(301 days)
The SleepApp™ is intended for the treatment of snoring and mild to moderate obstructive sleep apnea in adults 18 years of age and older.
Not Found
This document is a marketing clearance letter from the FDA for a medical device called "SleepApp™". It confirms that the device is substantially equivalent to legally marketed predicate devices.
The letter does not contain any information about acceptance criteria or performance studies of the device. It is a regulatory approval document based on the submission of a 510(k) premarket notification. Therefore, I cannot provide the requested information.
The sections you've provided, {0}, {1}, and {2}, are standard FDA communication and an "Indications for Use Form." None of these sections detail acceptance criteria, study methodologies, sample sizes, ground truth establishment, or multi-reader multi-case studies. These types of details would typically be found in the manufacturer's 510(k) submission itself, which is not provided here.
§ 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.”