SV70 Ventilator (SV70)

The SV70 Ventilator is a turbine blower-driven, electronically-controlled ventilator intended to provide ventilation assistance and breathing support for adult and pediatric patients (minimum 20 kg body weight) with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in professional healthcare facilities or during transport. It features EasySync trigger mechanism, RAMP functionality, SpO₂ and CO₂ monitoring, auxiliary pressure monitoring, and O₂ therapy modes, and must be operated by trained medical personnel.

The SV70 supports the same ventilation modes as predicate devices (CPAP, S, S/T, P-A/C, VAPS, PPV, O₂ Therapy, Apnea Ventilation) with equivalent setting and monitoring parameters. It includes similar safety features such as pressure relief, ramp, EasySync (similar to predicate), oxygen enrichment, backup ventilation, and leakage compensation. Additional features include auxiliary pressure monitoring, sidestream and microstream CO₂ measurement, and multiple SpO₂ measurement options (Mindray, Masimo, Nellcor).

Biocompatibility testing per ISO 10993-1, 10993-5, 10993-10, and ISO 18562-1/2/3; EMC and electrical safety per IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8; particular requirements per ISO 80601-2-12, 80601-2-55, 80601-2-61, 80601-2-90; software verification and validation per FDA guidance; bench testing including functional and system-level testing per ASTM F1100-90.

The SV70 is substantially equivalent because it supports identical ventilation modes and parameters to the primary predicate (V60 Ventilator) with equivalent specification ranges and intended use for the same patient population. Performance testing including biocompatibility, EMC, electrical safety, software validation, and bench testing demonstrates the device meets all applicable consensus standards and performs equivalently to the predicate devices.