(25 days)
The St. Jude Medical CPS Direct PL Peelable Outer Guide Catheter 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, CPS Direct PL Peelable Outer Guide Catheters can work with inner catheters as a system.
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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details for the CPS Direct™ PL Peelable Outer Guide Catheter.
The document is an FDA 510(k) clearance letter, which primarily focuses on classifying the device and confirming its substantial equivalence to a predicate device. It defines the "Indications for Use" but does not delve into detailed performance studies or statistical outcomes typically associated with acceptance criteria validation.
§ 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).