(78 days)
Electrodes intended for use as reusable (by a single patient), cutaneous, flexible, conductive garment/fabric electrodes for interface between electrical stimulators such as powered muscle stimulators, interferential devices, qalvanic devices, transcutaneous electrical nerve stimulators, etc. and a patient's skin for the delivery of electrical stimulation.
Not Found
This is a premarket notification for AG Garments Conductive Electrodes (K023212). The provided document is a 510(k) clearance letter from the FDA, indicating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or specific study results that prove the device meets such criteria.
The document primarily focuses on regulatory approval based on substantial equivalence to an existing device, rather than detailed performance study outcomes typically found in a clinical study report or a summary of safety and effectiveness data.
Therefore, I cannot provide the requested information from this document. To answer your questions, one would need access to the actual 510(k) submission, specifically the sections dealing with performance testing and clinical data, if any were submitted beyond basic electrical and biocompatibility testing for an electrode.
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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
FC 1 3 2002
AG Garments Athena Shudde President 1762 Columbia Street San Diego, California 92101
Re: K023212
Trade/Device Name: AG Garments Conductive Electrodes Regulation Number: 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: September 25, 2002 Received: September 26, 2002
Dear Ms. Shudde:
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
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Page 2 – Ms. Athena Shudde
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), 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
forCelia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Paqe
510(k) Number(if known): K023212
Device Name: AG GARMENTS CONDUCTIVE ELECTRODES Indications for use:
Electrodes intended for use as reusable (by a single patient), cutaneous, flexible, conductive garment/fabric electrodes for interface between electrical stimulators such as powered muscle stimulators, interferential devices, qalvanic devices, transcutaneous electrical nerve stimulators, etc. and a patient's skin for the delivery of electrical stimulation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109
OR
Over-The-Counter Use
Miriam C. Provost
I Restorative (Optional Format 1-2-90)
§ 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).