(80 days)
- AN ORA/ Appliance to be used for the theatment of mild And Moderate Obstructive Sleep ApNCA
- For the treatment of SNORING
- For the prevENTION OF DRUKIEM.
The Full Breath Sleep Appliance is a custom fabricated device typically by a professional dental laboratory and delivered by a dentist. This is a simple enhancement to the design of the Quiet Night & Quiet Night MA (K032410). It incorporates the Quiet Night and the NTI (K010867) anterior discluding element for bruxism and control of vertical dimension and anterior mandibular advancerient for reduction/elimination of snoring. It also has the posterior trans-palatal bar to prevent the tongue from sealing against the palate and reducing snoring, and restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's and reduction of ODI's.
This document is a 510(k) summary for the Full Breath Sleep Appliance. The device is intended for the treatment of mild and moderate Obstructive Sleep Apnea, the treatment of snoring, and the prevention of bruxism.
The key information provided includes:
- Acceptance Criteria and Device Performance: Not explicitly stated as acceptance criteria in the prompt's sense. However, the device is considered substantially equivalent to predicate devices, implying it meets similar performance expectations. The efficacy is based on its design incorporating features from existing devices known to achieve these indications.
- Sample Size and Data Provenance: No specific study data, sample size, or provenance (country of origin, retrospective/prospective) is provided in this 510(k) summary. The submission focuses on substantial equivalence to predicate devices rather than new clinical trials.
- Ground Truth Establishment: Not applicable as no new clinical study validating performance against a ground truth is presented.
- Expert and Adjudication Methods: Not applicable as no new clinical study validating performance against a ground truth is presented.
- MRMC Comparative Effectiveness Study: Not performed or reported in this document. The submission is not related to assessing AI assistance.
- Standalone Performance: Not applicable as this is not a standalone algorithm, but a physical medical device.
- Type of Ground Truth: Not applicable, as detailed above.
- Training Set Sample Size and Ground Truth: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
Summary of Device Performance (Implied by Substantial Equivalence):
The Full Breath Sleep Appliance (AB and ABB) is described as a simple enhancement to existing predicate devices (Quiet Night & Quiet Night MA - K032410, and NTI - K010867). Its design incorporates the anterior discluding element for bruxism and control of vertical dimension and anterior mandibular advancement for reduction/elimination of snoring, similar to the NTI. It also includes a posterior trans-palatal bar, which is stated to prevent tongue sealing against the palate, reduce snoring, and restrain the tongue from up and back movement, leading to "reduced AHI/RDI's and reduction of ODI's."
Predicate Device Comparison Table:
| Product Name | 510(k) | Product Code | Indicated Use | Method of Delivery |
|---|---|---|---|---|
| Full Breath Sleep Appl. | Pending | LQZ | Treatment of Mild & Mod. OSA, Prevent Bruxism, Snoring | By prescription |
| Quiet Night Quiet Nt. MA | K032410 | LQZ | Prophylactic treatment of medically diagnosed migraine pain, Prevent Bruxism | By prescription |
| NTI Tension Suppression System | K010876 | LQZ | Prophylactic treatment of medically diagnosed migraine pain, Prevent Bruxism | By prescription |
| Breathe EZ Anti-Snoring Device | K022891 | LRK | Treatment of snoring, Prevent Bruxism | By prescription |
| Sleepbite | K103808 | LRK | Treatment of snoring, Prevent Bruxism | By Prescription |
| Dr. B's Mouthpiece | K991948 | LRK | Treatment of snoring, Prevent Bruxism | By prescription |
Note: The FDA's 510(k) clearance process involves demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials that explicitly define acceptance criteria and studies to meet them in the manner described in the prompt for AI/algorithm-based devices. The "study" in this context is the comparison to existing, approved devices and the rationale for how the new device's design achieves similar intended effects.
§ 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.”