(30 days)
The Drakon™ and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The Drakon™ and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials. The Drakon™ and the SeQure® microcatheters should not be used in cerebral vessels.
The Drakon™ and Sequre® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The Sequre®'s distal end has side holes and two radiopaque markers while the Drakon™'s distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters. The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer laver. which ensures high lubricity when wet with saline or blood. The Drakon™ and Sequre® microcatheters are sterile single lumen devices and are available in several different diameters (1.7 Fr., 2.4 Fr, 2.7 Fr., 2.8Fr, and 3.0 Fr.) and lengths (105 cm, 130 cm, or 150 or 155 cm).
The provided text describes a 510(k) premarket notification for Drakon™ and Sequre® microcatheters. This document details the device description, indications for use, comparison with a predicate device, and performance data from various bench and biocompatibility tests. However, this document does not contain information about a study proving device performance against clinical acceptance criteria for an AI/algorithm-based device, or details about expert consensus, ground truth establishment, or multi-reader multi-case studies.
The information provided is typical for a traditional medical device (catheter) clearance, focusing on physical and biocompatibility testing. It doesn't involve AI or algorithms that would require the specific types of acceptance criteria and study designs outlined in your prompt (e.g., sensitivity, specificity, human reader improvement with AI).
Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving an AI device meets those criteria, as the provided document pertains to a physical medical device (microcatheter) and not an AI or algorithmic device.
The "acceptance criteria" mentioned in the document refer to the criteria for passing the various bench tests (e.g., tensile strength, burst pressure) and biocompatibility tests, not clinical performance metrics for an AI system.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).