ALPHAONE BIOFEEDBACK SYSTEM

K071661 · Telediagnostic Systems, Inc. · HCC · Sep 5, 2007 · Neurology

Device Facts

• Record ID: K071661
• Device Name: ALPHAONE BIOFEEDBACK SYSTEM
• Applicant: Telediagnostic Systems, Inc.
• Product Code: HCC · Neurology
• Decision Date: Sep 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AlphaOne EEG biofeedback system is intended for use in relaxation training. In applications for relaxation training, the AlphaOne system provides visual and/or auditory signals that correlate with changes in EEG activity useful for achieving a state of relaxation. This device does not provide alarms and does not provide automated diagnostic analysis of EEG data. US Federal Law restricts this device to sale by, or on the order of, a licensed healthcare provider.

Device Story

AlphaOne EEG Biofeedback System captures EEG signals; transforms signals into real-time visual/auditory feedback; assists users in achieving relaxation states. Operated by healthcare providers or patients under provider supervision in clinical or home settings. Output provides biofeedback cues to facilitate self-regulation of physiological states. Device lacks automated diagnostic analysis or alarm functions. Benefits include non-invasive relaxation training support.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

EEG biofeedback system; provides visual/auditory feedback based on EEG activity; non-diagnostic; no automated analysis or alarms. Class II device (21 CFR 882.5050).

Indications for Use

Indicated for individuals requiring relaxation training via EEG biofeedback. No specific age or gender restrictions noted. Contraindications not specified.

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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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 an abstract image of an eagle or bird-like figure with three stylized wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2007

TeleDiagnostic Systems, Inc % Mr. Larry Woodward 2483 Old Middlefield Way Suite 202 Mountain View, California 94043

K071661 Re:

> Trade/Device Name: AlphaOne EEG Biofeedback System Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback Device Regulatory Class: Class II Product Code: HCC, GWQ Dated: August 7, 2007 Received: August 9, 2007

Dear Mr. Woodward:

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. Ilsting 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.

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## Page 2 -- Mr. Larry Woodward

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Neil R.P. Ogden
Mark Melkerson

Director Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use

AlphaOne EEG Biofeedback System

Device Name:

Indications For Use:

The AlphaOne EEG biofeedback system is intended for use in relaxation training. In applications for relaxation

training, the AlphaOne system provides visual and/or auditory signals that correlate with changes in EEG activity useful for achieving a state of relaxation.

This device does not provide alarms and does not provide automated diagnostic analysis of EEG data.

US Federal Law restricts this device to sale by, or on the order of, a licensed healthcare provider.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Concurrence of CDRA Office of Device Evaluation (ODE)
for mxm
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

| 510(k) Number | K071661 |
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