Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)

The Quantum Micro-Cardioplegia Delivery System delivers micro-cardioplegia (whole blood cardioplegia mixed with arrest agents and additives) to the heart during open-heart surgery lasting up to six hours. It consists of a delivery module, workstation, roller pump, diagnostic/ventilation module, and heat exchanger, and is intended for use by trained clinicians in hospital operating rooms.

The device uses a syringe plunger driven by a stepper motor with a lead screw for arrest agent/additive delivery, whereas the predicate uses a single piston pump. Both devices interlock arrest agent and additive delivery with blood flow, monitor drug concentrations, flow rates, pressures, and temperature, and use external heater-cooler units and heat exchangers. The proposed device has a concentration range of 0-25 mEq/L for arrest agent compared to the predicate's 0-40 mEq/L.

IEC 60601-1 Electrical Safety Tests, IEC 60601-1-2 Electromagnetic Compatibility Tests, and general nonclinical bench testing including functional/performance tests, software verification tests, human factors/usability tests, and environmental/storage and transportation tests.

Both devices deliver microplegia with independent control of arrest agent and additive interlocked to blood flow, use integrated touchscreen control, monitor the same parameters, rely on external temperature regulation, and employ disposable accessories. Although the infusion mechanisms differ (syringe-based stepper motor versus piston pump) and the arrest agent concentration range is narrower in the proposed device, testing demonstrates these technological differences do not raise different safety and effectiveness questions.