(435 days)
The FloPump 57mL Centrifugal Pump is a 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.
The FloPump 57mL is a single use disposable centrifugal pump has an inlet that draws blood from a patient and an outlet that pushes the blood out, where it then passes through an oxygenator and back to the patient. The pump mates with the Sorin Group Stöckert Centrifugal Pump Console and rotates the internal impeller using a magnetic driver. The FloPump 57mL is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The FloPump 57mL is part of the extracorporeal circuit, and is therefore in contact with the patient's blood while circulating. The FloPump 57mL does not have any other patient contact.
This document describes the FloPump 57mL Centrifugal Pump, a non-roller type blood pump intended for use in extracorporeal circuits for periods less than 6 hours.
Here's an analysis of the acceptance criteria and supporting studies as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list specific quantitative "acceptance criteria" with corresponding "reported device performance" in a structured table as might be expected for an AI/CAD device. Instead, it states that non-clinical testing was performed and the results were "Substantially equivalent to predicates" for a range of performance characteristics.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Flow curves | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Heat generation | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Prime volume | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Air handling | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Hemolysis | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Reliability | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Biocompatibility | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Sterilization | Sterilization process results in a SAL of 10^-6 | The sterilization process results in a SAL of 10^-6 |
| Packaging durability | No signs of damage and functioned as intended following testing | No signs of damage and functioned as intended following testing |
| Shelf-life | No signs of damage and functioned as intended following testing | No signs of damage and functioned as intended following testing |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not contain any information regarding sample sizes for a standalone (test set) for clinical performance, as it explicitly states that clinical testing was not required. The testing mentioned is non-clinical, likely laboratory-based or bench testing. Therefore, there's no information on data provenance (country of origin, retrospective/prospective) related to a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical testing was required or performed, there is no information on experts establishing ground truth for a clinical test set. The "ground truth" for the non-clinical tests would have been established by engineering specifications, validated test methods, and comparison against the performance of predicate devices.
4. Adjudication Method for the Test Set:
Given that no clinical testing requiring human interpretation or judgment was performed, there is no information on an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:
No MRMC comparative effectiveness study was done as clinical testing was not required for this device. This device is a mechanical pump, not an AI/CAD diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable to the FloPump 57mL Centrifugal Pump. This device is a physical, mechanical blood pump, not an algorithm or AI system. The "standalone" performance here refers to the device's functional performance on its own, which was evaluated through the non-clinical tests listed.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" was based on:
- Engineering specifications and design requirements: For parameters like priming volume, flow rates, and maximum rated pressure.
- Established test methods and standards: For sterilization (SAL of 10^-6), biocompatibility, and perhaps reliability testing.
- Performance of predicate devices: The primary method for proving substantial equivalence was demonstrating similar performance to legally marketed predicate devices for flow curves, heat generation, prime volume, air handling, hemolysis, and reliability. This implies that the accepted performance range of the predicate devices served as the "ground truth" for comparison.
8. The Sample Size for the Training Set:
Not applicable. This device is a mechanical blood pump, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As stated above, this is a mechanical device, not an AI/ML system requiring a training set.
§ 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.