(117 days)
Cora Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic contrast.
The coraForce and coraFlex Support Catheters are devices intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and coronary vasculature. The device consists of a support catheter body with a luer end and a polymer tip (coraFlex) or metallic tip (coraForce). The through-lumen of the device can serve as a conduit for the delivery of diagnostic contrast.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as it relates to performance metrics like sensitivity, specificity, or F1-score which are typically found in AI/ML device studies. The document describes a medical device called "coraForce and coraFlex Support Catheters" and its substantial equivalence to predicate devices, focusing on technological characteristics and bench testing.
Therefore, I cannot provide the requested table or details about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).