(76 days)
Restores the integrity of damaged endotracheal and tracheostomy pilot tubes
When the endotracheal or tracheostomy pilot tube no longer maintains cuff inflation pressure, the needle of the BE 409 Pilot Tube Repair Kit is inserted into the cut pilot tube. The cuff can then be re-inflated in the usual manner. Such a repair can deter the need to replace the entire endotracheal or tracheostomy tube because of a damaged pilot tube.
BE 409 Pilot Tube Repair Kit
The provided text is a 510(k) clearance letter for a medical device: "BE 409 Pilot Tube Repair Kit." This document is related to regulatory approval based on substantial equivalence to a predicate device, not an AI or algorithm-based device. Therefore, it does not contain the information required to answer the questions about acceptance criteria for an AI study, such as sample sizes for training/test sets, ground truth establishment, expert qualifications, or MRMC studies.
The document describes the intended use of the device and its function:
- Device: BE 409 Pilot Tube Repair Kit
- Summary: Restores the integrity of damaged endotracheal and tracheostomy pilot tubes. When the pilot tube no longer maintains cuff inflation pressure, the kit's needle is inserted into the cut pilot tube, allowing the cuff to be re-inflated in the usual manner. This avoids replacing the entire endotracheal/tracheostomy tube due to a damaged pilot tube.
Since this is a physical repair kit and not an AI device, the requested information (acceptance criteria, study details for AI, sample sizes for AI training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) is not applicable or available in this document.
§ 868.5750 Inflatable tracheal tube cuff.
(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).