ULSPIRA TS™ Nitric Oxide Therapy System

The ULSPIRA TS™ Nitric Oxide Therapy System is a medical device intended for healthcare professionals to deliver inhaled nitric oxide (NO) gas and monitor inspired NO, nitrogen dioxide (NO2), and oxygen (O2) concentrations in neonates with hypoxic respiratory failure and pulmonary hypertension. The system operates in a neonatal intensive care unit (NICU) and during neonatal transport, delivering NO in the 0–80 ppm range with continuous monitoring, touch-screen controls, and an integrated pneumatic backup system for manual ventilation.

The proposed device is identical to the predicate (K212409) in all hardware specifications, physical dimensions, weight, gas connectors, battery backup duration, power supply, and operating modes. The only differences are: (1) software version updated from 1.5 to 1.6 with minor onscreen appearance improvements and bug fixes; (2) user manual revised to add six additional validated respiratory devices to the compatibility list. All clinical specifications including NO delivery accuracy (±20% or 2 ppm), monitoring ranges, and alarm systems remain unchanged.

Not stated in this summary.

Substantial equivalence is established because the predicate and proposed devices share identical intended use (neonatal NO therapy), indications, patient population, clinical settings, and all material technological specifications including hardware design, NO delivery ranges, monitoring accuracy, and alarm functionality. The minor software and labeling updates do not alter device function or safety profile; testing confirmed the system performs within specifications when used with seven ventilators at multiple NO delivery levels, and risk assessments did not identify new safety or effectiveness concerns, making the device functionally equivalent despite the documentation updates.