(209 days)
The device is a single use, sterile, cuffed tracheal intubation and indicated for airway management.
consists of a clear, implant tested, P.V.C. tube with an encapsulated stainless steel reinforcing spiral. The tube is graduated with multiple centimeter markings to allow easy determination of the intubated length, and is terminated with a fully inserted connector. The tube is fitted with a low pressure, high volume cuff, which is inflated through a lueractivated valve, pilot baloon, inflation tube and lumen in the wall of the main tube.
The provided document is a 510(k) Substantial Equivalence Summary for the Rusch Reinforced Tracheal Tube - Cuffed, sterile. This document is for a medical device regulatory submission and does not contain any information about clinical studies, acceptance criteria, or performance data of the kind requested.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to pre-existing devices based on design, materials, and intended use, rather than presenting results from a performance study against specific acceptance criteria.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).