UB ERP System
Universal BrainThe UB ERP System from Universal Brain is a medical device that records and analyzes electrical signals from the brain using electrodes placed on the head. It captures and presents EEG signals and event-related potentials to assist clinicians in diagnosing brain activity-related conditions. The system includes hardware EEG caps with dry and disposable electrodes and software running on a Windows PC to acquire, analyze, and generate reports from brain electrical activity data. It enhances clinical workflow by providing automated ERP reports but requires expert interpretation of the results.
Intended Use
Intended for acquisition, display, analysis, storage, and reporting of electrical activity of a patient’s brain, including EEG signals and ERPs, obtained by placing electrodes on the head of adults and adolescents to aid in diagnosis in healthcare facilities under professional supervision.
Technology
The device consists of an EEG Cap with dry and disposable electrodes, an electronics module for amplification and signal processing, connected via USB to a Windows PC running Neurotique-2 software that presents stimuli, collects EEG data, analyzes event-related potentials, and generates ERP reports automatically. Differences from predicates include fewer channels, use of dry electrodes, additional ERP tasks, and photodiode for signal timing accuracy; these differences do not raise new safety or efficacy questions.
Performance
The device passed electrical safety, EMC, electroencephalograph, and software verification testing per relevant IEC standards. Clinical testing showed safe and effective measurement of brain EEG and P300 ERPs in 80% of participants across multiple ERP tasks. Blink detection and usability assessments confirmed accurate artifact correction and clear user interface. Overall, the device demonstrated substantial equivalence to predicate devices and is safe and effective for intended clinical use.
Predicate Devices
No predicate devices specified
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