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510(k) Data Aggregation

    K Number
    K090503

    Validate with FDA (Live)

    Device Name
    ZQUIET MOUTHPIECE
    Manufacturer
    SLEEPING WELL, LLC
    Date Cleared
    2009-03-10

    (13 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K061688
    Predicate For
    K093407,K140777,K160531,K180124
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ZQuiet Anti-Snoring device is intended for the treatment of nightime snoring in adults.
    The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults.

    Device Description

    The ZQuiet ® Mouthpiece is an Anti-Snoring device consisting of :

    • Two trayed plates fitted in front and between the upper and lower teeth and gums . and integrated with each other with the same material as the upper and lower plates.
    • The device is made of Thermoplastic elastomer .
    • ◆ May be used as supplied
    AI/ML Overview

    Here's an analysis of the provided text regarding the ZQuiet® Mouthpiece, focusing specifically on acceptance criteria and supporting studies.

    Important Note: The provided document is a 510(k) summary and subsequent FDA clearance letter. It is designed to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove efficacy or establish novel performance criteria through extensive clinical trials. Therefore, the information regarding acceptance criteria and performance studies will be limited by the nature of this regulatory submission.

    Acceptance Criteria and Device Performance

    Based on the provided text, specific quantitative acceptance criteria for device performance (e.g., reduction in snoring decibels, AHI improvement) are not explicitly stated or provided in a table format. The submission focuses on demonstrating substantial equivalence to a predicate device (SomnoGuard Series, K061688) based on shared intended use, materials, design, and theory of operation, implying that if the new device is substantially equivalent, it meets the inherent safety and effectiveness standards already established for the predicate.

    Implicit Acceptance Criteria (based on substantial equivalence):

    Acceptance Criteria CategoryDescriptionReported Device Performance (ZQuiet® Mouthpiece)
    Intended UseTreatment of nighttime snoring in adults.Intended for the treatment of nighttime snoring in adults. (Identical to predicate)
    Device TypeMandibular Advancement Device; intraoral device.Mandibular Advancement Device; intraoral device. (Identical to predicate)
    Core FunctionalityReduces or helps alleviate snoring by advancing the lower jaw to open the upper airway.Functions by advancement of lower jaw to open upper airway. (Identical to predicate)
    Material CompositionMade of Thermoplastic elastomer.Made of Thermoplastic elastomer. (Identical to predicate)
    BiocompatibilityExpected to be biocompatible for intraoral use, not raising new safety concerns."ZQuiet® Anti-Snoring Device has been evaluated for safety through in vitro tests and animal safety studies." The conclusion states it "does not raise any new issues concerning safety and effectiveness" compared to the predicate device, implying satisfactory biocompatibility.
    Design CharacteristicsKey design features such as being ready-to-use, having upper and lower trays, a one-piece design, allowing breathing through the mouth, daily placement/removal, and daily cleaning. (Differences noted for "Boil and Bite fitting" and indication for "mild to moderate" sleep apnea are highlighted as not raising new safety/effectiveness issues for this non-Boil & Bite, snoring-only device).Ready-to-Use; Upper and lower trays; One piece design; Permits patient to breathe through the mouth; Placed in user's mouth each evening; Cleaned daily; Easily removed from the mouth. (All match predicate, with noted differences in fitting method and specific apnea indication that are argued not to raise new issues).
    Regulatory ClassificationClass II medical device, product code LRK.Classified as Class II, product code LRK.

    Study Details:

    1. Sample Size and Data Provenance for Test Set:

      • The submission does not mention a clinical study with a "test set" or a comparison against a "ground truth" to establish the device's efficacy in reducing snoring.
      • The "Non-Clinical Performance Data" section only mentions "in vitro tests and animal safety studies" for biocompatibility. No sample sizes are provided for these.
      • This is typical for a 510(k) submission where substantial equivalence to a predicate device is the primary argument, rather than a de novo efficacy claim requiring human clinical trials for performance.

    2. Number of Experts and Qualifications for Ground Truth:

      • Not applicable. There is no mention of establishing ground truth using experts for performance claims, as no performance study is described. The assessment focuses on the device's technical characteristics and safety relative to a predicate.

    3. Adjudication Method for Test Set:

      • Not applicable. No test set or related adjudication process is described for performance evaluation.

    4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

      • No such study was done or is reported. This type of study is common for imaging or diagnostic devices where human interpretation is involved. The ZQuiet® Mouthpiece is a therapeutic device, and the submission does not involve human interpretation of data where MRMC would be relevant.

    5. Standalone Performance Study (Algorithm Only):

      • No such study was done or is reported. This device is a physical medical device, not an algorithm or software. Its performance is directly tied to its physical interaction with the user's anatomy.

    6. Type of Ground Truth Used:

      • For the non-clinical safety evaluation, the "ground truth" for biocompatibility would be established by standard biological safety testing protocols (e.g., ISO 10993 series), rather than clinical outcomes or expert consensus.
      • For the overall regulatory clearance, the "ground truth" is the legally marketed predicate device (SomnoGuard Series K061688), against which the new device is deemed substantially equivalent in terms of intended use, technology, and safety/effectiveness.

    7. Sample Size for Training Set:

      • Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

    8. How Ground Truth for Training Set was Established:

      • Not applicable. As above, no training set is relevant to this type of device and submission.

    In summary: The K090503 submission for the ZQuiet® Mouthpiece is a 510(k) premarket notification. Its "study" for acceptance criteria is primarily a comparison to a legally marketed predicate device to demonstrate substantial equivalence, rather than a clinical trial designed to prove independent efficacy against quantitative acceptance criteria. The acceptance criteria are implicit: that the device's characteristics (components, materials, intended use, mechanism of action, design) are sufficiently similar to the predicate that it raises no new questions of safety or effectiveness. The only explicit performance data mentioned are non-clinical (in vitro and animal safety studies) to assess biocompatibility, but no details or sample sizes are provided for these.

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