Brainscope Ahead 200
BRAINSCOPE COMPANY, INC.The BrainScope Ahead 200 is a portable EEG device designed to aid physicians in evaluating patients with mild traumatic brain injury by measuring and analyzing brain electrical activity. It supports clinical decision-making regarding the need for head CT scans by providing objective quantitative EEG parameters. The device is intended for use as an adjunct to standard clinical practice and includes features such as continuous impedance monitoring and cognitive assessment tools for military use. It helps clinicians by providing rapid brain activity data to support the assessment of brain injury severity without replacing imaging such as CT scans.
Intended Use
The Ahead 200 is indicated as an adjunct to standard clinical practice to aid evaluation of patients considered for head CT after closed head injury, presenting as mild traumatic brain injury within 24 hours, ages 18-80. It is not a substitute for CT and is for physicians trained in device use.
Technology
The device is a portable, non-invasive EEG system composed of a handheld unit and disposable electrode headset. It records, processes, and analyzes frontal EEG signals using standard quantitative EEG parameters such as absolute power, relative power, asymmetry, coherence, and fractal dimension. The system uses the Harmony classification algorithm to assist diagnosis. There are two models, military (M-200) including Military Acute Concussion Evaluation (MACE) cognitive tests, and civilian (CV-200).
Performance
Performance testing included software and hardware verification, system performance validation, algorithm performance, safety and electromagnetic compatibility testing, biocompatibility, and reliability assessments. The device met applicable standards including IEC 60601-1, IEC 60601-2-26, ISO 10993-1, and ANSI/AAMI EC12. Testing demonstrated substantial equivalence to the predicate device, the BrainScope Ahead 100.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/22/2014
4 months - 2
FDA Approval
5/15/2015
Other devices from BRAINSCOPE COMPANY, INC.
- BrainScope TBI2019 • 510K
- Ahead 3002016 • 510K
- BrainScope Ahead 1002014 • DE NOVO
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