(122 days)
The St. Jude Medical (SJM) Agilis™ Steerable Catheter Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The Agilis™ Steerable Catheter Introducer set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to improve fluoroscopic visualization. The device is provided sterile and is intended for single-use only.
The provided text is a 510(k) Summary for the Agilis™ Steerable Catheter Introducer. It includes information about the device, its intended use, and a comparison to predicate devices, but it does not contain any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical study methodologies.
The document explicitly states: "Where dimensional and material differences exist between the proposed device and the predicate devices, mechanical and biocompatibility testing demonstrated that these differences do not adversely affect safety and effectiveness." This indicates that mechanical and biocompatibility testing were performed, but the details of these tests (e.g., acceptance criteria, specific results, sample sizes) are not provided in this summary.
Therefore, I cannot provide the requested information. The 510(k) Summary focuses on establishing substantial equivalence to a predicate device based on technological characteristics and general safety and effectiveness considerations, rather than detailing specific performance studies with acceptance criteria as typically found in clinical validation reports or more comprehensive technical documentation.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).