(43 days)
Chronic otitis media with effusion (serous, mucoid, or purulent) Recurrent episodes of acute otitis media despite conventional medical treatment . A record of persistent high negative middle ear pressure associated with one or . more of the following system: 1. Conductive hearing loss that is symptomatic 2. Persistent or recurrent otalgia 3. Persistent or recurrent vertigo, tinnitus, or both . Atelectasis resultant from retraction pocket of the tympanic membrane or . eustachian tube dysfunction.
The Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes are manufactured from Blue (PTFE) Fluoroplastic and are supplied sterile. Various designs are available.
This document is a 510(k) premarket notification for the Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes. It asserts substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a performance study with acceptance criteria.
§ 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.