(14 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 intraarterial therapy and infusion of embolic materials. The Drakon™ and 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 layer, 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., 1.9 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 FDA 510(k) Pre-Market Notification does not contain information about a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria, nor does it detail a study involving human reader performance, ground truth establishment, or training/test set data for such a device.
The document pertains to the Drakon™ and Sequre® microcatheters, which are physical medical devices (intravascular catheters) used for infusing contrast media, drugs, or embolic materials. The "performance data" section (Section VII) outlines bench testing and biocompatibility testing conducted to demonstrate that the modified microcatheters are substantially equivalent to their predicate devices, and that these physical devices meet predefined acceptance criteria for metrics such as bead compatibility, tensile strength, burst pressure, torque strength, etc.
Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/SaMD, and the provided text is for a physical medical catheter, I cannot extract the requested information as it does not exist in this document.
Therefore, I must state that the provided text does not contain the information requested regarding acceptance criteria and studies for an AI/SaMD, human reader performance, training/test set details, or ground truth establishment relevant to an AI model. The document explicitly focuses on the substantial equivalence of a physical microcatheter based on bench testing.
§ 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).