BNA ANALYSIS SYSTEM

K121119 · Eiminda , Ltd. · OLU · Jul 25, 2014 · Neurology

Device Facts

• Record ID: K121119
• Device Name: BNA ANALYSIS SYSTEM
• Applicant: Eiminda , Ltd.
• Product Code: OLU · Neurology
• Decision Date: Jul 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

BNA Analysis System is an EEG accessory software; processes EEG-ERP data acquired during auditory oddball tasks. System performs post-hoc statistical analysis comparing individual patient data against a task-matched normative reference group (RBNM). Outputs include Z-score tables, Z-score maps, and BNA Composite Scores representing amplitude and absolute time similarity to the normative group. Used by qualified medical professionals in clinical settings to complement clinical evaluation; not for stand-alone diagnostic use. Provides quantitative metrics to assist clinicians in assessing brain function.

Clinical Evidence

Bench testing only. Repeatability of BNA scores assessed via Bland-Altman analysis across two test sessions (7±3 days apart) in a cohort. Evaluated three auditory oddball stimuli (Frequent, Novel, Target) across two parameters (amplitude, absolute time). Results provided as mean differences and 95% limits of agreement.

Technological Characteristics

Software-based EEG/ERP analysis accessory. Operates on amplitude and latency characteristics. Outputs Z-scores based on normative reference group comparisons. Developed per IEC 62304 and FDA software validation guidance.

Indications for Use

Indicated for post-hoc statistical analysis of EEG/ERP data in individuals aged 14 to 24 years, using the auditory oddball task.

Regulatory Classification

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.

Predicate Devices

• Neuroguide Analysis System (K041263)
• Neuromarker Data Acquisition and Analysis Software (K050192)
• Human Brain Index Software (K112077)

Submission Summary (Full Text)

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K121119

#### 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: [phone] 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

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(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-<br>Altman 95% | Upper Bland-<br>Altman 95% |
|----------|---------------|--------------------|--------------------------|----------------------------|----------------------------|
| | | Mean<br>Difference | STD of the<br>Difference | Limit of<br>Agreement | Limit of<br>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

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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.

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Comparison Table

| | BNA ANALYSIS SYSTEM<br>SUBSTANTIAL EQUIVALENCE CHART | | | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | BNAT™ Analysis System | Human Brain Index<br>Software (K112077) | Neuroguide Analysis<br>System (K041263) | Neuromarker Data<br>Acquisition and Analysis<br>Software (K050192) |
| | The BNAT™ Analysis<br>System is to be used by<br>qualified medical<br>professionals for the post-<br>hoc statistical analysis of<br>the human<br>electroencephalogram<br>("EEG"), utilizing evoked<br>response potentials<br>("ERP"). This device is<br>indicated for use in<br>individuals 14 to 24 years of<br>age. The BNAT™ Analysis<br>System is to be used with<br>the auditory oddball task<br>only | The HBIdb product is to be<br>used by qualified medical<br>professionals for the post-<br>hoc statistical<br>evaluation of the human<br>electroencephalogram<br>(EEG), utilizing evoked<br>response potentials (ERP).<br>The HBIdb product is<br>intended for use on<br>children and adults from<br>age 7 to 80 years. | For clinical use the<br>NeuroGuide Analysis<br>system is to be used by<br>qualified medical or clinical<br>professionals for the<br>statistical evaluation of the<br>human<br>electroencephalogram<br>(EEG). | The BRC software product<br>is to be used by qualified<br>medical professionals for<br>the post-hoc<br>statistical evaluation of the<br>human<br>electroencephalogram<br>(EEG), utilizing evoked<br>response potentials (ERP). |

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and the comments of the comments of

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. . . . .

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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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