BrainScope One

K181179 · Brainscope Company, Inc. · PIW · May 18, 2018 · Neurology

Device Facts

• Record ID: K181179
• Device Name: BrainScope One
• Applicant: Brainscope Company, Inc.
• Product Code: PIW · Neurology
• Decision Date: May 18, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1450
• Device Class: Class 2

Intended Use

BrainScope One is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head CT, who sustained a closed head injury within 72 hours, present with a Glasgow Coma Scale score (GCS) of 13-15 (including concussion / mild Traumatic Brain Injury (mTBI)), and are between the ages of 18-85 years. The BrainScope One should not be used as a substitute for a CT scan. The BrainScope One device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope One calculates and displays for the following standard QEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of EEG signals for interpretation by a qualified user. A negative BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with no structural brain injury visible on head CT. A positive BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with a structural brain injury visible on head CT. An equivocal BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation. The BrainScope One provides a measure of brain function (EEG Brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG). BrainScope One also provides clinicians with quantitative measures of cognitive performance to aid in the assessment of an individual's level of cognitive function. These measures do not interact with any other device measures, and are stand alone. BrainScope One also stores and displays electronic of standardized clinical assessment tools that should be used in accordance with the assessment tools' general instructions. These tools do not interact with any other device measures, and are stand alone.

Device Story

Portable, non-invasive, point-of-care device for TBI assessment. Inputs: frontal EEG signals via single-use Ag/AgCl electrode headset. Processing: records/analyzes EEG to calculate QEEG parameters (Absolute/Relative Power, Asymmetry, Coherence, Fractal Dimension) and EEG Brain Function Index (BFI). Outputs: structural injury classification (Negative, Positive, Equivocal), BFI, cognitive performance scores, and digitized clinical assessment tools. Used by clinicians in clinical settings to aid decision-making regarding head CT necessity. Benefits: provides objective data to support clinical assessment of head injury.

Clinical Evidence

No new clinical or non-clinical performance data submitted. Relies on clinical performance data from predicate Ahead 300 (K161068).

Technological Characteristics

Portable device; Android OS on Trimble T41 platform. Single-use Ag/AgCl electrode sensor array (ANSI/AAMI EC12). 10-20 electrode system (Fp1, Fp2, Fpz, AFz, F7, F8, A1, A2). 1kHz sampling, downsampled to 100Hz. CMRR < -100 dB. Compliant with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-26, and ISO 10993 standards.

Indications for Use

Indicated for patients 18-85 years old with closed head injury within 72 hours and GCS 13-15 (mTBI/concussion) to aid evaluation for head CT. Not a substitute for CT.

Regulatory Classification

Identification

A brain injury adjunctive interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.

Special Controls

In combination with the general controls of the FD&C Act, the Ahead 100 is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information: (i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed. (ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed. (2) The device parts that contact the patient must be demonstrated to be biocompatible. (3) The device must be designed and tested for electrical safety, electromagnetic compatibility (EMC), thermal, and mechanical safety. (4) Clinical performance testing must demonstrate the accuracy, precision-repeatability and reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs). (5) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with respect to the study prevalence per the device intended use. (6) The device design must include safeguards to ensure appropriate clinical interpretation of the device output ( *e.g.,* use in appropriate patient population, or for appropriate clinical decision).(7) The labeling and training information must include: (i) A warning that the device is not to be used as a stand-alone diagnostic. (ii) A detailed summary of the clinical performance testing, including any adverse events and complications. (iii) The intended use population and the intended use environment. (iv) Any instructions technicians should convey to patients regarding the collection of EEG data. (v) Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway. (vi) Information allowing clinicians to understand how to integrate the device output into their diagnostic pathway when the device is unable to provide a classification or final result.

Predicate Devices

• Ahead 300 (K161068)

Submission Summary (Full Text)

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BrainScope Company Inc. Michael Singer CEO 4350 East West Hwy. Ste 1050 Bethesda, Maryland 20814

May 18, 2018

#### Re: K181179

Trade/Device Name: BrainScope One Regulation Number: 21 CFR 882.1450 Regulation Name: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Regulatory Class: Class II Product Code: PIW, PKQ, OLU Dated: May 2, 2018 Received: May 2, 2018

Dear Michael Singer:

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.

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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.

For comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael J. Hoffmann -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

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#### Indications for Use

510(k) Number (if known) K181179

Device Name BrainScope One

Indications for Use (Describe)

· BrainScope One is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head CT, who sustained a closed head injury within 72 hours, present with a Glasgow Coma Scale score (GCS) of 13-15 (including concussion / mild Traumatic Brain Injury (mTBI)), and are between the ages of 18-85 years. The BrainScope One should not be used as a substitute for a CT scan.

· The BrainScope One device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope One calculates and displays for the following standard QEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of EEG signals for interpretation by a qualified user.

· A negative BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with no structural brain injury visible on head CT.

· A positive BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with a structural brain injury visible on head CT.

· An equivocal BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.

· The BrainScope One provides a measure of brain function (EEG Brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG).

· BrainScope One also provides clinicians with quantitative measures of cognitive performance to aid in the assessment of an individual's level of cognitive function. These measures do not interact with any other device measures, and are stand alone.

· BrainScope One also stores and displays electronic of standardized clinical assessment tools that should be used in accordance with the assessment tools' general instructions. These tools do not interact with any other device measures, and are stand alone.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for BrainScope. The logo is in blue and features the word "BrainScope" in a stylized font. There are two horizontal lines under the word. The registered trademark symbol is to the right of the word.

4350 East-West Highway.Suite 1050.Bethesda.Maryland.20814

www.brainscope.com

# 510(k) SUMMARY1

| Submitter: | BrainScope® Company, Inc.<br>4350 East West Highway Suite #1050<br>Bethesda, MD 20814<br>Phone: [phone]<br>Fax: [phone]<br>www.brainscope.com |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michael E. Singer, Ph.D.<br>Chief Executive Officer<br>BrainScope Company, Inc.<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Prepared By: | Sabyasachi Roy, Ph.D.<br>Director Regulatory Affairs, Quality Assurance<br>Compliance |
| Device Proprietary Name: | BrainScope One |
| Device Common Name: | Brain Injury Adjunctive Interpretive<br>Electroencephalograph Assessment Aid |
| Device Classification Name: | Brain Injury Adjunctive Interpretive<br>Electroencephalograph Assessment Aid |
| Classification Regulation: | 21 CFR § 882.1450 |
| Panel: | Neurology |
| Product Codes: | PIW, PKQ, OLU |
| Predicate Device: | Ahead 300 (K161068) |

¹ Prepared in accordance with 21 CFR § 807.87(h) and 21 CFR § 807.92(c). BrainScope One 510(k) Summary

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Image /page/5/Picture/0 description: The image shows the word "BrainScope" in blue font. There are two horizontal lines above and below the word. The "O" in scope has a brainwave image in the middle of it. There is a registered trademark symbol to the right of the word.

## Device Description:

BrainScope One is a portable, non-invasive, non-radiation emitting, point of care device intended to provide results and measures to support clinical assessments and aid in the diagnosis of traumatic brain injury (TBI). It also contains configurable, selectable cognitive performance tests and digitized standard assessment forms intended to provide a panel of measures to support the clinical assessment of head injury. BrainScope One provides healthcare professionals with a set of well-developed and researched concussion assessment tools.

#### Indications for Use:2

The BrainScope One's Indications for Use are as follows:

- BrainScope One is indicated for use as an adjunct to standard clinical practice to . aid in the evaluation of patients who are being considered for a head CT, who sustained a closed head injury within 72 hours, present with a Glasgow Coma Scale score (GCS) of 13-15 (including concussion / mild Traumatic Brain Injury (mTBI)), and are between the ages of 18-85 years. BrainScope One should not be used as a substitute for a CT scan.
- . The BrainScope One device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope One calculates and displays raw measures for the following standard QEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of EEG signals for interpretation by a qualified user.
- A negative BrainScope One Structural Injury Classification using brain electrical . activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with no structural brain injury visible on head CT.
- . A positive BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with a structural brain injury visible on head CT.
- An equivocal BrainScope One Structural Injury Classification using brain electrical . activity in patients who sustained a closed head injury within 72 hours, may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.
- BrainScope One provides a measure of brain function (EEG Brain Function Index, .

² The differences between the BrainScop One and its predicate (Ahead 300) do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicates. The subject and predicate devices have the same overall intended use.

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Image /page/6/Picture/0 description: The image shows the BrainScope logo. The logo is in blue and features the word "BrainScope" in a stylized font. The "S" in "Scope" is designed to look like a brainwave. There is a horizontal line above the word "Brain" and below the word "Scope". There is a registered trademark symbol to the right of the word "Scope".

(BFI)) for the statistical evaluation of the human electroencephalogram (EEG).

- BrainScope One also provides clinicians with quantitative measures of cognitive . performance to aid in the assessment of an individual's level of cognitive function. These measures do not interact with any other device measures, and are stand alone.
- . BrainScope One also stores and displays electronic versions of standardized clinical assessment tools that should be used in accordance with the assessment tools' general instructions. These tools do not interact with any other device measures, and are stand alone.

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Image /page/7/Picture/0 description: The image shows the BrainScope logo. The logo is in blue and features the word "BrainScope" in a stylized font. There are two horizontal lines above and below the word. The "o" in "Scope" is replaced with a brainwave symbol. There is a registered trademark symbol to the right of the word.

# Table 1: Indications for Use Comparison to Predicate devices

| Proposed Device:<br>BrainScope One<br>(K# Not Yet Assigned) | Predicate:<br>Ahead 300<br>(K161068) | Comments |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BrainScope One is indicated for<br>use as an adjunct to standard<br>clinical practice to aid in the<br>evaluation of patients who are<br>being considered for a head CT,<br>who sustained a closed head<br>injury within 72 hours, present<br>with a Glasgow Coma Scale<br>score (GCS) of 13-15 (including<br>concussion / mild Traumatic<br>Brain Injury (mTBI)), and are<br>between the ages of 18-85<br>years. BrainScope One should<br>not be used as a substitute for a<br>CT scan. | The Ahead 300 is indicated for<br>use as an adjunct to standard<br>clinical practice to aid in the<br>evaluation of patients who are<br>being considered for a head<br>CT, who sustained a closed<br>head injury within 72 hours,<br>present with a Glasgow Coma<br>Scale score (GCS) of 13-15,<br>and are between the ages of<br>18-85 years. The BrainScope<br>One should not be used as a<br>substitute for a CT scan. | Equivalent. Additional<br>clarification in<br>BrainScope One IFU to<br>accommodate use of<br>"concussion", "mTBI"<br>across academia, DoD,<br>CDC and FDA. |
| The BrainScope One device is<br>intended to record, measure,<br>analyze, and display brain<br>electrical activity utilizing the<br>calculation of standard<br>quantitative EEG (QEEG)<br>parameters from frontal locations<br>on a patient's forehead. The<br>BrainScope One calculates and<br>displays raw measures for the<br>following standard QEEG<br>measures: Absolute and<br>Relative Power, Asymmetry,<br>Coherence and Fractal<br>Dimension. These raw measures<br>are intended to be used for post<br>hoc analysis of EEG signals for<br>interpretation by a qualified user. | The Ahead 300 device is<br>intended to record, measure,<br>analyze, and display brain<br>electrical activity utilizing the<br>calculation of standard<br>quantitative EEG (QEEG)<br>parameters from frontal<br>locations on a patient's<br>forehead. The BrainScope One<br>calculates and displays raw<br>measures for the following<br>standard QEEG measures:<br>Absolute and Relative Power,<br>Asymmetry, Coherence and<br>Fractal Dimension. These raw<br>measures are intended to be<br>used for post hoc analysis of<br>EEG signals for interpretation<br>by a qualified user. | Same |
| A negative BrainScope One<br>Structural Injury Classification<br>using brain electrical activity in<br>patients who sustained a closed<br>head injury within 72 hours,<br>likely corresponds to those with<br>no structural brain injury visible<br>on head CT. | A negative Ahead 300<br>Structural Injury Classification<br>using brain electrical activity in<br>patients who sustained a<br>closed head injury within 72<br>hours, likely corresponds to<br>those with no structural brain<br>injury visible on head CT. | Same |
| A positive BrainScope One<br>Structural Injury Classification<br>using brain electrical activity in<br>patients who sustained a closed | A positive Ahead 300 Structural<br>Injury Classification using brain<br>electrical activity in patients<br>who sustained a closed head | Same |
| Proposed Device:<br>BrainScope One<br>(K# Not Yet Assigned) | Predicate:<br>Ahead 300<br>(K161068) | Comments |
| head injury within 72 hours,<br>likely corresponds to those with<br>a structural brain injury visible on<br>head CT. | injury within 72 hours, likely<br>corresponds to those with a<br>structural brain injury visible on<br>head CT. | |
| An equivocal BrainScope One<br>Structural Injury Classification<br>using brain electrical activity in<br>patients who sustained a closed<br>head injury within 72 hours, may<br>correspond to structural brain<br>injury visible on head CT or may<br>indicate the need for further<br>observation or evaluation. | An equivocal Ahead 300<br>Structural Injury Classification<br>using brain electrical activity in<br>patients who sustained a<br>closed head injury within 72<br>hours, may correspond to<br>structural brain injury visible on<br>head CT or may indicate the<br>need for further observation or<br>evaluation. | Same |
| BrainScope One provides a<br>measure of brain function (EEG<br>Brain Function Index, (BFI)) for<br>the statistical evaluation of the<br>human electroencephalogram<br>(EEG). | The Ahead 300 provides a<br>measure of brain function (EEG<br>Brain Function Index, (BFI)) for<br>the statistical evaluation of the<br>human electroencephalogram<br>(EEG). | Same |
| BrainScope One also provides<br>clinicians with quantitative<br>measures of cognitive<br>performance to aid in the<br>assessment of an individual's<br>level of cognitive function. These<br>measures do not interact with<br>any other device measures, and<br>are stand alone. | The Ahead 300 also provides<br>clinicians with quantitative<br>measures of cognitive<br>performance to aid in the<br>assessment of an individual's<br>level of cognitive function.<br>These measures do not interact<br>with any other device<br>measures, and are stand alone. | Same |
| BrainScope One also stores and<br>displays electronic versions of<br>standardized clinical assessment<br>tools that should be used in<br>accordance with the assessment<br>tools' general instructions. These<br>tools do not interact with any<br>other device measures, and are<br>stand alone. | The Ahead 300 also stores and<br>displays electronic versions of<br>standardized clinical<br>assessment tools that should<br>be used in accordance with the<br>assessment tools' general<br>instructions. These tools do not<br>interact with any other device<br>measures, and are stand alone. | Equivalent. The<br>BrainScope One<br>contains an expanded<br>number of standard<br>clinical assessment<br>tools (library functions). |

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Image /page/8/Picture/0 description: The image shows the BrainScope logo. The logo is in blue and features the word "BrainScope" in a stylized font. There are lines above and below the word. The letter "C" in scope is stylized to look like a brainwave.

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Image /page/9/Picture/0 description: The image shows the BrainScope logo. The logo is in blue and features the word "BrainScope" in a stylized font. There are lines above and below the word. The "O" in scope is replaced with a brainwave graphic. There is a registered trademark symbol to the right of the word.

# Comparison of Technological Characteristics with the Predicate Device:

BrainScope One incorporates additional clarification in the Indications for Use statement of its predicate (Ahead 300) to accommodate widely accepted definitions for "concussion" and "mild Traumatic Brain Injury (mTBI)". The core capabilities of BrainScope One and its fundamental scientific technology remain unaltered compared to the Ahead 300 (predicate). The device modifications discussed do not alter the BrainScope One's safety or effectiveness and neither do they change its intended use compared to the Ahead 300 (predicate). BrainScope One is substantially equivalent to the predicate the Ahead 300.

| Topic / Area | Proposed Device:<br>BrainScope One | Primary Predicate:<br>Ahead 300 | Comments |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|----------|
| Platform | Trimble T41 mobile<br>device, Android OS | Trimble T41 mobile<br>device, Android OS | Same |
| Processed<br>EEG<br>Bandwidth | 1kHz sampled data<br>with DC to 300Hz<br>bandwidth and 100Hz<br>sampled data with<br>0.67Hz to 43Hz<br>bandwidth | 1kHz sampled data with<br>DC to 300Hz bandwidth<br>and 100Hz sampled<br>data with 0.67Hz to<br>43Hz bandwidth | Same |
| Common<br>Mode<br>Rejection<br>Ratio (CMRR) | < -100 dB (or better) | < -100 dB (or better) | Same |
| System Noise<br>Floor | < 0.4 µV in 0.67 Hz to<br>43Hz bandwidth | < 0.4 µV in 0.3 Hz to<br>43Hz bandwidth | Same |
| ADC<br>Resolution | 45 nV/bit | 45 nV/bit | Same |
| ADC<br>Sampling<br>Rate | 1000 Hz, down<br>sampled to 100 Hz for<br>algorithm processing | 1000 Hz, down sampled<br>to 100 Hz for algorithm<br>processing | Same |
| Electrode<br>Placement<br>System | The International 10-<br>20 System | The International 10-20<br>System | Same |
| Electrode<br>Positions<br>Utilized | Fp1, Fp2, Fpz, AFz,<br>F7, F8, A1, A2 | Fp1, Fp2, Fpz, AFz, F7,<br>F8, A1, A2 | Same |
| Electrode<br>Material | Single use Ag/AgCl<br>electrode sensor array<br>headset with solid gel | Single use Ag/AgCl<br>electrode sensor array<br>headset with solid gel | Same |
| Real Time<br>EEG Display | Yes | Yes | Same |
| Classification<br>Algorithm<br>(Structural | Three tier<br>classification with<br>results of Negative, | Three tier classification<br>with results of Negative,<br>Equivocal and Positive | Same |

#### Table 2, Technological Comparison to Predicate Device

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Image /page/10/Picture/0 description: The image shows the word "BRAINSCOPE" in large, bold, blue letters. The letters are slightly stylized, with a line running underneath the word. The "O" in "SCOPE" is replaced with a graphic of a brainwave.

| Topic / Area | Proposed Device:<br>BrainScope One | Primary Predicate:<br>Ahead 300 | Comments |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Injury<br>Classification) | Equivocal and Positive<br>outputs. | outputs. | |
| Results<br>Presentation<br>and Reporting<br>Features | Specific raw<br>measures.<br>EEG playback.<br>Structural injury<br>classification and brain<br>function index display.<br>Cognitive performance<br>raw and standard<br>scores including<br>percentiles.<br>Electronic versions of<br>Standard Clinical<br>Assessments. | Specific raw measures.<br>EEG playback.<br>Structural injury<br>classification and brain<br>function index display.<br>Cognitive performance<br>raw and standard<br>scores including<br>percentiles.<br>Electronic versions of<br>Standard Clinical<br>Assessments. | Equivalent.<br>BrainScope One<br>has an expanded<br>list of library<br>functions (standard<br>clinical<br>assessments). |

# Performance Data:

No clinical or non-clinical performance data was submitted to support the device modification being made. All clinical performance data from the Ahead 300 (predicate) submission still apply.

The BrainScope One device, like its predicate (Ahead 300) is compliant to following standards:

- o IEC 60601-1/A1:2012 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2/A1:2007 Medical electrical equipment Section1.2 o Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-6/A1:2013 General Requirements For Basic Safety And o Essential Performance - Collateral Standard: Usability
- IEC 60601-2-26:2012 Particular requirements for the basic safety and o essential performance of electroencephalographs
- ANSI/AAMI EC12:2000/(R)2010 Disposable ECG Electrodes O
- ANSI/AAMI/ISO 10993-1:2009 Biological evaluation of medical devices o Part 1: Evaluation and testing within a risk management process
- ANSI/AAMI/ISO 10993-5:2009 Biological Evaluation of Medical Devices o Part 5: Tests for In Vitro Cytotoxicity
- ANSI/AAMI/ISO 10993-10:2010 Biological evaluation of medical devices o Part 10: Test for irritation and skin sensitization

BrainScope One 510(k) Summary

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Image /page/11/Picture/0 description: The image shows the logo for BrainScope. The logo is in blue and features the word "BrainScope" in a stylized font. The "O" in Scope has a brainwave graphic in the middle of it. There is a registered trademark symbol to the right of the word.

- MIL-STD-810G, Department of Defense Test Method Standard for o Environmental Engineering Considerations and Laboratory Tests
- IEC 60529 (2004) Degree of Protection Provided by Enclosures o
- ASTM D4169 09, Standard Practice for Performance Testing of Shipping o Containers and Systems

## Conclusion:

BrainScope One's fundamental scientific technology remain unaltered compared to the predicate (Ahead 300). The device modifications do not alter the BrainScope One's safety or effectiveness and neither do they change its intended use. BrainScope One is substantially equivalent to the predicate the Ahead 300.