(149 days)
The CHASE coronary sinus perfusion cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
The CHASE coronary sinus perfusion cannula is a triple lumen cannula. The main lumen is the delivery conduit for blood or cardioplegia solution. A second lumen is a pressure monitoring line and begins at the tip of the cannula and terminates with a connector for coupling to a pressure monitoring device. A third lumen is used as a means to inject or withdraw air or fluid for the inflation and deflation of a balloon located near the tip of the cannula. The cannula's silcone body is reinforced with wire wound axially along the length of the cannula. A stylet is included to facilitate transatrial placement of the cannula into the coronary sinus. A syringe is included for balloon inflation and deflation.
This document is a "Summary of Safety and Effectiveness" for a medical device, specifically a "Coronary Sinus Perfusion Cannula." It details the device's purpose, description, classification, and claims of substantial equivalence to a predicate device.
The document describes functional testing and other safety/effectiveness data. However, it does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML device performance. The information provided pertains to the physical and functional aspects of a traditional medical device (cannula), including material composition, sterilization, leak tests, bond strength, and packaging integrity.
Therefore, I cannot fulfill your request for the detailed table and analysis related to AI/ML device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies. This document does not describe an AI/ML device.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).