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    K Number
    K182002
    Device Name
    Cumulus Remover
    Manufacturer
    Kitazato Corporation
    Date Cleared
    2018-10-23

    (89 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K081639
    Why did this record match?
    Device Name :

    Cumulus Remover

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

    Cumulus Remover is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.

    Device Description

    Cumulus Remover is an enzyme solution containing recombinant human hyaluronidase that digests hyaluronic acid that binds the cumulus and corona cells surrounding oocytes together. This function of hyaluronidase can be used for denuding cumulus and coronal cells from oocytes prior to performing Intracytoplasmic Sperm Injection (ICSI) fertilization procedures. Cumulus Remover is provided in a polypropylene vial (package size 0.5 mL), and five vials are packaged together in a box. This product is aseptically processed and has a shelf-life of six months when stored at 2-8°C. Cumulus Remover is tested for pH, osmolality, endotoxin, sterility, embryotoxicity, and hyaluronidase activity before lot release.

    AI/ML Overview

    The provided text describes the "Cumulus Remover," a hyaluronidase solution used for removing cumulus complex and corona radiata from oocytes in preparation for ICSI. Here's a breakdown of the acceptance criteria and the study details:

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance CriteriaReported Device Performance
    pH7.2-7.67.2-7.6 (specified as falling within this range)
    Osmolality270-295 mOsm270-295 mOsm (specified as falling within this range)
    SterilityNo microbial growth (per USP )No microbial growth
    Endotoxin)
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