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510(k) Data Aggregation

    K Number
    K022244
    Device Name
    G-1 VERSION 3, MODEL 10048
    Manufacturer
    VITROLIFE SWEDEN AB
    Date Cleared
    2002-09-06

    (56 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-1 VERSION 3, MODEL 10048

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

    Medium for culture of embryos from the pronucleate stage to day 2 or day 3.

    Device Description

    Bicarbonate buffered medium containing Hyaluronan. For use after the addition of G-MMTM or HSA-solution™ and pre-equilibration at +37°C and 6% CO2.

    AI/ML Overview

    The provided text is a 510(k) premarket notification summary and a letter from the FDA regarding the G-1TM version 3 Assisted Reproduction Media. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a medical device utilizing AI/machine learning would.

    This device is a culture medium, not an AI-powered diagnostic tool. Therefore, the requested information about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size, and ground truth establishment for training sets, is not applicable and cannot be extracted from this document.

    The document focuses on demonstrating substantial equivalence to a predicate device (G1.2TM) based on technological characteristics and intended use. The "improvement in performance" mentioned refers to the chemical formulation of the culture medium itself, not the performance of an algorithm or diagnostic accuracy.

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