(106 days)
This product is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.
This product is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures, and to assist in crossing de novo coronary total occlusions (CTO).
This device should not be used in neurovasculature.
The ASAHI Corsair Pro® XS consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. The device has a hydrophilic coating on the outer surface of the shaft tube to provide a smooth transition in blood vessels. The distal tip of the ASAHI Corsair Pro® XS has a tapered shape and is designed to have increased flexibility towards the distal end. The inner lumen of the catheter is PTFE for the purposes of a smooth transition and exchange of guidewires.
The microcatheter also contains wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.
As compared to the predicate device, the primary change presented in this 510(k) involves a minor change in the dimensions of the tip and catheter shaft and the structure of inner layer (rope coil) of the catheter shaft.
I am sorry, but the provided text does not contain the acceptance criteria and study details for an AI-powered medical device.
The document is a 510(k) Pre-market Notification for a medical device called "ASAHI Corsair Pro® XS", which is described as a percutaneous catheter used to facilitate the placement of guide wires and assist in the delivery of contrast media.
The document discusses non-clinical testing and biocompatibility testing for this physical device to demonstrate its substantial equivalence to a predicate device. It does not mention any AI component, software, or algorithm that would require the kind of acceptance criteria, study design, and performance metrics typically associated with AI/ML medical devices.
Therefore, I cannot provide the requested information based on the given context.
§ 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).