(90 days)
The Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Guiding Catheter is intended to be used in the coronary or peripheral vascular system.
The Hydrophilic Guiding Catheter consists of a reinforced body with a hub and strain relief at the proximal end and an intermediate and soft tip at the distal end. The distal part of the catheter features a specific tip shape. A part of the catheter body features a hydrophilic coating. The (distal part of the) catheter body is provided either with or without "in-line" side holes.
The guiding catheter is a flexible plastic tube featuring a luer hub, strain relief, a body, an intermediate tip, and a soft tip. The body and the intermediate tip consist of an inner liner (basecoat) and an outer jacket (topcoat) reinforced with a tightly wound stainless steel braid wire in between the layers. The central lumen of the catheter is used for the percutaneous, transluminal passage and placement of guidewires, diagnostic and therapeutic devices within the vascular system. After the catheter is inserted through the skin using a dilator, a sheath (introducer) and guide wire is brought into position. Subsequently, a guidewire is advanced through its lumen and tracked over by a diagnostic device and/or a therapeutic devices to the intended location. The distal section of the catheters has a variety of preformed shapes (e.g. Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multi-purpose (MP), hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) small "in-line" side holes in the intermediate tip section to maintain perfusion of the target vessel. This device is a single-use device (i.e., single patient, single procedure, single purpose use). After finalizing the procedure, the catheter is withdrawn, removed and discarded.
This document is an FDA 510(k) clearance letter for a medical device, specifically a "Primum Hydrophilic Guiding Catheter." It is NOT about a software-based AI/ML device, and therefore does not contain the information requested in your prompt regarding acceptance criteria, study details, human reader studies, or ground truth for AI models.
The device discussed is a physical catheter, and its acceptance criteria and proof of performance are based on bench testing (biocompatibility, physical properties tests) and comparison to a "predicate" device (another catheter already on the market) that is essentially the same product under a different trade name.
Therefore, I cannot provide the information requested in your prompt related to AI/ML device evaluation, as the provided text describes a traditional medical device clearance.
§ 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).