(166 days)
The text explicitly states "Reference Device(s) Not Found". Therefore, there are no reference devices to list from the provided text.
Yes
The device description explicitly mentions a "new multivariate classification algorithm" used to compute the Concussion Index (CI) from EEG, neurocognitive performance, and clinical symptoms. While not explicitly stating "AI" or "ML," a multivariate classification algorithm is a common technique used in machine learning for pattern recognition and prediction based on multiple input variables. The description of validation studies with training and test sets further supports the use of a data-driven algorithmic approach consistent with ML.
No
The device is indicated for use as an "aid in the evaluation" and "clinical assessment" of concussion/mTBI, not for treatment.
Yes
The "Intended Use / Indications for Use" section states that the device is "indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury." It also provides a "multi-parameter measure (CI)) to aid in the evaluation of concussion" and uses "brain electrical activity (EEG) to determine the likelihood of structural brain injury visible on head CT". The "Device Description" also explicitly states it is "intended to provide results and measures to support clinical assessments and aid in the diagnosis of concussion / mild traumatic brain injury (mTBI)". These phrases explicitly indicate that the device is used to diagnose or aid in the diagnosis of certain conditions, classifying it as a diagnostic device.
No
The device description explicitly states that the BrainScope TBI (model: Ahead 500) is a "portable, non-invasive, non-radiation emitting, point of care device" and 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." This indicates the device includes hardware for acquiring EEG data, making it more than just software.
Based on the provided information, the BrainScope TBI device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The core function of an IVD is to examine samples like blood, urine, tissue, etc., outside of the body to provide information about a person's health.
- BrainScope TBI analyzes brain electrical activity (EEG). The device directly measures electrical signals from the patient's forehead. While this is a physiological measurement, it does not involve the analysis of a specimen removed from the body.
- The intended use and device description focus on non-invasive measurement and analysis of brain activity. The device is described as "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)." This aligns with a device that interacts directly with the patient, not with a biological sample.
Therefore, the BrainScope TBI falls under the category of a medical device that performs physiological measurements and analysis, rather than an In Vitro Diagnostic.
No
The provided text explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found". There is no mention of the FDA reviewing or clearing a PCCP for this device, which is required for a 'Yes' answer.
Intended Use / Indications for Use
- BrainScope TBI is a multi-modal, multi-parameter assessment indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury, and have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion/mild traumatic brain injury (mTBI)).
- BrainScope TBI provides a multi-parameter measure (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 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.
Product codes
PIW, PKQ, OLU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Electroencephalogram (EEG)
Anatomical Site
Brain/Head (Forehead for EEG parameters)
Indicated Patient Age Range
- 13-25 years for Concussion Index (CI)
- 18-85 years for Structural Injury Classification (SIC) and Brain Function Index (BFI)
- 13-85 years for cognitive performance measures
Intended User / Care Setting
Trained healthcare provider / Point of care setting (e.g., High Schools, Colleges, Concussion Clinics)
Description of the training set, sample size, data source, and annotation protocol
A cutoff (threshold) CI was derived from an algorithm development study that was independent of the validation study. No further details provided.
Description of the test set, sample size, data source, and annotation protocol
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 Sport quidelines (McCrory 2017;2013) as well as National Collegiate Athletic Association (NCAA) concussion policy.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance data was submitted to support the device modification.
Study Type: Clinical validation study
Sample Size: 580 subjects
Co-primary endpoints: sensitivity and specificity based on a cutoff CI.
Performance goals (defined in SAP): sensitivity 0.69, specificity 0.565.
Observed performance: sensitivity 0.8599 (95% CI: 0.8050, 0.9041), specificity 0.7078 (95% CI: 0.6588, 0.7535).
Key Results: The validation study achieved the pre-specified performance targets for the primary endpoint. Analysis demonstrated that the change in CI over time, measured at a population level in the non-head injured population, demonstrate that the CI is a stable measure and that the change can be interpreted reliably.
Additional analyses: The CI discriminant score and the 22-question Concussion Symptom Inventory (CSI) total score had a correlation of (r = 0.7971, R2 = 0.6354). The CI and the 12-question CSI total score had a correlation of (r = 0.8047, R2 = 0.6475).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.8599 (95% CI: 0.8050, 0.9041)
Specificity: 0.7078 (95% CI: 0.6588, 0.7535)
Predicate Device(s)
BrainScope TBI (model: Ahead 400) (K183241)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 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 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
1
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
2
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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3
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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 #1000
Bethesda, MD 20814
Phone: (240) 752-7680
Fax: (240) 752-7679
www.brainscope.com |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michael E. Singer, Ph.D.
Executive Chairman
BrainScope Company, Inc.
Phone: (240) 752-7677
Fax: (240) 752-7679
Email: 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 Interpretive
Electroencephalograph Assessment Aid |
| Device Classification Name: | Brain Injury Adjunctive Interpretive
Electroencephalograph Assessment Aid |
| Classification Regulation: | 21 CFR § 882.1450 |
| Panel: | Neurology |
| Product Codes: | PIW, PKQ, OLU |
| Predicate 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
5
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.
6
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, model
Ahead 500
(TBD) | Primary Predicate:
BrainScope TBI, model
Ahead 400
(K183241) | Comments | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BrainScope TBI is a multi-
modal, multi-parameter
assessment indicated for
use as an adjunct to
standard clinical practice to
aid in the evaluation of
patients who have sustained
a closed head injury, and
have a Glasgow Coma Scale
(GCS) score of 13-15
(including patients with
concussion/mild traumatic
brain injury (mTBI)). | 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 | Equivalent.
Moved patient age range and
72 hour time frame to SIC and
BFI specific statements below.
Moved statement regarding
substitute for a CT scan to the
SIC specific statement below. | |
| Proposed Device:
BrainScope TBI, model
Ahead 500
(TBD) | Primary Predicate:
BrainScope TBI, model
Ahead 400
(K183241) | Comments | |
| | (mTBI)), and are being
considered for a head CT.
BrainScope TBI should not
be used as a substitute for a
CT scan. | | |
| 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 GCS
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. | 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. | Equivalent.
The CI algorithm augments
patient's EEG measures with
neurocognitive performance
and selected clinical
symptoms to compute a multi-
modal index. This is consistent
with current clinical practice of
using a multi-modal approach
in concussion evaluation. The
CI expands upon the clinical
performance of the BFI by
assessing presence of
concussion at time of injury. | |
| 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 | 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. | Equivalent.
Included patient age range,
GCS score, 72 hour timeframe
and statement regarding
substitute for a CT scan to the
BrainScope TBI (Ahead 500)
IFU for clarification. | |
| Proposed Device:
BrainScope TBI, model
Ahead 500
(TBD) | Primary Predicate:
BrainScope TBI, model
Ahead 400
(K183241) | Comments | |
| 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, 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). | 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. | Equivalent.
Age range, GCS score and 72
hour timeframe added to the
BrainScope TBI (Ahead 500)
IFU for clarification. | |
| 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. | 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
One calculates and displays
raw measures for the
following standard QEEG
measures: Absolute and
Relative Power, Asymmetry,
Coherence and Fractal
Dimension. These raw
measures are intended to be
used for post hoc analysis of
EEG signals for
interpretation by a qualified
user. | Same as predicate. | |
| BrainScope TBI also
provides clinicians with
quantitative measures of | BrainScope TBI also
provides clinicians with
quantitative measures of | Equivalent.
Ahead 500 IFU statement was
modified in two ways: | |
| Proposed Device:
BrainScope TBI, model
Ahead 500
(TBD) | Primary Predicate:
BrainScope TBI, model
Ahead 400
(K183241) | Comments | |
| 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
Cl and can be used stand
alone. | 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. | • Specifying the intended
age group of 13-85
years as cleared under
predicate's 510(k)
K183241.
• Clarification that since
the CI includes
cognitive performance
inputs and they do
interact with EEG
measures to produce
CI. The cognitive
performance
assessments can also
be used standalone. | |
| 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 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. | Same as predicate. | |
| Topic /
Area | Proposed Device:
BrainScope TBI,
model : Ahead 500 | Predicate:
BrainScope TBI,
model: Ahead 400
(K183241) | Comments |
| Platform | Trimble T41 mobile
device, Android OS | Trimble T41 mobile
device, Android OS | Same as predicate. |
| Processed
EEG
Bandwidth | 1kHz sampled data with
DC to 300Hz bandwidth
and 100Hz sampled
data with 0.67Hz to
43Hz bandwidth | 1kHz sampled data with
DC to 300Hz bandwidth
and 100Hz sampled
data with 0.67Hz to
43Hz bandwidth | Same as predicate. |
| Common
Mode
Rejection
Ratio
(CMRR) |