BraiN20® (BraiN20)
Time IS Brain, S.L.BraiN20® is a portable, non-invasive medical device that helps clinicians monitor neurological status by recording and analyzing somatosensory evoked potentials (SSEP), specifically the N20 cortical response. It stimulates and records electrical signals in real-time, providing objective data on nerve function, which assists in neurological monitoring during clinical assessments.
Intended Use
The BraiN20® is intended for use in monitoring neurological status by recording the N20 response of somatosensory evoked potentials (SSEP).
Technology
BraiN20® is an active, portable, non-invasive medical device incorporating embedded software, rechargeable batteries, stimulation and signal acquisition electronics, and an integrated touchscreen for user interface. It delivers controlled electrical stimulation and synchronously acquires electrophysiological signals through disposable electrodes for transient use (<24 hours). Embedded software analyzes signals in real time to identify and measure the N20 SSEP response, displaying results on the device.
Performance
Performance testing included electrical safety (IEC 60601-1, IEC 60601-2-10, IEC 60601-2-40), electromagnetic compatibility (IEC 60601-1-2), software verification (IEC 62304), biocompatibility testing (ISO 10993 series), bench performance (including signal acquisition and stimulation), shelf-life testing supporting 24-month component shelf life, and usability testing per IEC 62366-1 and IEC 60601-1-6. No clinical studies were required.
Predicate Devices
No predicate devices specified
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