(344 days)
The Ursa™ angiographic catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the coronary and peripheral vasculature. The device is for single use only. This device is not intended for use in the neurovasculature.
The Ursa™ angiographic catheters are sterile, single use, disposable devices designed to deliver radiopaque contrast media to selected sites in the vascular system. It is available in 39 different curve shapes and three sizes of 4. 5 and 6F. Each device consists of a catheter with luer connector; strain relief, catheter shaft, catheter soft extension and soft distal tip. The distal end of the catheter is formed into a variety of shapes required to access a variety of vascular anatomies. All versions of the catheters are designed to accept a maximum guidewire diameter of 0.038" and have a strain relief at the hub to shaft junction. Sideholes may be incorporated into the shaft to facilitate injection of radiopaque contrast media.
This submission for the Ursa™ Angiographic Catheter does not contain an AI/ML powered device, nor does it present a study with detailed acceptance criteria and performance data for such a device. The 510(k) summary focuses on establishing substantial equivalence to predicate devices for a conventional medical device (an angiographic catheter) through physical and functional performance testing, along with biocompatibility.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them based on the provided text. The document describes a standard medical device submission process for an angiographic catheter and does not involve AI or machine learning.
§ 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).