(203 days)
Portex Blue Line Ultra Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients.
The Blue Line Ultra (BLU) tracheostomy tube provides an airway to the patients lungs when the upper airway / larynx / pharynx or oral & nasal routes are occluded or compromised due to traumatic injury, illness, or during surgery, and is elective for long term ventilated patients. The tube can be used for ventilated, or spontaneously breathing patients. The BLU is available in sizes 6.0, 7.0, 7.5, 8.0, 8.5 and 9.0mm only. BLU is available in cuffed and uncuffed variants. The cuff provides a seal against the trachea, ensuring that inspiratory and expiatory gasses are routed through the tube and not allowed to escape to the patients upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. Uncuffed tubes are used when patients require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration. The outer tube can be used with or without an inner cannula lines the bore of the outer tube, and can be removed, cleaned and replaced to ensure that the bore of the tube is kept patent. The BLU is supplied pre-loaded onto an obturator. The obturator reduces the risk of the distal end of the product from damaging the trachea upon insertion. The obturator has an internal pathway for a guide wire, so that a guide wire can be used to help position the tube through the stoma site for tube change insertion. The BLU tracheostomy tube is packed in several kit variants to suit clinician preferences. Each kit contains a tracheostomy tube holder, an inner cannula cleaning brush, disconnection wedge and a patient notes label. The change kit includes a tube change i tip guide wire. This wire is used to help place a second tracheostomy tube in a pre-existing stoma when the first tube needs to be changed. Each kit is individually packed in a blister and shelf carton (tracheostomy tube holder and cleaning bush packed outside of the blister in a polyethylene bag), and the products are sterile by ETO. Replacement Blue Line Ultra inner cannula are available in packs of 20 or 50. The cannula are individually packed in a blister to maintain sterility, and contained within a shelf carton. The inner cannula lines the bore of the outer tube, and can be removed, cleaned and replaced to ensure that the bore of the tube is kept patent.
This document is a 510(k) summary for the Portex Ltd. Blue Line Ultra Tracheostomy Tube. It details the device's description, intended use, and comparison to predicate devices, ultimately concluding substantial equivalence. However, it does not contain acceptance criteria or a study proving device performance against such criteria in the manner of a clinical trial or performance study with quantified metrics.
The document states: "Performance data for the proposed device is shown in section 8.0 Performance." but Section 8.0 is not included in the provided text. Without Section 8.0, it is impossible to provide the requested information about acceptance criteria and performance data.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is primarily a regulatory filing (510(k)) focused on establishing substantial equivalence to existing devices, not presenting the results of a standalone performance study with detailed metrics and statistical analysis.
§ 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.