(176 days)
The SleepTight Mouthpiece (STZ) is intended for use by adult patients 18 years of age or older as an aid to reduce snoring.
The SleepTight Mouthpiece (STZ) is intended for use by adult patients 18 years of age or older as an aid to reduce snoring. The STZ advances and holds the lower jaw forward during sleep which enlarges and stiffens the airway to alleviate or reduce snoring. The STZ attaches to both upper and lower teeth which maintains a properly opened airway. The STZ utilizes a biocompatible thermoplastic mouthpiece material to treat snoring. The raw material is ethylene-vinyl acetate (EVA). The STZ uses the common boil and bite technique familiar to athletes who heat and mold their mouth guard to fit their teeth. In this process the user softens the mouthpiece in hot water according to detailed directions provided with packaging. The user bites into the softened plastic and compresses the softened material to their teeth and gums while holding the jaw slightly forward until the material cools and stiffens. After cooling, the device maintains its shape and is used to hold the jaw open and forward during sleep to alleviate or reduce snoring.
The provided document is a 510(k) Premarket Notification from the FDA regarding the "SleepTight Mouthpiece STZ." This document primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a clinical study or performance data like those typically found in a clinical trial report for AI/machine learning devices.
Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria and the detailed study that proves the device meets those criteria.
The document states:
- "Additional non-clinical testing was not performed for this submission as the performance of the STZ is identical to the previously cleared primary predicate STM." (Page 7)
- "The STZ, Substantial equivalence is based on non-clinical data as it relates to the historical use of cleared intraoral devices that reposition the jaw forward to alleviate or reduce snoring and to historical and ongoing documented scientific research confirming mandibular advancement devices to treat snoring." (Page 7)
- "Since the materials and methods of manufacture of the STZ are identical to the materials utilized in the STM K132506 predicate, no additional biocompatibility testing is provided. The STZ and STM are identical in terms of biocompatibility." (Page 8)
The core argument for clearance is that the SleepTight Mouthpiece STZ is technologically identical to a previously cleared prescription device (STM) and functionally similar to other cleared over-the-counter (OTC) devices (SnoreRx, ZQuiet), with the key difference being an update to labeling and inclusion of a "STOPBang" questionnaire to make it suitable for OTC use. The FDA's review in this context is about confirming this substantial equivalence, not evaluating new performance data from a dedicated clinical study against pre-defined acceptance criteria as would be done for a novel AI/ML device.
Therefore, it is impossible to extract the requested information from the provided text. The prompt's questions pertain to a type of study and data not present in this 510(k) submission.
§ 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.”