, which is crucial for determining if the device is software-only or includes hardware components.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description states the device measures galvanic skin response by measuring the electrical resistance of the skin. This is a measurement taken on the body, not from a sample taken from the body.
- Intended Use: The intended use is to determine autonomic responses as physiological indicators. While this data might be used in a diagnostic process, the device itself is not performing a diagnostic test on a biological sample.
- Lack of Diagnostic Claims: The description explicitly states "There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities." This further reinforces that the device is not intended for direct diagnosis.
Therefore, this device falls under the category of a physiological measurement device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Measurement of skin resistance to determine autonomic responses as physiological indicators by measuring the electric resistance of the skin and tissue path between 2 electrodes applied to the skin.
There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities.
Product codes
GZO
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
skin
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1540 Galvanic skin response measurement device.
(a)
Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of a human figure with outstretched arms, resembling a bird in flight. The figure is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2002
Mr. Stephen Emond President Vibrant Health D/O 1182508 Ontario Ltd 150 Des Grands Coteaux Beloeil, Quebec Canada, J3G 2C9
Re: K020565
Trade/Device Name: EAV Combi-2 Regulation Number: 882.1540 Regulation Name: Galvanic skin response measurement device Regulatory Class: II Product Code: GZO Dated: February 11, 2002 Received: February 20, 2002
Dear Mr. Emond:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) promatice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars actiment date of the Medical Device Amendments, or to commerce prior to May 26, 1976, the exactitions of the Federal Food. Drug, devices that have occh recassinod in accee approval of a premarket approval application (PMA). and Cosmette Act (10t) that to her requent to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the 110 labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classified (600 above) and Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of t thay be subject to such additions, 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 Frease oc advised that I Dris issuantes virth other requirements of the requirements of the Act that I Dri has made a collinistered by other Federal agencies. You must of any I could statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fart 6077, laceming (21 CFR Part 820); and if applicable, the electronic forth in the quality by well be (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Stephen Emond
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yourse FDA finding of substantial equivalence of your device to a legally promation wolfication. The side 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 11 you desire specific arris 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CHC Fat 807.10 Idditionally, for questions on the promotion and advertising of Compinance at (301) 59 + 165 Office of Compliance at (301) 594-4639. Also, please note the your de roos, product "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oinor general international and Consumer 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,
Muriam C. Provost
Col Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510 (k) #: K020565 EAV Combi-2 Product:
Indications For Use:
Galvanic Skin Response
Measurement of skin resistance to determine autonomic responses as physiological indicators by measuring the electric resistance of the skin and tissue path between 2 electrodes applied to the skin.
There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Musiam C. Provost
on of General, Restorative and Neurological Devic
510(k) Number K020565