SHILEY FLEXTRA TRACHEOSTOMY TUBE

• K Number: K030787
• Device Name: SHILEY FLEXTRA TRACHEOSTOMY TUBE
• Manufacturer: NELLCOR PURITAN BENNETT, INC.
• Date Cleared: 2003-11-14 ( 247 days)
• Product Code: JOH
• Regulation Number: 868.5800
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: K003315 , K962173 , K963732 , K880247 , K811447 , K810106
• Predicate For: N/A

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Regulation Number and Section

§ 868.5800 Tracheostomy tube and tube cuff.

(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.