(205 days)
The Portex Blue Line Ultra Suctionaid Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients. Suctionaid allows aspiration of mucous and subglottic secretions that collect and build up between the tracheostomy tube cuff and the glottis.
The Blue Line Ultra Suctionaid (BLUS) 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 BLUS is available in sizes 6.0, 7.0, 7.5, 8.0, 8.5 and 9.0mm only. BLUS is cuffed. The cuff provides a seal against the trachea, ensuring that inspiratory and expiratory 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. BLUS has a clear suction line terminating with a suction orifice above the cuff which allows any pooled secretions to be aspirated. The suction line terminates with a connector for suction devices and a Luer port to connect to either a syringe or a vacuum control valve which is included in the pack. 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 BLUS 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 stoma site for tube change insertion. The BLUS tracheostomy tube is packed in several kit variants to suit clinician preferences. Each kit contains a tracheostomy tube holder, an inner cannula, Tracheostomy tube disconnection wedge, cleaning brush and a patient notes label. The change kit includes a tube change J 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.
The provided text is a 510(k) summary for the Portex Ltd. Blue Line Ultra Suctionaid Tracheostomy Tube. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies or acceptance criteria with specific metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics are not present in the provided text.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Device Performance (Reported) |
|---|---|
| Substantial Equivalence (Overall) | The device is substantially equivalent in safety and effectiveness in its intended use to existing legally marketed devices. |
| Integrated Suction Line | Adds a lateral protrusion to the main tube without sharp corners or edges. |
| Inner Cannula (Reusable Feature) | Can be removed, cleaned, and replaced. Substantially equivalent to predicate 2 (Shiley Low Pressure Cuffed Tracheostomy Tube with Reusable Inner Cannula, K811033) in its reusable nature. |
| Tube Change Guide Wire | Additional component compared to predicate 1. Substantially equivalent to predicate 3 (Portex Inc. Percutaneous Dilatory Tracheostomy Kit with Speciality Tracheostomy Tube, K980466) in its tube change guide wire feature. |
| Disconnection Wedge | Additional component compared to predicate 1. Substantially equivalent to predicate 5 (Portex Inc Steri-Cath Closed Ventilation Suction System, K923559) in its disconnection wedge feature. |
| Suction Control Valve | Additional component compared to predicate 1. Substantially equivalent to predicate 6 (Bivona Aire-Cuf Tracheostomy Tube with talk attachment, K912967) in its suction control valve feature. |
| Aspiration of Subglottic Secretions | Allows aspiration of contaminated mucous and subglottic secretions that collect and build up between the tracheostomy tube cuff and the glottis. (Compared to Predicate 4: Mallinckrodt Hi-Lo Evac Tracheal Tube, K965132, regarding the procedure of removing subglottic secretions). |
| Airway Maintenance | Indicated for airway maintenance of tracheostomised patients. |
2. Sample Size for Test Set and Data Provenance
- Sample Size (Test Set): Not specified. The document refers to "Performance data for the proposed device is shown in section 8.0 Performance," but Section 8.0 is not included in the provided text. The submission relies on comparison to predicate devices, not specific clinical trial data with a defined test set.
- Data Provenance: Not specified. Given the nature of a 510(k) summary focusing on substantial equivalence, the "study" is primarily a comparative analysis against existing devices in terms of design, materials, and intended use, rather than a prospective clinical study generating new data.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable/Not specified. Ground truth as typically understood for AI models (e.g., expert consensus on images) is not relevant here. The evaluation is based on engineering design, material properties, and comparison to legally marketed predicate devices.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable/Not specified. This type of adjudication is typically for diagnostic interpretation studies, which is not the nature of this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not performed or described in this 510(k) summary. This document is for a physical medical device (tracheostomy tube), not an AI diagnostic/interpretive tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: No, a standalone algorithm performance study was not performed. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices and the demonstration that the proposed device is substantially equivalent in its design, materials, and intended use. This is primarily an engineering and regulatory comparison rather than a clinical ground truth like pathology or outcome data.
8. Sample Size for Training Set
- Sample Size (Training Set): Not applicable/Not specified. This concept is for AI/ML models, not for the regulatory approval of a physical medical device through a 510(k) pathway.
9. How Ground Truth for Training Set was Established
- How Ground Truth was Established: Not applicable. (See #8).
§ 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.