(111 days)
The Vital Sleep™ mandibular advancement device is intended for the treatment of nighttime snoring in adults.
Not Found
The provided text is an FDA 510(k) clearance letter for the Vital Sleep™ device. This letter does not include information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices for treating nighttime snoring.
Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval, not a scientific study report.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”