Search Results

The Shiley FlexTra Tracheostomy Tube with Disposable Inner Cannula is intended to provide tracheal access for airway management.

Cuffed Shiley FlexTra products sizes 7.0, 8.0, and 9.0 mm ID are also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.

The Shiley FlexTra disposable tracheostomy tubes are double cannula tracheostomy tubes with disposable inner cannula. The device is latex-free, sterile, and for single patient use only.

The device is intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The device is used to provide an artificial airway in order to assist in the treatment of a variety of respiratory diseases and airway management for adult patients. After insertion in place through a tracheotomy incision in the patient's neck and trachea, the device is then secured in place through the tracheostomy tube's swivel neck plate/flange with the use of a neck strap. Once in place, the device provides a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.

Selected cuffed Shiley FlexTra products are also intended for use in conjunction with Percutaneous Dilatational Tracheotomy. The device is inserted into the patient using the appropriate loading dilator provided in a separate percutaneous dilatational kit. The device is intended to be used as an artificial airway immediately post tracheotomy.

This document is a 510(k) premarket notification for the Shiley® FlexTra™ Tracheostomy Tube. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices.

Therefore, I cannot provide the requested information. The document explicitly states:

• "The technological characteristics of the Shiley FlexTra tracheostomy tube and the results of bench tests do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices."

This indicates that the submission relies on comparing the device's characteristics and bench test results (which are not detailed) to existing predicate devices, rather than presenting a study with specific acceptance criteria for performance metrics.

Ask a specific question about this device