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The Rutler Supra Stomal Stent is indicated for the prevention and treatment of laryngeal and tracheal stenosis.

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This document is a 510(k) substantially equivalent letter from the FDA regarding the "Rutter Supra Stomal Stents." It does not contain information about acceptance criteria, device performance metrics, or study details. It is a regulatory approval letter.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and the substantial equivalence determination, not on a detailed scientific study supporting device performance.

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1. To repair simple anterior glottic stenosis due to anterior commissure web formation.
2. 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).
3. 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.

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