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510(k) Data Aggregation

    K Number
    K150961
    Device Name
    EmbryoSlide Culture Dish
    Manufacturer
    VITROLIFE A/S
    Date Cleared
    2015-12-04

    (238 days)

    Product Code
    MQK,MOK
    Regulation Number
    884.6160
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K070047,K092183
    Why did this record match?
    Reference Devices :

    K070047

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

    The EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used only with the EmbryoScope device.

    Device Description

    The Vitrolife A/S EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. The Vitrolife A/S EmbryoSlide culture dish is intended to be used with the EmbryoScope device that was previously cleared via K092183, K111715 and K133712. A previous version of the EmbryoSlide culture dish was cleared via K092183. Minor modifications have been made to the original EmbryoSlide culture dish as described below.

    The proposed EmbryoSlide culture dish contains two types of wells which are only used for rinsing and handling the embryos before or after incubation and wells in which the embryos reside during incubation. The original EmbryoSlide culture dish included only wells for which the embryos reside during incubation.

    This EmbryoSlide culture dishfits exactly on the culture dish holder in the incubator and holds a maximum of 12 embryos in separate micro wells. As with the original EmbryoSlide culture dish, the proposed EmbryoSlide culture dish contains a large oil reservoir with 12 wells for the incubation of 12 individual embryos. Each well has a volume of 25 ul. Inside each well there is a central depression where the embryo rests. The well has a diameter of approximately 250 um.

    As described above, the proposed EmbryoSlide culture dish includes 4 special wells, two at each end of the culture dish that are intended for rinsing and general handling of the embryos either before or after incubation. Like the other wells, these handling/rinsing wells are designed to hold a volume of 25ul.

    AI/ML Overview

    The provided document is a 510(k) summary for the Vitrolife A/S EmbryoSlide Culture Dish. It details the device, its intended use, and performance testing conducted to demonstrate substantial equivalence to a predicate device.

    Here's an analysis of the acceptance criteria and study information provided:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    1-cell Mouse Embryo Assay (MEA)
    Blastocyst rate of at least 80% at 96 hoursThe EmbryoSlide® culture dish is tested per LOT for performance by 1-cell Mouse Embryo Assay (MEA) testing, which requires a blastocyst rate of at least 80% at 96 hours for adequate performance. (Implies that the device meets this, as it is stated as a requirement for adequate performance)
    In vitro cytotoxicity (USP , ISO 10993-5)
    Cytotoxicity grade ≤ 2The cytotoxicity grade was ≤ 2, meeting the requirements of ISO 10993-5 and USP .
    Bacterial endotoxins (USP , )
    Less than 20 EU/deviceThe test solution contained less than 20 EU/device, meeting the maximum stated in USP and .

    2. Sample size used for the test set and the data provenance

    • MEA Testing: "tested per LOT" is mentioned, indicating ongoing quality control testing rather than a specific sample size for a single clearance study. The document does not specify a numerical sample size for the MEA test set used for this 510(k) submission.
    • Cytotoxicity Testing: Not specified.
    • Bacterial Endotoxins Testing: Not specified, also "tested per LOT".
    • Data Provenance: Not explicitly stated but implied to be from laboratory testing conducted by the manufacturer, Vitrolife A/S. No country of origin for specific data or whether it was retrospective/prospective is detailed.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Not applicable/Not mentioned. The testing described (MEA, cytotoxicity, endotoxins) are lab-based performance tests with objective endpoints, not requiring expert ground truth or interpretation in the way clinical studies or image analysis algorithms would.

    4. Adjudication method for the test set

    • Not applicable/Not mentioned. The tests are analytical/quantitative laboratory assays.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • No MRMC study was conducted or mentioned. This device is a culture dish, not an AI-powered diagnostic or assistive tool for human readers.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not applicable. This device is a physical labware product, not an algorithm.

    7. The type of ground truth used

    • The "ground truth" for the performance tests mentioned are defined by established biological and chemical assay standards:
      • MEA: Successful development of embryos to the blastocyst stage.
      • Cytotoxicity: Absence of adverse effects on cultured mammalian cells per USP and ISO 10993-5.
      • Bacterial Endotoxins: Concentration of endotoxins below a specified threshold per USP and .

    8. The sample size for the training set

    • Not applicable. This is a medical device (culture dish), not a machine learning model, so there is no training set in the AI context.

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

    • Not applicable. As above, there is no training set for this type of device.
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