EVOLVE Nitric Oxide Delivery System

The EVOLVE Nitric Oxide Delivery System administers INOMAX (nitric oxide gas) to neonates with hypoxic respiratory failure and pulmonary hypertension. It delivers a constant user-set NO concentration into the patient's breathing circuit via a specialized injector module, provides continuous monitoring of inspired NO and NO2 with alarms, includes a battery backup for up to 4 hours of operation, and incorporates an integrated electronic blender as a redundant backup delivery mechanism.

The device uses component-based technology with a main EVOLVE delivery device, an eINOblender for backup, and a cart for cylinder storage. The key change in this submission is expanded labeling documentation for compatibility with 13 additional ventilator and breathing devices (e.g., Dräger Savina 300, Vyaire Avea, Fisher & Paykel Airvo 3) beyond those cleared in the predicate K240410.

Not stated in this summary.

The EVOLVE system has identical intended use and all identical physical/functional features to predicate K240410; the only change is labeling expansion for additional ventilator compatibility. The same Ventilator/Gas Delivery System Validation Test Protocol that was previously accepted for the predicate was applied to validate performance across all new platform combinations. Since the device hardware and core functionality are unchanged and validation testing confirms equivalent performance across the additional ventilators, substantial equivalence is established.