(247 days)
Portex® tracheal tubes are intended for oral and/or nasal intubation for airway management. Expert clinical judgement should be exercised in the selection of the appropriate tracheal tube size and style for an individual patient. For adult, Paediatric excluding neonatal and infant use.
A range of sterile, single use tracheal tubes for oral and/or nasal intubation intended for airway management. Manufactured from clear polyvinyl chloride (PVC) incorporating the following features:
• Thermosensitive materials with sufficient initial rigidity for intubation which then conforms to the individuals respiratory tract at body temperature ensuring minimum trauma.
• Radio-opaque Blue Line ® to confirm correct tube placement by X-ray
• All Portex® tracheal tubes are packed with a 15mm connector conforming to ISO5356
• Sterile unless the unit pack is opened or damaged
• Cuffed tracheal tubes are designed with a high volume tapered low pressure cuff and all have an attached pilot balloon with a one way luer valve
• Smooth Murphy eye
• As a reference during intubation, the tracheal tubes have depth marks in centimetres which indicates the distance to distal tip.
The provided document describes a 510(k) premarket notification for the Portex® Tracheal Tube. This document establishes substantial equivalence to a predicate device rather than presenting a study proving performance against defined acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not applicable.
Here's an analysis of the provided information in the context of your request:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The submission is for substantial equivalence, meaning the device's performance is demonstrated by its similarity to an already legally marketed device, not by meeting specific, quantitative acceptance criteria through a dedicated performance study.
2. Sample sized used for the test set and the data provenance
This information is not applicable as no specific "test set" and associated study data were provided in the context of acceptance criteria and proven device performance. The submission relies on a comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as no specific "test set" and ground truth establishment by experts were performed for this substantial equivalence submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no specific "test set" with expert adjudication was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This submission is for a medical device (tracheal tube), not an AI-powered diagnostic or assistive tool where MRMC studies would typically be conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This submission is for a physical medical device (tracheal tube), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable. The submission establishes equivalence based on design characteristics, materials, intended use, and conformance to standards, rather than proving performance against a specific ground truth.
8. The sample size for the training set
This information is not applicable as there is no mention of a training set or machine learning algorithm in the context of this traditional medical device submission.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
Summary of Relevant Information from the Document:
The submission focuses on demonstrating substantial equivalence of the Portex® Tracheal Tube to a predicate device, the Well Lead Aircare™ Endotracheal tube (K042683). The basis for equivalence is primarily by comparison of:
- Indications for Use: Both devices are intended for oral and/or nasal intubation for airway management, for adult and pediatric excluding neonatal and infant use.
- Device Design and Material Composition: The document states that equivalence data between the Portex Tracheal Tube and the predicate device is provided in Table 4 (which is not included in the provided snippets, but implied to detail similarities).
- Performance Characteristics: The general description mentions features like thermosensitive materials, radio-opaque blue line for X-ray confirmation, 15mm connector conforming to ISO5356, sterile packaging, high volume tapered low-pressure cuff, smooth Murphy eye, and depth marks in centimeters. These features are standard for tracheal tubes and are presumably consistent with the predicate device.
- Compliance with Standards: The Portex® Tracheal Tube conforms to ISO 5361:1999 (Anaesthetic and respiratory equipment - Tracheal tubes and connectors). This standard conformance acts as a performance benchmark.
In essence, the "proof" that the device meets "acceptance criteria" is that it is sufficiently similar to a device already deemed safe and effective by the FDA. There are no explicit quantitative acceptance criteria or a dedicated performance study described in the provided text.
§ 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).