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.

AI/ML Overview

This submission does not contain a study to prove the device meets acceptance criteria. The Ultramind Biofeedback System with de-STRESS Software is a modification of a previously cleared device (RelaxPlus™ System K951213) and claims substantial equivalence.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is the information that can be extracted:

Acceptance Criteria and Device Performance

Since no specific performance metrics or acceptance criteria are listed for the de-STRESS Software itself, and the device is claiming substantial equivalence based on minor modifications, the "performance" is implicitly considered to be equivalent to the predicate device.

Acceptance Criteria	Reported Device Performance
Not specified in the document	Not specified in the document

Study Details

The provided document describes a 510(k) submission based on substantial equivalence to a predicate device, not a new performance study for the Ultramind Biofeedback System with de-STRESS Software. Therefore, the following information is not available:

Sample size used for the test set and the data provenance: Not applicable as no new test set study is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a biofeedback device, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is for biofeedback with human interaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no new performance study is presented.
The sample size for the training set: Not applicable as a new algorithm training study is not described.
How the ground truth for the training set was established: Not applicable.

Summary

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

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: 972-3-535-6535 Fax: 972-3-535-6880 E-mail: telsh(@ultramind.co.il

Contact Person:

Shoshana Friedman Push-med Ltd. 117 Ahuzah St. Ra'ananna 43373. Israel Tel: 972-9-771-8130 Fax: 972-9-771-8130

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.

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

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:

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

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

{3}------------------------------------------------

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.

{4}------------------------------------------------

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 (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,

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

{5}------------------------------------------------

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.

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

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)

Over the Counter Use X

Regulation Number and Section

§ 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.