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    K Number
    K151506
    Device Name
    Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
    Manufacturer
    Salter Labs
    Date Cleared
    2016-03-11

    (281 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K890298,K892407
    Why did this record match?
    Device Name :

    Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula

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

    The intended use is to deliver oxygen to the patient nasally, controlled by a demand system.

    Device Description

    The demand cannula is a special cannula designed to give adult and pediatric users of dual port oxygen conservation delivery system all the comfort and conveniences of a Salter-Style® cannula. Unique dual tubing delivers oxygen on demand through one tube while inspiratory / expiratory effort is also sensed through the other tube. Meets dual port device manufacturers' specifications.

    AI/ML Overview

    The provided document describes the acceptance criteria and a study to demonstrate substantial equivalence for the NOP Demand Nasal Oxygen Cannula and NOP Modified Demand Nasal Oxygen Cannula.

    Here's the breakdown of the requested information:

    1. A table of acceptance criteria and the reported device performance

    CriteriaReported Device Performance
    Shall not have a back pressure that exceeds 3 psi at a maximum flow rate in ambient of 5°C, 20°C, and 40°C.The NOP Demand/Modified Demand Nasal Oxygen Cannula met the objective back pressure requirements. Maximum back pressure was found to be less than 2 psi.
    The bonded components of the set will have a bond strength that is ≥ 2 lbs. when pulled at a rate of 5 inches per minute.The NOP Demand/Modified Demand Nasal Oxygen Cannula passed all bond strength requirements. All test samples measured above the bond interface tensile load limit. The worst case cannula sample was able to achieve over 2 times the minimum allowable value.
    The cannula shall withstand storage and transport temperatures. A high temperature limit of 50°C and a low temperature limit of -29°C.The NOP Demand/Modified Demand Nasal Oxygen Cannula met the above performance criteria after storage and transport environmental conditioning.

    2. Sample size used for the test set and the data provenance

    • Sample Size: A minimum required sample size of 29 was used for the performance testing.
    • Data Provenance: The document does not specify the country of origin of the data. It is a retrospective study conducted by the manufacturer (Salter Labs) to demonstrate substantial equivalence for a material change.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    This information is not provided in the document. The study focuses on direct physical and performance testing of the device, not on expert evaluation or consensus for a "ground truth" as might be relevant for diagnostic or AI-based devices.

    4. Adjudication method for the test set

    This information is not applicable/provided as the study did not involve expert adjudication for establishing ground truth. The testing involved objective measurements against predefined criteria.

    5. 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

    This information is not applicable. The device is a nasal oxygen cannula, not an AI-based diagnostic tool, so an MRMC study is not relevant.

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

    This information is not applicable. The device is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

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

    The concept of "ground truth" as typically defined for diagnostic or AI studies is not directly applicable here. Instead, the study establishes "truth" through direct physical performance measurements (e.g., back pressure, bond strength, temperature resistance) against specified engineering and product design criteria.

    8. The sample size for the training set

    This information is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.

    9. How the ground truth for the training set was established

    This information is not applicable. As there is no training set, there is no ground truth for it. The study established performance data through direct physical testing.

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