(29 days)
The SENDERO Microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.
The SENDERO Microcatheter is a single lumen, variable stiffness catheter with a radiopaque marker on the distal end and a Luer-lock hub on the proximal end. A hydrophilic coating on the catheter shaft reduces friction during navigation through the vasculature. The device is delivered to the target location using standard interventional techniques (e.g. use of guidewire, guide catheter, etc.) under fluoroscopic guidance. Once at the target location, the lumen of the device allows for the introduction of diagnostic and therapeutic agents into the peripheral vasculature.
The provided text is a 510(k) summary for the SENDERO Microcatheter, a medical device. This document describes the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.
However, the request asks for information typically associated with a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria, including details about a test set, expert ground truth establishment, MRMC studies, standalone performance, and training set information.
The provided FDA 510(k) summary for the SENDERO Microcatheter does NOT contain information about an AI/SaMD, nor does it describe a study involving human readers, expert adjudication, or AI performance metrics.
The SENDERO Microcatheter is a physical medical device (a microcatheter) used for infusion, and its clearance relies on non-clinical performance testing (e.g., mechanical testing, biocompatibility) to demonstrate substantial equivalence to a predicate device.
Therefore, I cannot fulfill the request as the necessary information regarding AI/SaMD acceptance criteria and study details (test set, ground truth experts, MRMC, training set, etc.) is not present in the provided text.
The document explicitly states: "No clinical studies were required." This further indicates that the type of study described in the prompt (involving human readers, AI performance, etc.) was not conducted for this device's regulatory 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).