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510(k) Data Aggregation

    K Number
    K013536
    Device Name
    EMTRAC; DELPHIN; SEMTRAC 2000 SET
    Manufacturer
    GYNETICS MEDICAL PRODUCTS NV
    Date Cleared
    2001-11-30

    (38 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EMTRAC; DELPHIN; SEMTRAC 2000 SET

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

    The Delphin is to be used for embryo transfer and intra uterine insemination procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures.

    Emtrac Catheters are to be used for embryo transfer procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures.

    Semtrac Sets are to be used for embryo transfer procedures for in Semilac Sets are to be acount. In the substition technology (ART) procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry but this document is a 510(k) clearance letter from the FDA, not a study report. It states that the referenced medical devices (Emtrac, Delfin, and Semtrac Embryo Transfer and IUI Catheters) are substantially equivalent to legally marketed predicate devices.

    Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance. It does not include:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test sets or data provenance.
    • Information on experts used for ground truth or adjudication methods.
    • Details on MRMC comparative effectiveness studies or standalone algorithm performance.
    • Type of ground truth used.
    • Sample size for training sets or how ground truth for training sets was established.
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