(140 days)
No
The description focuses on standard signal processing (separating into frequency bands) and displaying results, with no mention of AI/ML terms or capabilities like learning, prediction, or complex pattern recognition beyond basic signal analysis.
No
Explanation: The device is described as being for "general relaxation training" and explicitly states it "does not provide any diagnostic conclusions nor provide any index, classification, diagnosis, or clinical interpretation of the data." While it's used in conjunction with "health care practitioners trained in neurofeedback," its fundamental purpose is not to treat a specific medical condition.
No
The "Intended Use / Indications for Use" states that the device is "to be used for general relaxation training." The "Device Description" explicitly states, "The software does not provide any diagnostic conclusions nor provide any index, classification, diagnosis, or clinical interpretation of the data."
Yes
The device description explicitly states it is a "software-only component" and relies on external, FDA-approved hardware (amplifier/encoders) for data acquisition, indicating the device itself is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "general relaxation training." This is a therapeutic or training purpose, not a diagnostic one.
- Device Description: The description clearly states that the software "does not provide any diagnostic conclusions nor provide any index, classification, diagnosis, or clinical interpretation of the data." This is a key characteristic that differentiates it from an IVD.
- Functionality: The device processes EEG data and displays it as biofeedback indications. This is for the user to observe and potentially modify their brain activity for relaxation, not to diagnose a condition.
IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not perform such analysis on biological specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
This device is to be used for general relaxation training when used with supported amplifier/encoders.
Product codes
HCC
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 displays the results as biofeedback indications to a user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operators of this device are expected to be health care practitioners trained in neurofeedback or technicians trained in neurofeedback supervised by health care practitioners.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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EEGer4
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: (818) 886-1443
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 (818) 886-2585 ph ~ (818) 886-1443 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
K990538 | NeuroAmp
K073557 | ProComp
K903497 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-------------------------------------------|----------------------------------------|
| Software | EEGer4 | BMT | Cygnet (proprietary
version of BioEra) | Biograph |
| Intended
use | General relaxation when
used with supported
amplifier/encoders. | Relaxation Training | Biofeedback and
Relaxation | Biofeedback and
Relaxation |
| Supported
devices | Mfr: Brainmaster
Brainmaster 2E
Atlantis versions
Mfr: Thought Technology
ProComp versions
Infiniti versions
Flexcomp
Mfr: J&J Engineering
C2 versions
C2+ versions | Brainmaster only | NeuroAmp only | ProComp or
Infiniti devices
only |
Comparison to predicate devices:
EEGer4
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2
EEGer4
K122879
510(k) Summary
| Parameter | EEGer4 | Brainmaster 2E
K990538 | NeuroAmp
K073557 | ProComp
K903497 |
|------------------------------|---------------------------------------------------------------------------|---------------------------|---------------------|------------------------------------------------|
| | Mfr: Telediagnostics
A200 versions
A400 versions | | | |
| Operating
System | Microsoft Windows (XP and later) | | | |
| Computer | Generic PC computer supported by Microsoft Windows | | | |
| Sampling
Rate | 256 Hz | 120-256 Hz | 240/250 Hz | 64-512 Hz |
| Number of
EEG
channels | 4 | 2 | 2 | 4 |
| Bandwidth | 0 - 50 Hz | 0.8 - 40 Hz | 0.08-70 Hz | 2-1000 Hz |
| Power
Supply | Not Applicable
(software only) | Rechargeable
batteries | Via USB port | AA batteries,
single use or
rechargeable |
| Filtering | Digital Filters | | | |
| Device
Interface | Depends on
amplifier/encoder used
(serial, USB, Bluetooth,
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
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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 (800) 638-2041 or (301) 796-7100 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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