BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE

K990538 · Brainmaster · HCC · May 19, 1999 · Neurology

Device Facts

• Record ID: K990538
• Device Name: BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
• Applicant: Brainmaster
• Product Code: HCC · Neurology
• Decision Date: May 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BrainMaster™ 2E is indicated for relaxation training using alpha EEG Biofeedback. In the protocol for relaxation, BrainMaster™ provides a visual and/or auditory signal that corresponds to the patient's increase in alpha activity as an indicator of achieving a state of relaxation.

Device Story

The BrainMaster 2E is a two-channel digital biofeedback/EEG device. It utilizes standard EEG electrodes and paste to acquire EEG signals from the patient. The hardware module connects to a standard Windows-based PC, which serves as the control and display console. The device processes the input EEG signals using digital filtering to identify alpha activity. It provides real-time visual and/or auditory feedback to the patient, corresponding to increases in alpha activity, to facilitate relaxation training. The device is intended for use in a clinical or educational setting. Healthcare providers or trained operators use the system to monitor patient progress and guide the biofeedback protocol. The output allows the patient to self-regulate their physiological state, potentially benefiting those undergoing relaxation training.

Clinical Evidence

No clinical data. Safety and effectiveness are supported by bench testing, including electrical, mechanical, and environmental performance testing per FDA 1993 guidance and IEC 60601-1, as well as electromagnetic and magnetic field testing.

Technological Characteristics

Two-channel digital EEG biofeedback system. Uses standard 9mm gold disk electrodes. Connectivity via serial port to Windows-based PC. Digital filtering (40 Hz notch). Common mode rejection >100 dB. Gain 20,000. 8-bit sampling. Input impedance 10 M ohms. Powered by rechargeable batteries. Software includes BMT (educational/research) and PT (clinical) modules.

Indications for Use

Indicated for relaxation training via alpha EEG biofeedback for patients seeking to achieve a state of relaxation.

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

• Lexicor NRS-2D (K961645)
• Stoelting AT 62 EEG (K965006)

Submission Summary (Full Text)

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K990538

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

#### Submitter's Identification: 1.

BrainMaster 6588 Woodhawk Drive Cleveland, Ohio 44124

Date Summary Prepared: Contact: Thomas F. Collura, Ph.D. October 1998

#### 2. Name of the Device:

The BrainMaster™ 2E

#### 3. Predicate Device Information:

- The Lexicor NRS-2D, Lexicor Medical Technology, Inc., Boulder, 1. Colorado, K#961645.
- 2. Stoelting AT 62 EEG, Stoelting Company, K#965006.

#### 4. Device Description:

### Executive Summary and Device Description:

This two-channel digital Biofeedback/EEG device uses industry-accepted standard Windows - based PC as control and display console. The device consists of the following:

- a) BrainMaster™ 2E Hardware Module
- BrainMaster™ BMT (basic educational/research SW) b)
- BrainMaster™ PT (clinical SW) c)

The System uses commercially available standard EEG electrodes and pastes such as 9 mm gold disks with 10 - 20 paste.

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#### ડ. Intended Use:

The BrainMaster™ 2E is indicated for relaxation training using alpha EEG Biofeedback. In the protocol for relaxation, BrainMaster™ provides a visual and/or auditory signal that corresponds to the patient's increase in alpha activity as an indicator of achieving a state of relaxation.

#### Comparison to Predicate Devices: 6.

#### Table of Comparison to Legally Marketed Devices: શે.

The following is a Comparison Chart outlining differences and similarities between the BrainMaster™ 2E device and the Lexicor NRS-2D/Stoelting AT 62 EEG devices:

| Device Parameters | BrainMaster™ Type 2E<br>Device | NRS-2D Device | Stoelting Autogenice<br>AT62 |
|--------------------------|--------------------------------|-------------------------------|------------------------------|
| Software | BMT | BioLex | AT62 |
| Interface | Serial Port | Parallel Port | none - standalone |
| Channels | 1 or 2 | 1 or 2 | one |
| Sampling Rate | 120 / second | 128 / second | N/A |
| Notch Filtering | 40 Hz cutoff | 50 or 60 Hz | none |
| Common Mode<br>Rejection | >100 dB | >90 dB | 120dB |
| Gain | 20,000 | 8000 | 50,000 |
| Sampling | 8 bit | 12 bit | N/A |
| Input Impedance | 10 M ohms | >1 G ohm | 200 K ohms |
| Operating System | Windows | MS-DOS | built-in |
| Frequency Analysis | Digital Filtering | FFT | Analog Filtering |
| Power | rechargeable batteries | medical grade<br>power supply | rechargeable batteries |

### 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

### Section 7 - Electrical, Mechanical and Environmental Testing

Testing information demonstrating safety and effectiveness of The BrainMaster™ Type 2E in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.

Testing was conducted by a contract testing laboratory on the BrainMaster™ 2E device per IEC 60601-1 (electrical isolation).

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards.

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It was a contract testing laboratory conclusion that BrainMaster™ 2E tested product met all relevant requirements of the aforementioned test.

In addition, the following testing was conducted by a contract testing laboratory:

Radiated and Conducted Electromagnetic Energy and Magnetic Field Testing on the BrainMaster™ 2E. Testing was conducted per the DCRND Reviewer's Guideline, November 1993. All testing met required parameters.

#### Discussion of Clinical Tests Performed: 8.

Not Applicable

#### 9. Conclusions:

The BrainMaster™ 2E device is substantially equivalent in intended use, design, material and technology as the Lexicor NRS-2D/Stoelting AT 62 EEG devices. All devices use EEG Signals, measure EEG and process it to produce frequency band energy. Differences do not affect functionality of the device thus, when compared to the predicate device, The BrainMaster™ 2E does not incorporate any changes in intended use, method of operation, material or design that could affect safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 19 1999

BrainMaster c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K990538 Trade Name: The BrainMaster 2E Regulatory Class: II Product Code: HCC and GWQ Dated: February 17, 1999 Received: February 19, 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.

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### Page 2 -- Ms. Susan D. Goldstein-Falk

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 predicate device results in a classification for your device and thus, permits vour 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,

Russell Sage

In 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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# EXHIBIT B

Page _ 1 __ of __ 1 __

510(k) NUMBER (IF KNOWN): K990538

DEVICE NAME: The BrainMaster™ 2E

INDICATIONS FOR USE:

The BrainMaster™ 2E is indicated for relaxation training using alpha EEG Biofeedback. In the protocol for relaxation, BrainMaster™ provides a visual and/or auditory signal that corresponds to the patient's increase in alpha activity as an indicator of achieving a state of relaxation.

# (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 Devices | |
| 510(k) Number | K950335 |

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:center;">OR</div> | Over-The-Counter Use<br>(Optional Format 1-2-96) |
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