BrainScope TBI

K190815 · Brainscope Company, Inc. · PIW · Sep 11, 2019 · Neurology

Device Facts

• Record ID: K190815
• Device Name: BrainScope TBI
• Applicant: Brainscope Company, Inc.
• Product Code: PIW · Neurology
• Decision Date: Sep 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1450
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

Intended Use

BrainScope TBI is a multi-modal, multi-parameter assessment indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury, and have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion/mild traumatic brain injury (mTBI)). BrainScope TBI provides a multi-parameter measure (CI) to aid in the evaluation of concussion in patients between the ages of 13-25 years who present with a GCS score of 15 following a head injury within the past 72 hours (3 days), in conjunction with a standard neurological assessment of concussion. The CI is computed from a multivariate algorithm based on the patient's electroencephalogram (EEG), augmented by neurocognitive measures and selected clinical symptoms. The BrainScope TBI Structural Injury Classification ("SIC") uses brain electrical activity (EEG) to determine the likelihood of structural brain injury visible on head CT for patients between the ages of 18-85 years (have a GCS score of 13 – 15), have sustained a closed head injury within the past 72 hours (3 days) who are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan. Negative likely corresponds to those with no structural brain injury visible on head CT. Positive likely corresponds to those with a structural brain injury visible on head CT. Equivocal may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation. BrainScope TBI provides a measure of brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG), aiding in the evaluation of head injury as part of a multi-modal, multi-parameter assessment, in patients 18-85 years of age (have a GCS score of 13 - 15) who have sustained a closed head injury within the past 72 hours (3 days). The BrainScope TBI 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 TBI 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. BrainScope TBI also provides clinicians with quantitative measures of cognitive performance in patients 13-85 years of age to aid in the assessment of an individual's level of cognitive function. These measures interact with the CI and can be used stand alone. BrainScope TBI 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.

Device Story

Portable, non-invasive, point-of-care device for concussion/mTBI assessment. Inputs: frontal EEG signals, neurocognitive performance tests, clinical symptoms. Processing: multivariate algorithm computes Concussion Index (CI); Structural Injury Classification (SIC) and Brain Function Index (BFI) algorithms analyze EEG for structural injury likelihood and brain function. Output: multi-parameter measures, raw QEEG data (Absolute/Relative Power, Asymmetry, Coherence, Fractal Dimension), and electronic clinical assessment tools. Used by clinicians in clinics/sports settings to aid concussion evaluation and CT scan decision-making. Benefits: provides objective, multi-modal data to support clinical judgment, potentially reducing unnecessary CT scans and aiding return-to-play decisions.

Clinical Evidence

Prospective validation study (n=580) across 10 US sites (ages 13-25, GCS 15). Subjects included healthy volunteers, matched controls, and those with witnessed head injury. Primary endpoints: sensitivity and specificity of CI. Results: sensitivity 0.8599 (95% CI: 0.8050, 0.9041); specificity 0.7078 (95% CI: 0.6588, 0.7535). CI correlated with Concussion Symptom Inventory (r=0.7971-0.8047).

Technological Characteristics

Portable device using Trimble T41 mobile platform (Android 4.1). EEG sensing via single-use Ag/AgCl electrode array (International 10-20 system). Connectivity: USB, Wi-Fi (802.11b/g/n). Encryption: AES-128 (intra-device), AES-256 (files). Standards: IEC 60601-1, IEC 60601-1-2 (EMC), IEC 60601-2-26, ISO 10993 (biocompatibility).

Indications for Use

Indicated for patients 13-85 years with closed head injury and GCS 13-15. Concussion Index (CI) for ages 13-25 (GCS 15) within 72 hours of injury. Structural Injury Classification (SIC) and Brain Function Index (BFI) for ages 18-85 within 72 hours of injury.

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

• BrainScope TBI (model: Ahead 400) (K183241)

Submission Summary (Full Text)

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BrainScope Company, Inc. Michael Singer CEO 4330 East West Highway, Suite #1000 Bethesda, Maryland 20814

Re: K190815

Trade/Device Name: BrainScope TBI 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: July 19, 2019 Received: July 22, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K190815

### Device Name BrainScope TBI (model: Ahead 500)

### Indications for Use (Describe)

· BrainScope TBI is a multi-modal, multi-parameter assessment indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury, and have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion/mild traumatic brain injury (mTBI)).

· BrainScope TBI provides a multi-parameter measure (Cl)) to aid in the evaluation of concussion in patients between the ages of 13-25 years who present with a GCS score of 15 following a head injury within the past 72 hours (3 days), in conjunction with a standard neurological assessment of concussion. The CI is computed from a multivariate algorithm based on the patient's electroencephalogram (EEG), augmented by neurocognitive measures and selected clinical symptoms.

· The BrainScope TBI Structural Injury Classification ("SIC") uses brain electrical activity (EEG) to determine the likelihood of structural brain injury visible on head CT for patients between the ages of 18-85 years (have a GCS score of 13 – 15), have sustained a closed head injury within the past 72 hours (3 days) who are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan. Negative likely corresponds to those with no structural brain injury visible on head CT. Positive likely corresponds to those with a structural brain injury visible on head CT. Equivocal may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.

· BrainScope TBI provides a measure of brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG), aiding in the evaluation of head injury as part of a multi-modal, multi-parameter assessment, in patients 18-85 years of age (have a GCS score of 13 - 15) who have sustained a closed head injury within the past 72 hours (3 days).

· The BrainScope TBI 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 TBI 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.

· BrainScope TBI also provides clinicians with quantitative measures of cognitive performance in patients 13-85 years of age to aid in the assessment of an individual's level of cognitive function. These measures interact with the CI and can be used stand alone.

· BrainScope TBI 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.

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 word "Brain" is in blue, and the word "Scope" is in gray. There is a registered trademark symbol to the right of the word "Scope".

4330 East-West Highway.Suite 1000.Bethesda.Maryland.20814

www.brainscope.com

phone [phone]

### 510(k) SUMMARY1

| Submitter: | BrainScope® Company, Inc.<br>4330 East West Highway Suite #1000<br>Bethesda, MD 20814<br>Phone: [phone]<br>Fax: [phone]<br>www.brainscope.com |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michael E. Singer, Ph.D.<br>Executive Chairman<br>BrainScope Company, Inc.<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Prepared By: | Sabyasachi Roy, Ph.D.<br>Sr. Director Regulatory Affairs, Quality Assurance &<br>Compliance |
| Device Proprietary Name: | BrainScope TBI (Model: Ahead 500) |
| 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: | BrainScope TBI (model: Ahead 400) (K183241) |

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

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### Device Description:

BrainScope TBI (model: Ahead 500) 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 concussion / mild traumatic brain injury (mTBI). The BrainScope TBI includes a new multivariate classification algorithm that analyzes a patient's electroencephalogram (EEG), augmented by neurocognitive performance and selected clinical symptoms to compute a multi-modal index called the Concussion Index (CI). BrainScope TBI provides the healthcare provider with a multi-parameter measure to aid in the evaluation of concussion following a head injury within the past 72 hours (3 days). The BrainScope TBI (Ahead 500) retains all the capabilities of the predicate (BrainScope TBI, model: Ahead 400) including the Structural Injury Classification (SIC) and the Brain Function Index (BFI). It also contains configurable, selectable computerized cognitive performance tests and digitized standard clinical assessment tools intended to provide a multi-modal panel of measures to support the clinical assessment of concussion / mTBI.

### Indications for Use:2

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

- BrainScope TBI is a multi-modal, multi-parameter assessment indicated for use as . an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury, and have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion/mild traumatic brain injury (mTBI)).
- . BrainScope TBI provides a multi-parameter measure (Concussion Index (CI)) to aid in the evaluation of concussion in patients between the ages of 13-25 years who present with a GCS score of 15 following a head injury within the past 72 hours (3 days), in conjunction with a standard neurological assessment of concussion. The CI is computed from a multivariate algorithm based on the patient's electroencephalogram (EEG), augmented by neurocognitive measures and selected clinical symptoms.
- The BrainScope TBI Structural Injury Classification ("SIC") uses brain electrical . activity (EEG) to determine the likelihood of structural brain injury visible on head CT for patients between the ages of 18-85 years (have a GCS score of 13 - 15), have sustained a closed head injury within the past 72 hours (3 days) who are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan. Negative likely corresponds to those with no structural brain injury visible on head CT. Positive likely corresponds to those with a structural brain injury visible on head CT. Equivocal may correspond to structural

² The differences between the BrainScope TBI and its predicate do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the subject and predicate device have the same overall intended use.

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brain injury visible on head CT or may indicate the need for further observation or evaluation.

- BrainScope TBI provides a measure of brain function (EEG Brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG), aiding in the evaluation of head injury as part of a multi-modal, multi-parameter assessment, in patients 18-85 years of age (have a GCS score of 13 – 15) who have sustained a closed head injury within the past 72 hours (3 days).
- The BrainScope TBI 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 TBI 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.
- BrainScope TBI also provides clinicians with quantitative measures of cognitive . performance in patients 13-85 years of age to aid in the assessment of an individual's level of cognitive function. These measures interact with the CI and can be used stand alone.
- BrainScope TBI 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,

| Proposed Device:<br>BrainScope TBI, model<br>Ahead 500<br>(TBD) | Primary Predicate:<br>BrainScope TBI, model<br>Ahead 400<br>(K183241) | Comments | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BrainScope TBI is a multi-<br>modal, multi-parameter<br>assessment indicated for<br>use as an adjunct to<br>standard clinical practice to<br>aid in the evaluation of<br>patients who have sustained<br>a closed head injury, and<br>have a Glasgow Coma Scale<br>(GCS) score of 13-15<br>(including patients with<br>concussion/mild traumatic<br>brain injury (mTBI)). | BrainScope TBI is a multi-<br>modal, multi-parameter<br>assessment indicated for<br>use as an adjunct to<br>standard clinical practice to<br>aid in the evaluation of<br>patients who have sustained<br>a closed head injury within<br>the past 72 hours (3 days),<br>are between the ages of 18-<br>85 years, have a Glasgow<br>Coma Scale (GCS) score of<br>13-15 (including patients<br>with concussion / mild<br>traumatic brain injury | Equivalent.<br>Moved patient age range and<br>72 hour time frame to SIC and<br>BFI specific statements below.<br>Moved statement regarding<br>substitute for a CT scan to the<br>SIC specific statement below. | |
| Proposed Device:<br>BrainScope TBI, model<br>Ahead 500<br>(TBD) | Primary Predicate:<br>BrainScope TBI, model<br>Ahead 400<br>(K183241) | Comments | |
| | (mTBI)), and are being<br>considered for a head CT.<br>BrainScope TBI should not<br>be used as a substitute for a<br>CT scan. | | |
| BrainScope TBI provides a<br>multi-parameter measure<br>(Concussion Index (CI)) to<br>aid in the evaluation of<br>concussion in patients<br>between the ages of 13-25<br>years who present with GCS<br>of 15 following a head injury<br>within the past 72 hours (3<br>days), in conjunction with a<br>standard neurological<br>assessment of concussion.<br>The CI is computed from a<br>multivariate algorithm based<br>on the patient's<br>electroencephalogram<br>(EEG), augmented by<br>neurocognitive measures<br>and selected clinical<br>symptoms. | BrainScope TBI provides a<br>measure of brain function<br>(EEG Brain Function Index,<br>(BFI)) for the statistical<br>evaluation of the human<br>electroencephalogram<br>(EEG), aiding in the<br>evaluation of head injury as<br>part of a multi-modal, multi-<br>parameter assessment. | Equivalent.<br>The CI algorithm augments<br>patient's EEG measures with<br>neurocognitive performance<br>and selected clinical<br>symptoms to compute a multi-<br>modal index. This is consistent<br>with current clinical practice of<br>using a multi-modal approach<br>in concussion evaluation. The<br>CI expands upon the clinical<br>performance of the BFI by<br>assessing presence of<br>concussion at time of injury. | |
| The BrainScope TBI<br>Structural Injury<br>Classification ("SIC") uses<br>brain electrical activity (EEG)<br>to determine the likelihood of<br>structural brain injury visible<br>on head CT for patients<br>between the ages of 18-85<br>years (have a GCS score of<br>13 – 15), have sustained a<br>closed head injury within the<br>past 72 hours (3 days) who<br>are being considered for a<br>head CT. BrainScope TBI<br>should not be used as a<br>substitute for a CT scan.<br>Negative likely corresponds<br>to those with no structural<br>brain injury visible on head<br>CT. Positive likely<br>corresponds to those with a<br>structural brain injury visible | The BrainScope TBI<br>Structural Injury<br>Classification ("SIC") uses<br>brain electrical activity to<br>determine the likelihood of<br>structural brain injury visible<br>on head CT. Negative likely<br>corresponds to those with no<br>structural brain injury visible<br>on head CT. Positive likely<br>corresponds to those with a<br>structural brain injury visible<br>on head CT. Equivocal may<br>correspond to structural<br>brain injury visible on head<br>CT or may indicate the need<br>for further observation or<br>evaluation. | Equivalent.<br>Included patient age range,<br>GCS score, 72 hour timeframe<br>and statement regarding<br>substitute for a CT scan to the<br>BrainScope TBI (Ahead 500)<br>IFU for clarification. | |
| Proposed Device:<br>BrainScope TBI, model<br>Ahead 500<br>(TBD) | Primary Predicate:<br>BrainScope TBI, model<br>Ahead 400<br>(K183241) | Comments | |
| on head CT. Equivocal may<br>correspond to structural<br>brain injury visible on head<br>CT or may indicate the need<br>for further observation or<br>evaluation. | | | |
| BrainScope TBI provides a<br>measure of brain function<br>(EEG Brain Function Index,<br>(BFI)) for the statistical<br>evaluation of the human<br>electroencephalogram<br>(EEG), aiding in the<br>evaluation of head injury as<br>part of a multi-modal, multi-<br>parameter assessment, in<br>patients 18-85 years of age<br>(have a GCS score of 13 –<br>15) who have sustained a<br>closed head injury within the<br>past 72 hours (3 days). | BrainScope TBI provides a<br>measure of brain function<br>(EEG Brain Function Index,<br>(BFI)) for the statistical<br>evaluation of the human<br>electroencephalogram<br>(EEG), aiding in the<br>evaluation of head injury as<br>part of a multi-modal, multi-<br>parameter assessment. | Equivalent.<br>Age range, GCS score and 72<br>hour timeframe added to the<br>BrainScope TBI (Ahead 500)<br>IFU for clarification. | |
| The BrainScope TBI device<br>is intended to record,<br>measure, analyze, and<br>display brain electrical<br>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<br>TBI calculates and displays<br>raw measures for the<br>following standard QEEG<br>measures: Absolute and<br>Relative Power, Asymmetry,<br>Coherence and Fractal<br>Dimension. These raw<br>measures are intended to be<br>used for post hoc analysis of<br>EEG signals for<br>interpretation by a qualified<br>user. | The BrainScope TBI device<br>is intended to record,<br>measure, analyze, and<br>display brain electrical<br>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<br>One calculates and displays<br>raw measures for the<br>following standard QEEG<br>measures: Absolute and<br>Relative Power, Asymmetry,<br>Coherence and Fractal<br>Dimension. These raw<br>measures are intended to be<br>used for post hoc analysis of<br>EEG signals for<br>interpretation by a qualified<br>user. | Same as predicate. | |
| BrainScope TBI also<br>provides clinicians with<br>quantitative measures of | BrainScope TBI also<br>provides clinicians with<br>quantitative measures of | Equivalent.<br>Ahead 500 IFU statement was<br>modified in two ways: | |
| Proposed Device:<br>BrainScope TBI, model<br>Ahead 500<br>(TBD) | Primary Predicate:<br>BrainScope TBI, model<br>Ahead 400<br>(K183241) | Comments | |
| cognitive performance in<br>patients 13-85 years of age<br>to aid in the assessment of<br>an individual's level of<br>cognitive function. These<br>measures interact with the<br>Cl and can be used stand<br>alone. | cognitive performance to aid<br>in the assessment of an<br>individual's level of cognitive<br>function. These measures do<br>not interact with any other<br>device measures, and are<br>stand alone. | • Specifying the intended<br>age group of 13-85<br>years as cleared under<br>predicate's 510(k)<br>K183241.<br>• Clarification that since<br>the CI includes<br>cognitive performance<br>inputs and they do<br>interact with EEG<br>measures to produce<br>CI. The cognitive<br>performance<br>assessments can also<br>be used standalone. | |
| BrainScope TBI also stores<br>and displays electronic<br>versions of standardized<br>clinical assessment tools<br>that should be used in<br>accordance with the<br>assessment tools' general<br>instructions. These tools do<br>not interact with any other<br>device measures, and are<br>stand alone. | BrainScope TBI also stores<br>and displays electronic<br>versions of standardized<br>clinical assessment tools<br>that should be used in<br>accordance with the<br>assessment tools' general<br>instructions. These tools do<br>not interact with any other<br>device measures, and are<br>stand alone. | Same as predicate. | |
| Topic /<br>Area | Proposed Device:<br>BrainScope TBI,<br>model : Ahead 500 | Predicate:<br>BrainScope TBI,<br>model: Ahead 400<br>(K183241) | Comments |
| Platform | Trimble T41 mobile<br>device, Android OS | Trimble T41 mobile<br>device, Android OS | Same as predicate. |
| Processed<br>EEG<br>Bandwidth | 1kHz sampled data with<br>DC to 300Hz bandwidth<br>and 100Hz sampled<br>data with 0.67Hz to<br>43Hz bandwidth | 1kHz sampled data with<br>DC to 300Hz bandwidth<br>and 100Hz sampled<br>data with 0.67Hz to<br>43Hz bandwidth | Same as predicate. |
| Common<br>Mode<br>Rejection<br>Ratio<br>(CMRR) | < -100 dB (or better) | < -100 dB (or better) | Same as predicate. |
| System<br>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 as predicate. |
| ADC<br>Resolution | 45 nV/bit | 45 nV/bit | Same as predicate. |
| ADC<br>Sampling<br>Rate | 1000 Hz, down sampled<br>to 100 Hz for algorithm<br>processing | 1000 Hz, down sampled<br>to 100 Hz for algorithm<br>processing | Same as predicate. |
| Electrode<br>Placement<br>System | The International 10-20<br>System | The International 10-20<br>System | Same as predicate. |
| Electrode<br>Positions<br>Utilized | Fp1, Fp2, Fpz, AFz, F7,<br>F8, A1, A2 | Fp1, Fp2, Fpz, Afz, F7,<br>F8, A1, A2 | Same as predicate. |
| 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 as predicate. |
| Real Time<br>EEG<br>Display | Yes | Yes | Same as predicate. |
| EEG<br>Based<br>Classificati<br>on<br>Algorithms | SIC with three tier<br>•<br>classification outputs<br>(Negative, Equivocal<br>and Positive)<br>BFI<br>•<br>CI | SIC with three tier<br>•<br>classification outputs<br>(Negative, Equivocal<br>and Positive)<br>BFI<br>• | Equivalent.<br>Both devices share identical<br>SIC and BFI algorithms.<br>In addition, the BrainScope<br>TBI (Ahead 500) includes<br>the new multivariate<br>algorithm to compute CI. |

### Table 1: Indications for Use Comparison to Predicate device

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Image /page/9/Picture/8 description: The image shows the logo for BrainScope. The word "Brain" is in blue, and the word "Scope" is in gray. There is a registered trademark symbol to the upper right of the word "Scope".

### Comparison of Technological Characteristics with the Predicate Device:

BrainScope TBI (model: Ahead 500) has similar technological characteristics as the legally marketed predicate device. BrainScope TBI includes the following modifications when compared to the predicate (BrainScope TBI, model: Ahead 400):

- . The Concussion Index (CI) is derived from a multivariate classification algorithm that analyzes a patient's EEG, augmented by neurocognitive performance and selected clinical symptoms to compute a multi-modal index for patients 13 - 25 years of age, with a GCS of 15. The Cl aids the trained healthcare provider in evaluating a patient for concussion within 3 days of head injury.
The EEG-based Structural Injury Classification (SIC) and Brain Function Index (BFI) algorithms in both devices are limited to the FDA-authorized age range of 18 to 85 years (Adolescent subgroup and Adult age patients).

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The minor technological differences between BrainScope TBI (Ahead 500) and the predicate do not raise new questions of safety and effectiveness, and performance data demonstrates that the BrainScope TBI is as safe and effective as the predicate.

BrainScope TBI (Ahead 500) is substantially equivalent to the predicate BrainScope TBI (Ahead 400).

| | Table 2, Technological Comparison to Predicate Device | | | |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | | | |
| Topic /<br>Area | Proposed Device:<br>BrainScope TBI,<br>model : Ahead 500 | Predicate:<br>BrainScope TBI,<br>model: Ahead 400<br>(K183241) | Comments | |
| Cognitive<br>Performance Tests | Procedural Reaction Time Match to Sample Simple Reaction Time Go/No-Go Simple Reaction Time Test Repeated Device has ability to compare patient's<br>cognitive performance<br>and produce a Reliable<br>Change Index (RCI).<br>Tests include<br>Adolescent and Adult<br>ages of 13 - 85 years. | Procedural Reaction Time Match to Sample Simple Reaction Time Go/No-Go Simple Reaction Time Test Repeated Device has ability to compare patient's<br>cognitive performance<br>and produce a Reliable<br>Change Index (RCI).<br>Tests include<br>Adolescent and Adult<br>ages of 13 - 85 years. | Same as predicate. | |
| Standard<br>Clinical<br>Assessments | Multiple electronic<br>version of "paper and<br>pencil" based standard<br>clinical assessments of<br>concussion such as:<br>PECARN | Multiple electronic<br>version of "paper and<br>pencil" based standard<br>clinical assessments of<br>concussion such as:<br>PECARN | Equivalent. | |
| Results<br>Presentation and<br>Reporting<br>Features | Specific raw measures.<br>EEG playback.<br>Structural injury<br>classification, brain<br>function index (BFI)<br>Concussion Index (CI)<br>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 TBI (Ahead<br>500) includes additional Cl<br>related results and<br>reporting. | |
| Software | BrainScope TBI<br>implements its software<br>with low-level<br>modifications to the<br>T41's off-the-shelf<br>configuration and a<br>kiosk mode application<br>running on Android 4.1. | BrainScope TBI<br>implements its software<br>with low-level<br>modifications to the<br>T41's off-the-shelf<br>configuration and a<br>kiosk mode application<br>running on Android 4.1. | Equivalent.<br>Updated architecture to<br>improve device<br>maintainability, scalability<br>and to support the new CI<br>functionality. | |
| Graphical<br>User<br>Interface | BrainScope developed<br>UI leveraging Android<br>Frameworks. | BrainScope developed<br>UI leveraging Android<br>Frameworks. | Equivalent.<br>New CI functionality<br>included. | |
| Topic /<br>Area | Proposed Device:<br>BrainScope TBI,<br>model : Ahead 500 | Predicate:<br>BrainScope TBI,<br>model: Ahead 400<br>(K183241) | Comments | |
| Test<br>Reporting | Test output for EEG and<br>standardized<br>assessments can be<br>configured to meet user<br>requirements including<br>disabling tests and<br>redaction of personally<br>identifiable information | Test output for EEG and<br>standardized<br>assessments can be<br>configured to meet user<br>requirements including<br>disabling tests and<br>redaction of personally<br>identifiable information | Same as predicate. | |
| Data<br>Management | All data stored (binary<br>format) to non-volatile<br>memory.<br>Data available via USB<br>and wireless<br>connection.<br>Certificate based<br>authentication for wireless<br>communication | All data stored (binary<br>format) to non-volatile<br>memory.<br>Data available via USB<br>and wireless<br>connection. | Equivalent.<br>BrainScope TBI (model:<br>Ahead 500) enables secure<br>communication with cloud<br>based infrastructure to support<br>data synchronization. | |
| Connectivity | USB 2.0 Full-Speed GPS Wi-Fi: 802.11b/g/n, 2.4 GHz band All other interfaces disabled in software | USB 2.0 Full-Speed GPS Wi-Fi: 802.11b/g/n, 2.4 GHz band All other interfaces disabled in software | Equivalent. | |
| Encryption | AES-128 for intra-<br>device communication<br>AES-256 for encrypted<br>files | AES-128 for intra-<br>device communication<br>AES-256 for encrypted<br>files | Same as predicate. | |

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BrainScope TBI 510(k) Summary

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### Performance Data:

Clinical performance data was submitted to support the device modification made to the predicate. Validation data analysis was performed on 580 subjects across 10 US clinical sites including High Schools, Colleges and Concussion Clinics. The validation study population included subjects ages 13.09 - 25.93 years, with mean=19.52 (SD=2.28, median=19.71), 53.62%…