(69 days)
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.
Not Found
This letter pertains to a 510(k) premarket notification for the "EAV Kindling 2000s," a Galvanic Skin Response measurement device. The FDA determined the device is substantially equivalent to legally marketed predicate devices.
However, the provided document is a regulatory approval letter from the FDA. It does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a submission summary or clinical study report. The letter explicitly states: "There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities." This indicates that the device is approved for measuring galvanic skin response, but not for making specific diagnostic claims or for demonstrating clinical efficacy in a way that would require the type of performance metrics usually associated with "acceptance criteria" for diagnostic accuracy.
Therefore,Based on the provided document, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: Not available in this regulatory letter. This letter confirms substantial equivalence but does not detail specific performance thresholds or metrics.
- Sample sizes used for the test set and the data provenance: Not available. The letter does not describe any specific test set or data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available.
- If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a galvanic skin response measurement device, not an AI algorithm.
- The type of ground truth used: Not applicable/available.
- The sample size for the training set: Not applicable/available.
- How the ground truth for the training set was established: Not applicable/available.
Conclusion:
This FDA 510(k) approval letter confirms that the EAV Kindling 2000s device is substantially equivalent to a predicate device for its indicated use (measurement of skin resistance to determine autonomic responses) and can be marketed. However, it does not provide any information regarding specific acceptance criteria for performance, study designs, sample sizes, expert involvement, or ground truth establishment, which are typically found in a 510(k) summary or detailed study report. The letter explicitly states no claims are made for the usefulness of the data or specific diagnostic capabilities, suggesting the equivalence was likely based on technical specifications and safety rather than a clinical performance study with defined diagnostic acceptance criteria.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen Emond President Vibrant Health D/O 1182508 Ontario Ltd 150 Des Grands Coteaux Beloeil, Quebec Canada, J3G 2C9
Re: K020564
Trade/Device Name: EAV Kindling 2000s 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.
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APR 3 0 2002
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) 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 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,
Muriam 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) #: K020564 EAV Kindling 2000s 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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020564
§ 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.