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510(k) Data Aggregation

    K Number
    K033101
    Device Name
    G-PGD
    Manufacturer
    VITROLIFE SWEDEN AB
    Date Cleared
    2004-05-07

    (221 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K021358
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Medium for In Vitro Fertilization Procedures
    Medium for embryo biopsy

    Device Description

    Medium for In Vitro Fertilization Procedures

    AI/ML Overview

    This document is a 510(k) premarket notification for the G-PGD™ Assisted Reproduction Media. It does not contain information about acceptance criteria, device performance, specific studies with sample sizes, ground truth establishment, or clinical performance metrics.

    The document indicates that the device's technological characteristics are "essentially similar to those of the predicate device" (Embryo Biopsy Medium, K021358) and states that "None of these changes raise new questions of safety or effectiveness." This implies that the device achieved substantial equivalence based on its similarity to a previously approved device, rather than through extensive new performance studies detailed in this particular submission.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than presenting detailed study data for the new device.

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