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510(k) Data Aggregation

    K Number
    K040498
    Device Name
    MYSHELL
    Manufacturer
    SEDAT S.A.
    Date Cleared
    2004-07-02

    (127 days)

    Product Code
    DTL
    Regulation Number
    870.4290
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K991102
    Predicate For
    K072552,K080472,K143252
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MYSHELL is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (<.098") during interventional procedures.

    The 3-way stopcock, Alligatork and guidewire introducer are accessories used in conjunction with MYSHELL to facilitate interventional procedures.

    MYSHELL and its accessories are indicated for assisting, manipulating and maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (.098") used in interventional procedures.

    Device Description

    MYSHELL is an ergonomically designed y-connector/hemostatic valve that accepts materials up to 9F in size (<.098").

    The watertight double hemostatic silicone valve is manipulated by a valve opening mechanism on the external body of MYSHELL. The opening mechanism allows for precise control of the internal valve: press gradually on the mechanism for a controlled opening, push the mechanism entirely in for a complete and locked opening, or completely close the valve by depressing on the mechanism in its locked position.

    AI/ML Overview

    The provided text states that "The safety and efficacy of MYSHELL and its accessories... have been demonstrated," but it does not provide any specific acceptance criteria or details of a study verifying those criteria.

    Therefore, I cannot populate the table or answer the specific questions about the study from the provided document. The submission is a 510(k) summary for a medical device (Y-Connector/Hemostatic Valve), which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results with acceptance criteria.

    Information not found in the provided document:

    • A table of acceptance criteria and reported device performance.
    • Sample size used for the test set.
    • Data provenance for the test set.
    • Number of experts used to establish ground truth for the test set.
    • Qualifications of experts.
    • Adjudication method for the test set.
    • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
    • Effect size (if MRMC was done).
    • Whether a standalone performance study was done.
    • Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
    • Sample size for the training set.
    • How ground truth for the training set was established.
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