(90 days)
Not Found
None
No
The summary does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
Yes
The device is indicated for "general relaxation" and is used under the supervision of health professionals, which points to a therapeutic purpose.
No
The device is described as being for "data acquisition and operant conditioning of the EEG" and "general relaxation," which are not inherently diagnostic functions. It acquires data but doesn't interpret it for diagnostic purposes based on the provided information.
Unknown
The provided summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components for EEG data acquisition and operant conditioning.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "data acquisition and operant conditioning of the EEG" and "general relaxation." This involves interacting with the patient's physiological signals (EEG) directly, not analyzing samples taken from the body (like blood, urine, or tissue) in a laboratory setting.
- Input Modality: The input modality is EEG, which is a measurement of electrical activity on the scalp, not an analysis of a biological sample.
- Anatomical Site: The anatomical site is the scalp, where the EEG electrodes are placed, not a site from which a sample is collected.
IVDs are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
NeuroComp is indicated for use in data acquisition and operant conditioning of the EEG. The device is to be used under the supervision of health professionals. This system is used for general relaxation.
Product codes
HCC, GWO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
EEG
Anatomical Site
scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health professionals, Prescription Use
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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 7 2000
Ms. Susan D. Goldstein-Falk Official Correspondent for NeuroCybernetics NeuroCybernetics C/O MDI Consultants 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
- K993654 Re:
Trade Name: Neurocomp Regulatory Class: II Product Code: HCC & GWO Dated: October 27, 1999 Received: October 29, 1999
Dear Ms. Goldstein-Falk:
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.
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
1
Page 2 - Ms. Susan D. Goldstein-Falk
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.gov/cdrh/dsmamain.html".
Sincerely yours,
Stupt Rhodes
fa
Ja
An
De
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
of Page
| 10(k) Number (if known): | K993654 |
|---|---|
| Device Name: | NeuroComp |
Indications For Use:
NeuroComp is indicated for use in data acquisition and operant conditioning of the EEG. The device is to be used under the supervision of health professionals. This system is used for general relaxation. Anatomical site measured is the scalp.
. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K993654 |
| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- |
(Optional Format 1-2-96)