MODIFICATION TO A620 EEG

K012011 · Stoelting Co. · HCC · Oct 10, 2001 · Neurology

Device Facts

• Record ID: K012011
• Device Name: MODIFICATION TO A620 EEG
• Applicant: Stoelting Co.
• Product Code: HCC · Neurology
• Decision Date: Oct 10, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5050
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

EEG/Neurofeedback is indicated where general relaxation training is desired. The Model A620-3 EEG biofeedback instrument is used by professionals for general relaxation training of patients.

Device Story

Autogenics Model A620-3 is an EEG biofeedback instrument. Device acquires EEG signals from patients; processes signals to provide feedback for relaxation training. Operated by professionals in clinical settings. Output allows healthcare providers to monitor patient physiological states; facilitates relaxation training to benefit patient stress management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

EEG biofeedback instrument; Class II; Product Code HCC. Operates under 21 CFR 882.5050. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for patients requiring general relaxation training. Used by professionals.

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)

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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" around the perimeter. Inside the circle is a stylized image of an eagle or bird with outstretched wings, depicted in a simple, graphic style.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2001

Mr. Kenneth L. Bird Division Manager Autogenics 620 Wheat Lane Wood Dale, Illinois 60191

Re: K012011

Trade/Device Name: Autogenics Model A620-3 EEG Biofeedback Instrument Regulation Number: 882.5050 Regulation Name: Biofeedback device Regulatory Class: II Product Code: HCC Dated: September 5, 2001 Received: September 10, 2001

Dear Mr. Bird :

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

Page 2 - Mr. Kenneth L. Bird

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walker, MD

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indication For Use Form

510(k) Number: K012011

## Device Name: Autogenics Model A620-3 EEG Biofeedback Instrument

Indications for use:

EEG/Neurofeedback is indicated where general relaxation training is desired.

The Model A620-3 EEG biofeedback instrument is used by professionals for general relaxation training of patients.

Image /page/2/Picture/6 description: The image is a black and white photograph. The image is blurry and contains a lot of noise. There are some shapes in the image, but it is difficult to tell what they are.

(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
and Neurological Devices

Prescription Use
(Per 21CFR 801.109)
510(k) Number
K012011
Or Over The Counter Use