(38 days)
Ventilation tubes are indicated where cases of enstachian tube dysfunction fails to respond conventional therapy. This includes : Chronic otitis Media with effusion (serous , mucoid, or pur ulent). Recurrent acute ofitis Media . persistent high negative A record of with associated middle ear pressure, hearing conductive Symptomatic otalgia, vertige and for timmitas brangia, version of the tympanic membraine.
Tympanostomy Ventilation Tube-TVT 800
The provided text is a 510(k) premarket notification letter from the FDA regarding a Tympanostomy Ventilation Tube (TVT 800). It is a regulatory document addressing the substantial equivalence of this medical device.
This document does NOT contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies. It is a regulatory approval letter, not a device performance study report.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document confirms that the device is "substantially equivalent" to legally marketed devices, but it does not detail the specific performance metrics or studies used to determine this equivalence.
§ 874.3880 Tympanostomy tube.
(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.