New Wave System

The New Wave System is an electroencephalograph (EEG) device intended for prescription use in outpatient healthcare facilities or home settings to acquire, transmit, display, and store EEG and optional auxiliary signals (ECG, EOG, EMG, orientation sensor data, photic sensor data, external trigger signals, and video) for adults and children, excluding newborns. The device is limited to short-term recordings up to 2.5 hours and uses 19 EEG electrodes plus up to 8 auxiliary inputs.

The New Wave shares identical core EEG acquisition performance with the predicate Flexset System: 19-channel electrode configuration, 500 Hz sampling rate, 24-bit A/D conversion, approximately 1 μV RMS noise, active dry Ag/AgCl electrodes, flexible semi-rigid headset architecture, and wireless communication (Wi-Fi and LTE). Minor differences include a higher capacity 5000 mAh battery (versus 3950 mAh) supporting 2.5-hour operation, a commercial-grade charger instead of medical-grade, upgraded 5G Hz LTE capability, and reduced internal storage (25 hours versus 250 hours), all appropriate for the narrower intended use.

IEC 60601-1 (medical device safety requirements) is cited as the internal safety standard. ISO 13485 clauses 7.3, 8.3, 8.5.2, 8.5.3, and 4.2.3 are referenced for quality management system requirements. The 10-20 EEG system standard is mentioned for electrode positioning compliance.

The New Wave is substantially equivalent to the predicate Flexset System (K233403) because both devices share identical technological characteristics, signal acquisition performance, and clinical functionality for EEG measurement. The only differences are a narrower intended use environment (home and outpatient healthcare facilities only versus broader healthcare/transport settings) and reduced recording duration (2.5 hours versus 6-7 hours), which represent a subset of the predicate's approved scope and do not introduce new safety or effectiveness questions. No software validation or clinical testing was required because the firmware and software are materially unchanged from the predicate.