(220 days)
The Well Lead Reinforced Endotracheal Tubes are designed for oral or nasal intubation for airway management during anaesthesia. The product may be used where the patient's neck is likely to be moved or flexed or the patient is in the prone positiom so that a non-reinforced tracheal tube might become kinked.
Single Use. A Tracheal tube with addidional metal wire spiral reinforcement to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery, and oral surgery. The plastic material and the spring allow the tube to be easily bent in all directions. The steel reinforcement maintains the patency of the lumen. The Well Lead Reinforced Endotracheal tube is available in cuffed and uncuffed variants. The cuff is intended to provide 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. Uncuffed tubes are used mainly for paediatric patients or when patients require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration.
The acceptance criteria and device performance for the Well Lead Reinforced Endotracheal Tube are based on conformity to the international standard ISO 5361:1999(E).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 5361:1999(E) (all aspects except OD tolerance) | Conformed |
| • Dimension | Conformed |
| • Design | Conformed |
| • Material | Conformed |
| • Sterility | Conformed |
| • Packaging | Conformed |
| • Tolerance of the Outside Diameter (OD) | Not fully conformed (stated as "except the tolerance of the outside diameter") |
2. Sample Size and Data Provenance for Test Set
The provided document does not contain information regarding a specific "test set" in the context of clinical studies with human subjects or a defined set of data for performance evaluation. The device's performance is asserted by its conformity (or non-conformity in one aspect) to a manufacturing standard. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not available from this document.
3. Number of Experts and Qualifications for Ground Truth
The document does not detail any studies that involved human experts to establish ground truth for the device's performance. The "ground truth" for this device's acceptance is based on its adherence to manufacturing standards (ISO 5361:1999(E)).
4. Adjudication Method for Test Set
Since no specific test set involving expert review is described, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned or implied in the provided 510(k) summary. This type of study typically assesses the impact of AI assistance on human reader performance, which is not relevant for this device.
6. Standalone (Algorithm Only) Performance
The device is a physical medical instrument (Reinforced Endotracheal Tube), not a software algorithm. Therefore, the concept of "standalone (algorithm only) performance" does not apply.
7. Type of Ground Truth Used
The "ground truth" for the device's acceptance is primarily based on conformance to international engineering and manufacturing standards (ISO 5361:1999(E)). This standard dictates various physical and functional properties of tracheal tubes.
8. Sample Size for the Training Set
As this is a physical medical device and not an AI/algorithmic device, there is no "training set" in the computational context described.
9. How Ground Truth for Training Set Was Established
Similarly, since there is no training set, the method of establishing ground truth for it is not applicable.
§ 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).