(28 days)
The CPS Direct™ Universal slittable outer guide catheter 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 other devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. In addition, the CPS Direct Universal slittable outer quide catheters can work with inner catheters as a system.
The device description of the CPS Direct™ Universal slittable outer guide catheter, 3D, is as follows.
· The CPS Direct™ Universal slittable outer quide catheter lead delivery during cardiac resynchronization therapy (CRT) procedures. The CPS Direct Universal provides access to the coronary venous system and acts as a conduit for contrast medium. The key design features of the CPS Direct™ Universal sittable outer quide catheter, 3D, has only undergone minimal changes to the shaft length, the curve design, and the package tray configuration. The diator packaged with the catheter has undergone a change in shaft length to accommodate the shaft length of the 3D catheter. The accessories listed in the device instructions for use have not changed. The key design features of the catheter are listed below:
- · Braid reinforced, varying durometer PEBAX shaft with molded proximal hub.
- · Atraumatic distal soft tip.
- · The outside surface and inside surfaces of the catheter shaft are coated with Siloxane to provide lubricity during use.
- · The distal end of the shaft has gold marker bands and tungsten stripes for fluoroscopic visibility.
- · Hub contains a sideport with extension tubing for contrast delivery, aspiration, or saline flush using a 3-way stopcock.
- · Accessories such as VBT used to assist the insertion of Abbott Devices (leads, quidewires, inner catheters, etc)
The provided document is a 510(k) summary for the Abbott Medical CPS Direct™ Universal slittable outer guide catheter (DS2C029). This document does not contain the acceptance criteria or study details in the format requested.
The document states that "limited functional and packaging design verification (DV) testing, compatibility testing, and a sterilization adoption assessment study" were conducted. It concludes that "Completion of all verification activities demonstrated that the modified catheter with associated components meets its predetermined design and that the subject CPS Direct™ Universal slittable outer guide catheter model DS2C029 (3D curve) is substantially equivalent to the predicate device."
However, it does not provide specific acceptance criteria, reported device performance (numerical metrics), sample sizes, data provenance, ground truth establishment, expert qualifications, or details on comparative effectiveness studies (MRMC or standalone).
Therefore, I cannot populate the table or answer the specific questions about the study design fully based on the provided text. The document confirms that non-clinical tests were performed to demonstrate substantial equivalence, but it does not elaborate on the specifics of these tests.
§ 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).