(86 days)
Cutaneous (Disc) Electrode is intended for non-invasive use as a recording (active/reference) electrode during electromyographic (EMG) recordings.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA to Neuro Supplies, Inc. for several types of cutaneous electrodes. It states that the devices are substantially equivalent to legally marketed predicate devices.
Crucially, this document is an FDA clearance letter, not a study report or clinical trial documentation. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.
The letter is a regulatory approval notice, indicating that the devices (Cutaneous (Bar) Electrode, Cutaneous Ground Electrode, Digital Ring Electrode, and Cutaneous (Disc) Electrode) can be marketed. It confirms that the FDA has determined these devices are substantially equivalent to previously approved devices based on the information provided in the 510(k) submission.
Therefore, I cannot provide the requested information because it is not present in the provided text. The prompt asks for details that would typically be found in a clinical study report or a detailed technical submission, neither of which is this document.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right, layered on top of each other. The profiles are arranged in a way that creates a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the central image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1999
Mr. Ronald Luich, PE President Neuro Supplies, Inc. 86 Boston Post Road Waterford, Connecticut 06385
K991769 Re:
Trade Name: Cutaneous (Bar) Electrode K991770 Trade Name: Cutaneous Ground Electrode K991771 Trade Name: Digital Ring Electrode K991772 Trade Name: Cutaneous (Disc) Electrode Regulatory Class: II Product Code: GXY Dated: May 21, 1999 Received: May 24, 1999
Dear Mr. Luich:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 devices 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. Ronald Luich, PE
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, 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,
Thurell F. Kinger
der Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Neuro Supplies, Inc. 510(k) Submission Cutaneous (Disc) Electrode, K991772
Section 11 - Intended Use Statement
610(k) Number (if known): K991772
Device Name: Cutaneous (Disc) Electrode
Indications For Use:
Cutaneous (Disc) Electrode is intended for non-invasive use as a recording (active/reference) electrode during electromyographic (EMG) recordings.
Russell Payan surJ20
(Division Sign-Off) Division of General Restorative Devices 510(k) Number ﮐ קיק
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
§ 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).