(232 days)
The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults 18 years or older.
The ZQuiet anti-snoring device is a single piece anti-snoring device, which moves the lower jaw forward and helps reduce the likelihood of snoring. This is achieved by covering the upper and lower teeth with a resilient non-toxic thermoplastic elastomer compound. The ZQuiet is easy to wear and simple to use. The single shot manufacturing process incorporates a resilient hinge in the molar area to provide a single piece device. The anti-snore device comprises an upper member adapted to engage the maxillary dentition of a human and a lower member adapted to engage the mandibular dentition of the human, the upper and lower members being resiliently hinged together.
The ZQuiet Mouthpiece is an anti-snoring device. The study performed for its clearance was a non-clinical evaluation rather than a clinical study. The device claims substantial equivalence to its predicate device (K090503 ZQuiet Mouthpiece) based on identical intended use and design, with a material change that was tested to ensure safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Standard/Methodology | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Agar Diffusion Test (in vitro cytotoxicity) | ISO 10993-5: 1999 "Tests for in vitro cytotoxicity" | Not cytotoxic | Pass - Not considered cytotoxic |
| Primary Dermal Irritation in Rabbits | Federal Hazardous Substances Act Regulations (16 CFR 1500.41) | Not a primary dermal irritant | Pass - Not a primary dermal irritant |
| Guinea Pig Closed Patch Sensitization Test | ISO 10993-10: 2002 Tests for irritation and delayed type hypersensitivity | No sensitizing properties | Pass - No sensitizing properties |
| Oral Mucosal Irritation Study | ISO 10993 – Part 10 – Tests for Irritation and Delayed-Type Hypersensitivity | Minimal irritant or less | Considered to be a minimal irritant. |
2. Sample size used for the test set and the data provenance:
- Agar Diffusion Test: Not specified (in vitro test).
- Primary Dermal Irritation in Rabbits: Rabbits (specific number not provided but typically a small group for such tests). The data provenance is pre-clinical animal testing.
- Guinea Pig Closed Patch Sensitization Test: Guinea pigs (specific number not provided). The data provenance is pre-clinical animal testing.
- Oral Mucosal Irritation Study: Not specified (likely animal model or in vitro, but typically animal models for irritation studies). The data provenance is pre-clinical testing.
The document does not specify country of origin for the data, but these are standard international bio-compatibility tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The tests performed were bio-compatibility and safety studies (in vitro and animal models), not human clinical studies involving expert interpretation of results. The "ground truth" was established by the scientific methodologies of the respective ISO standards and regulations.
4. Adjudication method for the test set:
Not applicable. These were laboratory tests with objective endpoints (e.g., cytotoxicity, irritation scores) rather than subjective assessments requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
No. This was a non-clinical safety evaluation for a material change, not a study assessing diagnostic or treatment effectiveness involving human readers or cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This device is a physical anti-snoring mouthpiece, not a software algorithm.
7. The type of ground truth used:
The ground truth used was based on established scientific methodologies and standards for biocompatibility and safety testing (e.g., ISO 10993 standards, Federal Hazardous Substances Act Regulations). The "truth" refers to the cytotoxic, irritating, or sensitizing potential of the material under test.
8. The sample size for the training set:
Not applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. There is no training set as it's not an AI/ML device.
§ 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.”