Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);

The Quantum Perfusion Blood Oxygenator (VT75-E3, VT160-E3, VT200-E3) is a diffusion membrane oxygenator designed to oxygenate blood and remove carbon dioxide during cardiac surgery requiring cardiopulmonary bypass. The device also measures blood pressure and temperature during the procedure and is limited to 6 hours of use. The VT75-E3 is intended for pediatric patients with body surface area 0.6–1 m², while the VT160-E3 and VT200-E3 are for adult patients.

The proposed E3 devices are substantially identical to their E1 predicate counterparts in design, materials (polymethylpentene hollow fibers with phosphorylcholine biocompatible coating), sensor specifications, gas transfer performance, sterilization method (EtO), and operational parameters. The main contacting materials, connector types, blood flow rates, exchange surface area, priming volume, and sensor accuracy ranges are unchanged from the predicate devices.

ISO 10993-1:2018 for biocompatibility evaluation; ISO 13485 design control and quality management requirements; electromagnetic compatibility (EMC) and electrical safety (ES) testing per applicable standards; and FDA Guidance on biocompatibility standards.

The devices are substantially equivalent because they maintain the same intended use, design principles, materials, performance characteristics, and operational specifications as the legally marketed predicate devices (K203424 and K231982). Non-clinical testing including gas transfer, sensor verification, mechanical integrity, and biocompatibility demonstrates safety and effectiveness consistent with the predicate devices, and no new risks or different performance are introduced.