(834 days)
Not Found
No
The device description focuses on conventional statistical analysis (Z-scores, amplitude, latency) and comparisons to a normative group, without mentioning AI or ML techniques. The performance study also uses traditional statistical methods (Bland-Altman analysis).
No.
The device is described as an analysis system that performs post-hoc statistical analysis of EEG/ERP data and generates Z-scores and composite scores to express differences between a patient and a reference group. It is an "accessory to EEG" and is used to analyze data, not to provide therapy or directly treat a disease or condition. The "Intended Use" clearly states it is for "statistical analysis" and does not mention any therapeutic function.
Yes
The "Intended Use / Indications for Use" section states that the system is used for "posthoc statistical analysis of the human electroencephalogram ('EEG'), utilizing evoked response potentials ('ERP')" and it produces "Z-scores" to express "differences between the patient (individual) and a task-matched reference group". This analysis of a patient's data against a reference group to identify differences is characteristic of a diagnostic device. While it states that the scores "should not be used as stand-alone information", it still provides analytical information that can contribute to a diagnosis.
Yes
The device description explicitly states that the BNA Analysis System is a "software device" and describes its function as analyzing EEG-ERP data and generating reports. It is an accessory to EEG hardware, but the device itself is software.
Based on the provided information, the BNA™ Analysis System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The BNA™ Analysis System analyzes the human electroencephalogram (EEG), which is a measurement of electrical activity on the surface of the scalp, not a sample taken from the body (like blood, urine, or tissue).
- The device description focuses on analyzing existing EEG-ERP data. It takes the output of an EEG recording and performs statistical analysis on it.
- The intended use is for posthoc statistical analysis of EEG. This reinforces that it's working with data already acquired from the patient, not performing a test on a biological sample.
Therefore, the BNA™ Analysis System falls under the category of a medical device that analyzes physiological signals, rather than an IVD.
N/A
Intended Use / Indications for Use
The BNA™ Analysis System is to be used by qualified medical professionals for the posthoc statistical analysis of the human electroencephalogram ("EEG"), utilizing evoked response potentials ("ERP"). This device is indicated for use in individuals 14 to 24 years of age. The BNA™ Analysis System is to be used with the auditory oddball task only.
Product codes
OLU
Device Description
The BNA Analysis System is an accessory to EEG. The BNA Analysis System is a software device that is used to analyze EEG-ERP data with regards to conventional, well established characteristics of amplitude and latency. Statistical analysis is performed to express the differences between the patient (individual) and a task-matched reference group in the indicated age group in the form of Z-scores.
The BNA Analysis System report displays the test results in the following format; (1) Test and Patient Information; (2) ERP waveforms; (3) Summarized patient results - Z-Score Tables, Z-Score Maps and BNA Composite Scores.
BNA Composite Scores are a calculation of the global comparison of the individual to the normative group (RBNM) for the following well-established EEG-ERP components: amplitude and absolute time. These calculations are a measure of the overall similarity of the single subject EEG-ERP components to the EEG-ERP components of the normative group (RBNM) based on Z-scores. The BNA scores should not be used as stand-alone information: rather, such scores should complement all of the information included in the report, as well as the clinical evaluation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Electroencephalogram ("EEG")
Anatomical Site
Not Found
Indicated Patient Age Range
14 to 24 years of age
Intended User / Care Setting
qualified medical professionals
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance testing was conducted to assess the repeatability of the BNA scores between two identical test sessions that were conducted within 7(±3) days of each other. In order to assess the repeatability of the BNA scores, Bland-Altman analysis was performed. This analysis was performed for the three stimuli of the auditory oddball task and two BNA parameters (amplitude and absolute time) for each stimulus as shown in the table below.
Mean BNA Difference between Visits, Mean Standard Deviation (STD) of the Difference and Bland-Altman 95% Limits of Agreement by Stimulus and Parameter:
| Stimulus | Parameter | Mean Difference | STD of the Difference | Lower Bland-Altman 95% Limit of Agreement | Upper Bland-Altman 95% Limit of Agreement |
|---|---|---|---|---|---|
| Frequent | Amplitude | 4.10 | 25.35 | -45.60 | 53.79 |
| Absolute Time | 3.02 | 23.56 | -43.16 | 49.20 | |
| Novel | Amplitude | 0.46 | 22.79 | -44.20 | 45.13 |
| Absolute Time | 5.44 | 27.19 | -47.85 | 58.74 | |
| Target | Amplitude | -5.65 | 21.97 | -48.71 | 37.41 |
| Absolute Time | -6.78 | 24.05 | -53.91 | 40.36 |
The subject device software was developed, verified and validated according to the software development requirements as defined in the IEC 62304 and General Principles of Software Validation; Final Guidance for Industry and FDA Staff (FDA, CDRH, 11/1/02).
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
§ 882.1400 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
510(k) SUMMARY
UL 2 5 2014
ElMindA Ltd.'s BNA™ Analysis System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
ElMindA Ltd. 16 Haminhara St. Beit Bachar Herzliva 46586 lsrael
Phone: 972-9-951-6476 Facsimile: 972-9-951-6477
Contact Person: Dalia Dickman, Ph.D.
Date Prepared: July 18, 2014
Proprietary Name of Device and Name/Address of Sponsor
BNA™ Analysis System
Common or Usual Name/ Classification Name
Electroencephalogram ("EEG")
Regulation Number
· 882.1400
Product Code
OLU
Predicate Devices
Neuroguide Analysis System (K041263) Neuromarker Data Acquisition and Analysis Software (K050192) Human Brain Index Software (K112077)
Intended Use / Indications for Use
The BNA™ Analysis System is to be used by qualified medical professionals for the posthoc statistical analysis of the human electroencephalogram ("EEG"), utilizing evoked response potentials ("ERP"). This device is indicated for use in individuals 14 to 24 years of age. The BNA™ Analysis System is to be used with the auditory oddball task only.
Technological Characteristics / Principles of Operation
The BNA Analysis System is an accessory to EEG. The BNA Analysis System is a software device that is used to analyze EEG-ERP data with regards to conventional, well established characteristics of amplitude and latency. Statistical analysis is performed to express the differences between the patient
1
(individual) and a task-matched reference group in the indicated age group in the form of Z-scores.
The BNA Analysis System report displays the test results in the following format; (1) Test and Patient Information; (2) ERP waveforms; (3) Summarized patient results - Z-Score Tables, Z-Score Maps and BNA Composite Scores.
BNA Composite Scores are a calculation of the global comparison of the individual to the normative group (RBNM) for the following well-established EEG-ERP components: amplitude and absolute time. These calculations are a measure of the overall similarity of the single subject EEG-ERP components to the EEG-ERP components of the normative group (RBNM) based on Z-scores. The BNA scores should not be used as stand-alone information: rather, such scores should complement all of the information included in the report, as well as the clinical evaluation.
Performance Data
Clinical performance testing was conducted to assess the repeatability of the BNA scores between two identical test sessions that were conducted within 7(±3) days of each other. In order to assess the repeatability of the BNA scores, Bland-Altman analysis was performed. This analysis was performed for the three stimuli of the auditory oddball task and two BNA parameters (amplitude and absolute time) for each stimulus as shown in the table below.
| | | | | Lower Bland-
Altman 95% | Upper Bland-
Altman 95% |
|----------|---------------|--------------------|--------------------------|----------------------------|----------------------------|
| | | Mean
Difference | STD of the
Difference | Limit of
Agreement | Limit of
Agreement |
| Stimulus | Parameter | | | | |
| Frequent | Amplitude | 4.10 | 25.35 | -45.60 | 53.79 |
| | Absolute Time | 3.02 | 23.56 | -43.16 | 49.20 |
| Novel | Amplitude | 0.46 | 22.79 | -44.20 | 45.13 |
| | Absolute Time | 5.44 | 27.19 | -47.85 | 58.74 |
| Target | Amplitude | -5.65 | 21.97 | -48.71 | 37.41 |
| | Absolute Time | -6.78 | 24.05 | -53.91 | 40.36 |
Mean BNA Difference between Visits, Mean Standard Deviation (STD) of the Difference and Bland-Altman 95% Limits of Agreement by Stimulus and Parameter
The subject device software was developed, verified and validated according to the software development requirements as defined in the IEC 62304 and General Principles of Software Validation; Final Guidance for Industry and FDA Staff (FDA, CDRH, 11/1/02).
Substantial Equivalence
The BNA™ Analysis System is as safe and effective as the Neuroguide Analysis System (K041263), the Neuromarker Data Acquisition and Analysis Software (K050192), and the Human Brain Index Software (K112077). The BNATM Analysis System has the same intended uses/indications for use, and similar technological characteristics and principles of operation as the identified
2
predicate devices (see table below). The minor technological differences between the BNA™ Analysis System and its predicate devices raise no new Section the DRAT - Analysis of Jolen and Re products as not not.
issues of safety or effectiveness. Performance data demonstrate that the BNA™ Analysis System is as safe and effective as the cleared predicate devices. Thus, the BNATM Analysis System is substantially equivalent.
3
Comparison Table
| | BNA ANALYSIS SYSTEM
SUBSTANTIAL EQUIVALENCE CHART | | | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | BNAT™ Analysis System | Human Brain Index
Software (K112077) | Neuroguide Analysis
System (K041263) | Neuromarker Data
Acquisition and Analysis
Software (K050192) |
| | The BNAT™ Analysis
System is to be used by
qualified medical
professionals for the post-
hoc statistical analysis of
the human
electroencephalogram
("EEG"), utilizing evoked
response potentials
("ERP"). This device is
indicated for use in
individuals 14 to 24 years of
age. The BNAT™ Analysis
System is to be used with
the auditory oddball task
only | The HBIdb product is to be
used by qualified medical
professionals for the post-
hoc statistical
evaluation of the human
electroencephalogram
(EEG), utilizing evoked
response potentials (ERP).
The HBIdb product is
intended for use on
children and adults from
age 7 to 80 years. | For clinical use the
NeuroGuide Analysis
system is to be used by
qualified medical or clinical
professionals for the
statistical evaluation of the
human
electroencephalogram
(EEG). | The BRC software product
is to be used by qualified
medical professionals for
the post-hoc
statistical evaluation of the
human
electroencephalogram
(EEG), utilizing evoked
response potentials (ERP). |
4
and the comments of the comments of
.
. . . . .
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement. The text is written in all capital letters.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W(%6-G609 Silver Spring, MD 20903-0002
July 25, 2014
ElMindA Ltd. Dalia Dickman. PhD VP Clinical & Regulatory Affairs 16 Haminhara Street Beit Bachar Herzliya 46586 lsrael
રિટ: K121119
Trade/Device Name: BNA™ Analysis System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLU Dated: September 3. 2013 Received: September 3, 2013
Dear Dr. Dickman:
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 cither 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 mav publish further announcements concerning your device in the Federal Register.
6
Page 2 - Dalia Dickman, PhD
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 not 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the election is 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 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,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K121119
Device Name BNA Analysis System
Indications for Use (Describe)
The BNA Analysis System is to be used by qualified medical professionals for the post-hoc statistical analysis of the human electroencephalogram ("EEG"), utilizing evoked response potentials ("ERP"). This device is indicated for use in individuals 14 to 24 years of age. The BNA Analysis System is to be used with the auditory oddball task only.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Carlos L. Pena -S
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