(217 days)
The PathBuilder™ Transseptal Guiding Introducer is introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
PathBuilder™ Transseptal Guiding Introducer is comprised of a sheath, a dilator and a guidewire. At the distal end of the sheath, a marker band is embedded to mark the position of the sheath during the procedure. Near the marker band, there are three vent holes to reduce cavitation during aspiration and device withdrawal. At the proximal end of the sheath, a sideport with three-way stopcock is located for aspiration, fluid infusion, blood sampling and pressure monitoring. Sheath is fitted with a valve to provide hemostasis during catheter introduction and/or exchange over a guidewire. The dilator, which is mainly used to expand the opening during the inter-atrial septal puncture, is a straight tube with a specially curved portion. The distal end of the dilator is designed to a tip and there is a hub at the proximal end where the needle goes through. The internal lumen of dilator is tapered at the distal tip to fix the location of the needle. Both the sheath and dilator are with a specially curved portion to accommodate positioning against the atrial septum. When the dilator is inserted into the sheath, the sheath tip fit that of dilator well, which help the set to enter the sheath. Guidewire is a thin wire leading the introducer set to the desired position.
The provided text is a 510(k) summary for the PathBuilder™ Transseptal Guiding Introducer and does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.
This document describes a conventional medical device (catheter introducer) and its comparison to a predicate device for substantial equivalence. The "Non-Clinical Performance Testing" section details various bench tests and validations performed on the physical device, not an AI/ML algorithm.
Therefore, I cannot provide the requested information for an AI/ML device based on this document. The document explicitly states: "No clinical study was used to support this submission."
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).