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510(k) Data Aggregation

    K Number
    K070135
    Device Name
    VITRIFREEZE MEDIUM; VITRITHAW MEDIUM
    Manufacturer
    FERTI PRO N.V.
    Date Cleared
    2007-08-16

    (212 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K060168
    Why did this record match?
    Device Name :

    VITRIFREEZE MEDIUM; VITRITHAW MEDIUM

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

    VitriFreeze Media are intended for ultra-rapid freezing of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures.

    VitriThaw media are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing for Assisted Reproductive Technology (A.R.T.) procedures.

    Device Description

    The seven (7) media that comprise the two (2) VitriFreeze and VitriThaw media are all based upon a modified formulation of other media.

    The three (3) freeze media in VitriFreeze are intended for use sequentially and are named Pre-incubation medium, VitriFreeze Medium 1 and VitriFreeze Medium 2. These media are used for preparation for and cryopreservation of human blastocysts. Preincubation medium is used to equilibrate the blastocysts. VitriFreeze, Medium 1 is used for the preparation to the vitrification. VitriFreeze, Medium 2 is the actual vitrification medium that is used during cryostorage.

    The four (4) thawing media in VitriThaw are also for sequential use in the thawing and recovery of cryopreserved human blastocysts. VitriThaw media includes VitriThaw Medium 1, VitriThaw Medium 2, VitriThaw Medium 3, VitriThaw Medium 4

    AI/ML Overview

    The provided text describes VitriFreeze Media and VitriThaw Media, which are products used for cryopreservation and recovery of human blastocysts in Assisted Reproductive Technology (ART) procedures. However, the document is a 510(k) premarket notification summary and an FDA clearance letter, focusing on substantial equivalence to a predicate device.

    It does not contain the detailed information required to answer your request about acceptance criteria, specific device performance, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies. These types of detailed performance studies are typically part of a Premarket Approval (PMA) application or a more extensive clinical trial report, not generally mandated or included in a 510(k) submission for substantial equivalence.

    Therefore, based solely on the provided text, I cannot generate the requested table and study details. The document explicitly states: "The predicates and these devices were compared in the following areas and found to have similar technological characteristics and to be equivalent. Formula Special controls Packaging Performance Testing." This indicates that performance testing was done to show similarity, but the specific metrics, acceptance criteria, and study methods are not detailed here.

    To answer your questions, I would need a different type of document, such as a full clinical study report or a detailed technical specification.

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