ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE

K980373 · Ultramind International , Ltd. · HCC · Apr 29, 1998 · Neurology

Device Facts

• Record ID: K980373
• Device Name: ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE
• Applicant: Ultramind International , Ltd.
• Product Code: HCC · Neurology
• Decision Date: Apr 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ultramind Biofeedback System with de-STRESS Software is a biofeedback system designed to be used for relaxation training.

Device Story

System uses finger-worn sensor with two electrodes to detect electro-dermal activity (EDA) or galvanic skin response (GSR); data transmitted via cordless link to personal computer. Software analyzes, records, and displays physiological data as scientific graphs or interactive animations. User modulates animation through thoughts and emotions; biofeedback loop enables user to learn correlation between mental state and physiological response. Intended for relaxation training; practice allows user to retain learned capabilities for use without system. Operates in home or clinic settings; user-operated.

Clinical Evidence

No clinical data provided; bench testing only. Device complies with IEC 601-1 and IEC 601-1-2 safety and electromagnetic compatibility standards.

Technological Characteristics

Finger-worn sensor with two electrodes; cordless transmission to PC. Measures electro-dermal activity (EDA)/galvanic skin response (GSR). Complies with IEC 601-1 (general safety) and IEC 601-1-2 (EMC).

Indications for Use

Indicated for relaxation training in users seeking to learn control over physiological responses, including autonomic nervous system responses, through biofeedback.

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.

Predicate Devices

• Ultramind RelaxPlus™ System (K951213)

Submission Summary (Full Text)

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## APR 2 9 1998

#### 510(k) Summary

Ultramind International Ltd.

# Ultramind Biofeedback System with de-STRESS Software 510(k) Number K 980373

#### Submitter's Name:

Ultramind International Ltd. Building 35A, Sheba Medical Center Tel Hashomer 56201, Israel Tel: [phone] Fax: [phone] E-mail: telsh(@ultramind.co.il

#### Contact Person:

Shoshana Friedman Push-med Ltd. 117 Ahuzah St. Ra'ananna 43373. Israel Tel: [phone] Fax: [phone]

### Trade Name:

Ultramind Biofeedback System with de-STRESS Software And States of States of American States of American States of American Article Andrews Andress of American Station Andrews And Childers Comments of American Comments of Arman

#### Classification Name:

Biofeedback Device

#### Classification:

The FDA has classified biofeedback devices as a class II device (product code 84 HCC) and it is reviewed by the Neurology Devices Branch.

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#### Predicate Devices:

Ultramind RelaxPlus™ System (K951213)

#### Performance Standards:

No performance standards applicable to the biofeedback devices have been established under Sections 514 of the Federal Food, Drug, and Cosmetic Act. However, the Ultramind Biofeedback System complies with IEC 601-1 and IEC 601-1-2.

#### Indication for Use:

The Ultramind Biofeedback System with de-STRESS Software is a biofeedback system designed to be used for relaxation training.

#### Device Description:

The Ultramind Biofeedback System comprises a sensor which transmits changes in the stress/relaxation levels to a receiver. In turn, the receiver feeds the information on line to a computer which, by means of the de-STRESS Software, is able to analyze, record, and select data as well as display instructions on how to use the system for the purpose of learning the art of relaxation.

The user wears on his/her finger a small plastic mold that contains two electrodes. The electrodes detect minute physiological changes, measured in terms of relative electro-dermal activity (EDA) or galvanic skin response (GSR), that reflect the user's conscious, subconscious or physical state. This information is transmitted by cordless link to a personal computer and is displayed in the form scientific graphs, or used to drive animation.

The animation depends on the user's state of mind, i.e., the user is able to change the animation by his/her thoughts or emotions. Through this "play", as the user learns to correlate between thoughts and emotions and the response of the computer game, he/she learns to control physiological responses - even in the realm of the autonomic nervous system.

After practice, the user retains the newly-learned capabilities, and can use them at will without the system. The learning process is accelerated through use of advance psychological techniques which enable the user to learn with both hemispheres of the brain, with the intellect and the subconscious.

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## Substantial Equivalence:

The Ultramind Biofeedback System with de-STRESS Software is substantial equivalent to the RelaxPlus™ System cleared under K951213 (Ultramind International Ltd.). In fact, the Ultramind Biofeedback System with de-STRESS Software is a modification of the RelaxPlus™ System incorporating a set of minor changes in software, hardware, and design of the user interface

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1998

Ms. Shoshana Friedman 'Ultramind International Limited C/O Push-Med Limited 117 Ahuzah Street Ra'ananna, Israel 43373

к980373 Re: Trade Name: Ultramind Biofeedback System with de-STRESS Software Regulatory Class: II Product Code: HCC Dated: January 25, 1998 January 30, 1998 Received:

Dear Ms. Friedman:

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. ਜੋ substantially equivalent determination assumes compliance with ____ the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlatory In addition, FDA may publish further announcements action. 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.

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#### Page 2 - Ms. Friedman

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 leqally 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 [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,

G. Galit, M. Witter, Ph. D., M.

Celia 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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## INDICATIONS FOR USE

| 510(k) Number (if known): | K980373 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

Ultramind Biofeedback System with de-STRESS Software

Indications for Use:

Biofeedback The Ultramind System with de-STRESS Software is a biofeedback system designed to be used for relaxation training.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) 65 16 Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices

510(k) Number K980633

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use X