(77 days)
The St. Jude Medical CPS Direct® SL II Slittable Outer Catheters intended use is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices, including implantable left heart leads and delivery tools, and support of fluids where minimizing blood loss is essential. In addition, the outer guide catheters can work with inner catheters as a system.
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I am sorry, but the provided text from the FDA 510(k) approval letter for the "CPS Direct SL II Slittable Outer Catheter Models DS2C007 and DS2C017" does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
This document is a letter confirming the substantial equivalence of the device to pre-existing predicate devices, which is a regulatory step, not a detailed report of clinical or performance studies with specific statistical metrics.
Therefore, I cannot fulfill your request for details on the acceptance criteria and the study proving the device meets them based on this 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).