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The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter is intended to prevent pressure from developing in the chest, averting lung collapse and providing a means for fluid to drain from the chest cavity.

The Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray will include all components commonly required to perform a chest drainage procedure in a single procedure-ready package. This procedure tray will be available in several configurations of tray components. The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter will be available in 8, 10 and 12 fr sizes. The device incorporates a blunt, multi-sideholed, springloaded inner cannula coaxially housed within a conventional sharp-beveled hollow needle. This entire assembly is housed within polyurethane tapered catheter, which is used as a standard small bore percutaneously placed thoracic catheter. The tapered catheter incorporates four distal side-holes to facilitate drainage.

This document is a 510(k) summary for a medical device (Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray), which focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain the kind of information requested in your prompt (acceptance criteria, device performance metrics, study design, expert evaluation, etc.).

The information you are looking for is typically found in clinical studies, validation reports, or performance testing summaries, which are distinct from a 510(k) summary. A 510(k) summary primarily addresses the device's intended use, technological characteristics, and comparison to a predicate device to establish that it is as safe and effective.

Therefore, I cannot fulfill your request using the provided input because it does not contain the necessary details about acceptance criteria or a study proving device performance.

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