NEUROCOMP

K993654 · Neurocybernetics · HCC · Jan 27, 2000 · Neurology

Device Facts

• Record ID: K993654
• Device Name: NEUROCOMP
• Applicant: Neurocybernetics
• Product Code: HCC · Neurology
• Decision Date: Jan 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

NeuroComp system performs EEG data acquisition and operant conditioning; scalp electrodes capture electrical brain activity; system processes signals to facilitate general relaxation training; operated by health professionals in clinical settings; output provides feedback to user/clinician to guide relaxation; aids in stress reduction and relaxation therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

EEG data acquisition system; scalp-based electrode sensing; operant conditioning functionality; intended for professional use; software-based signal processing.

Indications for Use

Indicated for individuals requiring EEG data acquisition and operant conditioning for general relaxation. Intended for use under the supervision of health professionals. No specific age or disease state contraindications provided.

Regulatory Classification

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.

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 when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.

Submission Summary (Full Text)

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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

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## 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 [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,

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James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 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.

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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)