(89 days)
K#961645, K#965006
Not Found
No
The summary describes a standard biofeedback/EEG device that provides signals based on alpha activity. There is no mention of AI, ML, or any advanced algorithms for data analysis or interpretation beyond basic signal processing for biofeedback.
No
The device is indicated for "relaxation training" which is a general wellness claim, not a therapeutic treatment for a specific condition or disease, and biofeedback is often considered an adjunct to treatment, not a standalone therapeutic intervention in this context.
No
The device is indicated for "relaxation training using alpha EEG Biofeedback" and provides signals for the patient's increase in alpha activity "as an indicator of achieving a state of relaxation." This describes a therapeutic or training device, not one used for identifying or determining the nature of a disease or condition.
No
The device description explicitly lists a "BrainMaster™ 2E Hardware Module" as a component of the system, indicating it is not solely software.
Based on the provided information, the BrainMaster™ 2E is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- BrainMaster™ 2E Function: The BrainMaster™ 2E is described as a Biofeedback/EEG device used for relaxation training. It measures electrical activity in the brain (EEG) and provides feedback to the user.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The device interacts directly with the patient's scalp to measure electrical signals.
Therefore, the BrainMaster™ 2E falls under the category of a medical device used for biofeedback and relaxation training, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HCC, GWQ
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.
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
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K#961645, K#965006
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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.
-
- 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.
1
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
Device | NRS-2D Device | Stoelting Autogenice
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
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
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.
2
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.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines beneath them, resembling a stylized caduceus.
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.
4
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 (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,
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
5
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
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ------------------------------------------ | -------------------------------------------------- |
|---|