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510(k) Data Aggregation
(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.
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(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.
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