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510(k) Data Aggregation

    K Number
    K150748
    Device Name
    Flexipet Denuding Pipette, Flexipet Manipulation Pipette
    Manufacturer
    COOK INCORPORATED
    Date Cleared
    2015-12-18

    (270 days)

    Product Code
    MQH,FLE,MOH
    Regulation Number
    884.6130
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K993699
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Flexipet® Denuding Pipettes are intended to be used for blastomere or polar body manipulation, occyte and embryo manipulation, or denuding.

    The Flexipet® Manipulation Pipettes are intended to be used for blastomere or polar body manipulation, oocyte and embryo manipulation, blastocyst handling, and manipulation of the oocyte-cumulus complex.

    Device Description

    The Flexipet® Denuding Pipettes are polycarbonate tubes with inner diameters measuring 600 um (microns) at the proximal end which taper in diameter in a range from 120 µm to 170 µm on the distal end. The micropipettes are all 3.5 inches in length and constructed from polycarbonate. The devices are supplied gamma sterilized and are intended for one-time use.

    The Flexipet® Manipulation Pipettes are polycarbonate tubes with inner diameters measuring 600 um (microns) at the proximal end which taper in diameter in a range from 80 um to 600 um on the distal end. The micropipettes are all 3.5 inches in length and constructed from polycarbonate. The devices are supplied gamma sterilized and are intended for one-time use.

    AI/ML Overview

    1. Table of Acceptance Criteria and Reported Device Performance:

    Test NameAcceptance CriteriaReported Device Performance
    MEA (Mouse Embryo Assay)≥80% 1-cell embryos developed to blastocyst within 96 hours.The predetermined acceptance criterion was met.
    LAL (Limulus Amebocyte Lysate)< 20 EU/deviceThe predetermined acceptance criterion was met.
    CytotoxicityAll test extracts must have a reaction grade of less than 2 (mild reactivity).The predetermined acceptance criterion was met.
    Accelerated AgingDevices remained flexible and did not become brittle after sterilization and accelerated aging.The acceptance criterion was met.
    Pull-Out ForceMinimum of 0.4 lbf required to pull the pipette out of the aspiration tool.The predetermined acceptance criterion was met. (Results showed it was met)
    Aspiration TestFluid was aspirated through the Flexipet® Denuding Pipettes and Flexipet® Manipulation Pipettes using the Cook Flexipet® Adjustable Handle.The acceptance criterion was met.

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

    • MEA Testing: The document refers to "lot-release Mouse Embryo Assay testing," implying that samples from manufacturing lots were tested. The specific sample size (number of embryos or pipettes tested per lot) is not provided.
    • LAL Testing: Similar to MEA, "lot-release tested" implies samples from manufacturing lots. The specific sample size is not provided.
    • Cytotoxicity Testing: The number of devices or test extracts used is not specified.
    • Accelerated Aging: The number of devices subjected to accelerated aging is not specified.
    • Pull-Out Force Testing: The number of pipettes tested is not specified.
    • Aspiration Test: The number of pipettes tested is not specified.

    The data provenance is not explicitly stated. Given that these are release tests for a manufactured device, it is presumed to be prospective testing carried out by the manufacturer (Cook Incorporated) at their facilities.

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

    This document describes performance testing for a medical device (pipettes), not an AI algorithm that requires expert-established ground truth. Therefore, this information is not applicable. The "ground truth" for these tests are objective, measurable criteria (e.g., embryo development percentage, endotoxin levels, reaction grades, force measurements, successful fluid aspiration).

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    This is not applicable as the tests described are objective, quantitative or semi-quantitative laboratory tests without a need for expert adjudication.

    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:

    This is not applicable. The document describes performance testing for physical pipettes, not an AI algorithm.

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

    This is not applicable. The document describes performance testing for physical pipettes, not an AI algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    The "ground truth" for the tests described are objective, pre-defined measurable outcomes based on biological (e.g., embryo development, cytotoxicity), chemical (e.g., LAL endotoxin), and physical (e.g., force, flexibility, aspiration) properties and performance specifications of the device.

    8. The sample size for the training set:

    This is not applicable. This document describes performance testing for physical pipettes, not an AI algorithm that requires a training set.

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

    This is not applicable. This document describes performance testing for physical pipettes, not an AI algorithm that requires a training set.

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