butterflyBVM

The butterflyBVM™ is a single-use, manually operated bag-valve-mask resuscitator designed to deliver emergency pulmonary resuscitation across all patient populations (adults, adolescents, children, infants, and neonates) in both transport/EMS settings and professional healthcare facilities. It features adjustable tidal volume and peak inspiratory pressure dials to allow one device to serve multiple patient sizes.

The butterflyBVM uses a bellows design with adjustable tidal volume (30–715 mL) and peak inspiratory pressure (15–60 cmH₂O) dials, compared to the predicate Spur II which comes in three fixed sizes. Both are non-sterile, single-patient-use, prescription-only devices compatible with standard anaesthetic connectors and capable of delivering ≥85% FiO₂ at 15 LPM oxygen flow. The subject device underwent more comprehensive biocompatibility testing (ISO 18562 gas pathway series) than the predicate.

ISO 10651-4 (operator-powered resuscitators), ISO 5356-1 (conical connectors), ISO 10993 series (biocompatibility), and ISO 18562 series (breathing gas pathway biocompatibility). All tests passed.

Both devices share the same intended use (emergency manual ventilation across all patient populations), same regulatory classification (21 CFR 868.5915, Class II), identical operating and storage temperature ranges, and comparable performance in delivered tidal volumes and oxygen concentrations. The butterflyBVM's adjustable dial design replaces the predicate's size-based approach but achieves equivalent clinical function; comparative pressure-limiting testing shows the butterflyBVM actually demonstrates superior repeatability and precision in achieving target pressures. Material biocompatibility testing was more rigorous for the subject device, raising no new safety or effectiveness concerns.