(75 days)
BioMed Products biopotential skin electrode will be used by the Bio Medical Community for the acquisition of all surface biopotentials, i.e. Electroencephalographs (EEG), Electromyographs (EMG), and Electrooculographs (EOG).
Biopotential Skin Electrode
The provided document is a 510(k) clearance letter for a medical device (Biopotential Skin Electrode). It does not contain any information regarding acceptance criteria related to device performance or a study proving its conformance to such criteria.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, not a demonstration of specific performance metrics against pre-defined acceptance criteria.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study proving the device meets them based on the provided text. The document is administrative in nature, detailing regulatory clearance, and does not include scientific study results or performance data.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 22 1999
Mr. Timothy C. Thygeson President Biomed Products 5262 Vista Grande Drive Santa Rosa, California 95403
Re: K991199
Trade Name: Biopotential Skin Electrode Regulatory Class: II Product Code: IKA, GXY, BWY, and HLY Dated: April 2, 1999 Received: April 8, 1999
Dear Mr. Thygeson:
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 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 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. Timothy Thygeson
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 vour 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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,
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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"STATEMENT OF INDICATIONS FOR USE"
510(k) K991199
Device Name: Biopotential Skin Electrode
Indications For Use:
BioMed Products biopotential skin electrode will be used by the Bio Medical Community for the acquisition of all surface biopotentials, i.e. Electroencephalographs (EEG), Electromyographs (EMG), and Electrooculographs (EOG).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
N Prescription Use (Per 21 CFR 801.109)
Over-the-counter Use
7-1
OR
bcooles
(Division Sign-Off) Division of General Restorative Des 510(k) Number_
§ 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).