(412 days)
No
The description focuses on statistical analysis and comparison to a normative database, not on learning from data or using AI/ML algorithms.
No.
Explanation: The device is described as a software program for the post-hoc statistical analysis of the human electroencephalogram (EEG) for diagnostic purposes, specifically for statistical evaluation and comparison against normative databases using z-scores. It does not perform any therapeutic function.
Yes
The device is used for the statistical evaluation of the human electroencephalogram (EEG) to compare patient data against a normative database, expressing differences as z-scores. This process of identifying deviations from normal values is a diagnostic function.
Yes
The device description explicitly states that the device "consists of a set of tables that represent the reference means and standard deviations for representative samples. These tables are implemented as computer files that provide access to the exact tabular data resource for use by software that uses the tables as an information resource." It also states that the EEG is "recorded on a separate device (i.e., the host system)" and then transferred to the QPD for analysis. This indicates that the device itself is the software and the data it uses, and it relies on external hardware for data acquisition. The performance studies also focus on software validation and comparison of the software's output to a predicate device's output.
Based on the provided information, the qEEG-Pro System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: An IVD is a medical device used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. The tests are performed in vitro (in glass, or outside the body).
- qEEG-Pro System Function: The qEEG-Pro System analyzes electroencephalogram (EEG) data. EEG is a measurement of electrical activity in the brain, recorded from electrodes placed on the scalp. This is a measurement of a physiological signal from the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for the "statistical evaluation of the human electroencephalogram (EEG)." This aligns with analyzing a physiological signal, not performing a test on a biological sample.
- Device Description: The description clearly states it's a "software program for the post-hoc statistical analysis of the human electroencephalogram (EEG)." It processes data recorded by a separate EEG device.
In summary, the qEEG-Pro System analyzes a physiological signal (EEG) recorded from the body, rather than performing a test on a sample taken from the body. This places it outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The qEEG-Pro System is to be used by qualified clinical professionals for the statistical evaluation of the human electroencephalogram (EEG).
Product codes
OLU
Device Description
qEEG Pro Database (QPD) is a software program for the post-hoc statistical analysis of the human electroencephalogram (EEG). EEG recorded on a separate device (i.e., the host system) is transferred to the QPD for display and user-review. The device herein described consists of a set of tables that represent the reference means and standard deviations for representative samples. These tables are implemented as computer files that provide access to the exact tabular data resource for use by software that uses the tables as an information resource. The system requires that the user select reliable samples of artifact-free, eyes-closed or eyes open, resting digital EEG for purposes of analysis.
Analysis consists of the Fast-Fourier Transformation (FFT) of the data to extract the spectral power for each of the designated frequency bands (e.g. delta, theta, alpha, and beta), and frequency information from the EEG. The results of this analysis are then displayed in statistical tables and topographical brain maps of absolute and relative power, power asymmetry, and coherence for 19 monopolar and 171 selected bipolar derivations of the EEG. In all over 5,000 measures are derived for comparison against carefully constructed and statistically controlled age-regressed, normative database in which the variables have been transformed and validated for their Gaussian distribution.
Each variable extracted by the analysis is compared to the database using parametric statistical procedures that express the differences between the patient and an appropriate age-matched reference group in the form of z-scores.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
electroencephalogram (EEG)
Anatomical Site
human electroencephalogram (EEG)
Indicated Patient Age Range
4-82 years
Intended User / Care Setting
qualified clinical professionals / 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
Non-Clinical Testing: Software documentation up to a moderate level of concern was submitted which included validation performance testing. Non-clinical performance testing included delta, theta, alpha, and beta comparison of the subject and predicate device using a variety of simulated signals which were analyzed for frequency and power. These performance data demonstrated confirmation by examination of pre-specified, objective evidence to specify that output requirements for the software have been fulfilled and met through static and dynamic analyses and code and document inspections. The software testing performance data further established that the software device's specifications consistently conform to the pre-specified user needs and the intended use. The algorithms and statistical methods used for data analysis were also evaluated through these tests. Therefore, the testing demonstrated the that the system accurately translates and presents EEGs from patients.
Clinical Testing: Clinical testing of the subject device included a study of 3 subjects who were used to validate performance of subject device database to that of the predicate K041263. These subjects were adequate to provide a range of values of the databases to verify performance since they are part of the adult and pediatric range of ages as well as the frequencies within the databases. Acceptance criteria were defined as the qEEG-Pro produces results sufficiently in agreement with the predicate devices and that the R-squared factor shall be 0.8 or better. Additionally, the observed range of results obtained from the predicate devices shall be used to verify that the qEEG-Pro produces results in agreement with the results obtained from the predicate device. The pre-defined acceptance criteria were met as 9-minute EEG recordings for eyes closed and open of the subjects (1 pediatric 9 years, 2 adult 48 and 46 both male and female) were de-artifacted and used to calculate z-scores for absolute power for the subject and predicate databases. Although the sample size was small, it was possible to validate results by computing values for all discrete ages ranging between 6 and 60, resulting in 55 sets of zscores for each subject's EEG sample which were compared with the predicate device's output and found to also be similar.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
July 1, 2018
BrainMaster Technologies, Inc. % Maria F. Griffin Senior Consultant mdi Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021
Re: K171414
Trade/Device Name: qEEG-Pro Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLU Dated: April 11, 2017 Received: May 15, 2017
Dear Maria F. 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay R. Gupta -S
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) K171414
Device Name qEEG-Pro
Indications for Use (Describe)
The qEEG-Pro System is to be used by qualified clinical professionals for the statistical evaluation of the human electroencephalogram (EEG).
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K171414 510(k) SUMMARY
I. SUBMITTER BrainMaster Technologies, Inc. 195 Willis Street, Suite 3 Bedford, OH 44146
| Contact Person: | Tom Collura, President |
|---|---|
| Tel: | 440-232-6000 ext. 205 |
Date Prepared: June 29, 2018
II. DEVICE
| Name of Device: | qEEG-Pro |
|---|---|
| Common Name: | Normalizing Quantitative Electroencephalograph Software |
| Classification Name: | Electroencephalograph |
| Regulatory Class: | II |
| Product Code: | OLU |
III. PREDICATE DEVICE
NeuroGuide Analysis System (NAS), K041263
IV. DEVICE DESCRIPTION
qEEG Pro Database (QPD) is a software program for the post-hoc statistical analysis of the human electroencephalogram (EEG). EEG recorded on a separate device (i.e., the host system) is transferred to the QPD for display and user-review. The device herein described consists of a set of tables that represent the reference means and standard deviations for representative samples. These tables are implemented as computer files that provide access to the exact tabular data resource for use by software that uses the tables as an information resource. The system requires that the user select reliable samples of artifact-free, eyes-closed or eyes open, resting digital EEG for purposes of analysis.
Analysis consists of the Fast-Fourier Transformation (FFT) of the data to extract the spectral power for each of the designated frequency bands (e.g. delta, theta, alpha, and beta), and frequency information from the EEG. The results of this analysis are then displayed in statistical tables and topographical brain maps of absolute and relative power, power asymmetry, and coherence for 19 monopolar and 171 selected bipolar derivations of the EEG. In all over 5,000 measures are derived for comparison against
4
carefully constructed and statistically controlled age-regressed, normative database in which the variables have been transformed and validated for their Gaussian distribution.
Each variable extracted by the analysis is compared to the database using parametric statistical procedures that express the differences between the patient and an appropriate age-matched reference group in the form of z-scores.
INDICATIONS FOR USE V.
The qEEG-Pro System is to be used by qualified medical or qualified clinical professionals for the statistical evaluation of the human electroencephalogram (EEG).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE VI. DEVICE
| Item | qEEG-Pro | NeuroGuide Analysis System
(NAS) K041263 |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The qEEGpro system is to be
used by qualified medical and
qualified clinical professionals
for the post-hoc statistical
evaluation of the human
electroencephalogram (EEG).
Rx-only | The NAS system is to be used by
qualified medical and qualified
clinical professionals for the
post-hoc statistical evaluation of
the human electroencephalogram
(EEG).
OTC |
| EEG data
comparison
against normative
database | Yes; 1482 samples (eyes-
closed);1231 subjects (eyes-
open) | Yes; 625 samples |
| EEG Spectral
Analysis | Yes; 4 frequency bands (delta,
theta, alpha, and beta) | Yes; 4 frequency bands (delta,
theta, alpha, and beta) |
| Age Range
Included in the
Normative
Database | 4-82 years | 2 months-82 years |
| Product code | OLU | OLU |
| Classification | 882.1400 | 882.1400 |
| Visual Display of
EEG | Yes | Yes |
| Software | Proprietary via DLL | Proprietary via DLL |
PERFORMANCE DATA VII.
The following performance data were provided in support of the substantial equivalence determination.
5
Non-Clinical Testing
Software documentation up to a moderate level of concern was submitted which included validation performance testing. Non-clinical performance testing included delta, theta, alpha, and beta comparison of the subject and predicate device using a variety of simulated signals which were analyzed for frequency and power. These performance data demonstrated confirmation by examination of pre-specified, objective evidence to specify that output requirements for the software have been fulfilled and met through static and dynamic analyses and code and document inspections. The software testing performance data further established that the software device's specifications consistently conform to the pre-specified user needs and the intended use. The algorithms and statistical methods used for data analysis were also evaluated through these tests. Therefore, the testing demonstrated the that the system accurately translates and presents EEGs from patients.
Potential adverse effects of the use of the device are known if the qEEG-Pro is used as a standalone diagnostic system in the absence of other clinical data from more traditional means of patient evaluation. Relying only upon the use of a single index (such as relative power or the topological maps alone) without reviewing the traditional EEG, the epochs selected for analysis, or the complete set of statistical summary tables is also contraindicated and a source of potential error. Additional sources of error could arise from the inappropriate selection of EEG (selecting artifacted EEG epochs, or selecting EEG representative of other states, such as drowsiness or eyes-open EEG when comparing to an eyes-closed database, or by purposely selecting conditions for testing other than those specified. Additionally, it is possible that errors will occur through the purposeful falsification of symptoms in the patient history and patient age.
Clinical Testing
Clinical testing of the subject device included a study of 3 subjects who were used to validate performance of subject device database to that of the predicate K041263. These subjects were adequate to provide a range of values of the databases to verify performance since they are part of the adult and pediatric range of ages as well as the frequencies within the databases. Acceptance criteria were defined as the qEEG-Pro produces results sufficiently in agreement with the predicate devices and that the R-squared factor shall be 0.8 or better. Additionally, the observed range of results obtained from the predicate devices shall be used to verify that the qEEG-Pro produces results in agreement with the results obtained from the predicate device. The pre-defined acceptance criteria were met as 9-minute EEG recordings for eyes closed and open of the subjects (1 pediatric 9 years, 2 adult 48 and 46 both male and female) were de-artifacted and used to calculate z-scores for absolute power for the subject and predicate databases. Although the sample size was small, it was possible to validate results by computing values for all discrete ages ranging between 6 and 60, resulting in 55 sets of zscores for each subject's EEG sample which were compared with the predicate device's output and found to also be similar.
VIII. CONCLUSIONS
The qEEG-Pro has the same intended use as the predicate device, and it has the same manner of use and function, being a software-based database. Furthermore, it has similar requirements for training and expectations of intended users. The systems have equivalent performance in terms of data sampling and accuracy in the reference norms across age. Based on the device
6
description, IFU, and performance testing, the qEEG-Pro is substantially equivalent to the predicate.