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510(k) Data Aggregation

    K Number
    K120072
    Device Name
    VENOUS DRAINAGE CANNULA WITH DURAFLO COATING
    Manufacturer
    EDWARDS LIFESCIENCES, LLC.
    Date Cleared
    2012-05-08

    (119 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K831769,K033464,K092509
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Single Stage Venous Cannulae:
    Venous return cannulae are intended for cannula drainage from the right atrium or superior and inferior vena cava during extracorporeal circulation for a duration of ≤6 hours.
    Venous cannulae may be used in pediatric populations or adult populations based on flow rate requirements and patient anatomy. Please see labeling for maximum flow rate information.
    Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

    Dual Stage Venous Cannulae:
    Dual drainage venous return cannulae are indicated for venous cannulation so that extracorporeal circulation of the venous blood to a heart-lung machine may be achieved, for a duration of ≤6 hours.
    Venous cannulae may be used in pediatric populations or adult populations based on flow rate requirements and patient anatomy. Please see labeling for maximum flow rate information.
    Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

    Device Description

    Edwards Lifesciences venous return cannulae are soft cannulae with encapsulated steel wire reinforcement. Venous return cannulae are offered with various tip styles, hole patterns, French sizes, lengths, straight or angled tubing, and two sizes of connectors. Some styles are offered with obturators.

    The exterior and inner-luminal cannula surfaces of product codes containing a "D" or "DII" are coated with Duraflo heparin. When used on devices for cardiopulmonary surgery, the Duraflo coating improves the blood compatibility of non-biological surfaces in the extracorporeal circuit.

    Each Edwards Lifesciences device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch.

    AI/ML Overview

    This 510(k) summary (K120072) describes venous drainage cannulae. The document primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about a study to prove acceptance criteria for a novel device or AI algorithm.

    Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided text. The document concerns a traditional medical device (cannulae), not an AI/ML-driven device.

    Based on the provided text, I can only provide the following limited information:

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

    The document does not explicitly state acceptance criteria or report performance data in the way one would for a diagnostic accuracy study. Instead, the "performance" described relates to demonstrating equivalence in fundamental scientific technology, material types, principles of operation, and functional performance evaluations with predicate devices.

    Acceptance Criteria (Inferred from Substantial Equivalence Claim)Reported Device Performance (as stated in the document)
    Same technological characteristics (design, material, chemical composition, energy source) as predicate devices."The subject devices with revised Indications for Use statements have the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices."
    Comparable to predicate devices in fundamental scientific technology, material types, principles of operation, and functional performance evaluations."It has been demonstrated that the subject Venous Drainage Cannulae are comparable to the predicate devices in fundamental scientific technology, material types, principles of operation, and functional performance evaluations."
    No new issues of safety or efficacy raised compared to predicate devices."No new issues of safety or efficacy have been raised."

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

    • Sample Size: Not applicable/not provided. This is not a study involving a test dataset for an algorithm.
    • Data Provenance: Not applicable/not provided.

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

    • Not applicable/not provided. This section is relevant for studies involving expert interpretation or consensus, which is not described here.

    4. Adjudication method for the test set:

    • Not applicable/not provided.

    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:

    • No. This is not an AI/ML device, and no MRMC study is mentioned.

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

    • No. This is a medical device, not an algorithm.

    7. The type of ground truth used:

    • Not applicable/not provided. The "truth" here is the assessment of substantial equivalence based on engineering and material comparisons, not diagnostic ground truth.

    8. The sample size for the training set:

    • Not applicable/not provided. There is no training set for an AI algorithm mentioned.

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

    • Not applicable/not provided.
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