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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/Gynecology
    Reference & Predicate Devices
    K081639
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K081639

    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 <71>)No microbial growth
    Endotoxin<0.25 EU/ml (per USP <85>)<0.25 EU/ml
    Mouse Embryo Assay (MEA)≥80% of embryos expand to blastocyst stage by 96hMet (implied by statement "in comparison with the control group" and overall conclusion of substantial equivalence)
    Hyaluronidase Activity70-90 units/ml (per Japanese Pharmacopoeia, JP17)70-90 units/ml (average 80 units/ml)
    Shelf-lifeAll above specifications met at time zero and 6 monthsMet (implied by statement that testing was conducted)

    2. Sample Size Used for the Test Set and Data Provenance

    • pH, Osmolality, Sterility, Endotoxin, Hyaluronidase activity: The sample sizes for these tests are not explicitly stated in terms of number of batches or individual samples. However, the tests are conducted as part of lot release, suggesting a representative sample from each manufactured lot.
    • Mouse Embryo Assay (MEA): The sample size for embryos used in the MEA is not specified.
    • Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that the manufacturer is Kitazato Corporation in Japan, it's likely the studies were conducted there. The studies appear to be prospective, laboratory-based tests conducted on the manufactured product.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    This type of information is generally not applicable to the non-clinical performance tests described for this device (pH, sterility, MEA, etc.). These are objective, laboratory-measured parameters, not subject to expert interpretation for ground truth establishment.

    4. Adjudication Method for the Test Set

    Not applicable. The tests are objective laboratory measurements, not assessments requiring adjudication.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

    No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for interpretative diagnostic devices where human reader performance is a key metric.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    Yes, the studies described are standalone performance evaluations of the device itself (the Cumulus Remover solution) in controlled laboratory settings, independent of human interaction within a clinical workflow.

    7. The Type of Ground Truth Used

    The "ground truth" for each specific test is defined by established scientific and regulatory standards:

    • pH: Measured directly against a standard scale.
    • Osmolality: Measured directly against a standard scale.
    • Sterility: Absence of microbial growth, determined by standard microbiological culture methods.
    • Endotoxin: Concentration of endotoxins, determined by standard LIMULUS Amebocyte Lysate (LAL) assay.
    • Mouse Embryo Assay (MEA): The ability of mouse embryos to develop to the expanded blastocyst stage, which is a biological outcome observed and assessed without subjective expert consensus regarding "ground truth" per se, but rather against a predefined biological benchmark.
    • Hyaluronidase Activity: Measured directly against a standard activity unit, per Japanese Pharmacopoeia, JP17.

    8. The Sample Size for the Training Set

    Not applicable. This device is a chemical solution assessed through laboratory performance tests, not an AI/ML algorithm that requires a training set of data.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable, as there is no training set for this device.

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