(228 days)
The Cordis BRITECROSS Support Catheters are indicated to guide and support a guide wire during access to the peripheral vasculature, allow for exchange of guide wires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The BRITECROSS Support Catheter is a flexible single lumen catheter that is intended to cross lesions to facilitate guidewire access and/or the delivery of saline/contrast during peripheral vascular interventions. The subject device is designed to allow for fluoroscopic visualization of the catheter. The radiopaque distal tip allows for accurate placement of the tip relative to the lesion. Further, there are two (2) radiopaque marker bands incorporated along the shaft to provide the clinician with a length reference facilitating approximation of the lesion length. On the proximal end, the hub has an integrated strain relief and a standard female luer to connect with a standard syringe. The BRITECROSS Catheter is available in various lengths and diameters and the size is printed on the hub for quick identification. The device is sterile and is for single use.
The provided text describes a 510(k) premarket notification for a medical device called the "Cordis BRITECROSS Support Catheter." This is a regulatory filing that aims to demonstrate that a new device is as safe and effective as an already legally marketed device (the predicate device).
Crucially, this document focuses on the substantial equivalence of a new medical device to a predicate device based on performance testing and predicate device comparison, not on the evaluation of an AI/ML algorithm. The provided text does not contain information about an AI/ML device, its acceptance criteria, or a study proving that an AI/ML device meets those criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML device meets the acceptance criteria using the provided text. The device described, the Cordis BRITECROSS Support Catheter, is a physical medical device (a catheter) and not an AI/ML algorithm.
The "Performance Data" section lists various physical, mechanical, and biological tests conducted on the catheter (e.g., dimensional, mechanical, in-vitro testing, biocompatibility, sterilization), which are typical for physical medical devices to demonstrate their safety and efficacy. It explicitly states "No clinical data was required" and "No animal performance data was required," further indicating that this is not an AI/ML study.
§ 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).