(24 days)
The Rüsch Microlaryngeal Tube is a sterile, single-use, oral/nasal tracheal tube intended to be used for airway management during laryngeal procedures.
The Rüsch Microlaryngeal Tube will be offered in three (3) sizes - 4.0mm, 5.0mm and 6.0mm ID. The devices will have a low-pressure/high volume cuff, inflated via a luer activated valve. A pilot balloon will be provided to give a visual indication of cuff status. The Rüsch Microlaryngeal Tube consists of a clear, implant-tested tracheal tube with a radiopaque stripe. The main tube is graduated with multiple centimeter markings to facilitate determination of intubated length.
The provided document is a 510(k) premarket notification for a medical device, the Rüsch Microlaryngeal Tube. It focuses on demonstrating substantial equivalence to pre-existing devices, rather than presenting a performance study with acceptance criteria in the context of an AI/ML powered device.
Therefore, the requested information regarding acceptance criteria, study data, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI/ML device is not available in this document.
This document describes a traditional medical device (a tracheal tube) and uses substantial equivalence as its regulatory pathway, which involves comparing its design, materials, and intended use to legally marketed predicate devices. It does not involve any AI/ML components or associated performance studies.
§ 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).