(534 days)
The Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors indicated for use exclusively with the Quantum Centrifugal Drive of Spectrum Medical is intended to pump the blood through an extracorporeal circuit and to monitor pressure 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
Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway (ii) necessary for open surgical procedures on the aorta or vena cava.
The Quantum Perfusion Centrifygal Blood Pump CP22 with Integrated Sensors is a standalone single use device intended to pump blood into the extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours. The device is equipped with two sensors integrated in the blood inlet and outlet connectors.
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 an analysis of the provided text regarding the acceptance criteria and study for the Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance letter and the 510(k) summary provided do not explicitly list quantitative acceptance criteria in a table format with corresponding reported performance for each criterion. Instead, the document states that "All testing passed by meeting the established requirements set for the devices." and that the device "does not raise any new issues in terms of product's safety or effectiveness as compared to the currently cleared predicate device."
However, the document does list the types of performance tests conducted, which imply the areas for which acceptance criteria would have been established. Based on the provided information, a conceptual table can be created, though without specific numerical targets or results:
| Acceptance Criterion Category | Performance Reported |
|---|---|
| Operating Parameters | Met established requirements. Implies successful operation within specified flow rates, pressures, and other operational limits. |
| Dynamic Blood Damage | Met established requirements. Implies minimal hemolysis or other blood component damage during operation. |
| Heat Generation | Met established requirements. Implies that the device does not generate excessive heat that could harm blood or patient. |
| Air Entrapment | Met established requirements. Implies that the device prevents or minimizes the entrapment of air in the blood path. |
| Mechanical Integrity | Met established requirements. Implies structural soundness and resistance to failure under expected operating conditions. |
| Durability/Reliability | Met established requirements. Implies the device maintains its performance and integrity over its intended use duration. |
| Product Shelf Life | Met established requirements (according to EP/UPS requirements). Implies the device remains sterile and functional for its specified shelf life. |
| Sterilization Process | Validation successful (according to ISO 11135:2014). Implies the ethylene oxide sterilization effectively renders the device sterile. |
| Packaging Validation | Validation successful (according to ISO 11607-1:2019). Implies the packaging maintains sterility and protects the device until point of use. |
| Biocompatibility | Met established requirements (according to ISO 10993-1:2018 and FDA Guidance). Implies the device materials are safe for blood contact and do not elicit adverse biological responses. This included mandatory biocompatibility animal tests. |
| Substantial Equivalence | Demonstrated. The device is considered substantially equivalent to the predicate device (Quantum PureFlow Centrifugal Blood Pump CP22, K202169) based on intended use, main technological characteristics, and results of non-clinical testing, raising no new safety or effectiveness issues compared to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of devices, number of repeated tests) for each in-vitro performance test. It broadly states that "In-vitro testing was performed."
- Data Provenance: The tests were "In-vitro" (laboratory-based) and conducted by Qura S.r.l. in Italy, where the company is based. The nature of these tests suggests they are prospective, as they were specifically designed and executed to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the studies described. The performance data presented are from non-clinical (in-vitro) testing, not studies involving independent expert assessment of, for example, diagnostic images. The "ground truth" for these engineering and performance tests would be defined by established standards (e.g., ISO, EP/UPS, FDA guidance) and the physical or chemical properties measured.
4. Adjudication Method for the Test Set
Not applicable. As noted above, these are non-clinical engineering and performance tests, not studies requiring expert adjudication of observations or diagnoses. The "adjudication" is essentially the comparison of measured results against pre-defined acceptance limits derived from standards and engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate device." This type of study is specifically for evaluating human reader performance, often with AI assistance, which is not relevant for this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable to the device described. The Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensors is a physical medical device (a centrifugal blood pump), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant. Its "standalone performance" refers to its operational performance as a device pumping blood and monitoring pressure, which was evaluated through the in-vitro tests listed.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was based on:
- Established requirements/standards: Applicable special controls (21 CFR 870.4360), ISO standards (ISO 11135:2014, ISO 11607-1:2019, ISO 10993-1:2018), and European Pharmacopoeia/United States Pharmacopeia (EP/UPS) requirements.
- Engineering specifications and design parameters: The device performance was measured against its own design specifications and intended performance characteristics.
- Predicate device characteristics: Substantial equivalence was demonstrated by showing performance comparable to the predicate device, implying the predicate device's established performance serves as a benchmark.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the computational sense. The design and manufacturing process would involve training of personnel, but not a data training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this device.
§ 870.4360 Nonroller-type blood pump.
(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers 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.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.