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510(k) Data Aggregation

    K Number
    K110713
    Device Name
    WATERPAP VALVE
    Manufacturer
    AIRWAYS DEVELOPMENT, LLC
    Date Cleared
    2011-09-12

    (181 days)

    Product Code
    BYE
    Regulation Number
    868.5965
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K090317
    Why did this record match?
    Device Name :

    WATERPAP VALVE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The WaterPAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing

    Device Description

    The WaterPAP Valve is an infant positive end expiratory pressure device used to increase end lung pressure above atmospheric in constant flow conditions.

    AI/ML Overview

    Here's an analysis of the provided text regarding the WaterPAP™ Valve, structured to address your specific questions about acceptance criteria and the supporting study:

    The provided text does not describe traditional "acceptance criteria" in the sense of predefined thresholds for diagnostic accuracy (e.g., sensitivity, specificity), nor does it conduct a study to prove the device meets such criteria for diagnostic performance. Instead, this submission is for a medical device (a Positive Airway Pressure Valve) where the primary evaluation is for substantial equivalence to a predicate device.

    The "acceptance criteria" are implicitly derived from the performance of the predicate device and the requirement that the new device performs "in a similar manner" within established specifications. The study described is a comparative performance test to demonstrate this substantial equivalence.

    Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Pressure Equivalence: Performance similar to predicate device within established specifications of ± 1 cm H₂O across flow rates of 4-12 L/min and pressures of 1-10 cm H₂O.Met: "Results indicated both PAP valves performed in a similar manner within established specifications of ± 1cm H20 with comparable test data."
    Water Level Change (Accumulation): Rate of water level change during simulated use should be equivalent to the predicate device.Met: "Results indicated the WaterPAP and Babi*Plus Valves accumulate an equivalent amount of water and therefore the Positive Airway Pressures changes in both valves are essentially equivalent."
    Response to Increased Flow Rates (Pressure Increase): Should demonstrate similar behavior to the predicate device in generating increased pressures with increased flow rates.Met: "The results demonstrate that the WaterPAP and Babi.Plus valves both generate increased pressures with increase flow rates." (The finding that both are predominantly above depth settings and require gauge reliance is an observation about both devices, not a failure of the WaterPAP to meet a comparative criterion).
    Resistance to Flow through Air Diffusers: Resistance should be within an acceptable range, ideally comparable to the predicate device, not negatively impacting intended use.Met: "The results showed that the WaterPAP Valve had slightly higher resistance across the full range of flow rates; however the resistance to flow in both devices is well below a level that could have a negative impact during their intended use." (Despite being slightly higher, it's considered acceptable).

    Study Details

    1. Sample Size Used for the Test Set and Data Provenance:

      • Sample Size: Not applicable in the traditional sense of patient data. The "test set" consists of multiple configurations of flow and pressure combinations (flow rates 4-12 L/min and pressures 1-10 cm H₂O). The exact number of unique combinations tested is not specified but described as "a full range."
      • Data Provenance: The data is from bench testing (simulated use), not clinical or patient data. Therefore, country of origin related to patient data is not relevant. It is a prospective bench study comparing the two devices.

    2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

      • Not applicable. This study is a bench test evaluating physical performance characteristics (pressure, flow, water level changes, resistance) against predefined engineering specifications and comparison to a predicate device. It does not involve expert interpretation or diagnostic ground truth.

    3. Adjudication Method for the Test Set:

      • Not applicable. No human interpretation or adjudication was involved in generating the performance data.

    4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

      • No. This is not an AI-assisted diagnostic device, nor is it a multi-reader, multi-case study. It's a bench test of a mechanical device.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

      • Not applicable. This is a mechanical device, not an algorithm. The "standalone" performance is the bench testing of the device itself.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • The "ground truth" here is the measured physical performance characteristics of the predicate device (Babi*Plus Bubble PAP Valve) and the established engineering specifications for such devices (e.g., ± 1 cm H₂O tolerance). The WaterPAP Valve's performance is compared against these established values.

    7. The sample size for the training set:

      • Not applicable. This is a mechanical device, not a machine learning algorithm, so there is no "training set."

    8. How the ground truth for the training set was established:

      • Not applicable. There is no training set for this type of device submission.
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