EEGER4 MODEL 4.3

K122879 · Eeg Software, LLC · HCC · Feb 6, 2013 · Neurology

Device Facts

• Record ID: K122879
• Device Name: EEGER4 MODEL 4.3
• Applicant: Eeg Software, LLC
• Product Code: HCC · Neurology
• Decision Date: Feb 6, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic

Intended Use

This device is to be used for general relaxation training when used with supported amplifier/encoders.

Device Story

EEGer4 is a software-only EEG biofeedback system operating on standard Windows PCs. It accepts raw EEG data from external FDA-approved amplifier/encoders (e.g., Brainmaster, Thought Technology, J&J Engineering, Telediagnostics). The software processes EEG signals by separating them into user-specified frequency bands and displays biofeedback information to the user. It is used in clinical settings by healthcare practitioners or trained technicians to facilitate relaxation training. The device does not provide diagnostic conclusions, classifications, or clinical interpretations. The output is presented as visual biofeedback, which the provider uses to guide the patient's relaxation training process.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Software-only biofeedback system; runs on standard Microsoft Windows PCs. Supports 4 EEG channels; 256 Hz sampling rate; 0-50 Hz bandwidth. Uses digital filters for signal processing. Interfaces with external hardware via serial, USB, or Bluetooth. No hardware components; no sterilization required.

Indications for Use

Indicated for general relaxation training in patients when used with supported external amplifier/encoders. Prescription use only; intended for use by healthcare practitioners or technicians supervised by healthcare practitioners.

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

• Brainmaster2E (K990538)
• NeuroAmp (K073557)
• ProComp (K903497)

Submission Summary (Full Text)

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EEGer4

K122879

510(k) Summary

# EEG Software.wwwwwwwwwwww

## 510(k) Summary

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

## Submitter:

EEG Software LLC 17625 Mayall Street Northridge, CA 91325 (818)-886-2585 Fax: [phone]

## Contact Person:

Howard P. Lightstone

## Summary preparation date: 30 January 2013

30 January 2013

Trade name: EEGer4

EEG biofeedback device Common name:

Classification name: Biofeedback device (HCC, 21 CFR §882-5050)

### Predicate devices:

| Device | 510(k) | Product code | Manufacturer |
|---------------|---------|--------------|--------------------------------------------|
| Brainmaster2E | K990538 | HCC | BrainMaster Technologies, Inc ,Bedford, OH |
| NeuroAmp | K073557 | HCC | Corsoience GmbH & Co. KG, Germany |
| ProComp | K903497 | HCC | Thought Technology LTD., Montreal,Quebec |

## Device Description:

This software-only component of an EEG biofeedback system uses industry-accepted standard Microsoft Windows-based computers to accept EEG data from external FDAapproved amplifier/encoders and provide biofeedback information. The software does not provide any diagnostic conclusions nor provide any index, classification, diagnosis, or clinical interpretation of the data.

The device processes EEG information, separates it into user-specified frequency bands, and

EEGer4 1 EEG Software LLC ~ 17625 Mayall Street ~ Northridge, CA 91325 www.eegsoftware.com [phone] ph ~ [phone] fax

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### EEGer4

displays the results as biofeedback indications to a user.

## Intended Use Statement

This device is to be used for general relaxation training when used with supported amplifier/encoders.

The Operator Manual contains the following text:

## Indications for Use

This device is to be used for general relaxation training when used with supported amplifier/encoders.

#### General Warnings

· US Federal Law restricts this device to sale by or on the order of health care practitioners.

• Operators of this device are expected to be health care practitioners trained in neurofeedback or technicians trained in neurofeedback supervised by health care practitioners.

The top level screen of the EEGer4 software contains the following message in the lower right corner:

Caution: Federal law restricts this device to sale by or on the order of a health care practitioner.

Intended use: General relaxation

| Parameter | EEGer4 | Brainmaster 2E<br>K990538 | NeuroAmp<br>K073557 | ProComp<br>K903497 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-------------------------------------------|----------------------------------------|
| Software | EEGer4 | BMT | Cygnet (proprietary<br>version of BioEra) | Biograph |
| Intended<br>use | General relaxation when<br>used with supported<br>amplifier/encoders. | Relaxation Training | Biofeedback and<br>Relaxation | Biofeedback and<br>Relaxation |
| Supported<br>devices | Mfr: Brainmaster<br>Brainmaster 2E<br>Atlantis versions<br>Mfr: Thought Technology<br>ProComp versions<br>Infiniti versions<br>Flexcomp<br>Mfr: J&J Engineering<br>C2 versions<br>C2+ versions | Brainmaster only | NeuroAmp only | ProComp or<br>Infiniti devices<br>only |

#### Comparison to predicate devices:

EEGer4

2

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## EEGer4

## K122879

510(k) Summary

| Parameter | EEGer4 | Brainmaster 2E<br>K990538 | NeuroAmp<br>K073557 | ProComp<br>K903497 |
|------------------------------|---------------------------------------------------------------------------|---------------------------|---------------------|------------------------------------------------|
| | Mfr: Telediagnostics<br>A200 versions<br>A400 versions | | | |
| Operating<br>System | Microsoft Windows (XP and later) | | | |
| Computer | Generic PC computer supported by Microsoft Windows | | | |
| Sampling<br>Rate | 256 Hz | 120-256 Hz | 240/250 Hz | 64-512 Hz |
| Number of<br>EEG<br>channels | 4 | 2 | 2 | 4 |
| Bandwidth | 0 - 50 Hz | 0.8 - 40 Hz | 0.08-70 Hz | 2-1000 Hz |
| Power<br>Supply | Not Applicable<br>(software only) | Rechargeable<br>batteries | Via USB port | AA batteries,<br>single use or<br>rechargeable |
| Filtering | Digital Filters | | | |
| Device<br>Interface | Depends on<br>amplifier/encoder used<br>(serial, USB, Bluetooth,<br>etc.) | Serial port | USB | USB or serial port |

#### Conclusion:

The EEGer4 software is substantially equivalent to the software component of the predicate devices, indeed using some of the same hardware components. All devices use EEG signals, measure EEG, and process it to produce frequency band energy indications for feedback. Differences between the predicates and EEGer4 are in the area of user interfaces and the ability to use multiple devices (one at a time). EEGer4 does not incorporate any changes in intended use, method of operation, material or design that could affect safety or effectiveness. .

This summary includes only information that is also covered in the body of the 510(k). This summary does not contain any trade secret or confidential information. This summary does not contain any patient identification information.

#### EEGer4

3

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circular logo.

February 6,2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

EEG Software LLC c/o Mr. Howard Lightstone 17625 Mayall Street Northridge, California 91325

Re: K122879

Trade/Device Name: EEGer4 Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback Device Regulatory Class: Class II Product Code: HCC Dated: January 15, 2013 Received: January 23, 2013

#### Dear Mr. Lightstone:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Howard Lightstone

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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.goy/Medica]Devices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Joyce M. Whang

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## EEGer4

## Indications for Use

510(k) Number (if known): _K122879

Device Name: ____EEGer4 Neurofeedback Software

Indications for Use:

This device is to be used for general relaxation training when used with supported amplifier/encoders.

Prescription Use X (Part 21 CFR 801 Subpart D)

## Joyce M. Whang

Division of Newological and Physical Medicine Devices 510(k) Number: K122879

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