(62 days)
The BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheters (BASHIR™+10, BASHIR™+20, BASHIR™+30, BASHIR™+40) are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.
The BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheter are continuous flush catheters designed to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. There is one model of the BASHIR™ Endovascular Catheter (Ref. No. 7201) and four models of the Bashir™ Plus Endovascular Catheter, (Ref. No. 7210, 7220, 7230, 7240). The design of the catheters allow for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. The infusion can be initiated into a distal infusion basket via the Basket Port either in the non-expanded position (for vessels with smaller diameters), or by controlled expansion of the infusion basket to a desired dimension inside the vessel by the interventional specialist under fluoroscopic guidance. When the infusion basket is expanded into a clot, the clot is fragmented and a channel created, providing an opportunity for restoration of endogenous blood flow. The physician-specified solution is delivered via multiple laser-drilled holes through the infusion limbs of the catheters after placement.
The BASHIR™ Plus Endovascular Catheters have a second Shaft Port, for delivery of infusion solutions into the shaft lumen adjacent to the infusion basket where multiple laserdrilled holes extend over 10 cm (BASHIR+10), 20 cm (BASHIR+20), 30 cm (BASHIR+30) or 40 cm (BASHIR+40) of shaft length.
After the completion of solution delivery, the infusion limbs are collapsed to a closed position and the BASHIR™ Endovascular Catheter and/or BASHIR™ Plus Endovascular Catheter are retracted into the sheath and removed.
The catheters are comprised of common materials used in vascular catheters are mechanical and contain no electrical components.
The provided text is a 510(k) summary for the BASHIR™ Endovascular Catheter and BASHIR™ Plus Endovascular Catheters. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a study with a defined test set, ground truth experts, and statistical analysis as would be done for an AI/ML medical device.
Therefore, the information required to answer the prompt (acceptance criteria, specific study design elements like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in the provided document. The document describes a medical device, not an AI/ML algorithm.
The "Performance Testing" section primarily refers to prior comprehensive testing (animal, bench, biocompatibility, sterilization, packaging) and then mentions "Clinical Evidence" from "Real-World use" by "15 different institutions" involving "45 patients with venous thrombus." This clinical evidence is presented to support a change in labeling (adding specific mention of venous thrombus) and demonstrate that no new safety or effectiveness issues are raised, rather than as a study designed to meet pre-defined acceptance criteria for a novel AI/ML algorithm's performance.
In summary, this document does not contain the information requested in your prompt regarding an AI/ML device's acceptance criteria and its validating study.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).