SV600, SV800 Ventilator

The SV600 and SV800 Ventilators are pneumatically-driven, electronically-controlled devices intended for intensive care situations to provide ventilation assistance and breathing support for adult, pediatric, and neonatal patients (minimum 0.5 kg body weight). They are operated by trained medical personnel within professional healthcare facilities and include monitoring modules for CO2, SpO2, and optional WiFi communication.

The subject device adds neonatal ventilation support (including nCPAP mode, neonatal flow sensor, and neonatal-specific parameter ranges) compared to the primary predicate K220107. Additional features include oxygen therapy capability, optional backup air supply (blower), WiFi communication, neonatal CO2 measurement, and support for Masimo and Nellcor SpO2 modules alongside existing Mindray SpO2 measurement. The main control board, display, and expiratory valve assembly structure were also modified.

ISO 10993 series (biocompatibility), ISO 18562 series (breathing gas pathway biocompatibility), IEC 60601-1 and IEC 60601-1-2 (electrical safety and EMC), IEC 60601-1-6 and IEC 60601-1-8 (usability and alarms), ISO 80601-2-12 (critical care ventilators), ISO 80601-2-55 (respiratory gas monitors), ISO 80601-2-61 (pulse oximetry), IEEE C63.27-2021 (wireless coexistence), and ASTM F1100-90 (critical care ventilator endurance testing).

The predicate K220107 (prior SV600/SV800 model) shares the same fundamental pneumatic and electronic control architecture, indications for use, and ventilation modes (V-A/C, SIMV, CPAP, PSV, etc.). Neonatal parameters and modes introduced in the subject device are supported by secondary predicates K083050 (Evita XL) and K180098 (Servo-U), which demonstrate equivalent safety and performance for neonatal ventilation. The BeneVision N Series modules (K213799 predicate) are incorporated unchanged, supporting new CO2 and SpO2 capabilities. Bench testing, biocompatibility, software verification/validation, and conformance to applicable consensus standards demonstrate the subject device meets predicate-equivalent safety and performance specifications.