EveryWare

EveryWare is a cloud-based platform that collects and displays patient treatment data from Breas respiratory devices via cellular modem. It enables healthcare representatives to remotely view patient data and adjust prescription and performance settings on compatible non-life support therapy devices. It is intended for use in hospital, institutional, provider, and home care settings.

EveryWare is a web-based data management system with wireless cellular connectivity to compatible therapy devices. It supports remote prescription and performance setting changes for MNS and MNT product codes but does not allow ventilation mode changes. It lacks humidifier settings capability compared to predicates. Data transfer occurs via cellular modem, SD card, or internet file upload.

IEC 60601-1 Edition 3.2:2020 (general safety and essential performance), IEC 60601-1-2 Edition 4.1:2020 (electromagnetic disturbances), IEC 62304 Edition 1.1 2015 (software lifecycle processes), FDA guidance on device software, off-the-shelf software, cybersecurity, and human factors engineering.

EveryWare shares the same intended use as AirView and Care Orchestrator—supporting clinicians in managing patient data and remotely adjusting non-life support device settings. Although EveryWare lacks therapy mode change and humidifier setting capabilities present in predicates, these omissions do not raise new safety or effectiveness questions. The device uses the same web-based platform architecture and similar wireless connectivity approach. No additional technological features are present that are not already cleared in the predicates.