(166 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, and have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion/mild traumatic brain injury (mTBI)).
BrainScope TBI provides a multi-parameter measure (CI)) to aid in the evaluation of concussion in patients between the ages of 13-25 years who present with a GCS score of 15 following a head injury within the past 72 hours (3 days), in conjunction with a standard neurological assessment of concussion. The CI is computed from a multivariate algorithm based on the patient's electroencephalogram (EEG), augmented by neurocognitive measures and selected clinical symptoms.
The BrainScope TBI Structural Injury Classification ("SIC") uses brain electrical activity (EEG) to determine the likelihood of structural brain injury visible on head CT for patients between the ages of 18-85 years (have a GCS score of 13 – 15), have sustained a closed head injury within the past 72 hours (3 days) who are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan. Negative likely corresponds to those with no structural brain injury visible on head CT. Positive likely corresponds to those with a structural brain injury visible on head CT. Equivocal may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.
BrainScope TBI provides a measure of brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG), aiding in the evaluation of head injury as part of a multi-modal, multi-parameter assessment, in patients 18-85 years of age (have a GCS score of 13 - 15) who have sustained a closed head injury within the past 72 hours (3 days).
The BrainScope TBI device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope TBI calculates and displays raw measures for the following standard QEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of EEG signals for interpretation by a qualified user.
BrainScope TBI also provides clinicians with quantitative measures of cognitive performance in patients 13-85 years of age to aid in the assessment of an individual's level of cognitive function. These measures interact with the CI and can be used stand alone.
BrainScope TBI also stores and displays electronic versions of standardized clinical assessment tools that should be used in accordance with the assessment tools' general instructions. These tools do not interact with any other device measures, and are stand alone.
BrainScope TBI (model: Ahead 500) is a portable, non-invasive, non-radiation emitting, point of care device intended to provide results and measures to support clinical assessments and aid in the diagnosis of concussion / mild traumatic brain injury (mTBI). The BrainScope TBI includes a new multivariate classification algorithm that analyzes a patient's electroencephalogram (EEG), augmented by neurocognitive performance and selected clinical symptoms to compute a multi-modal index called the Concussion Index (CI). BrainScope TBI provides the healthcare provider with a multi-parameter measure to aid in the evaluation of concussion following a head injury within the past 72 hours (3 days). The BrainScope TBI (Ahead 500) retains all the capabilities of the predicate (BrainScope TBI, model: Ahead 400) including the Structural Injury Classification (SIC) and the Brain Function Index (BFI). It also contains configurable, selectable computerized cognitive performance tests and digitized standard clinical assessment tools intended to provide a multi-modal panel of measures to support the clinical assessment of concussion / mTBI.
Here's a breakdown of the acceptance criteria and the study details for the BrainScope TBI (model: Ahead 500) device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Performance Goal) | Reported Device Performance (95% CI) |
|---|---|---|
| Sensitivity | 0.69 | 0.8599 (0.8050, 0.9041) |
| Specificity | 0.565 | 0.7078 (0.6588, 0.7535) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 580 subjects
- 229 matched controls
- 144 healthy volunteers
- 207 subjects who sustained closed head injury and were removed from play
- Data Provenance: The study was conducted across 10 US clinical sites, including High Schools, Colleges, and Concussion Clinics. The study design appears to be prospective, given it involved testing subjects at different time points and with specific inclusion/exclusion criteria.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used or their specific qualifications (e.g., "Radiologist with 10 years of experience") for establishing the ground truth.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, the document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study to assess how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone performance of the Concussion Index (CI) algorithm.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done for the Concussion Index (CI). The reported sensitivity and specificity values are for the algorithm's performance in classifying concussions.
7. Type of Ground Truth Used
The clinical reference standard (ground truth) incorporated elements from guidelines published in the International Conference on Concussion in Sport (McCrory 2017; 2013) as well as the National Collegiate Athletic Association (NCAA) concussion policy. This suggests a clinical diagnosis/consensus-based ground truth, likely established by clinicians based on established guidelines and possibly direct observations or outcomes related to concussion (e.g., "removed from play"). It's not explicitly stated to be solely pathology or patient outcomes data, but rather a combination of clinical criteria.
8. Sample Size for the Training Set
The document states that the "cutoff (threshold) CI [was] derived from an algorithm development study that was independent of the validation study," but it does not provide the sample size for this algorithm development (training) study.
9. How the Ground Truth for the Training Set Was Established
The document implies that the ground truth for the "algorithm development study" (training set) would have been established using similar clinical criteria as the validation study, i.e., "consistent with similar changes seen in subjects with concussion," incorporating elements from the International Conference on Concussion in Sport guidelines and NCAA concussion policy. However, it does not explicitly detail the process for establishing ground truth for the training set.
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BrainScope Company, Inc. Michael Singer CEO 4330 East West Highway, Suite #1000 Bethesda, Maryland 20814
Re: K190815
Trade/Device Name: BrainScope TBI Regulation Number: 21 CFR 882.1450 Regulation Name: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Regulatory Class: Class II Product Code: PIW, PKQ, OLU Dated: July 19, 2019 Received: July 22, 2019
Dear Michael Singer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190815
Device Name BrainScope TBI (model: Ahead 500)
Indications for Use (Describe)
· BrainScope TBI is a multi-modal, multi-parameter assessment indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury, and have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion/mild traumatic brain injury (mTBI)).
· BrainScope TBI provides a multi-parameter measure (Cl)) to aid in the evaluation of concussion in patients between the ages of 13-25 years who present with a GCS score of 15 following a head injury within the past 72 hours (3 days), in conjunction with a standard neurological assessment of concussion. The CI is computed from a multivariate algorithm based on the patient's electroencephalogram (EEG), augmented by neurocognitive measures and selected clinical symptoms.
· The BrainScope TBI Structural Injury Classification ("SIC") uses brain electrical activity (EEG) to determine the likelihood of structural brain injury visible on head CT for patients between the ages of 18-85 years (have a GCS score of 13 – 15), have sustained a closed head injury within the past 72 hours (3 days) who are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan. Negative likely corresponds to those with no structural brain injury visible on head CT. Positive likely corresponds to those with a structural brain injury visible on head CT. Equivocal may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.
· BrainScope TBI provides a measure of brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG), aiding in the evaluation of head injury as part of a multi-modal, multi-parameter assessment, in patients 18-85 years of age (have a GCS score of 13 - 15) who have sustained a closed head injury within the past 72 hours (3 days).
· The BrainScope TBI device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope TBI calculates and displays raw measures for the following standard QEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of EEG signals for interpretation by a qualified user.
· BrainScope TBI also provides clinicians with quantitative measures of cognitive performance in patients 13-85 years of age to aid in the assessment of an individual's level of cognitive function. These measures interact with the CI and can be used stand alone.
· BrainScope TBI also stores and displays electronic versions of standardized clinical assessment tools that should be used in accordance with the assessment tools' general instructions. These tools do not interact with any other device measures, and are stand alone.
Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for BrainScope. The word "Brain" is in blue, and the word "Scope" is in gray. There is a registered trademark symbol to the right of the word "Scope".
4330 East-West Highway.Suite 1000.Bethesda.Maryland.20814
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.Executive ChairmanBrainScope Company, Inc.Phone: (240) 752-7677Fax: (240) 752-7679Email: michael.singer@brainscope.com |
| Prepared By: | Sabyasachi Roy, Ph.D.Sr. Director Regulatory Affairs, Quality Assurance &Compliance |
| Device Proprietary Name: | BrainScope TBI (Model: Ahead 500) |
| 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 TBI (model: Ahead 400) (K183241) |
1 Prepared in accordance with 21 CFR § 807.87(h) and 21 CFR § 807.92(c). BrainScope TBI 510(k) Summary
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Device Description:
BrainScope TBI (model: Ahead 500) is a portable, non-invasive, non-radiation emitting, point of care device intended to provide results and measures to support clinical assessments and aid in the diagnosis of concussion / mild traumatic brain injury (mTBI). The BrainScope TBI includes a new multivariate classification algorithm that analyzes a patient's electroencephalogram (EEG), augmented by neurocognitive performance and selected clinical symptoms to compute a multi-modal index called the Concussion Index (CI). BrainScope TBI provides the healthcare provider with a multi-parameter measure to aid in the evaluation of concussion following a head injury within the past 72 hours (3 days). The BrainScope TBI (Ahead 500) retains all the capabilities of the predicate (BrainScope TBI, model: Ahead 400) including the Structural Injury Classification (SIC) and the Brain Function Index (BFI). It also contains configurable, selectable computerized cognitive performance tests and digitized standard clinical assessment tools intended to provide a multi-modal panel of measures to support the clinical assessment of concussion / mTBI.
Indications for Use:2
The BrainScope TBI's Indications for Use are as follows:
- BrainScope TBI is a multi-modal, multi-parameter assessment indicated for use as . an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury, and have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion/mild traumatic brain injury (mTBI)).
- . BrainScope TBI provides a multi-parameter measure (Concussion Index (CI)) to aid in the evaluation of concussion in patients between the ages of 13-25 years who present with a GCS score of 15 following a head injury within the past 72 hours (3 days), in conjunction with a standard neurological assessment of concussion. The CI is computed from a multivariate algorithm based on the patient's electroencephalogram (EEG), augmented by neurocognitive measures and selected clinical symptoms.
- The BrainScope TBI Structural Injury Classification ("SIC") uses brain electrical . activity (EEG) to determine the likelihood of structural brain injury visible on head CT for patients between the ages of 18-85 years (have a GCS score of 13 - 15), have sustained a closed head injury within the past 72 hours (3 days) who are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan. Negative likely corresponds to those with no structural brain injury visible on head CT. Positive likely corresponds to those with a structural brain injury visible on head CT. Equivocal may correspond to structural
2 The differences between the BrainScope TBI and its predicate do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the subject and predicate device have the same overall intended use.
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brain injury visible on head CT or may indicate the need for further observation or evaluation.
- BrainScope TBI provides a measure of brain function (EEG Brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG), aiding in the evaluation of head injury as part of a multi-modal, multi-parameter assessment, in patients 18-85 years of age (have a GCS score of 13 – 15) who have sustained a closed head injury within the past 72 hours (3 days).
- The BrainScope TBI device is intended to record, measure, analyze, and display . brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope TBI calculates and displays raw measures for the following standard QEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of EEG signals for interpretation by a qualified user.
- BrainScope TBI also provides clinicians with quantitative measures of cognitive . performance in patients 13-85 years of age to aid in the assessment of an individual's level of cognitive function. These measures interact with the CI and can be used stand alone.
- BrainScope TBI also stores and displays electronic versions of standardized . clinical assessment tools that should be used in accordance with the assessment tools' general instructions. These tools do not interact with any other device measures, and are stand alone,
| Proposed Device:BrainScope TBI, modelAhead 500(TBD) | Primary Predicate:BrainScope TBI, modelAhead 400(K183241) | Comments | |
|---|---|---|---|
| BrainScope TBI is a multi-modal, multi-parameterassessment indicated foruse as an adjunct tostandard clinical practice toaid in the evaluation ofpatients who have sustaineda closed head injury, andhave a Glasgow Coma Scale(GCS) score of 13-15(including patients withconcussion/mild traumaticbrain injury (mTBI)). | BrainScope TBI is a multi-modal, multi-parameterassessment indicated foruse as an adjunct tostandard clinical practice toaid in the evaluation ofpatients who have sustaineda closed head injury withinthe past 72 hours (3 days),are between the ages of 18-85 years, have a GlasgowComa Scale (GCS) score of13-15 (including patientswith concussion / mildtraumatic brain injury | Equivalent.Moved patient age range and72 hour time frame to SIC andBFI specific statements below.Moved statement regardingsubstitute for a CT scan to theSIC specific statement below. | |
| Proposed Device:BrainScope TBI, modelAhead 500(TBD) | Primary Predicate:BrainScope TBI, modelAhead 400(K183241) | Comments | |
| (mTBI)), and are beingconsidered for a head CT.BrainScope TBI should notbe used as a substitute for aCT scan. | |||
| BrainScope TBI provides amulti-parameter measure(Concussion Index (CI)) toaid in the evaluation ofconcussion in patientsbetween the ages of 13-25years who present with GCSof 15 following a head injurywithin the past 72 hours (3days), in conjunction with astandard neurologicalassessment of concussion.The CI is computed from amultivariate algorithm basedon the patient'selectroencephalogram(EEG), augmented byneurocognitive measuresand selected clinicalsymptoms. | BrainScope TBI provides ameasure of brain function(EEG Brain Function Index,(BFI)) for the statisticalevaluation of the humanelectroencephalogram(EEG), aiding in theevaluation of head injury aspart of a multi-modal, multi-parameter assessment. | Equivalent.The CI algorithm augmentspatient's EEG measures withneurocognitive performanceand selected clinicalsymptoms to compute a multi-modal index. This is consistentwith current clinical practice ofusing a multi-modal approachin concussion evaluation. TheCI expands upon the clinicalperformance of the BFI byassessing presence ofconcussion at time of injury. | |
| The BrainScope TBIStructural InjuryClassification ("SIC") usesbrain electrical activity (EEG)to determine the likelihood ofstructural brain injury visibleon head CT for patientsbetween the ages of 18-85years (have a GCS score of13 – 15), have sustained aclosed head injury within thepast 72 hours (3 days) whoare being considered for ahead CT. BrainScope TBIshould not be used as asubstitute for a CT scan.Negative likely correspondsto those with no structuralbrain injury visible on headCT. Positive likelycorresponds to those with astructural brain injury visible | The BrainScope TBIStructural InjuryClassification ("SIC") usesbrain electrical activity todetermine the likelihood ofstructural brain injury visibleon head CT. Negative likelycorresponds to those with nostructural brain injury visibleon head CT. Positive likelycorresponds to those with astructural brain injury visibleon head CT. Equivocal maycorrespond to structuralbrain injury visible on headCT or may indicate the needfor further observation orevaluation. | Equivalent.Included patient age range,GCS score, 72 hour timeframeand statement regardingsubstitute for a CT scan to theBrainScope TBI (Ahead 500)IFU for clarification. | |
| Proposed Device:BrainScope TBI, modelAhead 500(TBD) | Primary Predicate:BrainScope TBI, modelAhead 400(K183241) | Comments | |
| on head CT. Equivocal maycorrespond to structuralbrain injury visible on headCT or may indicate the needfor further observation orevaluation. | |||
| BrainScope TBI provides ameasure of brain function(EEG Brain Function Index,(BFI)) for the statisticalevaluation of the humanelectroencephalogram(EEG), aiding in theevaluation of head injury aspart of a multi-modal, multi-parameter assessment, inpatients 18-85 years of age(have a GCS score of 13 –15) who have sustained aclosed head injury within thepast 72 hours (3 days). | BrainScope TBI provides ameasure of brain function(EEG Brain Function Index,(BFI)) for the statisticalevaluation of the humanelectroencephalogram(EEG), aiding in theevaluation of head injury aspart of a multi-modal, multi-parameter assessment. | Equivalent.Age range, GCS score and 72hour timeframe added to theBrainScope TBI (Ahead 500)IFU for clarification. | |
| The BrainScope TBI deviceis intended to record,measure, analyze, anddisplay brain electricalactivity utilizing thecalculation of standardquantitative EEG (QEEG)parameters from frontallocations on a patient'sforehead. The BrainScopeTBI calculates and displaysraw measures for thefollowing standard QEEGmeasures: Absolute andRelative Power, Asymmetry,Coherence and FractalDimension. These rawmeasures are intended to beused for post hoc analysis ofEEG signals forinterpretation by a qualifieduser. | The BrainScope TBI deviceis intended to record,measure, analyze, anddisplay brain electricalactivity utilizing thecalculation of standardquantitative EEG (QEEG)parameters from frontallocations on a patient'sforehead. The BrainScopeOne calculates and displaysraw measures for thefollowing standard QEEGmeasures: Absolute andRelative Power, Asymmetry,Coherence and FractalDimension. These rawmeasures are intended to beused for post hoc analysis ofEEG signals forinterpretation by a qualifieduser. | Same as predicate. | |
| BrainScope TBI alsoprovides clinicians withquantitative measures of | BrainScope TBI alsoprovides clinicians withquantitative measures of | Equivalent.Ahead 500 IFU statement wasmodified in two ways: | |
| Proposed Device:BrainScope TBI, modelAhead 500(TBD) | Primary Predicate:BrainScope TBI, modelAhead 400(K183241) | Comments | |
| cognitive performance inpatients 13-85 years of ageto aid in the assessment ofan individual's level ofcognitive function. Thesemeasures interact with theCl and can be used standalone. | cognitive performance to aidin the assessment of anindividual's level of cognitivefunction. These measures donot interact with any otherdevice measures, and arestand alone. | • Specifying the intendedage group of 13-85years as cleared underpredicate's 510(k)K183241.• Clarification that sincethe CI includescognitive performanceinputs and they dointeract with EEGmeasures to produceCI. The cognitiveperformanceassessments can alsobe used standalone. | |
| BrainScope TBI also storesand displays electronicversions of standardizedclinical assessment toolsthat should be used inaccordance with theassessment tools' generalinstructions. These tools donot interact with any otherdevice measures, and arestand alone. | BrainScope TBI also storesand displays electronicversions of standardizedclinical assessment toolsthat should be used inaccordance with theassessment tools' generalinstructions. These tools donot interact with any otherdevice measures, and arestand alone. | Same as predicate. | |
| Topic /Area | Proposed Device:BrainScope TBI,model : Ahead 500 | Predicate:BrainScope TBI,model: Ahead 400(K183241) | Comments |
| Platform | Trimble T41 mobiledevice, Android OS | Trimble T41 mobiledevice, Android OS | Same as predicate. |
| ProcessedEEGBandwidth | 1kHz sampled data withDC to 300Hz bandwidthand 100Hz sampleddata with 0.67Hz to43Hz bandwidth | 1kHz sampled data withDC to 300Hz bandwidthand 100Hz sampleddata with 0.67Hz to43Hz bandwidth | Same as predicate. |
| CommonModeRejectionRatio(CMRR) | < -100 dB (or better) | < -100 dB (or better) | Same as predicate. |
| SystemNoiseFloor | < 0.4 µV in 0.67 Hz to43Hz bandwidth | < 0.4 µV in 0.3 Hz to43Hz bandwidth | Same as predicate. |
| ADCResolution | 45 nV/bit | 45 nV/bit | Same as predicate. |
| ADCSamplingRate | 1000 Hz, down sampledto 100 Hz for algorithmprocessing | 1000 Hz, down sampledto 100 Hz for algorithmprocessing | Same as predicate. |
| ElectrodePlacementSystem | The International 10-20System | The International 10-20System | Same as predicate. |
| ElectrodePositionsUtilized | Fp1, Fp2, Fpz, AFz, F7,F8, A1, A2 | Fp1, Fp2, Fpz, Afz, F7,F8, A1, A2 | Same as predicate. |
| ElectrodeMaterial | Single use Ag/AgClelectrode sensor arrayheadset with solid gel | Single use Ag/AgClelectrode sensor arrayheadset with solid gel | Same as predicate. |
| Real TimeEEGDisplay | Yes | Yes | Same as predicate. |
| EEGBasedClassificationAlgorithms | SIC with three tier•classification outputs(Negative, Equivocaland Positive)BFI•CI | SIC with three tier•classification outputs(Negative, Equivocaland Positive)BFI• | Equivalent.Both devices share identicalSIC and BFI algorithms.In addition, the BrainScopeTBI (Ahead 500) includesthe new multivariatealgorithm to compute CI. |
Table 1: Indications for Use Comparison to Predicate device
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Image /page/9/Picture/8 description: The image shows the logo for BrainScope. The word "Brain" is in blue, and the word "Scope" is in gray. There is a registered trademark symbol to the upper right of the word "Scope".
Comparison of Technological Characteristics with the Predicate Device:
BrainScope TBI (model: Ahead 500) has similar technological characteristics as the legally marketed predicate device. BrainScope TBI includes the following modifications when compared to the predicate (BrainScope TBI, model: Ahead 400):
- . The Concussion Index (CI) is derived from a multivariate classification algorithm that analyzes a patient's EEG, augmented by neurocognitive performance and selected clinical symptoms to compute a multi-modal index for patients 13 - 25 years of age, with a GCS of 15. The Cl aids the trained healthcare provider in evaluating a patient for concussion within 3 days of head injury.
The EEG-based Structural Injury Classification (SIC) and Brain Function Index (BFI) algorithms in both devices are limited to the FDA-authorized age range of 18 to 85 years (Adolescent subgroup and Adult age patients).
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The minor technological differences between BrainScope TBI (Ahead 500) and the predicate do not raise new questions of safety and effectiveness, and performance data demonstrates that the BrainScope TBI is as safe and effective as the predicate.
BrainScope TBI (Ahead 500) is substantially equivalent to the predicate BrainScope TBI (Ahead 400).
| Table 2, Technological Comparison to Predicate Device | ||||
|---|---|---|---|---|
| Topic /Area | Proposed Device:BrainScope TBI,model : Ahead 500 | Predicate:BrainScope TBI,model: Ahead 400(K183241) | Comments | |
| CognitivePerformance Tests | Procedural Reaction Time Match to Sample Simple Reaction Time Go/No-Go Simple Reaction Time Test Repeated Device has ability to compare patient'scognitive performanceand produce a ReliableChange Index (RCI).Tests includeAdolescent and Adultages of 13 - 85 years. | Procedural Reaction Time Match to Sample Simple Reaction Time Go/No-Go Simple Reaction Time Test Repeated Device has ability to compare patient'scognitive performanceand produce a ReliableChange Index (RCI).Tests includeAdolescent and Adultages of 13 - 85 years. | Same as predicate. | |
| StandardClinicalAssessments | Multiple electronicversion of "paper andpencil" based standardclinical assessments ofconcussion such as:PECARN | Multiple electronicversion of "paper andpencil" based standardclinical assessments ofconcussion such as:PECARN | Equivalent. | |
| ResultsPresentation andReportingFeatures | Specific raw measures.EEG playback.Structural injuryclassification, brainfunction index (BFI)Concussion Index (CI)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.BrainScope TBI (Ahead500) includes additional Clrelated results andreporting. | |
| Software | BrainScope TBIimplements its softwarewith low-levelmodifications to theT41's off-the-shelfconfiguration and akiosk mode applicationrunning on Android 4.1. | BrainScope TBIimplements its softwarewith low-levelmodifications to theT41's off-the-shelfconfiguration and akiosk mode applicationrunning on Android 4.1. | Equivalent.Updated architecture toimprove devicemaintainability, scalabilityand to support the new CIfunctionality. | |
| GraphicalUserInterface | BrainScope developedUI leveraging AndroidFrameworks. | BrainScope developedUI leveraging AndroidFrameworks. | Equivalent.New CI functionalityincluded. | |
| Topic /Area | Proposed Device:BrainScope TBI,model : Ahead 500 | Predicate:BrainScope TBI,model: Ahead 400(K183241) | Comments | |
| TestReporting | Test output for EEG andstandardizedassessments can beconfigured to meet userrequirements includingdisabling tests andredaction of personallyidentifiable information | Test output for EEG andstandardizedassessments can beconfigured to meet userrequirements includingdisabling tests andredaction of personallyidentifiable information | Same as predicate. | |
| DataManagement | All data stored (binaryformat) to non-volatilememory.Data available via USBand wirelessconnection.Certificate basedauthentication for wirelesscommunication | All data stored (binaryformat) to non-volatilememory.Data available via USBand wirelessconnection. | Equivalent.BrainScope TBI (model:Ahead 500) enables securecommunication with cloudbased infrastructure to supportdata synchronization. | |
| Connectivity | USB 2.0 Full-Speed GPS Wi-Fi: 802.11b/g/n, 2.4 GHz band All other interfaces disabled in software | USB 2.0 Full-Speed GPS Wi-Fi: 802.11b/g/n, 2.4 GHz band All other interfaces disabled in software | Equivalent. | |
| Encryption | AES-128 for intra-device communicationAES-256 for encryptedfiles | AES-128 for intra-device communicationAES-256 for encryptedfiles | Same as predicate. |
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BrainScope TBI 510(k) Summary
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Performance Data:
Clinical performance data was submitted to support the device modification made to the predicate. Validation data analysis was performed on 580 subjects across 10 US clinical sites including High Schools, Colleges and Concussion Clinics. The validation study population included subjects ages 13.09 - 25.93 years, with mean=19.52 (SD=2.28, median=19.71), 53.62% male, with a mean time since injury for Day 0 evaluation was 45.75 hours (SD=22.66, median=47.75). All subjects had GCS score of 15. Of these 580 subjects, there were 229 matched controls, 144 healthy volunteers and 207 subjects who sustained closed head injury and were removed from play. These subjects were divided into 3 groups: healthy, non-head injured subjects (pre-season baselines only), subjects with witnessed head injury, and matched controls (tested at 3 time points relative to those of their injured matched subject). Device performance was studied in subjects who were either removed from play, and were therefore deemed to have had a concussion, or were matched controls and healthy volunteers. The clinical reference standard incorporated elements from the guidelines published in International Conference on Concussion in BrainScope TBI 510(k) Summary 9
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Sport quidelines (McCrory 2017;2013) as well as National Collegiate Athletic Association (NCAA) concussion policy.
The co-primary endpoints of the study were the sensitivity and specificity based on a cutoff (threshold) CI derived from an algorithm development study that was independent of the validation study. The validation study sought to determine if the subject's CI was consistent with similar changes seen in subjects with concussion. This primary endpoint validates the clinical utility of the EEG-based, multimodal Concussion Index (CI) as an aid in evaluation of concussion in subjects ages 13-25 years who sustained a closed head injury.
The performance qoals that were defined in the Statistical Analysis Plan (SAP) for the coprimary endpoints were 0.69 for sensitivity and 0.565 for specificity. The observed performance of the Clinical validation study was sensitivity of 0.8599 with 95% confidence limits of (0.8050, 0.9041) and specificity of 0.7078 with 95% confidence limits of (0.6588, 0.7535).
Analysis of the study results demonstrated that the change in Cl over time, measured at a population level in the non-head injured population, demonstrate that the Cl is a stable measure and that the change can be interpreted reliably.
The validation study achieved the pre-specified performance targets for the primary endpoint. Additional analyses demonstrated that the CI discriminant score and the 22question Concussion Symptom Inventory (CSI) total score had a correlation of (r = 0.7971, R2 = 0.6354). The Cland the 12-question CSI total score had a correlation of (r = 0.8047, R2 = 0.6475).
These new modifications did not impact existing device functionality including core EEG based Structural Injury Classifier (SIC) and Brain Function Index (BFI) algorithms. The BrainScope TBI device conforms to all 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:
- IEC 60601-1/A1:2012 Medical Electrical Equipment Part 1: General o Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2 Edition 4.0 2014 General requirements for basic safety and o 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
- ANSI/AAMI EC12:2000/(R)2010 Disposable ECG Electrodes o
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- ANSI/AAMI/ISO 10993-1:2009 Biological evaluation of medical devices o Part 1: Evaluation and testing within a risk management process
- ANSI/AAMI/ISO 10993-5:2009 Biological Evaluation of Medical Devices o Part 5: Tests for In Vitro Cytotoxicity
- 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
- ASTM D4169 09. Standard Practice for Performance Testing of Shipping o Containers and Systems
Conclusion:
The BrainScope TBI (model: Ahead 500) device has the same intended use as the legally marketed predicate (BrainScope TBI. model: Ahead 400). The BrainScope TBI device has similar technological characteristics as the predicate. The differences in technological characteristics do not raise new questions of safety and effectiveness and performance data demonstrate that the BrainScope TBI (Ahead 500) is as safe and effective as the predicate.
§ 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.