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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.

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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.

Not Found

I am sorry, but the provided document discusses a 510(k) premarket notification for a medical device called "CPS Direct® SL II Slittable Outer Catheter." This document is a regulatory letter from the FDA and outlines the substantial equivalence determination for this device.

The information you requested, such as acceptance criteria, details of a study proving device performance, sample sizes, ground truth establishment, and expert qualifications, is not present in this regulatory document. This type of information would typically be found in a detailed study report or a technical capabilities document submitted as part of the 510(k) application, but not in the FDA's decision letter itself.

Therefore, I cannot fulfill your request using only the provided text.

Ask a specific question about this device