Nurochek-Pro System

The Nurochek-Pro System is a wearable headset system that generates visual evoked potentials (VEPs) and records electroencephalograms (EEGs) to aid in diagnosing mild traumatic brain injury (mTBI) in patients aged 12–44 years within 120 hours of head injury. It is used in healthcare facilities as a prescription device in conjunction with standard neurological assessment.

The subject device uses a Windows desktop application with mains power supply via USB-A, compared to the predicate's mobile application with rechargeable battery. Both systems have identical EEG electrode configurations (3 recording, 1 reference, 1 ground in the occipital lobe), same programmable gain amplifier settings, and produce the same outputs (EEG, electrode contact quality, mTBI likelihood assessment). The subject device connects via wired USB-A whereas the predicate uses Bluetooth wireless.

Biocompatibility per ISO 10993-5:2009 and ISO 10993-10:2010; software development per IEC 62304; electromagnetic compatibility and electrical safety per IEC 60601-1:2012, IEC 60601-1-2:2014, and IEC 60601-2-40:2016.

Both devices share nearly identical design, indications, and clinical performance characteristics—sensitivity 85.51% vs. 86.05% and specificity 67.05% vs. 67.16%. The only material differences are the power source (mains vs. battery) and connectivity method (wired vs. wireless), neither of which affect the core function of VEP generation, EEG acquisition, or mTBI analysis algorithms. The predicate has not been subject to design-related recalls, and the subject device's performance metrics are substantially comparable, demonstrating no different safety or effectiveness questions.