Inbentus Versatile

The INBENTUS VERSATILE is a multi-purpose ventilator that provides invasive (via endotracheal tube) and non-invasive (via mask) ventilatory support to adult, pediatric, and neonatal patients in hospital settings and during patient transport within facilities. It features a 15.6-inch touchscreen monitor and ventilation unit, operates on AC power and lithium-ion batteries, and is designed to be used only by qualified healthcare personnel.

The subject device has similar intended use, design dimensions, functions, and performance specifications as the Hamilton-C6 predicate. Key differences include absence of optional features (high flow oxygen therapy, pulse oximetry, and capnography). Both devices use identical methods for gas pressurization (internal turbine for air, compressed oxygen source), support the same ventilation modes for invasive and non-invasive therapy, and include comparable safety measures and alarm systems.

ISO 18562-1, ISO 18562-2, ISO 18562-3 (biocompatibility and emissions), IEC 62304 (software lifecycle), IEC 60601-1, IEC 60601-1-2, IEC TR 60601-4-2 (electrical and EMC safety), ISO 80601-2-12 (critical care ventilators), ISO 80601-2-55 (respiratory gas monitors), and IEC 62366-1 (usability).

The INBENTUS VERSATILE is substantially equivalent to the Hamilton-C6 predicate device because it shares identical intended use (invasive and non-invasive ventilation for adult, pediatric, and neonatal patients in hospitals), product classification code (CBK), CFR citation (21 CFR 868.5895), and comparable technological characteristics including ventilation modes, safety features, and performance. The absence of optional functionalities does not impact the intended use or safety and effectiveness of the core device.