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510(k) Data Aggregation

    K Number
    K151018
    Device Name
    Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
    Manufacturer
    COOK INCORPORATED
    Date Cleared
    2016-01-08

    (267 days)

    Product Code
    MQH,MOH
    Regulation Number
    884.6130
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K033904,K033903
    Why did this record match?
    Device Name :

    Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette

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

    The Embryo Biopsy Pipette is intended to aspirate a blastomere or trophectoderm to diagnose genetic disorders prior to embryo selection.

    The Polar Body Biopsy Pipette is intended to aspirate polar bodies to diagnose genetic disorders prior to embryo selection.

    The Testicular Sperm Extraction Pipette is intended to extract sperm cells from biopsied tessue.

    Device Description

    The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes are 970 microns (um) outer diameter borosilicate glass tubing that is bent and tapered. The Embryo Biopsy Pipette is tapered to a flat, smooth tip inner diameter of 30 um and 35 um. It is intended to be used for blastomere or trophectoderm aspiration. The Polar Body Biopsy Pipette is tapered to an inner diameter of 20 um and beveled to a spike to assist in piercing through the zona pellucida to biopsy the polar body. The Testicular Sperm Extraction Pipette is tapered to a flat angle with an inner diameter of 6.5 um. These pipettes are intended to extract sperm cells from biopsied testicular tissue. The device is supplied gamma sterilized and is intended for one-time use.

    AI/ML Overview

    The document describes three medical devices: Embryo Biopsy Pipette, Polar Body Biopsy Pipette, and Testicular Sperm Extraction Pipette. The acceptance criteria and the studies performed to demonstrate equivalence are detailed as follows:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test NameAcceptance CriterionReported Device Performance
    MEA (Mouse Embryo Assay)≥80% 1-cell stage embryos must develop to blastocyst within 96 hours.The predetermined acceptance criterion was met.
    LAL (Limulus Amebocyte Lysate)
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