Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)

The Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors is a single-use, EtO-sterilized extracorporeal blood pump designed to circulate blood for up to 6 hours during cardiopulmonary bypass or temporary circulatory bypass procedures on the heart, great vessels, aorta, or vena cava in adolescent patients (ages 12–21). Blood contact surfaces are coated with a biocompatible compound to reduce platelet activation.

The CP20NG has the same intended use, operating principle, and main technological characteristics as the predicate CP20 device. The design modifications consist of improvements to the rotor and housing of the centrifugal pump, but do not alter materials, contact type, contact duration, sterilization process, shelf-life, or packaging.

ISO 10993-1:2018 (biocompatibility), ISO 11135:2014 (EtO sterilization validation), ISO 11607-1:2019 (packaging validation), and 21 CFR 870.4360 special controls testing (operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, durability/reliability).

The subject device is substantially equivalent because it shares the same intended use and operating principle as the predicate CP20 (K220842), and performance testing confirms the rotor and housing modifications do not raise new safety or effectiveness concerns. Since the design changes do not affect the materials or sterilization process, previously validated biocompatibility, sterilization, shelf-life, and packaging data from the predicate remain applicable. The in vitro performance testing demonstrates equivalence across all critical parameters.