Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W

The Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W is a single-use, sterile device designed to manage blood temperature during cardiopulmonary bypass (CPB) procedures lasting up to 6 hours. It is powered by compatible heater-cooler systems using water or glycol-based heat transfer fluid and is intended for pediatric patients with a body surface area between 0.6 m² and 1 m², with a maximum blood flow rate of 3.0 liters per minute.

The proposed device shares the same regulation (21 CFR 870.4240), product code (DTR), and classification (Class II) as its reference device. It has identical technological features including stainless steel conductive material, polycarbonate housing with phosphorylcholine coating, 1/4-inch barbed blood connectors, CPC HFC fluid connectors, 24±2.5 ml priming volume, EtO sterilization, and single-use sterile condition. The key difference is the target population: this device targets pediatric patients (BSA 0.6–1 m²) versus adults for the reference device.

ISO 7199:2016 (performance evaluation for extracorporeal circuits), ISO 11135:2014 (EtO sterilization validation), ISO 11607-1:2019 (packaging validation), ISO 10993-1:2018 (biocompatibility evaluation), and FDA guidance on biological evaluation of medical devices. Testing included hemolysis, pressure drop, and heat transfer efficiency.

The proposed device is substantially equivalent because it is technologically identical to the reference device (K223879) except for the narrower target population specification. All performance testing, biocompatibility, sterilization validation, and packaging validation data from the reference device remain valid. The device maintains the same indications for use regarding CPB procedures up to 6 hours with identical design, materials, and operational parameters.