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510(k) Data Aggregation

    K Number
    K121857
    Device Name
    FEMMYCYCLE
    Manufacturer
    FEMCAP INCORPORATED
    Date Cleared
    2012-11-15

    (142 days)

    Product Code
    HHE
    Regulation Number
    884.5400
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    FEMCAP INCORPORATED

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

    The FemmyCycle® is a receptacle placed in the vagina to collect blood and cellular debris that is exuded from the uterus via the cervix during menstruation.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the FemmyCycle® menstrual cup, not a study evaluating the performance of an AI-powered device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and a study proving a device meets those criteria for an AI device.

    Specifically, the document does not contain:

    • A table of acceptance criteria and reported device performance.
    • Information on sample sizes, data provenance, or ground truth for test or training sets.
    • Details about experts, adjudication methods, or MRMC comparative effectiveness studies.
    • Information about standalone algorithm performance.

    The document is an FDA approval for a medical device (a menstrual cup) based on substantial equivalence to a predicate device, not on a detailed performance study with defined acceptance criteria in the context of an AI/software device.

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