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The Quantum PureFlow Centrifugal Blood Pump CP22 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The Quantum PureFlow Centrifugal Blood Pump CP37 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical (i) procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The Quantum PureFlow Centrifugal Blood Pump CP22/Quantum PureFlow Centrifugal Blood Pump CP37 is a standalone, single use device intended to be used in medical procedures requiring extracorporeal circulation circuits. The pump is designed to move blood by centrifugal force and allow blood flow through the cardiopulmonary bypass or extracorporeal circuits for periods lasting up to 6 hours. The pump is designed to allow the passage of blood through an impeller rotating around its axis.

The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.

Here's a breakdown of the acceptance criteria and study information for the Quantum PureFlow Centrifugal Blood Pump CP22 and CP37, based on the provided FDA 510(k) summary:

The primary purpose of this 510(k) submission is to document a change in labeling regarding the removal of a warning and a package symbol related to DEHP content. Therefore, the "acceptance criteria" and "device performance" are focused on demonstrating that this labeling change does not negatively impact the safety or effectiveness, and that the device remains substantially equivalent to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable in the traditional sense for this submission. The "test set" here refers to the review of standards compliance and labeling changes. No new physical device testing with a specific sample size is detailed.
• Data Provenance: The referenced standards (ISO 10993-18, ISO 15223-1:2016) are international standards. The evaluation of DEHP compliance and labeling update would have been conducted by Qura S.r.l. internally, likely using existing device specifications and documentation. The data is retrospective in that it refers to the original device design and its compliance with updated labeling and material standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The activities performed were:
  • DEHP evaluation: This is typically performed by specialists in material science, biocompatibility, and regulatory affairs, often with expertise in ISO 10993 series standards.
  • Labeling and IFU update: This would involve quality assurance and regulatory affairs personnel with expertise in medical device labeling regulations (e.g., ISO 15223-1:2016) and FDA requirements. The contact person is Raffaella Tommasini, QA&RA Director.

4. Adjudication Method for the Test Set

• Not applicable. This submission is about a labeling update and demonstrating continued substantial equivalence based on no design changes. It does not involve a "test set" in the context of clinical or performance data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This device is a blood pump, not an AI/imaging diagnostic tool, so MRMC studies are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No, this is not applicable. This device is a physical medical device (blood pump), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" here is compliance with established international standards for biocompatibility (ISO 10993-18) and medical device symbols/information (ISO 15223-1:2016), as well as the device's original design specifications from K192850. The "truth" is that the device's fundamental design and performance characteristics have not changed, and the labeling updates align with current regulatory expectations.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable.

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