(90 days)
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.
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.
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal acceptance criteria with numerical thresholds. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The performance data presented primarily confirms that the new modifications (cognitive performance tests, PECARN, wireless connectivity) work as specified and do not negatively impact existing functionalities.
Table of Acceptance Criteria (Inferred from Substantial Equivalence Claim) and Reported Device Performance:
| Acceptance Criteria (Inferred/Implicit) | Reported Device Performance |
|---|---|
| For Cognitive Performance Tests:Functionality of new cognitive tests | Normative data was collected from 707 healthy individuals (age 13-85) to construct databases for the cognitive tests. Test data demonstrated that the modifications (additional cognitive performance tests and PECARN) were implemented as per specifications. The new tests and Reliable Change Index (RCI) output are "well accepted in clinical practice for assessment of Adult and Adolescent patient population." |
| For Standard Clinical Assessments:Integration of PECARN | Test data demonstrated that the modifications (additional cognitive performance tests and PECARN) were implemented as per specifications. PECARN was added to the existing library of digitized standard clinical assessments. The expanded availability of clinical assessment tools does not affect safety and effectiveness and increases utility. |
| For Wireless Connectivity (OTA):Functionality of wireless connectivity | Test data demonstrated that the modifications (wireless connectivity) were implemented as per specifications. The BrainScope TBI has wireless connectivity to accept Over the Air (OTA) software upgrades. This provides additional data transfer capabilities. |
| For Existing EEG Algorithms (SIC, BFI, QEEG):No impact on existing functionality | The new modifications "did not impact existing device functionality including core EEG based algorithms" (e.g., Structural Injury Classification (SIC) and Brain Function Index (BFI)). The device maintains the same technical characteristics as the predicate for EEG parameters (e.g., bandwidth, CMRR, noise floor, ADC resolution, sampling rate, electrode placement, electrode positions, electrode material, real-time EEG display, EEG-based classification algorithm). |
| Basic Safety and EMC Standards:Conformity to relevant standards | The BrainScope TBI device conforms to "all same basic safety and EMC standards as the predicate." It was also tested to the most recent recognized consensus standard for EMC (IEC 60601-1-2 Ed. 4.0 2014) and other listed standards (e.g., IEC 60601-1/A1:2012, IEC 60601-1-6/A1:2013, IEC 60601-2-26:2012, ANSI/AAMI EC12:2000/(R)2010, ANSI/AAMI/ISO 10993-1:2009, ANSI/AAMI/ISO 10993-5:2009, ANSI/AAMI/ISO 10993-10:2010, MIL-STD-810G, IEC 60529 (2004), ASTM D4169 09). |
| Overall Safety and Effectiveness:Comparable to predicate devices | Performance data demonstrated that the BrainScope TBI is "as safe and effective as the predicates." |
2. Sample size used for the test set and the data provenance:
- Sample Size: 707 healthy individuals.
- Data Provenance: The document states that normative data was collected from "707 healthy individuals" for the cognitive tests. It does not specify the country of origin, but given the context of FDA submission, it is typically expected to be from a US-based population or a population generalizable to the US. It is a prospective collection for establishing normative data for the new cognitive tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set of the new cognitive performance tests. It refers to the new tests and RCI output being "well accepted in clinical practice," which implies expert consensus in the field, but no specific quantification of experts is provided within this document. For the EEG-based Structural Injury Classification (SIC), the ground truth is based on the visible injury on head CT, which is a clinical standard.
4. Adjudication method for the test set:
Not explicitly stated for the cognitive performance tests or the overall assessment of device modifications. Given the nature of normative data collection for cognitive tests, the "ground truth" is often statistical (e.g., population averages, standard deviations) rather than expert adjudication on individual cases for classification. For the SIC, the ground truth is based on head CT findings, which are objective imaging results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
The document does not mention an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is described as an "adjunct to standard clinical practice" and "should not be used as a substitute for a CT scan," suggesting it provides additional information rather than directly assisting in CT interpretation by a reader.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the Structural Injury Classification (SIC) and Brain Function Index (BFI) are described as "EEG based algorithms" which "use brain electrical activity to determine the likelihood of structural brain injury visible on head CT." This implies a standalone algorithmic assessment of the EEG data, providing "Negative, Equivocal and Positive outputs" for SIC and a "statistical evaluation of the human EEG" for BFI.
7. The type of ground truth used:
- For Structural Injury Classification (SIC): Visible structural brain injury on head CT. This is a form of outcomes data or a clinical standard.
- For Cognitive Performance Tests: Normative data derived from a population of healthy individuals. This establishes a baseline for cognitive function.
- For QEEG parameters: Standards related to the accurate recording, measuring, analyzing, and displaying of brain electrical activity, as well as comparison to the predicate device's performance characteristics.
8. The sample size for the training set:
The document does not specify the sample size for the training set. It only mentions the "normative data collected from 707 healthy individuals" used to construct databases for the cognitive tests, which likely serves as a reference/validation set for these specific components. The EEG-based algorithms (SIC, BFI) were likely developed and trained on separate, larger datasets that are not detailed in this particular summary, as these algorithms are shared with the predicate device (BrainScope One).
9. How the ground truth for the training set was established:
The document does not provide details on how the ground truth for the training set was established for the core EEG algorithms (SIC, BFI) as these algorithms were already established and cleared under the predicate device (BrainScope One). For the new cognitive performance tests and PECARN, the ground truth for the "normative data" was established by collecting data from "healthy individuals," implying a healthy control group without known head injury or cognitive impairment.
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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
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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) 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) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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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
phone 240.752.7680
510(k) SUMMARY1
| Submitter: | BrainScope® Company, Inc.4330 East West Highway Suite #1000Bethesda, 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: | BrainScope TBI (Model: Ahead 400) |
| 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 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
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Image /page/4/Picture/0 description: The image shows the logo for BrainScope. The logo is in blue and features the word "BrainScope" in a stylized font. There are two horizontal lines, 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.
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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) | SecondaryPredicate: ANAMTest System -Military Battery(K150154) | Comments |
|---|---|---|---|
| BrainScope TBI is amulti-modal, multi-parameter assessmentindicated for use as anadjunct to standardclinical practice to aidin the evaluation ofpatients who havesustained a closedhead injury within thepast 72 hours (3 days),are between the agesof 18-85 years, have aGlasgow Coma Scale(GCS) score of 13-15(including patients withconcussion / mildtraumatic brain injury(mTBI)), and are beingconsidered for a headCT. BrainScope TBIshould not be used asa substitute for a CTscan. | BrainScope One isindicated for use as anadjunct to standardclinical practice to aidin the evaluation ofpatients who are beingconsidered for a headCT, who sustained aclosed head injurywithin 72 hours,present with a GlasgowComa Scale score(GCS) of 13-15(including concussion /mild Traumatic BrainInjury (mTBI)), and arebetween the ages of18-85 years.BrainScope Oneshould not be used asa substitute for a CTscan. | N/A | Equivalent. Ascleared under510(k) K181785. |
| The BrainScope TBIdevice is intended torecord, measure,analyze, and displaybrain electrical activityutilizing the calculationof standard quantitativeEEG (QEEG)parameters from frontallocations on a patient'sforehead. TheBrainScope TBI | The BrainScope Onedevice is intended torecord, measure,analyze, and displaybrain electrical activityutilizing the calculationof standard quantitativeEEG (QEEG)parameters from frontallocations on a patient'sforehead. TheBrainScope One | N/A | Same as primarypredicate. |
| Proposed Device:BrainScope TBI(K183241) | Primary Predicate:BrainScope One(K181179) | SecondaryPredicate: ANAMTest System –Military Battery(K150154) | Comments |
| calculates and displaysraw measures for thefollowing standardQEEG measures:Absolute and RelativePower, Asymmetry,Coherence and FractalDimension. These rawmeasures are intendedto be used for post hocanalysis of EEGsignals forinterpretation by aqualified user. | calculates and displaysraw measures for thefollowing standardQEEG measures:Absolute and RelativePower, Asymmetry,Coherence and FractalDimension. These rawmeasures are intendedto be used for post hocanalysis of EEGsignals forinterpretation by aqualified user. | ||
| The BrainScope TBIStructural InjuryClassification (“SIC”)uses brain electricalactivity to determinethe likelihood ofstructural brain injuryvisible on head CT.Negative likelycorresponds to thosewith no structural braininjury visible on headCT. Positive likelycorresponds to thosewith a structural braininjury visible on headCT. Equivocal maycorrespond tostructural brain injuryvisible on head CT ormay indicate the needfor further observationor evaluation. | A negative BrainScopeOne Structural InjuryClassification usingbrain electrical activityin patients whosustained a closedhead injury within 72hours, likelycorresponds to thosewith no structural braininjury visible on headCT. | N/A | Equivalent. Ascleared under510(k) K181785. |
| A positive BrainScopeOne Structural InjuryClassification usingbrain electrical activityin patients whosustained a closedhead injury within 72hours, likelycorresponds to thosewith a structural braininjury visible on headCT. | N/A | Equivalent. Ascleared under510(k) K181785. | |
| An equivocalBrainScope OneStructural InjuryClassification usingbrain electrical activityin patients whosustained a closedhead injury within 72hours, likely | N/A | Equivalent. Ascleared under510(k) K181785. | |
| Proposed Device:BrainScope TBI(K183241) | Primary Predicate:BrainScope One(K181179) | SecondaryPredicate: ANAMTest System –Military Battery(K150154) | Comments |
| hours, may correspondto structural brain injuryvisible on head CT ormay indicate the needfor further observationor evaluation. | |||
| BrainScope TBIprovides a measure ofbrain function (EEGBrain Function Index,(BFI)) for the statisticalevaluation of thehumanelectroencephalogram(EEG), aiding in theevaluation of headinjury as part of a multi-modal, multi-parameterassessment. | The BrainScope Oneprovides a measure ofbrain function (EEGBrain Function Index,(BFI)) for the statisticalevaluation of thehumanelectroencephalogram(EEG). | N/A | Equivalent. Ascleared under510(k) K181785. |
| BrainScope TBI alsoprovides clinicians withquantitative measuresof cognitiveperformance to aid inthe assessment of anindividual's level ofcognitive function.These measures donot interact with anyother device measures,and are stand alone. | The BrainScope Onealso provides clinicianswith quantitativemeasures of cognitiveperformance to aid inthe assessment of anindividual's level ofcognitive function.These measures donot interact with anyother device measures,and are stand alone. | The ANAM TestSystem: MilitaryBattery providesclinicians withobjectivemeasurements ofcognitiveperformance inmilitary populationsages 18 to 65 years,to aid in theassessment of anindividual's level ofcognitivefunctioning. TheANAM Test Systemshould only be usedas an adjunctive toolfor evaluatingcognitive function. | Same as primarypredicate(BrainScope One)and equivalent tosecondarypredicate (ANAMTest System –Military Battery).BrainScope TBIextends age rangefrom 18-85 yearsin predicate(BrainScope One)to 13 – 85 years.Additionalperformance dataincluding normingstudy supportedthe extended agerange. |
| BrainScope TBI alsostores and displayselectronic versions ofstandardized clinicalassessment tools thatshould be used in | The BrainScope Onealso stores anddisplays electronicversions ofstandardized clinicalassessment tools that | N/A | Equivalent.Expanding theavailability ofclinicalassessment toolsdoes not affect the |
| Proposed Device:BrainScope TBI(K183241) | Primary Predicate:BrainScope One(K181179) | SecondaryPredicate: ANAMTest System –Military Battery(K150154) | Comments |
| accordance with theassessment tools'general instructions.These tools do notinteract with any otherdevice measures, andare stand alone. | should be used inaccordance with theassessment tools'general instructions.These tools do notinteract with any otherdevice measures, andare stand alone. | safety andeffectiveness ofthe device.Expandingfunctionalityincreases theutility of the deviceand better meetsuser needs. |
Table 1: Indications for Use Comparison to Predicate devices
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Image /page/6/Picture/0 description: The image shows the BrainScope logo. The logo is in blue and features the word "BrainScope" in a stylized font. 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".
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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.
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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 | ProposedDevice:BrainScope TBI | PrimaryPredicate:BrainScope One(K181179) | SecondaryPredicate: ANAMTest System –Military Battery(K150154) | Comments |
|---|---|---|---|---|
| Hardware | ||||
| Platform | Trimble T41mobile device,Android OS | Trimble T41mobile device,Android OS | PC: Dell LatitudeE6440 Laptop | Same as primarypredicate. |
| Topic /Area | ProposedDevice:BrainScope TBI | PrimaryPredicate:BrainScope One(K181179) | SecondaryPredicate: ANAMTest System -Military Battery(K150154) | Comments |
| ProcessedEEGBandwidth | 1kHz sampleddata with DC to300Hz bandwidthand 100Hzsampled datawith 0.67Hz to43Hz bandwidth | 1kHz sampleddata with DC to300Hz bandwidthand 100Hzsampled data with0.67Hz to 43Hzbandwidth | N/A | Same as primarypredicate. |
| CommonModeRejectionRatio(CMRR) | < -100 dB (orbetter) | < -100 dB (orbetter) | N/A | Same as primarypredicate. |
| SystemNoiseFloor | < 0.4 µV in 0.67Hz to 43Hzbandwidth | < 0.4 µV in 0.3 Hzto 43Hz bandwidth | N/A | Same as primarypredicate. |
| ADCResolution | 45 nV/bit | 45 nV/bit | N/A | Same as primarypredicate. |
| ADCSamplingRate | 1000 Hz, downsampled to 100Hz for algorithmprocessing | 1000 Hz, downsampled to 100 Hzfor algorithmprocessing | N/A | Same as primarypredicate. |
| ElectrodePlacementSystem | The International10-20 System | The International10-20 System | N/A | Same as primarypredicate. |
| ElectrodePositionsUtilized | Fp1, Fp2, Fpz,AFz, F7, F8, A1,A2 | Fp1, Fp2, Fpz,Afz, F7, F8, A1,A2 | N/A | Same as primarypredicate. |
| ElectrodeMaterial | Single useAg/AgClelectrode sensorarray headsetwith solid gel | Single useAg/AgCl electrodesensor arrayheadset with solidgel | N/A | Same as primarypredicate. |
| Assessment and Software | ||||
| Real TimeEEGDisplay | Yes | Yes | N/A | Same as primarypredicate. |
| EEGBasedClassificati | Three tierclassification withresults of | Three tierclassification withresults of | N/A | Same as primarypredicate. |
| Topic /Area | ProposedDevice:BrainScope TBI | PrimaryPredicate:BrainScope One(K181179) | SecondaryPredicate: ANAMTest System –Military Battery(K150154) | Comments |
| onAlgorithm(StructuralInjuryClassification) | Negative,Equivocal andPositive outputs. | Negative,Equivocal andPositive outputs. | Both devices alsoimplement sameEEG based BrainFunction Index(BFI) algorithmswhich are differentfrom the SICalgorithms. Bothdevices also sharethe same 8-typesof EEG artifactingalgorithms. | |
| CognitivePerformance Tests | Procedural Reaction Time Matching to Sample Simple Reaction Time Go/No-Go Simple Reaction Time Test Repeated Device has abilityto comparepatient's cognitiveperformance andproduce aReliable ChangeIndex (RCI).Tests includeAdolescent andAdult ages of 13– 85 years. | Procedural Reaction Time Matching to Sample No ability in devicesoftware toautomaticallycompare two testsbut this can bedone by clinicianmanually. No RCIoutput. Tests arefor Adolescent andAdult ages of 18 –85 years. | Modules include:Demographics Sleepiness Scale Symptoms Checklist Mood Scale TBI Questionnaire Simple Reaction Time Code Substitution – Learning Procedural Reaction Time Mathematical Processing Matching to Sample Code Substitution – Delayed Simple Reaction Time (R) Device has abilityto comparepatient's cognitive performance and | Equivalent.New tests and RCIoutput included inBrainScope TBIare well acceptedin clinical practicefor assessment ofAdult andAdolescent patientpopulation. |
| Topic /Area | ProposedDevice:BrainScope TBI | PrimaryPredicate:BrainScope One(K181179) | SecondaryPredicate: ANAMTest System -Military Battery(K150154) | Comments |
| produce a ReliableChange Index(RCI). Tests arefor Adolescent andAdult ages of 18 –65 years. | ||||
| StandardClinicalAssessments | Multiple electronicversion of “paperand pencil” basedstandard clinicalassessmentssuch as:• ConcussionSymptomInventory (CSI)• GradedSymptomChecklist(GSC)• SportsConcussionsAssessmentTool- 3rdEdition(SCAT3)• SportsConcussionsAssessmentTool- 5thEdition(SCAT5)• NationalFootballLeague -SportsConcussionsAssessmentTool (NFLSCAT)• StandardAssessment ofConcussion -2nd Edition(SAC)• Military AcuteConcussionEvaluation(MACE)• PECARN | Multiple electronicversion of “paperand pencil” basedstandard clinicalassessments suchas:• ConcussionSymptomInventory (CSI)• GradedSymptomChecklist (GSC)• SportsConcussionsAssessmentTool- 3rd Edition(SCAT3)• SportsConcussionsAssessmentTool- 5th Edition(SCAT5)• NationalFootball League- SportsConcussionsAssessmentTool (NFLSCAT)• StandardAssessment ofConcussion -2nd Edition(SAC)• Military AcuteConcussionEvaluation(MACE)• Others | N/A | Equivalent.PECARN added toexisting library ofdigitized StandardClinicalAssessment. |
| Topic /Area | ProposedDevice:BrainScope TBI | PrimaryPredicate:BrainScope One(K181179) | SecondaryPredicate: ANAMTest System –Military Battery(K150154) | Comments |
| • Others | ||||
| ResultsPresentation andReportingFeatures | Specific rawmeasures.EEG playback.Structural injuryclassification andbrain functionindex display.Cognitiveperformance rawand standardscores includingpercentiles.Electronicversions ofStandard ClinicalAssessments. | Specific rawmeasures.EEG playback.Structural injuryclassification andbrain functionindex display.Cognitiveperformance rawand standardscores includingpercentiles.Electronic versionsof StandardClinicalAssessments. | • No EEG• No StandardClinicalAssessments• Provides rawscores,standardscores andpercentiles(calculatedwith normativedatabase) foreach test. Alsoyields theANAMCompositeScores (ACS)Summarizingperformanceacross the testbattery. | Equivalent.BrainScope TBIincludes additionalCognitivePerformance tests. |
| Software | BrainScope TBIimplements itssoftware with low-levelmodifications tothe T41's off-the-shelfconfiguration anda kiosk modeapplicationrunning onAndroid 4.1. | BrainScope Oneimplements itssoftware with low-level modificationsto the T41's off-the-shelfconfiguration anda kiosk modeapplication runningon Android 4.1. | PC: Dell LatitudeE6440 LaptopComputer, twobutton USBconnected mouse,and Windows 7Operating System | Equivalent.Same architectureandimplementation.Software can beupdated over theair (OTA). |
| GraphicalUserInterface | BrainScopedeveloped UIleveragingAndroidFrameworks. | BrainScopedeveloped UIleveraging AndroidFrameworks. | Custom GUI onWindows 7Operating System | Same as primarypredicate. |
| Topic /Area | ProposedDevice:BrainScope TBI | PrimaryPredicate:BrainScope One(K181179) | SecondaryPredicate: ANAMTest System –Military Battery(K150154) | Comments |
| TestReporting | PDF reportgeneration forfacilitating printingout as paperrecord per userdiscretionTest output forEEG andstandardizedassessments canbe configured tomeet userrequirementsincludingdisabling testsand redaction ofpersonallyidentifiableinformation | PDF reportgeneration forfacilitating printingout as paperrecord per userdiscretionTest output forEEG andstandardizedassessments canbe configured tomeet userrequirementsincluding disablingtests andredaction ofpersonallyidentifiableinformation | N/A | Same as primarypredicate. |
| DataManagement | All data stored(binary format) tonon-volatilememory.Data available viaUSB and wirelessconnection. | All data stored(binary format) tonon-volatilememory.Data available viaUSB connection orSD card removal. | Standard PC | Equivalent.BrainScope TBIhas additional datatransfercapabilities usingwireless connection. |
| Connectivity | USB 2.0 Full-Speed GPS Cellular:UMTS/HSPA+:B1, B2, B5, B6,B8;GSM/GPRS/EDGE: 850, 900,1800, 1900MHz bands; Wi-Fi:802.11b/g/n,2.4 GHz band All otherinterfacesdisabled insoftware | USB 2.0 Full-Speed GPS All otherinterfacesdisabled insoftware | Standard PC | Equivalent.BrainScope TBIhas wirelessconnectivity toaccept Over theAir (OTA) softwareupgrades. |
| Encryption | AES-128 for intra-devicecommunication | AES-128 for intra-devicecommunication | N/A | Same as primarypredicate. |
| Topic /Area | ProposedDevice:BrainScope TBI | PrimaryPredicate:BrainScope One(K181179) | SecondaryPredicate: ANAMTest System -Military Battery(K150154) | Comments |
| AES-256 forencrypted files | AES-256 forencrypted files |
Table 2, Technological Comparison to Predicate Device
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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. The "i" in "BrainScope" is replaced with a waveform graphic, and there are horizontal lines above and below the word. The registered trademark symbol is located to the right of the word.
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Image /page/10/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 is a horizontal line above and below the word. The "o" in scope is replaced with a brainwave graphic, and there is a registered trademark symbol to the right of the word.
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Image /page/11/Picture/0 description: The image shows the logo for BrainScope. The logo is in blue and features the word "BrainScope" in a stylized font. There is a horizontal line above and below the word. The "O" in Scope has a brainwave graphic inside of it.
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Image /page/12/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 is a horizontal line above and below the word. The "o" in scope is replaced with a brainwave graphic, and there is a registered trademark symbol to the right of the word.
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Image /page/13/Picture/0 description: The image shows the logo for BrainScope. The logo is in blue and features the word "BRAINSCOPE" in a stylized font. The "I" in BrainScope is replaced with a brainwave graphic. There is a horizontal line above and below the word "BRAINSCOPE".
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Image /page/14/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 above and below the word. The "O" in "SCOPE" has a brainwave graphic inside of it. There is a registered trademark symbol to the right of the word.
Performance Data:
Performance data was submitted to support the device modification made to the predicate. Normative data was collected from 707 healthy individuals with age range of 13-85 years to construct databases for the cognitive tests implemented on the BrainScope TBI. Test data demonstrated that the modifications made to the predicate namely – additional cognitive performance tests, additional standard clinical assessment (PECARN) and wireless connectivity are implemented as per specifications. These new modifications did not impact existing device functionality including core EEG based algorithms. The BrainScope TBI device conforms to all same basic safety and EMC standards as the predicate. The BrainScope TBI device was also tested to the most recent recognized consensus standard for EMC (IEC 60601-1-2 Ed. 4.0 2014) as shown below.
The BrainScope TBI device conforms to the following standards:
- o IEC 60601-1/A1:2012 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
- o IEC 60601-1-2 Edition 4.0 2014 General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - 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
- ANSI/AAMI/ISO 10993-1:2009 Biological evaluation of medical devices o Part 1: Evaluation and testing within a risk management process
- ANSI/AAMI/ISO 10993-5:2009 Biological Evaluation of Medical Devices о Part 5: Tests for In Vitro Cytotoxicity
- o ANSI/AAMI/ISO 10993-10:2010 Biological evaluation of medical devices -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 o
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Image /page/15/Picture/0 description: The image shows the BrainScope logo. The logo is in blue and features the word "BrainScope" in a stylized font. There are two horizontal lines above and below the word. The "o" in "Scope" is replaced with a brainwave symbol. There is a registered trademark symbol to the right of the word.
- o ASTM D4169 09, Standard Practice for Performance Testing of Shipping Containers and Systems
Conclusion:
The BrainScope TBI device has the same intended use as the legally marketed primary predicate (BrainScope One) and secondary predicate (ANAM Test System - Military Battery). The BrainScope TBI device has similar technological characteristics as the predicates. The minor differences in technological characteristics do not raise new questions of safety and effectiveness and performance data demonstrate that the BrainScope TBI is as safe and effective as the predicates.
§ 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.