(14 days)
The Affinity™ CP Centrifugal Blood Pump with Carmeda® BioActive Surface 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 Carmeda® BioActive Surface is driven by the External Drive Motor or the Emergency Handcrank.
The Affinity™ CP Centrifugal Blood Pump with Carmeda® Bioactive Surface 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 Carmeda Bioactive Surface is coated with a nonleaching bioactive surface (heparin) to enhance blood compatibility and provide thromboresistant blood-contacting surfaces.
As with the uncoated Affinity CP pump the Affinity CP Centrifugal Blood Pump with Carmeda Bioactive Surface is driven by the External Drive Motor or the Emergency Handcrank (K100631). There have been no changes to these accessory devices.
This 510(k) summary describes a modification of an existing device, the Affinity CP Centrifugal Blood Pump, by adding a Carmeda BioActive Surface. Therefore, the "acceptance criteria" discussed are largely related to demonstrating that the coated pump is substantially equivalent to the uncoated predicate device and another coated predicate device. The performance data presented shows that the modified device meets the necessary safety and effectiveness requirements for this substantial equivalence claim.
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding performance values in the way one might see for a diagnostic device's sensitivity/specificity. Instead, it lists the types of performance testing conducted to demonstrate substantial equivalence. The "acceptance criteria" implicitly are that the device performs comparably to the predicate devices and meets relevant safety standards for each test.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence | Demonstrated function and intended use are the same as the uncoated pump. |
| Flow Rates | Performance testing included flow rates. (Implied acceptability given substantial equivalence conclusion.) |
| Heat Generation | Performance testing included heat generation. (Implied acceptability given substantial equivalence conclusion.) |
| Maximum Differential Pressure | Performance testing included maximum differential pressure. (Implied acceptability given substantial equivalence conclusion.) |
| Maximum Rotational Speed | Performance testing included maximum rotational speed. (Implied acceptability given substantial equivalence conclusion.) |
| Noise Generation | Performance testing included noise generation. (Implied acceptability given substantial equivalence conclusion.) |
| Duration of Performance (up to 6 hours) | Performance testing included duration of performance. (Implied acceptability given substantial equivalence conclusion and intended use up to 6 hours.) |
| Hydraulic Performance | Performance testing included hydraulic performance. (Implied acceptability given substantial equivalence conclusion.) |
| Pivot Bearing Wear | Performance testing included pivot bearing wear. (Implied acceptability given substantial equivalence conclusion.) |
| Prime Volume | Performance testing included prime volume. (Implied acceptability given substantial equivalence conclusion.) |
| Sterilization Efficacy | Performance testing included sterilization. (Implied acceptability given substantial equivalence conclusion.) |
| Biocompatibility | Performance testing included biocompatibility. (Implied acceptability given substantial equivalence conclusion and the nature of adding a bioactive surface.) |
| Hemolysis | Performance testing included hemolysis. (Implied acceptability given substantial equivalence conclusion; critical for blood-contacting devices.) |
| Bioactivity (of Carmeda surface) | Performance testing included bioactivity. (Implied acceptability given substantial equivalence conclusion; this confirms the heparin coating's intended function). |
| Heparin Leaching | Performance testing included heparin leaching. (Implied acceptability given substantial equivalence conclusion; critical to ensure coating stability and safety). |
| Heparin Coverage | Performance testing included heparin coverage. (Implied acceptability given substantial equivalence conclusion; critical to ensure the coating is uniformly applied and effective). |
| Mechanical Compatibility with accessories | The device is still driven by the External Drive Motor or Emergency Handcrank, with "no changes to these accessory devices." This demonstrates continued compatibility and acceptable performance with existing accessories. |
| Substantial Equivalence to Predicate Devices | "Verification and validation testing has demonstrated that the Affinity CP Centrifugal Blood Pump with Carmeda BioActive Surface is substantially equivalent to the predicates." |
| Safety and Effectiveness (overall) | Based on all data, the device is deemed "substantially equivalent to the currently marketed predicate devices." |
Study Details:
This document is a 510(k) summary, which provides a high-level overview of the device and the studies supporting its substantial equivalence. It does not contain detailed study protocols, raw data, or comprehensive statistical analysis that would typically be found in a full study report.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify the sample sizes (e.g., number of pumps tested) for any of the verification and validation tests listed.
- The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These types of tests are typically prospective laboratory bench and animal tests, not human clinical trials, when demonstrating substantial equivalence for a device modification like this.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This document describes engineering and biological performance testing for a medical device, not a diagnostic algorithm. Therefore, the concept of "ground truth established by experts" in the context of image interpretation or clinical diagnosis by human readers is not applicable here. The "ground truth" for these tests would be established by validated measurement techniques and established engineering/biological standards in a laboratory setting.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-AI interpretation studies, usually for clinical endpoints or image readings. This document discusses bench and biocompatibility testing for a blood pump.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical medical device (blood pump), not an AI diagnostic tool. Therefore, MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (blood pump), not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the performance tests listed (flow rates, heat generation, hemolysis, bioactivity, etc.), the "ground truth" would be established by standardized laboratory measurement protocols and validated analytical tests. For example, hemolysis would be measured using spectrophotometry against established benchmarks, and bioactivity (heparin effectiveness) would be measured through anti-coagulant assays. These are objective, quantitative measures rather than subjective expert consensus.
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The sample size for the training set:
- Not applicable. This refers to a physical medical device, not an AI model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As above, this document does not describe an AI model.
§ 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.