(193 days)
The Quantum PureFlow Centrifugal Blood Pump 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 Centrifygal Blood Pump is a standalone, single use device intended to be used in medical procedures requiring extracorporeal circuits. The pump is designed to move blood by centrifugal force and allow blood flow through the cardiopulmonary bypass or extracorporeal circulation 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.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Quantum PureFlow Centrifugal Blood Pump". This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria for AI/ML performance.
Therefore, many of the requested details, such as those related to AI/ML study design (sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth establishment, effect sizes of AI assistance), are not applicable and are not present in this document.
However, I can extract information related to the performance data presented to the FDA for this particular medical device.
Acceptance Criteria and Device Performance (Non-AI Device)
The document primarily discusses non-clinical testing to demonstrate performance and substantial equivalence to a predicate device. The general "acceptance criteria" here are that the device meets established requirements for safety and effectiveness, similar to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a non-AI/ML device, the performance data presented is focused on physical and biological characteristics. The acceptance criteria are implied to be "passed by meeting the established requirements," which are likely specific threshold values for each test (e.g., a certain hemolysis index, no air entrapment, stable operating parameters). The document states that "All testing passed by meeting the established requirements set for the use of Quantum PureFlow Centrifugal Blood Pump."
| Performance Metric | Implied Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|
| Operating Parameters | Within specified ranges for safe and effective operation | Passed, met established requirements |
| Dynamic Blood Damage | Within acceptable limits to minimize blood cell damage | Passed, met established requirements |
| Heat Generation | Within acceptable limits for patient safety | Passed, met established requirements |
| Air Entrapment | Prevention of significant air entrapment | Passed, met established requirements |
| Mechanical Integrity | Structural soundness and durability | Passed, met established requirements |
| Durability/Reliability | Ability to function reliably over its intended use period (up to 6 hours) | Passed, met established requirements |
| Hemolysis | Meeting standards per ASTM F1841-97 and ASTM F1830-97 | Passed, met established requirements |
| EtO Sterilization Process | Validation per ISO 11135:2014 | Passed, met established requirements |
| Packaging Validation | Validation per ISO 11607-1:2019 | Passed, met established requirements |
| Biocompatibility | Meeting standards per ISO 10993-1:2018 and FDA Guidance | Passed, met established requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. The performance data section broadly mentions "in-vitro testing" and "evaluated devices' performances," which implies multiple test runs or units. Specific sample sizes for each test (e.g., number of pumps tested) are not provided in this summary.
- Data Provenance: The testing was conducted by Qura S.r.l. in Italy, where the company is located. The tests are "in-vitro" and "non-clinical," implying laboratory-based testing rather than patient data. The document does not specify whether the tests were retrospective or prospective, but in-vitro testing for device performance is typically conducted prospectively as part of the development and verification process.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- Not applicable. This is a non-AI, non-diagnostic device. "Ground truth" in the context of AI/ML for image analysis or diagnosis is not relevant here. Performance is evaluated against engineering specifications and industry standards.
4. Adjudication Method for the Test Set
- Not applicable. As this is not an AI/ML study involving human interpretation or diagnosis, there's no adjudication method in the sense of reconciling expert opinions. Performance is assessed against pre-defined engineering and biological parameters.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is relevant for AI/ML-assisted diagnostic devices to assess the impact on human reader performance. It is not applicable to a centrifugal blood pump.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm with standalone performance metrics. Its performance is intrinsic to its mechanical and material properties.
7. The Type of Ground Truth Used
- Not applicable in the AI/ML sense. The "ground truth" for this device's performance is established by engineering specifications, international standards (e.g., ASTM, ISO), and established biological safety thresholds. For example, the "ground truth" for hemolysis is defined by the standard ASTM F1841-97.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML model that undergoes a training phase.
9. How the Ground Truth for the Training Set was Established
- Not applicable.
§ 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.