(191 days)
None
None
No
The summary does not mention AI, ML, image processing, or any other indicators of AI/ML technology.
No
The intended use is for Galvanic Skin Resistance Measurement, which is a diagnostic or monitoring function, not a therapeutic one. The "Prescription Use" designation also aligns with diagnostic devices.
Yes
Explanation: The intended use of the device is "Galvanic Skin Resistance Measurement," which is a physiological measurement often used as a diagnostic indicator in various medical and psychological contexts (e.g., assessing autonomic nervous system activity, emotional responses, or lie detection). Its prescription-use status further supports its medical application, implying it's used to gather information for diagnosis.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Galvanic Skin Resistance Measurement." This is a physiological measurement taken directly from the body, not a test performed on a sample of biological material (like blood, urine, or tissue) outside of the body.
- Lack of IVD Indicators: The description lacks any mention of:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information about a disease or condition based on analysis of biological samples.
IVDs are specifically designed to be used in vitro (in glass, or outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. Galvanic Skin Resistance measurement is an in vivo (in the body) measurement.
N/A
Intended Use / Indications for Use
Galvanic Skin Resistance Measurement
Product codes
84GZO
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
Prescription Use (Per 21 CFR 801.109)
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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Image /page/0/Picture/2 description: The image shows a black and white logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HC...USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 15
Mr. John Riva-Cambrin President of Operations Natural Herbal Products, Inc. 10534 124 Street; Suite 206 Edmonton, Alberta T5N 1S1 CANADA
Re: K970436 E-Reader Trade Name: Requlatory Class: II Product Code: 84GZO Dated: May 28, 1997 Received: June 4, 1997
Dear Mr. Riva-Cambrin:
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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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.
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Page 2 - Mr. John Riva-Cambrin
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 regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
Galvanic Skin Resistance Measurement
Prescription Use
(Per 21 CFR 801.109)
Thomas J. Callehan
(Division Siar ??? Division of Camera Section : Pespirator and Neurological Dewrological 510(k) Number ________________________________________________________________________________________________________________________________________________________________
piratory.
K970436
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