(228 days)
The PAsr/QuietNite, a dentist prescribed mandibular repositioning/advancement device is intended for the treatment of nighttime incidents of snoring and/or mild to moderate obstructive sleep apnea in persons 18 years of age or older. These devices are not indicated for the treatment of central apnea or severe obstructive sleep apnea and should only be prescribed by a Dentist after the undertaking of a sleep study.
The PAsr QuietNite, a dentist prescribed mandibular repositioning device, is worn during sleep and is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea. Before a dentist prescribes a PAsr QuietNite appliance for treatment, it is recommended that the patient receive a sleep study diagnosis.
The provided text describes a 510(k) summary for the PAsr QuietNite dental device, which is intended to reduce snoring and mild to moderate obstructive sleep apnea. However, the document does not contain any information regarding acceptance criteria, study details, or performance data for the PAsr QuietNite device itself.
The document primarily focuses on:
- Device Description: What the device is and its intended use.
- Intended Use Statement: Specific indications and contraindications.
- Predicate Device Identification: Comparison to a legally marketed device (SilentNite, K972424) for substantial equivalence.
- FDA Clearance Letter: Official notification of 510(k) clearance.
Therefore, I cannot provide the requested information as it is not present in the given text. The tables and study details would be blank or state "Not provided in the document."
To answer your request, a document that includes performance testing, clinical study reports, or a summary of safety and effectiveness would be necessary.
§ 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.”