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    K Number
    K162409
    Device Name
    Gems Vitrification Set, Gems Warming Set
    Manufacturer
    GENEA BIOMEDX PTY LTD
    Date Cleared
    2017-05-24

    (268 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K143724
    Why did this record match?
    Device Name :

    Gems Vitrification Set, Gems Warming Set

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

    Gems Vitrification Set is used for the vitrification of human blastocyst stage embryos for Assisted Reproductive Technology (ART) procedures.

    Gems Warming Set is used for the warming of human blastocyst stage embryos that have undergone vitrification.

    Device Description

    The Gems Vitrification Set and Gems Warming Set are intended for the vitrification and warming of human blastocysts as part of human ART procedures.

    The Gems Vitrification Set is designed to facilitate dehydration of blastocysts before vitrification via rapid cooling in liquid nitrogen. Dehydration of the blastocysts is achieved by the step-wise use of increasing concentrations of cryoprotectants in the Gems Vitrification Set, which results in water being withdrawn from the cell. The cryoprotectants also protect the blastocysts by reducing the potential for ice crystal formation during the vitrification process.

    The Gems Vitrification Set consists of three solutions (Vitsol 2, and Vitsol 3). The base formulation for Vitsol 1 and Vitsol 2 is a HEPES-buffered medium containing salts, energy substrates, amino acids, and human serum albumin. Vitsol 1 contains the cryoprotectant ethylene qlycol, while Vitsol 2 contains the cryoprotectants ethylene glycol and trehalose. Vitsol 3 consists of dimethyl sulphoxide (DMSO). The Gems Vitrification Set is not provided ready for use as Vitsol 3 must be added to the other vitrification solutions before use. Following DMSO addition to Vitsol 1 and 2, the final vitrification solutions for blastocyst vitrification procedures have the following properties:

    • . Vitrification Solution 1 (Vitsol 1 + DMSO) - 8% ethylene glycol and 8% DMSO
    • Vitrification Solution 2 (Vitsol 2 + DMSO) 16% ethylene glycol, 16% DMSO, and 0.57M trehalose ●

    The Gems Warming Set consists of three warming solutions (Warmsol 2, and Warmsol 3), which are designed to facilitate the re-hydration (warming) of vitrified blastocysts. In the warming process, trehalose in the media manages the inflow of water into blastocysts as concentrations of DMSO and ethylene glycol are reduced during the rehydration process.

    All three of the solutions in the Gems Warming Set consist of a HEPES-buffered medium containing salts, energy substrates, amino acids, and human serum albumin, with varying amounts of the cryoprotectant trehalose as described below:

    • . Warmsol 1 - 1.0 M trehalose
    • Warmsol 2 0.5 M trehalose ●
    • Warmsol 3 - No trehalose

    These media are single-use devices that are aseptically filled into sterilized bottles and have a sterility assurance level (SAL) of 10 3. The products are tested for pH, osmolality, embryotoxicity, endotoxin, and sterility before lot release.

    AI/ML Overview

    The provided document describes the acceptance criteria and performance testing for the "Gems Vitrification Set and Gems Warming Set" (subject device) in comparison to a predicate device, the "Cook Sydney IVF Blastocyst Vitrification Kit and Cook Sydney IVF Blastocyst Warming Kit" (K143724).

    Here's an analysis of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria / ParameterSubject Device - Gems Vitrification Set and Gems Warming Set (K162409) Reported PerformancePredicate Device - COOK Sydney IVF Blastocyst Vitrification Kit and COOK Sydney IVF Blastocyst Warming Kit (K143724)Comparison
    Intended UseVitrification and warming of human blastocyst stage embryos for ART procedures.Vitrification and warming of human blastocysts for ART procedures.Same
    FormulationHEPES buffered physiologic media containing ethylene glycol, DMSO, trehalose, and human serum albumin in addition to normal physiological salts. DMSO provided separately.HEPES buffered physiologic media containing ethylene glycol, DMSO, trehalose, human Serum albumin and gentamicin in addition to normal physiological salts. DMSO provided separately.Similar (differences in gentamicin and some concentrations, deemed not to raise different S&E questions)
    pH7.3-7.57.3-7.5Same
    Osmolarity (mOsm/kg)Warmsol 1: 1280-1320; Warmsol 2: 780-820; Warmsol 3: 295-305 (N/A for vitrification solutions)K-SIBW-SOL1: 657-683; K-SIBW-SOL2: 500-520; K-SIBW-SOL3: 285-295 (Other values for vitrification solutions not directly comparable)Different (higher in subject device for warming solutions due to cryoprotectant concentrations, deemed not to raise different S&E questions)
    Mouse Embryo Assay (MEA)1-Cell MEA: ≥80% developed to blastocysts at 96h2-Cell MEA: ≥80% blastocyst formation at 72hSimilar
    EndotoxinVitsol 1-2, Warmsol 1-3: and Endotoxin testing per USP .

    8. The sample size for the training set

    This information is not applicable. The device is not an AI algorithm that requires a training set. The descriptions relate to the manufacturing and quality control testing of physical chemical media.

    9. How the ground truth for the training set was established

    This information is not applicable for the same reason as point 8.

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