Mariana Minerva; Mariana Nimbus

The Mariana Minerva and Mariana Nimbus are non-invasive ventilation (NIV) devices that deliver pressurized air to patients with respiratory impairment or obstructive sleep apnea. They use a microprocessor-controlled blower with pressure and flow sensors, include optional heated humidification, provide therapeutic and technical data display, and are intended for home and hospital use in patients weighing over 30 lb (13 kg), or over 66 lb (30 kg) in iVAPS mode.

Both devices are substantially identical to the predicate Juno VPAP ST-A in core design: microprocessor-controlled centrifugal blower, same pressure ranges (4-20 cmH2O CPAP, 3-30 cmH2O bi-level), identical therapy modes (CPAP, S, ST, PAC, iVAPS with AutoEPAP), matching alarm functions, and integrated heated humidification. Minor differences include an LCD touch screen instead of dial/buttons, addition of Bluetooth wireless connectivity, lack of Timed Mode and external battery support (appropriate for non-dependent patients), and updated compliance to ISO 80601-2-70/74/79 standards.

IEC 60601-1 Edition 3.2:2020, IEC 60601-1-2:2014+AMD1:2021, IEC 60601-1-6 Edition 3.2:2020, IEC 60601-1-8:2006+AMD2:2021, IEC 60601-1-11:2020, ISO 80601-2-70, ISO 80601-2-74, ISO 80601-2-79, ISO 10993-1:2018, and ISO 18562-1:2024.

The Mariana devices have identical intended use and indications to the predicate Juno VPAP ST-A (non-invasive ventilation for respiratory impairment/OSA). All technological differences (touch screen, Bluetooth, removal of Timed Mode, no external battery) are non-clinical design choices that do not impact safety or efficacy. Bench testing confirms the devices meet all applicable consensus standards and perform identically to the predicate in therapy modes and functions.