Who is the manufacturer of BrainScope TBI (Model: Ahead 400)?

Brainscope Company, Inc. filed the 510(k) submission for BrainScope TBI (Model: Ahead 400) (K183241).

What is the FDA product code for BrainScope TBI (Model: Ahead 400)?

PIW. It is classified under 21 CFR 882.1450 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for BrainScope TBI (Model: Ahead 400)?

510(k) clearance (submission type: Traditional).

Does BrainScope TBI (Model: Ahead 400) use AI or machine learning?

Yes. BrainScope TBI (Model: Ahead 400) (K183241) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for BrainScope TBI (Model: Ahead 400)?

BrainScope One (K181179); ANAM Test System: Military Battery (K150154).

Who can help prepare an FDA 510(k) submission like BrainScope TBI (Model: Ahead 400)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like BrainScope TBI (Model: Ahead 400) get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

BrainScope TBI (Model: Ahead 400)

K183241 · Brainscope Company, Inc. · PIW · Feb 19, 2019 · Neurology

Device Facts

Record ID	K183241
Device Name	BrainScope TBI (Model: Ahead 400)
Applicant	Brainscope Company, Inc.
Product Code	PIW · Neurology
Decision Date	Feb 19, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1450
Device Class	Class 2
Attributes	AI/ML

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 within the past 72 hours (3 days), are between the ages of 18-85 years, have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion / mild traumatic brain injury (mTBI), and are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan. The BrainScope TBI Structural Injury Classification ("SIC") uses brain electrical activity to determine the likelihood of structural brain injury visible on head CT. 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. 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 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 TBI 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 mTBI assessment. Inputs: frontal EEG signals via single-use Ag/AgCl electrode headset; cognitive performance test responses; standardized clinical assessment data. Operation: records/analyzes EEG to calculate QEEG parameters (Absolute/Relative Power, Asymmetry, Coherence, Fractal Dimension) and Structural Injury Classification (SIC) via proprietary algorithms; provides cognitive performance measures and Reliable Change Index (RCI). Used by clinicians in clinical settings to aid head CT decision-making. Output: SIC (Negative/Positive/Equivocal), BFI, raw QEEG measures, cognitive scores, and electronic clinical assessment forms. Benefits: provides objective adjunctive data to support clinical evaluation of head injury, potentially optimizing CT utilization.

Clinical Evidence

Bench testing only. Normative data collected from 707 healthy individuals (ages 13-85) to construct databases for cognitive tests. Device conforms to IEC 60601-1, IEC 60601-1-2 (Ed 4.0), IEC 60601-1-6, IEC 60601-2-26, ANSI/AAMI EC12, and ISO 10993 standards. No clinical performance data for the TBI indication was required beyond that established for the predicate.

Technological Characteristics

Portable device using Trimble T41 platform (Android OS). EEG sensing via single-use Ag/AgCl electrode array (International 10-20 system). Bandwidth: DC-300Hz (1kHz sample) and 0.67-43Hz (100Hz sample). Connectivity: USB 2.0, Wi-Fi, Cellular. Software: Kiosk mode application. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, ANSI/AAMI EC12, ISO 10993, MIL-STD-810G.

Indications for Use

Indicated for patients aged 18-85 years who have sustained a closed head injury within the past 72 hours, present with a GCS score of 13-15 (including mTBI/concussion), and are being considered for a head CT scan.

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 One (K181179)
ANAM Test System: Military Battery (K150154)

Related Devices

K181179 — BrainScope One · Brainscope Company, Inc. · May 18, 2018
K190815 — BrainScope TBI · Brainscope Company, Inc. · Sep 11, 2019
K181785 — Modified BrainScope One · Brainscope Company, Inc. · Dec 19, 2018
K161068 — Ahead 300 · Brainscope Company, Inc. · Sep 22, 2016
K143643 — Brainscope Ahead 200 · Brainscope Company, Inc. · May 15, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ February 19, 2019 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. BrainScope Company Inc. Michael Singer CEO 4350 East West Hwy, Ste 1050 Bethesda. Maryland 20814 #### Re: K183241 Trade/Device Name: BrainScope TBI (Model: Ahead 400) Regulation Number: 21 CFR 882.1450 Regulation Name: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Regulatory Class: Class II Product Code: PIW, PKO, OLU Dated: November 20, 2018 Received: November 21, 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. 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 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 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Jay R. Gupta -S For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K183241 Device Name BrainScope TBI (Model: Ahead 400) #### 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 within the past 72 hours (3 days), are between the ages of 18-85 years, have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion / mild traumatic brain injury (mTBI), and are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan. • The BrainScope TBI Structural Injury Classification ("SIC") uses brain electrical activity to determine the likelihood of structural brain injury visible on head CT. 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. · 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 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 TBI 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) | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/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. 4330 East-West Highway.Suite 1000.Bethesda.Maryland.20814 www.brainscope.com phone 240.752.7680 # 510(k) SUMMARY1 | Submitter: | BrainScope® Company, Inc. 4330 East West Highway Suite #1000 Bethesda, MD 20814 Phone: (240) 752-7680 Fax: (240) 752-7679 www.brainscope.com | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Michael E. Singer, Ph.D. Chief Executive Officer BrainScope Company, Inc. Phone: (240) 752-7677 Fax: (240) 752-7679 Email: michael.singer@brainscope.com | | Prepared By: | Sabyasachi Roy, Ph.D. Director Regulatory Affairs, Quality Assurance & Compliance | | Device Proprietary Name: | BrainScope TBI (Model: Ahead 400) | | Device Common Name: | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid | | Device Classification Name: | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid | | Classification Regulation: | 21 CFR § 882.1450 | | Panel: | Neurology | | Product Codes: | PIW, PKQ, OLU | | Predicate Devices: | BrainScope One (K181179) ANAM Test System: Military Battery (K150154) | 1 Prepared in accordance with 21 CFR § 807.87(h) and 21 CFR § 807.92(c). BrainScope TBI 510(k) Summary {4}------------------------------------------------ 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, one above and one below the word. The "O" in scope has a brainwave graphic in the middle of it. ## Device Description: BrainScope TBI 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 mild traumatic brain injury (mTBI). It also contains configurable, selectable computerized cognitive performance tests and digitized standard clinical assessment intended to provide a multi-modal panel of measures to support the clinical assessment of concussion / mTBI. BrainScope TBI provides healthcare professionals with a set of validated and clinically accepted library of concussion / mTBI assessments. ## 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 within the past 72 hours (3 days), are between the ages of 18-85 years, have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion / mild traumatic brain injury (mTBI)), and are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan. - The BrainScope TBI Structural Injury Classification ("SIC") uses brain electrical . activity to determine the likelihood of structural brain injury visible on head CT. 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 (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. - . 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 to aid in the assessment of an individual's level of cognitive function. 2 The differences between the BrainScope TBI and its predicate (BrainScope One) do not alter the intended use of the device nor do they affect the safety and effectiveness of the predicate. The subject and predicate device have the same overall intended use. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the BrainScope logo in blue. The word "Brain" is written in a bold, sans-serif font with a horizontal line above and below it. The word "Scope" is written in a similar font, but with a wavy line in the middle of the "O" and a horizontal line below it. There is a registered trademark symbol to the right of the word "Scope". These measures do not interact with any other device measures, and are 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: BrainScope TBI (K183241) | Primary Predicate: BrainScope One (K181179) | Secondary Predicate: ANAM Test System - Military Battery (K150154) | Comments | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 within the past 72 hours (3 days), are between the ages of 18-85 years, have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion / mild traumatic brain injury (mTBI)), and are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan. | 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. | N/A | Equivalent. As cleared under 510(k) K181785. | | 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 | 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 | N/A | Same as primary predicate. | | Proposed Device: BrainScope TBI (K183241) | Primary Predicate: BrainScope One (K181179) | Secondary Predicate: ANAM Test System – Military Battery (K150154) | Comments | | 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. | 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. | | | | The BrainScope TBI Structural Injury Classification (“SIC”) uses brain electrical activity to determine the likelihood of structural brain injury visible on head CT. 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. | 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. | N/A | Equivalent. As cleared under 510(k) K181785. | | | 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. | N/A | Equivalent. As cleared under 510(k) K181785. | | | An equivocal BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely | N/A | Equivalent. As cleared under 510(k) K181785. | | Proposed Device: BrainScope TBI (K183241) | Primary Predicate: BrainScope One (K181179) | Secondary Predicate: ANAM Test System – Military Battery (K150154) | Comments | | | hours, 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 (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. | The BrainScope One provides a measure of brain function (EEG Brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG). | N/A | Equivalent. As cleared under 510(k) K181785. | | BrainScope TBI 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. | The 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. | The ANAM Test System: Military Battery provides clinicians with objective measurements of cognitive performance in military populations ages 18 to 65 years, to aid in the assessment of an individual's level of cognitive functioning. The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function. | Same as primary predicate (BrainScope One) and equivalent to secondary predicate (ANAM Test System – Military Battery). BrainScope TBI extends age range from 18-85 years in predicate (BrainScope One) to 13 – 85 years. Additional performance data including norming study supported the extended age range. | | BrainScope TBI also stores and displays electronic versions of standardized clinical assessment tools that should be used in | The BrainScope One also stores and displays electronic versions of standardized clinical assessment tools that | N/A | Equivalent. Expanding the availability of clinical assessment tools does not affect the | | Proposed Device: BrainScope TBI (K183241) | Primary Predicate: BrainScope One (K181179) | Secondary Predicate: ANAM Test System – Military Battery (K150154) | Comments | | accordance with the assessment tools' general instructions. These tools do not interact with any other device measures, and are stand alone. | 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. | | safety and effectiveness of the device. Expanding functionality increases the utility of the device and better meets user needs. | #### Table 1: Indications for Use Comparison to Predicate devices {6}------------------------------------------------ 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. There are horizontal lines above and below the word "BrainScope". The "o" in "Scope" is stylized with a brainwave pattern. There is a registered trademark symbol to the right of the word "Scope". {7}------------------------------------------------ Image /page/7/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 lines above and below the word, and the "O" in "Scope" is replaced with a brainwave graphic. A registered trademark symbol is located to the right of the word. {8}------------------------------------------------ Image /page/8/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 lines above and below the word, and the "O" in "Scope" is replaced with a brainwave graphic. A registered trademark symbol is located to the right of the word. # Comparison of Technological Characteristics with the Predicate Device: The BrainScope TBI has similar technological characteristics as the legally marketed predicate devices. The BrainScope TBI includes the following modifications when compared to the primary predicate (BrainScope One): - . Three additional computerized Cognitive Performance tests for a total of five. All five computerized Coqnitive Performance tests are intended for use on patients 13 - 85 years of age. - . The addition of PECARN – Pediatric Head Injury Predication Rule to the library of Standard Clinical Assessments already included in BrainScope One. - Expanded device connectivity to include an Over the Air (OTA) software upgrade . capability made possible using a Wi-Fi or Cellular connection. All EEG based algorithms in both devices are limited to the FDA authorized age range of 18 to 85 years (Adolescent subgroup and Adult age patients). The minor technological differences between the BrainScope TBI and the predicates do not raise new questions of safety and effectiveness and performance data demonstrate that the BrainScope TBI is as safe and effective as the predicate. The BrainScope TBI is substantially equivalent to the predicates the BrainScope One and ANAM Test System - Military Battery. | Topic / Area | Proposed Device: BrainScope TBI | Primary Predicate: BrainScope One (K181179) | Secondary Predicate: ANAM Test System – Military Battery (K150154) | Comments | |-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Hardware | | | | | | Platform | Trimble T41 mobile device, Android OS | Trimble T41 mobile device, Android OS | PC: Dell Latitude E6440 Laptop | Same as primary predicate. | | Topic / Area | Proposed Device: BrainScope TBI | Primary Predicate: BrainScope One (K181179) | Secondary Predicate: ANAM Test System - Military Battery (K150154) | Comments | | Processed EEG Bandwidth | 1kHz sampled data with DC to 300Hz bandwidth and 100Hz sampled data with 0.67Hz to 43Hz bandwidth | 1kHz sampled data with DC to 300Hz bandwidth and 100Hz sampled data with 0.67Hz to 43Hz bandwidth | N/A | Same as primary predicate. | | Common Mode Rejection Ratio (CMRR) | < -100 dB (or better) | < -100 dB (or better) | N/A | Same as primary predicate. | | System Noise Floor | < 0.4 µV in 0.67 Hz to 43Hz bandwidth | < 0.4 µV in 0.3 Hz to 43Hz bandwidth | N/A | Same as primary predicate. | | ADC Resolution | 45 nV/bit | 45 nV/bit | N/A | Same as primary predicate. | | ADC Sampling Rate | 1000 Hz, down sampled to 100 Hz for algorithm processing | 1000 Hz, down sampled to 100 Hz for algorithm processing | N/A | Same as primary predicate. | | Electrode Placement System | The International 10-20 System | The International 10-20 System | N/A | Same as primary predicate. | | Electrode Positions Utilized | Fp1, Fp2, Fpz, AFz, F7, F8, A1, A2 | Fp1, Fp2, Fpz, Afz, F7, F8, A1, A2 | N/A | Same as primary predicate. | | Electrode Material | Single use Ag/AgCl electrode sensor array headset with solid gel | Single use Ag/AgCl electrode sensor array headset with solid gel | N/A | Same as primary predicate. | | Assessment and Software | | | | | | Real Time EEG Display | Yes | Yes | N/A | Same as primary predicate. | | EEG Based Classificati | Three tier classification with results of | Three tier classification with results of | N/A | Same as primary predicate. | | Topic / Area | Proposed Device: BrainScope TBI | Primary Predicate: BrainScope One (K181179) | Secondary Predicate: ANAM Test System – Military Battery (K150154) | Comments | | on Algorithm (Structural Injury Classification) | Negative, Equivocal and Positive outputs. | Negative, Equivocal and Positive outputs. |…