(182 days)
Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
Home Care various models of self-adhesive electrodes - FA, CA, TA, FI, TI, FR, CR, and R Series
The provided document is a 510(k) premarket notification letter from the FDA regarding self-adhesive electrodes. This type of document is a regulatory approval letter and does not contain information about acceptance criteria, study designs, or performance metrics in the way you've requested for a device evaluation.
Therefore, I cannot provide the requested information. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the technical performance criteria or the studies that would typically be described in a clinical or validation report for a novel medical AI device.
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MAR 0 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Home Care Technology Co. Ltd. C/Ó: Dr. Jen, Ke-Min R.O.C. Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K022917 Dated: November 30, 2002 Received: December 4, 2002
Trade/Device Name: Home Care various models of self-adhesive electrodes - FA, CA, TA, FI, TI, FR, CR, and R Series Regulation Numbers: 21 CFR 882.1320 Regulation Names: Cutaneous electrodes Regulatory Class: Class II Product Codes: GXY
Dear Dr. Jen, Ke-Min
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
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Page 2 - Dr. Jen, Ke-Min
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. 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-. 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.
Mark A. Mellman
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) Number:
Device Name:
Home Care various models of self-adhesive electrodes - FA, CA, TA, FI, TI, FR, CR, and R Series
Indications For Use:
Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N Millkern
Division Si
is'on of General, Restorative
.d Neurological Devices
510(k) Number K022917
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).