(54 days)
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.
§ 874.4100 Epistaxis balloon.
(a)
Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.(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 § 874.9.