(28 days)
The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse / deliver diagnostic and therapeutic agents.
The ViperCross™ Support Catheters are single lumen catheters designed for use in the peripheral vasculature. The ViperCross™ Support Catheters provide guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The ViperCross support catheters have a hydrophilic coating on the distal 30cm, 40cm, 70cm, or 90cm dependent on model length to enhance deliverability to the target vasculature.
The ViperCross™ Support Catheters have three (3) radiopaque marker bands located 0.040" / 1.01mm, 1.968" / 50mm, and 3.937" / 100mm from the distal tip, respectively. The 135cm and 150cm catheters have white positioning marks located at 100cm and 110cm from the distal tip. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing.
The 014 or 018 ViperCross™ Support Catheter can be placed through the 035 ViperCross™ Support Catheter for extended reach and pushability.
The ViperCross™ Support Catheters have been sterilized with ethylene oxide.
The provided text is a 510(k) premarket notification regarding a medical device, the ViperCross™ Support Catheter. It outlines the device's intended use, indications for use, technological comparison to a predicate device, and performance testing.
However, it does not contain any information about an AI/ML powered device, associated acceptance criteria, specific study designs (like MRMC), sample sizes for training/test sets for AI, ground truth establishment for AI, or expert adjudication for AI..
The "Performance Testing" section lists various engineering and material tests conducted on the physical catheter, such as working length, leak tests, trackability, kink resistance, etc. These are standard tests for a physical medical device and do not relate to the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information based on the provided text, as the document describes a physical medical device and its traditional performance testing, not an AI/ML-powered device.
§ 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).