(191 days)
Galvanic Skin Resistance Measurement
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "E-Reader". It only indicates that the device is a "Galvanic Skin Resistance Measurement" device and is substantially equivalent to a pre-amendment device.
This document does not contain any information regarding:
- Acceptance criteria or reported device performance
- Details of any study (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set details).
Therefore, I cannot fulfill your request for a description of acceptance criteria and the study that proves the device meets them based on the provided text.
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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
9
§ 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.