WIRELESS EEG RECORDING SYSTEM MODEL W32

K963195 · Cme Telemetrix, Inc. · GYE · Jul 29, 1997 · Neurology

Device Facts

• Record ID: K963195
• Device Name: WIRELESS EEG RECORDING SYSTEM MODEL W32
• Applicant: Cme Telemetrix, Inc.
• Product Code: GYE · Neurology
• Decision Date: Jul 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1855
• Device Class: Class 2

Intended 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.

Device Story

Model W32 Wireless EEG Recording System captures electrophysiological signals (EEG, EOG, EMG, ECG) via conventional skin surface electrodes. Device amplifies, filters, and digitizes these signals, transmitting them via radio waves to a receiver unit. Receiver transfers data to a computer for display and evaluation by healthcare professionals. System facilitates remote or wireless monitoring of patient electrophysiological activity. Clinical benefit includes enabling non-tethered signal acquisition for diagnostic assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of a wireless transmitter and receiver unit. Inputs: electrophysiological voltages (EEG, EOG, EMG, ECG) via skin surface electrodes. Signal processing: amplification, filtering, and analog-to-digital conversion. Transmission: radio frequency (RF) wireless link. Output: digital data for computer display.

Indications for Use

Indicated for patients requiring electrophysiological monitoring (EEG, EOG, EMG, ECG) via skin surface electrodes. Intended for use by health professionals for signal amplification, filtering, digitization, and transmission to a computer for display and evaluation.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Anne Marie Cesario
Director, Regulatory Affairs
Schiff and Company
1129 Bloomfield Avenue
West Caldwell, New Jersey 07006

JUL 29 1997

Re: K963195
Trade Name: Wireless EEG Recording System - Model W32
Regulatory 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 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 - 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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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) Premarket Notification
CME Telemetrix, Waterloo, Ontario, Canada - Wireless EEG Recording System - Model W32

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 ☐ or Over-The-Counter Use ☑
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number 1963195

Prepared by Schiff & Company®, West Caldwell, NJ
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