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510(k) Data Aggregation

    K Number
    K250838
    Device Name
    Denudation Pipettes
    Manufacturer
    Guangzhou PINZHI Medical Device Co., Ltd.
    Date Cleared
    2025-07-03

    (105 days)

    Product Code
    MQH
    Regulation Number
    884.6130
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K161275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou PINZHI Medical Device Co., Ltd.

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

    Denudation Pipettes are used for the removal of cumulus oocyte complexes (COC) from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) as well as for the handling of gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART).

    Denudation Pipettes are not intended for biopsy of cells from oocytes or embryos.

    Device Description

    The Denudation Pipettes are extruded polycarbonate capillary tubes that are pulled at one end to form a tapered tip. They have an outer diameter (OD) of 0.9mm at the proximal end and fit into an actuating device. All tips are approximately 90mm in length and depending on the size of the pipette have a volumetric capacity of 18.6-21.9µl.

    The Denudation Pipettes are supplied in a range of inner diameter (ID) sizes at the distal end as shown below:

    • 80μm, 130μm, 140μm, 150μm, 160μm, 170μm, 180μm, 190μm, 210μm, 230μm, 250μm, 270μm, 290μm.

    The Denudation Pipettes are radiation sterilized and provided in a sterile pouch, supplied in two packaging options. Each pouch contains 5 or 10 pipettes. All pipettes are intended for single use and disposable.

    AI/ML Overview

    This 510(k) clearance letter is for Denudation Pipettes, a Class II medical device used in assisted reproductive technologies. This type of device is an instrument and does not fit the typical format for AI/ML-enabled devices so I have focused on the relevant mechanical and biological performance characteristics.

    Acceptance Criteria and Device Performance

    There is no single study described that proves the device meets all acceptance criteria. Instead, a series of non-clinical performance tests were conducted.

    Here's a table summarizing the acceptance criteria and the reported device performance for the Denudation Pipettes:

    Acceptance Criteria CategorySpecific Test/CharacteristicAcceptance CriteriaReported Device PerformanceComments
    Biocompatibility/Embryo SafetyOne-cell Mouse Embryo Assay (MEA)≥ 80% embryos developed to expanded blastocyst at 96 hours≥ 80% embryos developed to expanded blastocyst at 96 hoursMeets criteria. The subject device's MEA assessment time (96h) is shorter than the predicate (120h), but it's noted as the standard assessment time for this assay.
    Material ToxicityEndotoxin (LAL, USP)
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