(71 days)
Not Found
None
No
The summary describes a basic physiological measurement device (Galvanic Skin Response) and contains no mention of AI, ML, image processing, or any data analysis beyond the direct measurement of skin resistance.
No
The device measures electric resistance for physiological indicators and does not claim any therapeutic usefulness or diagnostic capabilities.
No
The "Intended Use / Indications for Use" explicitly states that there are no claims for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities. Therefore, it is not a diagnostic device.
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. The intended use describes a measurement process that typically requires hardware (electrodes).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of this device is to measure skin resistance by applying electrodes to the skin. This is a measurement taken directly from the body, not from a specimen (like blood, urine, tissue, etc.) that has been removed from the body.
- The description focuses on measuring a physiological response (autonomic responses via skin resistance). This falls under the category of a physiological monitoring or measurement device, not an in vitro diagnostic device.
- There are no claims about analyzing biological samples. The device measures an electrical property of the skin itself.
Therefore, based on the provided intended use, this device is not an IVD.
N/A
Intended Use / 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.
Product codes
GZO
Device Description
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 2 2002
Mr. Stephen Emond President Vibrant Health D/O 1182508 Ontario Ltd 150 Des Grands Coteaux Beloeil, Quebec Canada. J3G 2C9
Re: K020567
Trade/Device Name: Akuport M1 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 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 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 (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.
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Page 2 – Mr. Stephen Emond
This letter will allow you to begin marketing your device as described in your Section 510(k) remarket notification. The FDA finding of substantial equivalence of your device to a legally premaince noticated 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,
Miriam C. Provost
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
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510 (k) #: K020567 Akuport M l 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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020567