(62 days)
The Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
The Skyway support catheters are intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The Skyway OTW also may be used to subselectively infuse/deliver therapeutic agents.
The Twin-Pass™ Dual Access Catheter is a hydrophilically coated, dual lumen catheter designed for use in the arterial vasculature. The catheter provides support for 0.014"/0.36mm guidewires, and the dual lumen design allows for the delivery of a second guidewire into distal vasculature while leaving the initial guidewire in place. The Twin-Pass catheter comes with a stiffening mandrel to provide support and pushability during catheter insertion.
The SKYWAY catheters are single lumen, hydrophilically coated catheters designed for use in the arterial vasculature. The catheters provide support for 0.014"/0.36mm guidewires during interventional procedures, and allow for the exchange of one distally located guidewire for another one while maintaining access to distal vasculature.
This document is a 510(k) summary for the Twin-Pass and Skyway Catheters, which are intravascular catheters. It presents a "Summary of Non-Clinical Testing" and explicitly states "No clinical evaluations of this product were conducted."
Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be provided from the given document, as no such study was conducted or reported. The 510(k) relies on substantial equivalence to predicate devices rather than direct demonstration of performance against specific acceptance criteria through a study.
The document indicates:
- Summary of Non-Clinical Testing: Flow-rate testing was conducted using saline and a 76% contrast medium. This constitutes non-clinical testing, not a study to prove acceptance criteria in the context of device performance as one might expect for a diagnostic or AI-based device.
- Summary of Clinical Testing: "No clinical evaluations of this product were conducted."
Therefore, the sections of your request regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for a study are not applicable to the provided document.
§ 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).