(126 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 centrifygal blood pump is driven by the external drive motor or the emergency handcrank. The Affinity CP centrifugal blood pump is intended for use with pump speed controllers approved by Medtronic or may be used with the Stöckert and Sorin centrifygal pump systems or the Sarns and Terumo centrifygal systems by attaching the Affinity CP adapter.
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 for use with pump speed controllers approved by Medtronic or may be used with the Stöckert and Sorin centrifugal pump systems or the Sarns and Terumo centrifugal systems by attaching the Affinity CP adapter.
The Affinity CP centrifugal blood pump with Cortiva 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 centrifyal blood pump with Cortiva BioActive Surface is driven by the external drive motor or the emergency handcrank. The Affinity CP centrifugal blood pump with Cortiva BioActive Surface is intended for use with pump speed controllers approved by Medtronic or may be used with the Stöckert and Sorin centrifugal pump systems or the Sarns and Terumo centrifugal systems by attaching the Affinity CP adapter.
The Medtronic external drive motor 560A is indicated for use with the Affinity CP centrifygal blood pump.
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This is an FDA 510(k) clearance letter for a medical device (Affinity CP Centrifugal Blood Pump and External Drive Motor), not an AI/ML device. Therefore, the document does not contain the information requested about acceptance criteria, study details, ground truth establishment, or human-AI comparative effectiveness. The content focuses on regulatory compliance and substantial equivalence to predicate devices, not performance metrics based on an algorithm's output.
§ 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.