BrainScope One 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 One should not be used as a substitute for a CT scan.

The BrainScope One 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 One 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 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 in the tive 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 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 Description

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

AI/ML Overview

The provided document focuses on the Modified BrainScope One's 510(k) submission, stating its substantial equivalence to a previously cleared predicate device, BrainScope One (K181179). Crucially, the document does not contain detailed information about specific acceptance criteria or the study data that proves the device meets these criteria for the initial clearance of the BrainScope One (K181179), which would have established these performance metrics.

Instead, this submission (K181785) relies on the performance data from the prior submission (K161068), stating "All clinical performance data from the Ahead 300 (K161068) submission still apply." To fully answer your request regarding Acceptance Criteria and supporting study, one would ideally need access to the K161068 submission document.

However, based on the provided text, I can infer and extract some relevant information, particularly concerning the Structural Injury Classification (SIC) component, as this is a key diagnostic output. The document reiterates the indications for use and confirms that the algorithm for Structural Injury Classification outputs "Negative, Equivocal and Positive."

Let's break down what can be inferred from the provided text for the Modified BrainScope One and its relation to the original BrainScope One (K181179), and where information is explicitly stated to be from a prior submission (K161068).

Inferred/Deduced Information from the Provided Document:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, the most direct "performance" mentioned relates to the Structural Injury Classification (SIC). The document describes how the SIC outputs correspond to the likelihood of structural brain injury visible on head CT. While it doesn't give numerical criteria or reported performance values for each output (e.g., sensitivity, specificity), it defines what "Negative," "Positive," and "Equivocal" mean in the context of CT findings.

Acceptance Criterion (Inferred from Indication for Use)	Reported Device Performance (Inferred from Indication for Use)
Structural Injury Classification (SIC) - Negative:	Likely corresponds to patients with no structural brain injury visible on head CT.
Structural Injury Classification (SIC) - Positive:	Likely corresponds to patients with a structural brain injury visible on head CT.
Structural Injury Classification (SIC) - Equivocal:	May correspond to structural brain injury visible on head CT, or may indicate the need for further observation or evaluation.
Brain Function Index (BFI):	Provides a measure for statistical evaluation of EEG, aiding in head injury evaluation as part of a multi-modal, multi-parameter assessment. (No specific numerical performance stated in this document).
QEEG Parameters:	Calculates and displays raw measures for Absolute and Relative Power, Asymmetry, Coherence, and Fractal Dimension. (No specific numerical performance stated in this document).

Note: The document explicitly states, "All clinical performance data from the Ahead 300 (K161068) submission still apply." This implies that the definitive numerical acceptance criteria and their met performance values for the SIC and BFI would be found in the K161068 submission, not in this one. This document focuses on demonstrating substantial equivalence based on minor modifications not affecting safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not provided in this document. It refers to a previous submission (K161068) for "All clinical performance data."
Data Provenance: Not provided in this document (e.g., country of origin, retrospective/prospective). This information would be in the K161068 submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not provided in this document. This information would be in the K161068 submission.

4. Adjudication Method for the Test Set:

Not provided in this document. This information would be in the K161068 submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

Not explicitly stated in this document whether an MRMC study was performed. The device is intended as an "adjunct to standard clinical practice," implying human-in-the-loop assistance. However, the document does not provide details on comparative effectiveness studies showing improvement with AI assistance vs. without. The "Performance Data" section mentions "Pre-Specified analyses for the BFI... included a multinomial logistic regression analysis comparing the odds ratio of groups with differing levels of functional impairment... to a control group, as well as ANOVAs between these groups." This indicates statistical analysis of BFI, but not a direct MRMC comparative effectiveness study as described.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

The Structural Injury Classification (SIC) is described as using "brain electrical activity to determine the likelihood of structural brain injury visible on head CT." This implies a standalone algorithmic output (Negative, Positive, Equivocal) based on EEG data. However, direct metrics (e.g., sensitivity, specificity, AUC) for this standalone algorithm's performance are not provided in this document. This information would be in the K161068 submission.

7. The Type of Ground Truth Used:

For Structural Injury Classification (SIC): The ground truth reference is explicitly stated as "structural brain injury visible on head CT." This is an imaging-based ground truth.
For Brain Function Index (BFI): The document mentions "assessments from conventional concussion symptom scales" and "differing levels of functional impairment" being compared to a control group. This suggests that for BFI, ground truth involved clinical assessment scales/scores indicating functional impairment.

8. The Sample Size for the Training Set:

Not provided in this document. This information would be in the K161068 submission.

9. How the Ground Truth for the Training Set Was Established:

Not provided in this document. This information would be in the K161068 submission.

Summary of Missing Information (Likely in K161068 and/or K181179 Submissions):

The current document (K181785) is for a "Modified BrainScope One" and states that "All clinical performance data from the Ahead 300 (K161068) submission still apply." Therefore, the specific numerical acceptance criteria, detailed study designs (sample sizes, provenance, expert qualifications, adjudication methods), and quantitative results proving initial device performance would be found in the K161068 and subsequent K181179 submissions. This document's purpose is to demonstrate that the modifications do not alter the existing safety and effectiveness, leveraging the data from the predicate.

Summary

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December 19, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K181785

Trade/Device Name: Modified BrainScope One 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 28, 2018 Received: November 28, 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

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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

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Indications for Use

510(k) Number (if known) K181785

Device Name BrainScope One

Indications for Use (Describe)

• BrainScope One 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 One should not be used as a substitute for a CT scan.

· The BrainScope One 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 One 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 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 in the tive 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 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/3/Picture/0 description: The image is a logo for Brainscope. The word "BRAINSCOPE" is written in large, bold, blue letters. There are two horizontal blue lines above and below the word. The "O" in "SCOPE" is stylized to look like a brainwave. There is a registered trademark symbol to the right of the word.

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

www.brainscope.com

phone 240.752.7680

510(k) SUMMARY1

Submitter:	BrainScope® Company, Inc.4350 East West Highway Suite #1050Bethesda, MD 20814Phone: (240) 752-7680Fax: (240) 752-7679www.brainscope.com
Contact:	Michael E. Singer, Ph.D.Chief Executive OfficerBrainScope Company, Inc.Phone: (240) 752-7677Fax: (240) 752-7679Email: michael.singer@brainscope.com
Prepared By:	Sabyasachi Roy, Ph.D.Director Regulatory Affairs, Quality Assurance &Compliance
Device Proprietary Name:	Modified BrainScope One
Device Common Name:	Brain Injury Adjunctive InterpretiveElectroencephalograph Assessment Aid
Device Classification Name:	Brain Injury Adjunctive InterpretiveElectroencephalograph Assessment Aid
Classification Regulation:	21 CFR § 882.1450
Panel:	Neurology
Product Codes:	PIW, PKQ, OLU
Predicate Device:	BrainScope One (K181179)

1 Prepared in accordance with 21 CFR § 807.87(h) and 21 CFR § 807.92(c).

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Image /page/4/Picture/0 description: The image shows the word "BRAINSCOPE" in a stylized, blue font. The letters are bold and slightly italicized, with horizontal lines above and below the word. The "O" in "SCOPE" is replaced by a graphic of brainwaves, and a registered trademark symbol is located in the upper right corner of the image.

Device Description:

Indications for Use:2

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

BrainScope One 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 One should not be used as a substitute for a CT scan.
. The BrainScope One 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 One 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 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

Modified BrainScope One 510(k) Summary

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

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Image /page/5/Picture/0 description: The image shows the logo for BrainScope. The logo is in blue and features the word "BRAINSCOPE" in a bold, sans-serif font. There is a horizontal line above and below the word. The letter "O" in "SCOPE" is replaced with a stylized image of a brainwave. There is a registered trademark symbol to the right of the logo.

EEG signals for interpretation by a qualified user.

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/6/Picture/0 description: The image shows the logo for BrainScope. The logo is in blue and features the word "BRAINSCOPE" in a bold, sans-serif font. There are two horizontal lines under the word. The "C" in "SCOPE" is stylized to look like a brainwave pattern. There is a registered trademark symbol to the right of the word.

Table 1: Indications for Use Comparison to Predicate device

Proposed Device:Modified BrainScope One	Predicate:BrainScope One	Comments
BrainScope One is a multi-modal,multi-parameter assessment indicatedfor use as an adjunct to standardclinical practice to aid in theevaluation of patients who havesustained a closed head injury withinthe past 72 hours (3 days), arebetween the ages of 18-85 years,have a Glasgow Coma Scale (GCS)score of 13-15 (including patients withconcussion / mild traumatic braininjury (mTBI)), and are beingconsidered for a head CT. BrainScopeOne should not be used as asubstitute for a CT scan.	BrainScope One is indicated for useas an adjunct to standard clinicalpractice to aid in the evaluation ofpatients who are being considered fora head CT, who sustained a closedhead injury within 72 hours, presentwith a Glasgow Coma Scale score(GCS) of 13-15 (including concussion/ mild Traumatic Brain Injury (mTBI)),and are between the ages of 18-85years. BrainScope One should not beused as a substitute for a CT scan.	Expanded to includemulti-modal andmulti-parameterassessment.
The BrainScope One Structural InjuryClassification ("SIC") uses brainelectrical activity to determine thelikelihood of structural brain injuryvisible on head CT. Negative likelycorresponds to those with nostructural brain injury visible on headCT. Positive likely corresponds tothose with a structural brain injuryvisible on head CT. Equivocal maycorrespond to structural brain injuryvisible on head CT or may indicate theneed for further observation orevaluation.	A negative BrainScope OneStructural Injury Classification usingbrain electrical activity in patients whosustained a closed head injury within72 hours, likely corresponds to thosewith no structural brain injury visibleon head CT.A positive BrainScope One StructuralInjury Classification using brainelectrical activity in patients whosustained a closed head injury within72 hours, likely corresponds to thosewith a structural brain injury visible onhead CT.An equivocal BrainScope OneStructural Injury Classification usingbrain electrical activity in patients whosustained a closed head injury within72 hours, may correspond tostructural brain injury visible on headCT or may indicate the need forfurther observation or evaluation.	Equivalent.Combined for clarity.
BrainScope One provides a measureof brain function (EEG Brain FunctionIndex, (BFI)) for the statisticalevaluation of the humanelectroencephalogram (EEG), aidingin the evaluation of head injury as partof a multi-modal, multi-parameterassessment.	The BrainScope One provides ameasure of brain function (EEG BrainFunction Index, (BFI)) for thestatistical evaluation of the humanelectroencephalogram (EEG).	Equivalent.Clarification of devicecapabilities.
Proposed Device:Modified BrainScope One	Predicate:BrainScope One	Comments
The BrainScope One device isintended to record, measure, analyze,and display brain electrical activityutilizing the calculation of standardquantitative EEG (QEEG) parametersfrom frontal locations on a patient'sforehead. BrainScope One calculatesand displays raw measures for thefollowing standard QEEG measures:Absolute and Relative Power,Asymmetry, Coherence and FractalDimension. These raw measures areintended to be used for post hocanalysis of EEG signals forinterpretation by a qualified user.	The BrainScope One device isintended to record, measure, analyze,and display brain electrical activityutilizing the calculation of standardquantitative EEG (QEEG) parametersfrom frontal locations on a patient'sforehead. BrainScope One calculatesand displays raw measures for thefollowing standard QEEG measures:Absolute and Relative Power,Asymmetry, Coherence and FractalDimension. These raw measures areintended to be used for post hocanalysis of EEG signals forinterpretation by a qualified user.	Same
BrainScope One also providesclinicians with quantitative measuresof cognitive performance to aid in theassessment of an individual's level ofcognitive function. These measuresdo not interact with any other devicemeasures, and are stand alone.	BrainScope One also providesclinicians with quantitative measuresof cognitive performance to aid in theassessment of an individual's level ofcognitive function. These measuresdo not interact with any other devicemeasures, and are stand alone.	Same
BrainScope One also stores anddisplays electronic versions ofstandardized clinical assessment toolsthat should be used in accordancewith the assessment tools' generalinstructions. These tools do notinteract with any other devicemeasures, and are stand alone.	BrainScope One also stores anddisplays electronic versions ofstandardized clinical assessment toolsthat should be used in accordancewith the assessment tools' generalinstructions. These tools do notinteract with any other devicemeasures, and are stand alone.	Same

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Image /page/7/Picture/0 description: The image is a logo for Brainscope. The logo is in blue and features the word "BRAINSCOPE" in large, bold letters. The "O" in "SCOPE" is stylized with a waveform graphic, and there are horizontal lines above and below the word. There is also a registered trademark symbol to the right of the word.

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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 "Brain" in a bold, sans-serif font, with a line above it. The word "Scope" is next to "Brain" and also in blue, with a line above and below it. There is a registered trademark symbol to the right of the word "Scope".

Comparison of Technological Characteristics with the Predicate Device:

The Modified BrainScope One incorporates additional clarification in the Indications for Use statement of its predicate (BrainScope One) to accommodate widely accepted definitions for "concussion" and "mild Traumatic Brain Injury (mTBI)". The core capabilities of the Modified BrainScope One and its fundamental scientific technology remain unaltered compared to the BrainScope One (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 predicate. The Modified BrainScope One is substantially equivalent to the predicate BrainScope One.

Topic / Area	Proposed Device:Modified BrainScopeOne	Predicate:BrainScope One	Comments
Platform	Trimble T41 mobiledevice, Android OS	Trimble T41 mobiledevice, Android OS	Same
ProcessedEEGBandwidth	1kHz sampled datawith DC to 300Hzbandwidth and 100Hzsampled data with0.67Hz to 43Hzbandwidth	1kHz sampled datawith DC to 300Hzbandwidth and 100Hzsampled data with0.67Hz to 43Hzbandwidth	Same
CommonModeRejectionRatio (CMRR)	< -100 dB (or better)	< -100 dB (or better)	Same
System NoiseFloor	< 0.4 µV in 0.67 Hz to43Hz bandwidth	< 0.4 µV in 0.3 Hz to43Hz bandwidth	Same
ADCResolution	45 nV/bit	45 nV/bit	Same
ADCSamplingRate	1000 Hz, downsampled to 100 Hz foralgorithm processing	1000 Hz, downsampled to 100 Hz foralgorithm processing	Same
ElectrodePlacementSystem	The International 10-20System	The International 10-20System	Same
ElectrodePositionsUtilized	Fp1, Fp2, Fpz, AFz, F7,F8, A1, A2	Fp1, Fp2, Fpz, AFz,F7, F8, A1, A2	Same
ElectrodeMaterial	Single use Ag/AgClelectrode sensor arrayheadset with solid gel	Single use Ag/AgClelectrode sensor arrayheadset with solid gel	Same
Real TimeEEG Display	Yes	Yes	Same
Classification	Three tier classification	Three tier classification	Same

Table 2. Technological Comparison to Predicate Device

Modified BrainScope One 510(k) Summary

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Image /page/9/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 "BrainScope". There is a registered trademark symbol to the right of the word "BrainScope".

Topic / Area	Proposed Device:Modified BrainScopeOne	Predicate:BrainScope One	Comments
Algorithm(StructuralInjuryClassification)	with results ofNegative, Equivocaland Positive outputs.	with results ofNegative, Equivocaland Positive outputs.
ResultsPresentationand ReportingFeatures	Specific raw measures.EEG playback.Structural injuryclassification and brainfunction index display.Cognitive performanceraw and standardscores includingpercentiles.Electronic versions ofStandard ClinicalAssessments.	Specific raw measures.EEG playback.Structural injuryclassification and brainfunction index display.Cognitive performanceraw and standardscores includingpercentiles.Electronic versions ofStandard ClinicalAssessments.	Equivalent. Sameprimaryfunctionality withminorenhancementsmade to userinterface inmodifiedBrainScope One.

Performance Data:

The Pre-Specified analyses for the BFI (described in SAR for submission K161068) included a multinomial logistic regression analysis comparing the odds ratio of groups with differing levels of functional impairment, as determined by assessments from conventional concussion symptom scales, to a control group, as well as ANOVAs between these groups. Post-hoc analyses were performed to explore the relationship between conventional concussion symptom scales and the BFI, as well as the relationship between differing levels of functional impairment and the BFI.

All clinical performance data from the Ahead 300 (K161068) submission still apply.

The Modified BrainScope One device, like its predicate (BrainScope One), is compliant to the 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
o ANSI/AAMI EC12:2000/(R)2010 Disposable ECG Electrodes Modified BrainScope One 510(k) Summary

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Image /page/10/Picture/0 description: The image is a logo for BrainScope. The logo is in blue and features the word "BRAINSCOPE" in a stylized font. The letters are bold and have a slightly futuristic look. There are horizontal lines above and below the word "BRAINSCOPE" and a registered trademark symbol is present.

ANSI/AAMI/ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
o ANSI/AAMI/ISO 10993-5:2009 Biological Evaluation of Medical Devices 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
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 о
ASTM D4169 09, Standard Practice for Performance Testing of Shipping Containers and Systems

Conclusion:

The Modified BrainScope One has the same intended use and same technological characteristics as the predicate device (BrainScope One). The minor differences between the Modified BrainScope One and the predicate (BrainScope One) do not raise new questions of safety and effectiveness. Performance data establish that the modified BrainScope One is as safe and effective as the predicate (BrainScope One).

The Modified BrainScope One is substantially equivalent to the predicate (BrainScope One).

Regulation Number and Section

§ 882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.

(a)
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.(b)
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.