(389 days)
The Sterile Disposable Endotracheal Tube device is intended for oral or nasal intubation and for airway management.
The Accu-Cuff device is intended to inflate cuffs and to monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.
The tracheal tube is disposable and supplied as sterile. It is available in a number of sizes/variants. The tracheal tube is primarily made of polyvinyl chloride. The device is used for airway management by connecting to oxygen delivery equipment via a connector. Reinforced ETTs may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. All variants have a radio-opaque line embedded into the tube which enables identification the device when the patient is X-rayed. All variants have a hole at the tip called a Murphy's eye and a standard connector.
Cuffed variants are composed of an inflatable cuff, a lumen and pilot balloon with a one-way valve or pressure indicator. The cuff is specified with high volume and standard volume which is intended to be inflated in the trachea in order to seal the device to prevent loss of gas bypassing the tube and the inhalation of vomit.
The patient end, the cuff and the tubular body of these tracheal tubes have short-term contact (
The provided text is a 510(k) summary for a Disposable Endotracheal Tube, Sterile, and Accu Cuff™. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and detailed device performance through a standalone study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, and training set details for an AI/algorithm-based device is not available in this document.
However, based on the information provided, I can extract details about the performance data and testing standards used to demonstrate equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative table with corresponding "reported device performance" in the context of an AI/algorithm. Instead, it compares the specifications of the proposed device to predicate devices to establish substantial equivalence.
For the Accu Cuff™, the key performance criterion mentioned is the working pressure range.
| Acceptance Criteria (from Predicate/Standard) | Reported Device Performance (Proposed Accu Cuff™) |
|---|---|
| Cuff pressure (if applicable): 20 cmH2O |
§ 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).