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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) procedure up to 6 hours in duration. Devices are intended for adult patients.

The subject of the present Special 510(k) is the Quantum PureFlow Standard Heat Exchanger product family for inclusion of three additional variants with respect to the currently cleared (K220110) portfolio.

Quantum PureFlow Standard Heat Exchanger devices are designed to manage the temperature of blood during surgical procedures requiring cardiopulmonary bypass (CPB) for periods lasting less than 6 hours.

HX-S devices are designed to:

• 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.

Quantum PureFlow Standard Heat Exchangers have been designed to be powered by heatercooler systems that use

• Water
  or
• Glycol-based solution
  as Heat Transfer Fluid (HTF).

The provided text is an FDA 510(k) summary for a medical device called the "Quantum PureFlow Standard Heat Exchanger." It outlines the device's purpose, regulatory classification, and the comparison to an existing predicate device to demonstrate substantial equivalence.

However, the information requested in your prompt (Acceptance Criteria, Study Details, Sample Sizes, Expert Qualifications, Adjudication Methods, MRMC study, Standalone Performance, Ground Truth, Training Set Details) is typically related to the performance evaluation of AI/ML-based medical devices, particularly regarding diagnostic accuracy or clinical effectiveness.

The Quantum PureFlow Standard Heat Exchanger is a physical medical device (a cardiopulmonary bypass heat exchanger), not an AI/ML software device. Therefore, the types of studies and acceptance criteria described in your prompt (e.g., accuracy metrics, human reader improvement with AI, ground truth establishment by experts, training set details) are not applicable to this device.

The "Performance Data" section in the document (Page 5) does mention "NON-CLINICAL TESTING" and lists:

• Updating labeling and IFU according to ISO 15223-1:2021.
• Performance tests for new REF codes according to ISO 7199:2016.

This indicates that the acceptance criteria for this device would be related to meeting the standards outlined in ISO 7199:2016 for cardiopulmonary bypass heat exchangers (e.g., heat exchange efficiency, pressure drop, biocompatibility), as well as general safety and performance requirements for medical devices. The "study that proves the device meets the acceptance criteria" would be the non-clinical testing performed according to these standards.

In summary, none of the specific details you requested regarding AI/ML performance evaluation (such as number of experts for ground truth, MRMC study, sample sizes for test and training sets for an algorithm, etc.) are present in this document because it describes a hardware medical device, not an AI/ML software.

If this were an AI/ML device, the requested information would be crucial for understanding its validation and demonstrating its safety and effectiveness. Since it's a heat exchanger, the relevant "acceptance criteria" revolve around its physical performance (e.g., heat transfer rate, flow resistance) as per recognized standards (like ISO 7199), and the "study" would be bench testing to verify compliance with those standards.

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