(30 days)
The QuikPass Catheter is intended to be used to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and is also intended to assist in the delivery of contrast media into the coronary and/or peripheral vasculature.
The QuikPass Catheter is comprised of a proximal end containing a Luer connection and hub, a single-lumen shaft with radiopaque markers at the distal end, and a tapered distal tip with oval ports at 60° intervals. The single-lumen shaft of the QuikPass Catheter is constructed of two polymer layers that encapsulate a braid and coil affording increased tensile strength and torque transmission. The distal 40cm of the catheter has a hydrophilic coating to aid in navigating the device through the vasculature to the target location. The QuikPass Catheter is available in both 3 French and 4 French outer diameter sizes. Each version is available in 135cm and 150cm lengths, providing a total of four models. All models of the QuikPass Catheter are sold sterile. Sterility is achieved using ethylene oxide.
The provided text is a 510(k) summary for the QuikPass Catheter, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device (Turnpike® Catheter) rather than proving the device meets specific acceptance criteria through a clinical study involving AI or human reader performance.
Therefore, the information required to answer your questions regarding acceptance criteria and a study that proves the device meets them (especially those related to AI, human reader performance, ground truth, and expert adjudication) is not present in the provided document.
The document primarily describes:
- Device description and indications for use: The QuikPass Catheter is for accessing coronary/peripheral vasculature, facilitating guidewire placement/exchange, and delivering contrast media.
- Comparison to a predicate device: It highlights similarities in design, materials, and intended use, arguing that differences do not raise new questions of safety or effectiveness.
- Non-clinical performance data: It lists various bench tests (biocompatibility, sterilization, shelf-life, packaging, and general catheter performance like kink resistance, lubricity, radiopacity) that were performed to support substantial equivalence. These are standard engineering and material tests for medical devices, not clinical effectiveness studies.
In summary, there is no discussion of an AI algorithm, human-in-the-loop performance, expert readers, ground truth establishment for a test set, or MRMC studies in this regulatory filing. The acceptance criteria mentioned are related to engineering and material performance specifications for the catheter itself, not diagnostic performance based on AI or human interpretation of images.
§ 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).