(9 days)
The Affinity™ CP Centrifugal Blood Pump with Balance™ Biosurface is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours).
It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants).
The Affinity™ CP Centrifugal Blood Pump with Balance™ Biosurface is driven by the External Drive Motor or the Emergency Handcrank.
The Affinity™ CP Centrifugal Blood Pump with Balance™ Biosurface is intended to be used in medical procedures requiring extracorporeal circulation circuits. Functionality and intended use of the coated pump are the same as those for the uncoated pump. The pump is designed to move blood by centrifugal force generated by a combination of a smooth rotating cone and low-profile impeller fins. Energy is transferred from the pump in the form of pressure and velocity as the blood is driven toward the outlet port of the pump. The pump utilizes a pivot bearing design on a dual ceramic pivot.
The Affinity CP Centrifugal Blood Pump with Balance Biosurface is coated with a nonleaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function.
As with the uncoated Affinity CP pump the Affinity CP Centrifugal Blood Pump with Balance Biosurface is driven by the External Drive Motor or the Emergency Handcrank (K100631). There have been no changes to these accessory devices.
Device: Affinity™ CP Centrifugal Blood Pump with Balance™ Biosurface (model BBAP40)
This document describes the acceptance criteria and the study undertaken to demonstrate the substantial equivalence of the Affinity™ CP Centrifugal Blood Pump with Balance™ Biosurface to its predicate devices.
1. Acceptance Criteria and Reported Device Performance
The submission states that "Verification and validation testing has demonstrated that the Affinity CP Centrifugal Blood Pump with Balance Biosurface is substantially equivalent to the predicates." The performance testing covered a range of aspects, as listed below. The document does not provide specific quantitative acceptance criteria or numerical performance metrics for each test, but rather indicates that the device met the requirements for substantial equivalence.
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Equivalence to Predicates | Demonstrated substantial equivalence to predicate devices. | The primary acceptance criterion was achieving substantial equivalence to the predicate Affinity™ CP Centrifugal Blood Pump Model AP40 (K100631) and the Balance™ Biosurface as used on the Affinity Pixie™ Arterial Filter with Balance™ Biosurface Model BB4014 (K100646). |
| Flow Rates | Performance testing included flow rates. | No specific flow rate values or acceptance ranges are provided. Implicitly, the device's flow rate performance matched that of the predicate. |
| Heat Generation | Performance testing included heat generation. | No specific heat generation values or acceptance limits are provided. Implicitly, heat generation was within acceptable limits compared to the predicate. |
| Maximum Differential Pressure | Performance testing included maximum differential pressure. | No specific pressure values or acceptance limits are provided. Implicitly, the maximum differential pressure performance matched that of the predicate. |
| Maximum Rotational Speed | Performance testing included maximum rotational speed. | No specific rotational speed values or acceptance limits are provided. Implicitly, the maximum rotational speed performance matched that of the predicate. |
| Noise Generation | Performance testing included noise generation. | No specific noise levels or acceptance limits are provided. Implicitly, noise generation was within acceptable limits compared to the predicate. |
| Duration of Performance | Performance testing included duration of performance. | This likely refers to the ability of the pump to operate effectively for its indicated use period of up to 6 hours. No specific operational duration data is provided. |
| Hydraulic Performance | Performance testing included hydraulic performance. | No specific hydraulic performance metrics (e.g., pressure-flow curves) are provided. Implicitly, hydraulic performance matched that of the predicate. |
| Pivot Bearing Wear | Performance testing included pivot bearing wear. | No specific wear measurements or acceptance limits are provided. Implicitly, wear was within acceptable limits for the intended use duration. |
| Prime Volume | Performance testing included prime volume. | No specific prime volume values or acceptance ranges are provided. Implicitly, the prime volume was acceptable and comparable to the predicate. |
| Sterilization | Performance testing included sterilization. | This confirms the device can be effectively sterilized for clinical use. No specific sterilization method or validation results are detailed. |
| Biocompatibility | Performance testing included biocompatibility. | This confirms the material's compatibility with blood and tissues. No specific biocompatibility test results (e.g., cytotoxicity, sensitization, irritation) are detailed. |
| Hemolysis | Performance testing included hemolysis. | This confirms the device minimizes damage to red blood cells. No specific hemolysis index or acceptance criteria are detailed. |
| Bioactivity | Performance testing included bioactivity. | This likely refers to the biological effect of the Balance™ Biosurface. No specific bioactivity metrics are detailed. |
| Coating Leaching | Performance testing included coating leaching. | This ensures the Balance™ Biosurface does not release harmful substances into the blood. No specific leaching levels or acceptance limits are detailed. |
| Coating Coverage | Performance testing included coating coverage. | This confirms the Balance™ Biosurface is uniformly applied. No specific coverage metrics are detailed. |
2. Sample Size for the Test Set and Data Provenance
The provided summary does not specify the exact sample sizes (e.g., number of pumps, specific test runs) used for each performance test. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, the testing would typically be conducted prospectively in a controlled laboratory or in-vitro setting by the manufacturer (Medtronic, Inc., Mounds View, MN, USA).
3. Number of Experts and Qualifications for Ground Truth
This type of device (Affinity™ CP Centrifugal Blood Pump) does not involve image-based diagnosis or interpretation requiring expert review for ground truth establishment. Therefore, there were no experts used in this context to establish a ground truth for a test set in the way one would for an AI/CADe device. The "ground truth" for this device's performance is established through objective engineering and biological testing against predefined specifications and comparison to the predicate device's known performance.
4. Adjudication Method
As there is no "ground truth" established through expert consensus or interpretation for this device, there was no adjudication method (e.g., 2+1, 3+1) used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for AI devices that assist human readers in tasks like image interpretation, which is not applicable to the Affinity™ CP Centrifugal Blood Pump.
6. Standalone Performance Study (Algorithm Only)
No, a standalone (algorithm only) performance study was not done. The Affinity™ CP Centrifugal Blood Pump is a physical medical device, not a software algorithm, and therefore the concept of "standalone algorithm performance" is not applicable. Its performance is evaluated through direct physical and biological testing.
7. Type of Ground Truth Used
The "ground truth" for the performance of the Affinity™ CP Centrifugal Blood Pump is established through:
- Engineering Specifications: Adherence to defined mechanical, hydraulic, and electrical specifications.
- Biological Testing Standards: Compliance with recognized biocompatibility and hemocompatibility standards.
- Predicate Device Performance: Direct comparison of its performance characteristics to the already-marketed predicate devices.
- Intended Use Compatibility: Verification that the device performs as expected for its stated intended use (pumping blood for cardiopulmonary bypass for up to 6 hours).
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this physical medical device. Training sets are used in machine learning for AI algorithms. The development of the Affinity™ CP Centrifugal Blood Pump involved design, engineering, materials selection, and manufacturing processes, rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this physical device, there is no "ground truth for the training set" to be established in this context.
§ 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.