(90 days)
Not Found
No
The summary describes a device for acquiring and storing EEG signals and mentions a system for displaying and archiving them. There is no mention of AI, ML, or any related technologies for analysis or interpretation of the signals.
No
The device is described as an electroencephalograph intended to acquire, store, display, and archive electroencephalographic signals. These are diagnostic functions, not therapeutic ones.
Yes
The device acquires and stores electroencephalographic signals (electrical signals of the brain), and when connected to a system, it displays and archives these signals. The intent is to capture and potentially analyze brain signals, which falls under diagnostic purposes. The reference to FDA 510(k) # K980214 for NeuroWorks, which is a system for displaying and archiving these signals, further supports its role in diagnosis.
No
The device description explicitly states it is a "battery powered electroencephalograph," which is a hardware device intended to acquire and store electrical signals. While it connects to software (NeuroWorks), the core device itself is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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.
- Device Function: The "Ambulatory EEG" acquires and stores electrical signals directly from the brain (in vivo), not from a sample taken from the body (in vitro).
- Intended Use: The intended use is to acquire and store electroencephalographic signals, which are physiological measurements, not diagnostic tests performed on samples.
Therefore, the function and intended use of this device clearly place it outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The "Ambulatory EEG" is a battery powered electroencephalograph which is intended to acquire and store electroencephalographic signals (electical signals of the brain).
When connected, as part of a system, to the NeuroWorks [FDA 510(k) # K980214], the system is also intended to display and archive there signals.
Product codes
GWQ
Device Description
The "Ambulatory EEG" is a battery powered electroencephalograph which is intended to acquire and store electroencephalographic signals (electical signals of the brain).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
Not Found
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)
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/2 description: The image shows a partial view of the Department of Health & Human Services logo. The logo features a stylized depiction of an eagle or bird-like figure with three distinct head profiles layered on top of each other. The text "DEPARTMENT OF HEALTH &" is visible, wrapping around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 1998
Mr. John R. Mumford President Excel Tech, LTD. 2892 Portland Dr. Oakville, Ontario Canada L6H 5W8
Re: K982479 Trade Name: Excel Ambulatory EEG Regulatory Class: II Product Code: GWQ Dated: July 16, 1998 Received: July 16, 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 qeneral 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. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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. -------------------------------
1
Page 2 - Mr. John R. 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 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 (301) 594-4659. 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,
Cecelia M. Witten, Ph.D.
ia 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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EXCEL TECH, LTD. 510(K) NOTIFICATION OF A NEW DEVICE : "AMBULATORY EEG"
ATTACHMENT # 1 STATEMENT OF INDICATIONS FOR USE
| 510(k) Number (if known): | K982479 |
|---|---|
| Device Name: | Excel Ambulatory EEG |
| Indications For Use: |
Intended Use
The "Ambulatory EEG" is a battery powered electroencephalograph which is intended to acquire and store electroencephalographic signals (electical signals of the brain).
ﺔ ﺍﻟﻤﺘﺤﺪﺓ
When connected, as part of a system, to the NeuroWorks [FDA 510(k) # K980214], the system is also intended to display and archive there signals.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
EEDED) NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K982479 |
| Prescription Use
| er 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ---------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)