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The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may r he baneler is a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.

Disposable Sillicone Epistaxis Catheter

I am sorry, but without further information about the device and its performance, I cannot provide a detailed answer to your request. The provided text is a letter from the FDA regarding a 510(k) premarket notification for a "Disposable Silicone Epistaxis Catheter." It confirms the device's substantial equivalence to a predicate device and its regulatory classification. However, it does not contain any information about:

• Acceptance criteria for performance.
• Reported device performance data.
• Study details (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth type, training set details).

To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) summary that includes performance data and study design.

If you can provide a document that contains this information, I would be happy to help you extract and present it according to your requested format.

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The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may also be used as a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.

Epistaxis Catheter

The provided text details an FDA 510(k) clearance letter for the Vyker Silicone Epistaxis Catheter and its intended use. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot provide the requested information based on the input document. The document is solely an FDA clearance letter confirming substantial equivalence to a predicate device.

Ask a specific question about this device