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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 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 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:

• 트 keep circulating blood at a specific temperature, depending on the type of surgery being performed;
• maintain blood/patient thermoregulation during the CPB;
• 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;
• remove air measure/monitor temperature in the circuit.

Differently from the original submission K212688, 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
  or
• 트 Glycol-based solution
  as Heat Transfer Fluid (HTF).

This document is a 510(k) premarket notification for Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger. It describes the devices and their intended use, and importantly, declares their substantial equivalence to a predicate device.

However, the provided text does not contain the information requested about acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states:

• "NON-CLINICAL TESTING: The following activities were performed to demonstrate product safety and effectiveness, considering the proposed change and related impact: update of labeling and Instructions for Use (IFU) according to ISO 15223-1:2016 ... Performance tests for new REF code introduced in the portfolio, according to ISO 7199:2016 (only for sections applicable to Heat Exchangers). This 510(k) provided testing to demonstrate compatibility with a glycol-based heat transfer fluid (HTF) called CoolFlow DTX." (Page 7)
• "Animal Study: No animal studies have been performed to support changes object of the present 510(k)." (Page 7)
• "CLINICAL TESTING: No clinical data on Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger have been included in the current 510(k) submission." (Page 8)

This means the submission relies primarily on non-clinical performance testing against recognized standards (ISO 7199:2016 and ISO 15223-1:2016) and a demonstration of compatibility with a new heat transfer fluid, likely to show that the new device remains substantially equivalent to a previously cleared device (K212688).

Therefore, I cannot provide the requested information, which pertains to a de novo or comprehensive clinical study that would typically involve a test set, ground truth establishment, expert adjudication, or MRMC studies. The device is a "Class II Product Code: DTR Cardiopulmonary Bypass Heat Exchanger," which often relies on performance standards and substantial equivalence rather than extensive new clinical studies for clearance.

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