(109 days)
The AFFINITY™ CP Centrifugal Blood Pump 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 is driven by the External Drive Motor or the Emergency Handcrank.
The Medtronic AFFINITY CP Centrifugal Blood Pump is a sterile, single-use centrifugal blood pump. It is a non-invasive, nonpyrogenic device designed to move blood through the extracorporeal circuit by centrifugal force. The pump is the disposable portion of the pumping system and it is electromagnetically coupled to an instrument that monitors and displays the flow and pressure of the blood. Blood enters the inlet port of the pump, where a cone with impeller blades within the pump housing rotates and the blood is gently accelerated towards the outlet of the pump.
The AFFINITY CP Centrifugal Blood Pump can be driven through magnetic coupling by the following two devices:
- External Drive Motor (Model 560A)
- Emergency Handcrank (Model HC150A)
Here's an analysis of the acceptance criteria and study information based on the provided K100631 document. It's important to note that this document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial results for a novel AI device. Therefore, many of the requested points, particularly those related to AI algorithm performance (e.g., MRMC studies, training set details), may not be directly applicable or fully present in this type of submission.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical "acceptance criteria" in a table format. Instead, it describes general improvements and successful "verification and validation testing." The performance is compared qualitatively to the predicate device. For this submission, substantial equivalence to the predicate device is the primary acceptance criterion, demonstrated through comparative testing and design.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Demonstrated as safe and effective through verification and validation testing. |
| Substantial Equivalence to Predicate Device | The AFFINITY CP Centrifugal Blood Pump is substantially equivalent to the predicate device (Medtronic Bio-Medicus® Bio-Pump (BPX-80) Centrifugal Pump) in intended use and basic design (magnetic coupling to an external motor). Necessary design changes to the motor and handcrank allow compatibility. |
| Reduced Heat Generation | Bearing heat generation is reduced due to a ceramic pivot system. The blood pump is more efficient. |
| Reduced Priming Volume | Priming volume is reduced by 50%, to a volume of 40 mL. |
| Reduced Hemolysis | Hemolysis is reduced compared to the predicate device; less damaging to red blood cells. |
| Functional Performance (Various) | Other validation tests included: maximum pressure generation, flow rates, pivot bearing wear, maximum speed, port strength, magnetic coupling force, biocompatibility, noise generation, and prime volume. (Implied: met performance standards for these parameters). |
| Effectiveness under Simulated Conditions with Expert Users | Validation testing under simulated conditions of use with expert users also demonstrated the effectiveness of the AFFINITY CP Centrifugal Blood Pump. (Implied: met user needs and performed effectively in a realistic setting). |
| Intended Use Compatibility | Used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours), and for extracorporeal support systems not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, mitral valve reoperation, surgery of vena cava/aorta, liver transplants). (Implied: aligns with intended use statement). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "verification and validation testing" and "validation testing under simulated conditions of use." However, it does not specify the sample size (e.g., number of pumps tested, number of simulated runs) for these tests. There's also no information provided regarding data provenance (country of origin, retrospective/prospective). This type of detail is often found in the full testing report, not typically in the 510(k) summary.
3. 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)
The document mentions "expert users" in the context of validation testing under simulated conditions. However, it does not specify the number of experts used or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for the test set.
5. 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
The device is a mechanical blood pump, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a mechanical device, so "standalone algorithm-only performance" is not applicable. Performance was assessed based on the physical and functional characteristics of the pump and its drive systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this mechanical device, the "ground truth" for its performance would be established through:
- Engineering specifications and standards: For parameters like maximum pressure generation, flow rates, maximum speed, port strength, magnetic coupling force, noise generation, and prime volume.
- Laboratory measurements: For quantification of heat generation, priming volume, and hemolysis.
- Biocompatibility testing: To ensure safety when in contact with blood.
- Functional assessment by expert users: During simulated conditions of use.
There isn't a "ground truth" in the same sense as an AI diagnostic device (e.g., pathological diagnosis for an image analysis algorithm).
8. The sample size for the training set
This is a mechanical device, not an AI algorithm. Therefore, there is no training set in the context of machine learning. The device's design is based on engineering principles and previous device iterations (the predicate device), not on a data-driven training process.
9. How the ground truth for the training set was established
As there is no training set for an AI algorithm (since this is a mechanical device), this question is 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.