(90 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is not available to provide further clues.
No
The device is described as an electroencephalograph designed to display brain electrical signals, which is for diagnostic purposes, not therapeutic intervention.
Yes
The device is an electroencephalograph designed to display the electrical signals of the brain, a function typically used in the diagnosis of neurological conditions.
No
The device is described as an electroencephalograph, which is a hardware device used to measure electrical signals of the brain. While it might include software for data processing and display, the core function is tied to a physical hardware component.
Based on the provided information, the NeuroWorks EEG is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "display the electrical signals of the brain." This describes a device that measures physiological signals directly from the body (in vivo), not a device that examines specimens taken from the body (in vitro).
- Input Modality: Electroencephalography (EEG) is a method of recording electrical activity along the scalp. This is an in vivo measurement.
- Anatomical Site: The brain is an anatomical site within the body.
IVD devices are used to examine specimens such as blood, urine, or tissue outside of the body to provide information for diagnosis, monitoring, or screening. The NeuroWorks EEG operates by directly measuring electrical activity from the brain, which is an in vivo process.
N/A
Intended Use / Indications for Use
The NeuroWorks EEG is an electroencephalograph which is designed to display the electrical signals of the brain.
Product codes
GWQ
Device Description
The NeuroWorks EEG is an electroencephalograph which is designed to display the electrical signals of the brain.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line.
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping abstract shapes resembling birds or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 | 1998
Mr. John R. Mumford ·President Excel Tech. Limited 2892 Portland Drive Oakville, Ontario L7G 2X6 Canada
Re: K980214 Excel Neuro Works Trade Name: Regulatory Class: II Product Code: GWQ Dated: January 9, 1998 Received: January 21, 1998
Dear Mr. Mumford:
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 The general controls provisions of the Act 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. ਜੋ 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.
1
Page 2 - Mr. Mumford
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 leqally 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 (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.qov/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
2
FROM : Excel Tech
Page_1_of_1_
510 (k) Number (if known): K980214
Device Name: NeuroWorks
Indications for Use:
The NeuroWorks EEG is an electroencephalograph which is designed to display the electrical signals of the brain. -
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K960214
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
. .
(Optional Formal 1-2-96)