(79 days)
These stylets are wires intended to facilitate the placement of pacing leads during pacemaker implant procedures.
The straight stylets are used to direct passage of a lead to the appropriate heart chamber and to wedge the lead in the trabeculae of the ventricle.
The J-shaped stylets are used to direct passage of a lead in the atrium.
The new accessory kits will allow separate packaging of lead stylets currently marketed with Guidant pace/sense and defibrillation leads. The stylets are provided in 0.014 and 0.016 inch diameters, with their respective "stiffness" labeled soft and firm. Each stylet package will contain two stylets of the same diameter. The stylets are made of chromium-nickel 304 stainless steel spring wire and have polypropylene Hercules PD 701 Knobs. The stylets are inserted into a coiled polyethylene stylet ring for packaging and ease of use purposes.
This document is a 510(k) summary for the Accessory Stylet Kit. It explicitly states that no additional testing was deemed necessary because it concerns the separate packaging of currently marketed stylets. The document asserts that there are no changes to the design, materials, manufacturing process, packaging process, sterilization process, or shelf life of the subject device compared to previously cleared devices.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this 510(k) submission. The substantial equivalence was established by demonstrating that the new accessory kits are identical in all relevant aspects to previously cleared stylets and accessory kits.
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).