Vivo 45 LS

The Vivo 45 LS is a portable, microprocessor-controlled turbine-based ventilator providing continuous or intermittent mechanical ventilation for pediatric through adult patients weighing over 5 kg. It operates via external AC/DC power or integrated battery and can be used in homes, institutions, hospitals, and portable settings for both invasive and non-invasive ventilation. Optional SpO2 and CO2 sensors measure oxygen saturation/pulse rate and inspiratory/expiratory CO2 respectively.

The device shares the same mechanical parts, electronics, and software as the predicate Vivo 45 LS (K193586) except for two new features: Auto EPAP function for auto-titration of expiratory positive airway pressure in PSV+TgV+AE mode (adult patients, non-invasive with passive leakage circuits only), and a flow-based inspiratory trigger option equivalent to the Trilogy Evo predicate device for use with passive leakage circuits in pressure ventilation modes.

Not stated in this summary.

The Vivo 45 LS is substantially equivalent to its predicates because it shares the same intended use and mechanical design while maintaining the same safety and performance profile through comprehensive performance testing, including flow trigger verification, accuracy confirmation, alarm testing, cybersecurity validation, and software verification/validation. Real-world patient data (30 patients for safety, 30 for efficacy) and simulated lung model testing further supported equivalence of the new Auto EPAP feature.