(138 days)
The Quantum PureFlow Cardioplegia Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool cardioplegic solution, to remove air and to monitor the temperature cardiopulmonary bypass (CPB) procedures up to 6 hours duration. Any blood to be treated must contain anticoagulant. Contact with cardioplegic solution for longer than this period is not permitted. Devices are intended for adult patients.
The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Devices are intended for adult patients.
The Qura S.r.l. Quantum PureFlow Heat Exchangers described in this 510(k) are classified in two different product families:
- -Quantum PureFlow Standard Heat Exchanger (HX-S);
- -Quantum PureFlow Cardioplegia Heat Exchanger (HX-C).
The devices have been designed to manage the temperature of blood (HX-S) or cardioplegic solution and physiological fluids (HX-C) during surgical procedures requiring cardiopulmonary bypass (CPB) for periods lasting less than 6 hours.
HX-S is designed to:
- l keep circulating blood at a specific temperature, depending on the type of surgery being performed;
- l maintain blood/patient thermoregulation during the CPB;
- 트 rewarm blood at the conclusion of the CPB in order to restore normothermic patient condition.
HX-C is designed to:
- I ensure heating/cooling of cardioplegic solution;
- 트 ensure the cardioplegic solution cooling in order to arrest myocardium activity during-CPB;
- 트 remove air measure/monitor temperature in the circuit.
- -Quantum PureFlow Heat Exchangers (both product families, HX-S and HX-C) described in this 510(k) have been designed to be powered by heater-cooler systems that use water as Heat Transfer Fluid (HTF).
The provided text is a 510(k) premarket notification for the Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger. It details the device description, intended use, comparison to predicate devices, and performance data.
However, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning the performance of an AI/algorithm-driven device. The document explicitly states:
- "No clinical data on Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger have been included in the current Traditional 510(k) submission." (Page 8)
- "No animal studies have been performed except for mandatory biocompatibility tests..." (Page 8)
The performance data section (VII. PERFORMANCE DATA) lists non-clinical testing such as:
- Evaluation of devices' performances (Operating Parameters, Air Entrapment, Mechanical Integrity, Dynamic Blood Damage, Thermal Performance and Compliance)
- Performance evaluation according to ISO 7199:2016
- Validation of the EtO Sterilization process
- Packaging Validation tests
- Biocompatibility
These tests are standard for medical devices like heat exchangers, confirming their physical and functional properties, but they do not involve AI or algorithm performance, human-in-the-loop studies, multi-reader multi-case studies, or the establishment of ground truth by expert consensus.
Therefore, I cannot provide the requested information for an AI-based device, as the document describes a traditional medical device (heat exchanger) and its non-clinical performance evaluations, not an AI/algorithm study.
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).