(29 days)
- To repair simple anterior glottic stenosis due to anterior commissure web formation.
- To prevent anterior glottic stenosis in situations where anterior commissure stenosis is likely to occur (eg, following extralaryigeal or endolaryngeal trauma with loss of anterior commissure).
- To prevent the anterior glottic stenosis immediately following removal of the Montgomery Laryngeal Stent.
The Laryngeal Keel is an umbrella-shaped device designed to the anatomy of the anterior commissure. The keel is available is sizes 12mm, 14mm, and 16mm.
The provided text describes a medical device, the Montgomery Radiopaque Laryngeal Keel, and its 510(k) premarket notification. However, it does not contain information about acceptance criteria, device performance, results of a study, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report.
The document primarily focuses on:
- Device Description and Indications for Use: What the device is and what it's used for.
- Predicate Device: Identifying a legally marketed device for comparison.
- Limited Testing Information: Only mentions successful cytotoxicity testing and non-cytotoxicity, which are biocompatibility tests, not performance criteria for its intended clinical use.
- Regulatory Communication: Correspondence from the FDA regarding substantial equivalence.
Therefore, I cannot provide a table of acceptance criteria, reported performance, or details about a study proving the device meets those criteria because that information is not present in the provided text.
The only "testing" mentioned is:
Testing: Finished device samples passed cytotoxicity testing and were determined to be nonreactive and non-cytotoxic based on Elution Test, USP 23.
This is a biocompatibility test, not a test of the device's clinical efficacy or performance in treating laryngeal stenosis. It indicates the device is safe for biological contact but provides no information on its ability to repair or prevent glottic stenosis.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.