(121 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 Jtipped Amplatz guidewire.
Ventrax Delivery Systems 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.
Based on the provided text, the document is a 510(k) summary for a medical device (Ventrax Delivery System) and does not contain the detailed information about acceptance criteria and the study that proves the device meets those criteria in the way typically expected for an AI/software device. The document describes a physical medical device (a catheter delivery system) and its substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/software device. The provided text does not mention any AI component, nor does it detail a study with a test set, expert ground truth, MRMC studies, or standalone algorithm performance, as these are primarily relevant to software/AI device evaluation.
The "SUMMARY OF NON-CLINICAL TESTING" section (page 5) states: "Verification and validation testing of the Ventrax Delivery System was conducted to ensure that the subject device is safe and effective and meets the performance specifications and user needs considered essential for its intended use. Required performance testing was determined based on risk assessment, recognized consensus standards, FDA guidance documents and the anticipated clinical environment."
This generally refers to physical performance testing (e.g., strength, durability, flow rates) relevant to a catheter, not diagnostic accuracy studies with human readers or AI algorithms.
§ 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).