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510(k) Data Aggregation

    K Number
    K021893
    Device Name
    G-MOPS, MODEL 10030
    Manufacturer
    VITROLIFE SWEDEN AB
    Date Cleared
    2002-09-06

    (88 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    G-MOPS, MODEL 10030

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

    Medium for handling and manipulating oocytes and embryos in ambient atmosphere.

    Device Description

    MOPS buffered medium.
    For oocyte collection after temperature equilibration at +37°C and ambient atmosphere.
    For gamete and embryo manipulation after the addition of G-MM or HSA-solution and temperature equilibration at +37°C and ambient atmosphere.

    AI/ML Overview

    This document is a 510(k) premarket notification summary for the G-MOPS(TM) Assisted Reproduction Media. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or specific study data to prove device performance against such criteria.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

    Specifically, the document does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Details on sample sizes, data provenance for test sets, or ground truth establishment for test/training sets.
    3. Information about expert involvement or adjudication methods.
    4. Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
    5. The type of ground truth used for performance evaluation.
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