WAVE Clinical Platform (2.0.000)

The WAVE Clinical Platform 2.0 is software that receives, stores, routes, and displays physiological data, waveforms, alarms, and diagnostic information from hospital medical devices, electronic medical records (EMR), and clinical information systems (CIS). It is intended for use by healthcare professionals in hospital environments to remotely consult on patient conditions and review critical patient data to aid clinical decision-making. The platform supplements but does not replace the hospital's primary monitoring or data management systems.

The proposed device adds two new applications (AlarmView and AlarmNotification) for customer interface improvements compared to the predicate version 1.0, which had only PatientWatch and TeleTrend. Both versions use standard computers, network, and WiFi technology; utilize existing hospital server hardware or pre-loaded servers; and function as secondary annunciation means without controlling connected medical devices. The fundamental architecture, data routing, storage, and display capabilities remain substantially the same.

ISO 14971 (Risk Management for Medical Devices), IEC 62366-1 (Usability Engineering for Medical Devices), IEC 60601-8 (Alarm Systems for Medical Equipment). The submission also references FDA guidance documents on software validation, cybersecurity for networked medical devices, and human factors engineering.

The WAVE Clinical Platform 2.0 is substantially equivalent to its predicate (version 1.0, K171056) because both have identical intended use, the same regulatory classification (21 CFR 870.2300), comparable functionality for data display and alarm annunciation, and the additional applications do not affect the intended use or fundamental scientific technology. Non-clinical testing including verification and validation testing demonstrates comparable performance to the predicate device.