(114 days)
The Ventrax™ Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart.
The Ventrax™ Delivery System is designed to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. It provides support for positioning and maintaining the position of catheters at specific locations in the heart. The sheath may be used for percutaneous entry. The system consists of four components: a sheath, a pigtail dilator, a straight dilator and a J-tipped Amplatz guidewire.
VENTRAX™ DELIVERY SYSTEM COMPONENTS
A. 8.5F Guiding Sheath Introducer: provides a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. The sheath has an integrated valve to restrict blood loss, and a sideport for flushing and withdrawing blood.
B. Mating Pigtail Dilator: designed to conform to the sheath introducer inner diameter, has a tapered tip, has a pigtail at the distal end to assist aortic valve crossing, has an integrated valve to restrict blood loss, and has a sideport for flushing.
C. Mating Straight Dilator: designed to conform to the sheath introducer inner diameter and has a tapered tip. Usage of this straight dilator is optional. This straight dilator is intended to be used only when access is unsuccessful after using the mating pigtail dilator.
D. 0.035" X 220cm J-tipped Amplatz guidewire: provide path for sheath and dilator advancement.
This looks like a 510(k) summary for a medical device called the Ventrax™ Delivery System. However, this submission does not contain information about software with AI/ML components. The document focuses on the substantial equivalence of the Ventrax Delivery System to a previously cleared predicate device with respect to its physical design, materials, and mechanical performance. There is no mention of accepting criteria related to AI/ML device performance, or any studies designed to prove AI/ML performance.
Therefore, I cannot provide an answer based on the prompt's request for acceptance criteria and study details related to AI/ML. The provided text does not contain any of that information.
§ 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).