(72 days)
The BridgePoint Medical CrossBoss™ Catheter is intended to be used in conjunction with a guidewire in order to access discrete regions of the coronary or peripheral vasculature. It may be used to facilitate placement of guidewires and other interventional devices.
The CrossBoss Catheter is a single use over the wire disposable percutaneous catheter consisting of a full length coiled stainless steel shaft with polyester and polyurethane exterior. The coiled shaft provides torque and makes it possible to push the device, and also provides a guidewire lumen. The distal shaft transitions to an enlarged (1mm diamcter) rounded distal tip. This stainless steel tip provides an atraumatic element that is intended to enhance the catheter's ability to move within the vasculature with reduced risk of arterial tissue engagement while providing radiopaque visibility. The distal portion of the CrossBoss Catheter is hydrophilic coated to enhance lubricity. The proximal portion includes an internal stainless steel hypotube stiffener that provides the additional tolerance to push. A torque device, coaxially positioned over the proximal additional toferance to pass: "I reserveded a comfortable user interface for device portion of the CrossDoos Catalors, frinilar to a guidewire torque device) is positionable manipulation: "The torque as the catheter and includes a torsion release safety along the proximal portion of the on insures the torque input generated by the user remains within the torsional operating strength of the catheter shaft.
I am sorry, but based on the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, expert involvement, adjudication methods, or MRMC studies for the BridgePoint Medical CrossBoss Catheter.
This document is a 510(k) summary for a medical device which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results or performance metrics against specific acceptance criteria. The text explicitly states:
"Based upon the intended use and descriptive information provided in this pre-market Dusod upon the BridgePoint CrossBoss™ Catheter has been shown to be substantially equivalent to the currently marketed predicate device."
This indicates that the submission relies on the similarity to an already approved device (K081130), and therefore, a new, extensive study with acceptance criteria, sample sizes, and expert review as you've requested is not typically included in such a submission.
Therefore, I cannot populate the requested table or provide answers to points 2 through 9 based on the given input.
§ 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).