Saans (F4-01-00-000-000)

The Saans System is a continuous positive airway pressure (CPAP) device designed to deliver non-invasive respiratory support to spontaneously breathing neonates and infants weighing up to 10 kg, particularly those with respiratory distress syndrome (RDS) and other prematurity-related conditions. It blends ambient air and oxygen through a blower and proportional valve, delivers heated and humidified gas via breathing circuits to a nasal interface, and regulates pressure through an external bubble CPAP generator. The device is intended for use in hospital environments only.

The Saans System uses a blower and proportional valve to control air and oxygen delivery (similar to predicate), with external bubble CPAP pressure regulation. It operates with a flow range of 2–15 L/min, pressure range of 2–10 cmH₂O, FiO₂ range of 21–100%, and offers CPAP as its sole breathing mode. Key differences from the predicate (Nihon Kohden NKV-440) include narrower patient population (neonates/infants up to 10 kg versus adult/pediatric/neonatal), narrower pressure range (2–10 cmH₂O versus 0–30 cmH₂O), and CPAP-only mode versus multiple invasive and non-invasive modes.

Testing complied with ISO 5356-1, ISO 18082, ISO 18562 series (Parts 1–3), ISO 14971, ISO 62366-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 15223-1, IEC 63204, ISTA 3A, IEC 62133-2, ISO 20417, ISO 10993-1, ISO 5359, and ISO 4135. Performance testing included blending accuracy, flow rate accuracy, pressure accuracy, software verification and validation, biocompatibility evaluation, electrical safety, EMC testing, human factors and usability engineering, and cleaning/reprocessing validation.

The Saans System is substantially equivalent to the predicate device (Nihon Kohden NKV-440 in CPAP mode) because both use the same basic technology (blower and proportional valve for gas blending) and deliver CPAP therapy for respiratory support. Although the Saans System targets a narrower patient population and narrower operating ranges, nonclinical testing—including performance, biocompatibility, electrical safety, EMC, usability, and software testing—demonstrates it meets all design specifications and performs as safely and effectively as the predicate in its intended indication.