(82 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 Affinity CP Centrifugal Blood Pump is intended for use with Medtronic controllers or may be used with the Stöckert and Sorin centrifugal pump systems or the Sams and Terumo centrifugal systems by attaching the Affinity CP adapter.
Affinity CP Centrifugal Blood Pumps are intended to be used in medical procedures requiring extracorporeal circulation circuits. 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 internal impeller magnetically couples to a drive motor. Magnetic coupling is used since it precludes the need for a shaft through the pump housing. The pump is supplied uncoated or coated.
This submission covers expanded indications for use for the pump when used with the Affinity CP Adapter - Model AP40AST. These updates will allow the Affinity CP Pump to couple with the Affinity CP Adapter and enable the pump to be operated with the Stöckert and Sorin, or Sams and Terumo centrifugal pump systems. No changes are being made to Affinity CP Pump or its' performance specifications. The Affinity CP Adapter is a reusable non-sterile device. The use of the adapter does not require modification of the compatible systems.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medtronic Affinity™ CP Centrifugal Blood Pump:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence of the modified device (Affinity CP Pump with Adapter) to predicate devices, rather than establishing new acceptance criteria against specific performance metrics for a novel device. The "acceptance criteria" are implied to be meeting the performance specifications of the predicate devices and ensuring the adapter does not negatively impact safety or performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Pump Functionality: Propels blood through the extracorporeal circuit via a combination of a smooth rotating cone and low-profile impeller fins | Same as predicate |
| Pump Operating Principle/Technology: 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 | Same as predicate |
| Housing Material: Polycarbonate | Same as predicate (pump and adapter) |
| Pump Motor Interface: Magnetic coupling | Same as predicate (pump and adapter) |
| Pump Prime Volume: 40 mL | Same as predicate |
| Inlet/Outlet ID: 9.5 mm (3/8 in) | Same as predicate |
| Maximum Operating Pressure: 760 mm Hg (101 kPa) | Same as predicate |
| Maximum Flow Rate: 10 L/min | Same as predicate |
| Maximum Outlet Pressure: 700 mm Hg (93.3 kPa) | Same as predicate |
| Maximum Pump Speed: 4000 rpm | Pump: Same as predicate; Adapter: 3600 rpm |
| Uncoated and Coating Options: AP40: Uncoated Pump, BBAP40: Pump with Balance Biosurface, CBAP40: Pump with Carmeda BioActive Surface | Same as predicate |
| Sterilization Method: Ethylene Oxide (EtO) | Pump: Same as predicate; Adapter: Non-sterile |
| Compatible Systems: Not negatively affected by adapter | System verification and validation tests showed that the use of the adapter does not affect how a compatible system responds when safety-related RPM control response conditions are triggered. The adapter does not decouple from compatible system motor drives. |
| Safety and Effectiveness: Meeting established requirements | All testing passed by meeting the established requirements set forth for the Affinity CP Adapter with Affinity CP Centrifugal Blood Pumps. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes (e.g., number of pumps, adapters, or test runs) used for the in-vitro testing. It refers to "formal data collection, mechanical and performance verification, reliability verification, system verification, labeling and Instructions for Use (IFU) verification and validation tests."
- Data Provenance: The study was "In-vitro testing." The country of origin for the data is not explicitly stated, but given Medtronic's headquarters in Brooklyn Park, MN, USA, it is highly likely the testing was conducted within the United States. The testing is prospective for the purpose of this 510(k) submission, i.e., new tests were conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The study described is primarily an in-vitro engineering and performance verification study, not one that typically involves expert human interpretation and ground truth establishment in the way, for example, a diagnostic imaging AI study would.
4. Adjudication Method for the Test Set:
This information is not provided and is not applicable given the nature of the in-vitro engineering and performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
No, an MRMC comparative effectiveness study was not done. This device is a mechanical blood pump and adapter, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone study was done. The entire evaluation was focused on the purely technical and mechanical performance of the Affinity CP Centrifugal Blood Pump when used with the Affinity CP Adapter, without any human-in-the-loop performance evaluation. The "algorithm" in this context would be the mechanical design and operating principles of the pump and adapter.
7. The Type of Ground Truth Used:
The "ground truth" for this type of device and study is based on defined engineering specifications, performance standards, and safety requirements for centrifugal blood pumps. The tests were designed to verify that the modified device (pump + adapter) met these established technical and functional requirements, and that the adapter did not introduce new risks or degrade performance. This is evidenced by statements like: "All testing passed by meeting the established requirements set forth for the Affinity CP Adapter with Affinity CP Centrifugal Blood Pumps."
8. The Sample Size for the Training Set:
This information is not applicable as this is not an AI/machine learning device that requires a training set. The device is a mechanical medical device for which performance is verified through physical testing rather than data-driven model training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 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.