Summary of Indications for Use

 

•  BrainScope 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 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 a stable measure and change over time can be interpreted reliably. 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 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.

  • A negative SIC result likely corresponds to those with no structural brain injury visible on head CT.
  • A positive SIC result likely corresponds to those with a structural brain injury visible on head CT.
  • An equivocal SIC result may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.

•  BrainScope 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 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. BrainScope 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 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 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.

Department of Health and Human Services

Food and Drug Administration Indications for Use

510(k) Number: K190815 image-png-Feb-09-2021-03-09-15-53-AM

 

 

Please contact us with additional questions at customercare@brainscope.com or 855.927.2461