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510(k) Data Aggregation

    K Number
    K132390
    Device Name
    INSTINCT; PLAIN, DOTTED, ULTRA THIN
    Manufacturer
    PROFILATEX, S.A. DE C.V.
    Date Cleared
    2014-04-22

    (264 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Abbreviated
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Instinct brand condoms ( Instinct Plain, Instinct Dotted, Instinct Ultrathin) are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for INSTINCT BRAND CONDOMS. It does not contain information about a study with acceptance criteria and device performance metrics in the context of an AI/ML medical device. Therefore, I cannot extract the requested information from the provided text.

    Specifically, the document pertains to a traditional medical device (condoms) and its substantial equivalence to previously marketed devices, not an AI/ML-driven device that would involve performance metrics like sensitivity, specificity, or the use of training/test sets, expert adjudication, or MRMC studies.

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