(57 days)
The MedNet LOCATOR, INC., bobbin myringotomy tube is to be used by ear, nose and throat physicians for insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient.
Myringotomy Tube - Bobbin
The provided documents are a 510(k) premarket notification letter from the FDA and the associated "Indications For Use" statement for a medical device. These documents do not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested.
The FDA letter (K971943) simply states that the "Myringotomy Tube - Bobbin" device is substantially equivalent to legally marketed predicate devices and can proceed to market. The "Indications For Use" defines the intended use of the device.
Therefore, I cannot provide a response to your request, as the necessary information is not present in the given text.
§ 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.