Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)

The Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors is a single-use, EtO-sterilized device that pumps blood through an extracorporeal circuit via centrifugal force for up to 6 hours. It is intended for adult patients undergoing cardiopulmonary bypass during open heart surgery or temporary circulatory bypass during aorta or vena cava procedures. The blood contact surfaces are coated with a biocompatible compound to reduce platelet activation.

The CP22NG has the same intended use, main technological characteristics, and operating principle as the predicate device CP22 (K201320). The design modifications involve improvements to the rotor and housing of the centrifugal blood pump, but do not change the materials, contact type, contact duration, sterilization process, 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 (operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability).

The device has identical intended use and operating principle to the predicate. Since the design modifications (rotor and housing improvements) do not affect materials, blood contact characteristics, sterilization, or shelf-life, prior biocompatibility, sterilization, and packaging validation data from the predicate remain valid. New performance testing on the subject device confirmed it meets the same special controls and shows equivalence to the predicate with no new safety or effectiveness concerns raised by the design changes.