(348 days)
The Wireless EEG Recording System Model W32 is intended to amplify, filter and convert into digital values electrophysiological voltages (primarily EEG, EOG, EMG, and ECG) sensed by conventional skin surface electrodes which have been attached to the patient. These signals are then transmitted via radio waves to the receiver portion of the system which transfers them to a computer for display and evaluation by appropriate health professionals.
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I am sorry, but the provided text is a letter from the FDA to a medical device manufacturer, indicating the clearance of a device based on substantial equivalence. It does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. Therefore, I cannot generate the table and detailed study description you've asked for based on this document.
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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
Ms. Anne Marie Cesario Director, Requlatory Affairs Schiff and Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006
JUL 2 9 1997
Re : K963195 Wireless EEG Recording System - Model W32 Trade Name: Requlatory Class: II Product Code: 84GYE Dated: July 9, 1997 Received: July 10, 1997
Dear Ms. Cesario:
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 You provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 requlation (21 CFR Part 820) and that, through periodic OS 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 - Ms. Anne Marie Cesario
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. I
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) 594-4648. 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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510(k) Number (if known):
Not assigned yet
Device Name:
Model W32 Wireless EEG Recording System .
Indications for Use:
The Wireless EEG Recording System Model W32 is intended to amplify, filter and convert into digital values electrophysiological voltages (primarily EEG, EOG, EMG, and ECG) sensed by conventional skin surface electrodes which have been attached to the patient. These signals are then transmitted via radio waves to the receiver portion of the system which transfers them to a computer for display and evaluation by appropriate health professionals.
(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
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K963195
§ 882.1855 Electroencephalogram (EEG) telemetry system.
(a)
Identification. An electroencephalogram (EEG) telemetry system consists of transmitters, receivers, and other components used for remotely monitoring or measuring EEG signals by means of radio or telephone transmission systems.(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.