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510(k) Data Aggregation

    K Number
    K053646
    Device Name
    INVITRO MATURATION MEDIA
    Manufacturer
    SAGE IN-VITRO FERTILIZATION INC.
    Date Cleared
    2006-07-14

    (196 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K041284,K002836
    Why did this record match?
    Device Name :

    INVITRO MATURATION MEDIA

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

    System for maturing immature oocytes of infertile women undergoing in vitro fertilization who for medical reasons cannot or choose not to undergo conventional ovarian stimulation using drugs.

    Oocyte Washing Medium: This medium is used for washing immature oocytes contained within cumulus-oocyte complexes (COCs), collected from the follicles before maturation in culture.

    Oocyte Maturation Medium: This medium is used for maturation in culture of immature oocytes in an incubator.

    Embryo Maintenance: This medium is used for embryonic culture following insemination by intracytoplasmic sperm injection (ICSI).

    Device Description

    Oocyte Washing Medium is a balanced salt solution containing nutrients, amino acids and vitamins to maintain immature oocytes during their collection and washing.

    Oocyte Maturation Medium is a balanced salt solution containing nutrients, amino acids and vitamins for the in vitro culture of immature oocytes.

    Embryo Maintenance Medium is a balanced salt solution containing nutrients and amino acids for maintaining embryos in culture.

    AI/ML Overview

    This document is a 510(k) summary for reproductive media (Oocyte Washing Medium, Oocyte Maturation Medium, and Embryo Maintenance Medium) and does not describe an AI medical device. Therefore, it does not contain the information required to answer your questions regarding acceptance criteria and studies proving a device meets those criteria for an AI device.

    Specifically, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:

    1. Formula
    2. Indications for Use
    3. Performance Testing (though the details of this testing are not provided in the excerpt, it's mentioned as an area of comparison).

    The submission is for an "IVM System" (In-Vitro Maturation System) consisting of chemical media, not a software algorithm or AI. As such, concepts like "test set," "ground truth," "experts," "adjudication method," "MRMC study," "standalone performance," or "training set" for an AI device are not applicable to the information provided in this document.

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