VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)

The VentStar Resus heated (N) and VentStar Autobreath heated (N) are disposable, single-limb heated breathing circuits with integrated humidifier chambers designed for neonatal resuscitation and short-term ventilation in patients up to 10 kg body weight. They connect to the Fisher & Paykel MR850 humidifier and deliver humidified, heated breathing gas with adjustable positive end-expiratory pressure (PEEP) to patients via mask, laryngeal mask, or endotracheal tube.

Both devices feature electrical heating wires embedded in the hose walls to maintain gas temperature, 12 mm inner diameter breathing tubing, ISO 5356-1 conical connectors, and integrated PEEP valves—manual on the Resus model and automatic (controlled by resuscitation module) on the Autobreath model. Key differences from predicates include the addition of heating capability, a 1.8 m inspiratory line length (versus 1.0–1.6 m for predicates), and materials including PP, TPO, ABS, and aluminum in the humidifier chamber.

ISO 5367 (breathing sets), ISO 80601-2-74 (respiratory humidifying equipment), ISO 10651-5 (gas-powered emergency resuscitators), ISO 5356-1 (conical connectors), ISO 80369-1 (small-bore connectors), ISO 18190 (airways), IEC 60601-1 and IEC 60601-1-2 (electrical safety and EMC), ISO 10993 series (biocompatibility), ISO 18562 series (breathing gas pathway biocompatibility), and ISO 14971 (risk management).

The devices have identical intended use (neonatal short-term resuscitation with humidified gas and PEEP), patient population (≤10 kg), and fundamental technology (disposable breathing circuits with connectors and valves) as the Fisher & Paykel 900RD010 and Dräger MP02608 predicates. The addition of integrated heating represents an incremental enhancement in performance rather than a new intended use or mechanism—heating is established technology used in similar circuits (MP02608 reference device). All performance parameters (resistance, compliance, PEEP range, temperature control, humidification output) meet applicable ISO standards and remain within clinically acceptable ranges similar to predicates, and biocompatibility and electrical safety testing confirms material safety for the intended use.