(253 days)
The AMT Endotracheal Tube Bridle Retention System is indicated for use in the adult population for securing medically applied oral endotracheal tubes ranging in size from 5 to 10 mm in diameter. Target areas of use include intensive care, operating room, ambulatory units, endoscopy units, burn units, ENT, Gastroenterology, or any medical setting where oral tubes are placed and pullouts are a problem.
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The provided text is a letter from the FDA regarding a 510(k) premarket notification for the "AMT Bridle™ Endotracheal Tube Bridle Retention System." This document is an approval letter, not a study report or clinical trial summary. Therefore, it does not contain the detailed information about acceptance criteria, device performance, study design, expert involvement, or ground truth establishment that you are asking for.
The information you requested typically comes from the Clinical Study Report or similar documentation submitted as part of the 510(k) application, which is not provided in this extract. The letter itself only confirms that the FDA has reviewed the submission and found the device to be substantially equivalent to legally marketed predicate devices, based on the indications for use mentioned.
Without the actual study data, I cannot provide the specific details you've requested.
However, based on the provided text, I can infer the following:
- Device: AMT Endotracheal Tube Bridle Retention System
- Indication for Use: Securing medically applied oral endotracheal tubes ranging in size from 5 to 10 mm in diameter in the adult population. Target areas include intensive care, operating room, ambulatory units, endoscopy units, burn units, ENT, Gastroenterology, or any medical setting where oral tubes are placed and pullouts are a problem.
- Regulatory Classification: Class II device (21 CFR 876.5980)
To answer your questions about acceptance criteria and study details, you would need access to the full 510(k) submission (K140097), specifically the sections related to performance testing and clinical data, if any were required and submitted.
§ 868.5770 Tracheal tube fixation device.
(a)
Identification. A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.