(334 days)
Not Found
No
The description focuses on data acquisition, recording, transmission, and display of EEG data, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is indicated for acquiring, recording, transmitting, and analyzing data for electroencephalograph (EEG) studies. While EEG studies can be part of a diagnostic process that leads to therapeutic interventions, the device itself is a diagnostic tool, not one that directly provides therapy or treatment.
Yes
The device is indicated for prescription use to acquire, record, transmit, and data for electroencephalograph studies of patients, which are diagnostic studies for medical conditions.
No
The device description explicitly states it includes a "BrainMaster™ Discovery 24 Hardware Module" and other hardware components like an Electrocap and cables, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "acquire, record, transmit, and data for electroencephalograph studies of patients of all ages." This describes a device used to measure electrical activity in the brain directly from the patient.
- Device Description: The description details a system for acquiring electrophysiological data (EEG) using electrodes placed on the patient.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not process such specimens.
The device described is a medical device used for in vivo (within the living body) measurement of physiological signals.
N/A
Intended Use / Indications for Use
Indicated for prescription use to acquire, record, transmit, and data for electroencephalograph studies of patients of all ages.
Product codes (comma separated list FDA assigned to the subject device)
GWQ
Device Description
The BrainMaster™ Discovery 24 are two-channel, four- channel, and 24-channel electrophysiological acquisition and biofeedback devices.
The 24-channel (Discovery 24) digital EEG devices use industry-accepted Windowsbased PC as the control and display console. The devices consist of the following:
- BrainMaster™ Discovery 24 Hardware Module
- BrainMaster™ software - BrainMaster™ BrainAvatar Acquisition software
- Electrocap, which is sold separately.
The system also includes a full set of DIN-compliant touch-proof sockets, either on the main housing, or in an accessory cable, that allows the use of compliant sensors for use of "free sensors" without a cap.
These products are designed for use with a standard IBM PC/AT compatible computers (Windows 7 and later) and associated peripheral equipment such as keyboard, mouse, and monitor(s). When assembled with a computer, the BrainMaster™ Discovery 24 system will acquire EEG and display and save it to disc.
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
all ages
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The following non-clinical tests were performed to support the determination of substantial equivalence;
IEC 60601-1-2 Ed. 3: 2007 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-26 Ed. 3.0 B: 2012 Medical Electrical Equipment Part 2-26: Particular Requirements for the Basic Safety and Essential Performance of Electroencephalographs
Software Validation Testing per approved procedures
The devices passed all testing.
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.
The Vanguard System, K941551
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
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2016
Brainmaster Technologies, Inc. % Ms. Maria Griffin Official Correspondent MDI Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021
Re: K150498
Trade/Device Name: Discovery 24 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO Dated: December 1, 2015 Received: December 4, 2015
Dear Ms. Griffin:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael J. Hoffmann -A
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150498
Device Name Discovery 24
Indications for Use (Describe)
Indicated for prescription use to acquire, record, transmit, and data for electroencephalograph studies of patients of all ages.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
The assigned 510(k) number is:
-
- Submitter's Identification: Brainmaster Technologies, Inc. 195 Willis Street, Suite 3 Bedford. OH 44146
Contact Person: Tom Collura, President Tel: 440-232-6000 ext. 205
- Submitter's Identification: Brainmaster Technologies, Inc. 195 Willis Street, Suite 3 Bedford. OH 44146
Date Summary Prepared: January 25, 2016
2. Trade Name of the Device:
BrainMaster™ Discovery 24
-
- Common or Usual Name: full-montage standard electroencephalograph
Classification: 4.
Regulation: 21 CFR 882.1400 Product Code: GWQ
న. Predicate Device Information: The Vanguard System, K941551
6. Device Description:
The BrainMaster™ Discovery 24 are two-channel, four- channel, and 24-channel electrophysiological acquisition and biofeedback devices.
The 24-channel (Discovery 24) digital EEG devices use industry-accepted Windowsbased PC as the control and display console. The devices consist of the following:
- BrainMaster™ Discovery 24 Hardware Module 1.
-
- BrainMaster™ software - BrainMaster™ BrainAvatar Acquisition software
-
- Electrocap, which is sold separately.
The system also includes a full set of DIN-compliant touch-proof sockets, either on 4. the main housing, or in an accessory cable, that allows the use of compliant sensors for use of "free sensors" without a cap.
These products are designed for use with a standard IBM PC/AT compatible computers (Windows 7 and later) and associated peripheral equipment such as keyboard, mouse, and monitor(s). When assembled with a computer, the BrainMaster™ Discovery 24 system will acquire EEG and display and save it to disc.
4
7. Intended Use:
Indicated for prescription use to acquire, record, transmit, and display physiological and data for electroencephalograph (EEG) studies of patients of all ages.
8. Technological Comparison to Predicate Devices:
| PRODUCT | Cleveland Clinic
Vanguard System | BrainMaster
Discovery 24 |
|--------------------------------|-------------------------------------|--------------------------------|
| SCROLLED LIVE EEG | yes | yes |
| SYNCH VIDEO/EEG | yes | no |
| ADJUSTABLE VIEW | yes | yes |
| ADJUSTABLE VIEW
DURATION | yes | yes |
| ONSCREEN MARKERS | yes | yes |
| DIGITAL FILTERING | yes | yes |
| MONTAGE EDITOR | yes | yes |
| REMOTE SCREEN VIEW | yes | yes |
| POWER | CPU (EISA) bus | Isolated Power via USB
port |
| # OF EEG CHANNELS | 32-64 | 24 |
| A/D RESOLUTION | 12 bits | 24 bit |
| DIGITIZATION RATE | 200 Hz | 1024 Hz |
| SAMPLING RATE | 200 Hz | 256 Hz |
| IMPEDANCE CHECK | Yes | Yes |
| INDICATIONS FOR USE | Clinical EEG | Clinical EEG |
| SOFTWARE | EMach | BrainAvatar |
| PATIENT ISOLATION | optical | optical & magnetic |
| ISOLATION VOLTAGE | >2500V | >2500V |
| INTERFACE | EISA bus | USB |
| NOTCH FILTERING | 60/50 Hz | 60/50 Hz |
| COMMON MODE
REJECTION RATIO | >110 dB | >120 dB |
| GAIN | 1000 | 16 |
| INPUT IMPEDANCE | >100MOhm | >1000GOhm |
| INPUT NOISE | 1.5uV at input | 1.5uV at input |
| SELF-CAL | yes | yes |
| FREQUENCY RANGE | 0.5 - 70 Hz | 0.5 - 70 Hz |
| Input Range | 1250 µV p-p | 100 mV p-p |
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9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The following non-clinical tests were performed to support the determination of substantial equivalence;
IEC 60601-1-2 Ed. 3: 2007 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-26 Ed. 3.0 B: 2012 Medical Electrical Equipment Part 2-26: Particular Requirements for the Basic Safety and Essential Performance of Electroencephalographs
Software Validation Testing per approved procedures
The devices passed all testing.
10. Discussion of Clinical Tests Performed: Not applicable.
11. Discussion of Substantial Equivalence
The BrainMaster system has the same intended use in the same environments as the predicate device. It has the same manner of use, being a computer-based digital EEG system with basic functions, and it has a similar requirement for training and expectations of user. The safety requirements and expectations are the same. The systems have comparable performance in terms of data sampling and accuracy, and speed and resolution of displays. They use identical patient connectors and methodology, being standard clinical EEG sensor placement.
12. Conclusions:
Based on the information provided in this submission we conclude that BrainMaster™ Discovery 24 is substantially equivalent to the predicate and are safe and effective for its intended use.