(348 days)
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No
The summary describes a system for acquiring and transmitting physiological signals (EEG, EOG, EMG, ECG) for display and evaluation by health professionals. There is no mention of any analytical or interpretive functions that would typically involve AI/ML. The focus is on signal acquisition and transmission.
No
The device is used for recording and transmitting electrophysiological signals for display and evaluation, not for treating or preventing a disease or condition.
Yes
The device is described as capturing electrophysiological voltages (EEG, EOG, EMG, ECG) "for display and evaluation by appropriate health professionals," which indicates its use in assessing a patient's physiological state to aid in diagnosis.
No
The device description explicitly mentions hardware components like electrodes, a receiver, and a computer, indicating it is a system with both hardware and software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as amplifying, filtering, and converting electrophysiological voltages sensed by skin surface electrodes attached to the patient. This is a direct measurement of physiological signals from the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
This device operates in vivo (on the living body) rather than in vitro (in a test tube or laboratory setting).
N/A
Intended Use / 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.
Product codes
84GYE
Device Description
Model W32 Wireless EEG Recording System
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with three swooping lines forming its body and wings. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
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