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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/Gynecology
    Reference & Predicate Devices
    K033904,K033903
    Predicate For
    N/A
    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)< 20 EU/deviceThe predetermined acceptance criterion was met.
    Functionality Study (Embryo Biopsy Pipettes)Glass pipettes fitted to a micromanipulator, micro-injector, and Micro-injector holder are capable of aspirating fluid without breaking or leaking.The predetermined acceptance criterion was met.
    Shelf LifeMaintain sterility and functional performance characteristics over the proposed shelf life.The results of accelerated and real-time aging studies demonstrate this.
    Sterilization ValidationPerformed in accordance with FDA recognized standards.Sterilization validation was performed in accordance with FDA recognized standards.

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

    The document does not explicitly state the sample sizes for each specific test (MEA, LAL, Functionality). It mentions "lot release" for MEA and LAL testing, implying that samples are taken from each manufacturing lot. The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    This information is not provided in the document. The tests performed are laboratory-based and do not involve human expert adjudication for establishing ground truth in a clinical sense.

    4. Adjudication Method

    Not applicable, as the tests performed are laboratory-based and do not require expert adjudication in the context of clinical interpretation or diagnostic performance.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes performance testing for the physical and biological characteristics of the pipettes, not diagnostic efficacy involving human readers.

    6. Standalone (Algorithm Only) Performance Study

    No, a standalone (algorithm only) performance study was not done. The devices are physical microtools used in assisted reproduction procedures, not AI algorithms.

    7. Type of Ground Truth Used

    The ground truth used for these tests is based on objective, quantifiable biological and physical criteria:

    • MEA: Successful development of mouse embryos to the blastocyst stage.
    • LAL: Presence of endotoxins measured in Endotoxin Units.
    • Functionality Study: Observable physical performance of the pipettes (aspirating fluid without breaking or leaking).
    • Shelf Life: Maintenance of sterility and functional characteristics over time.
    • Sterilization Validation: Adherence to FDA recognized standards.

    8. Sample Size for the Training Set

    Not applicable. These are physical medical devices, not AI/ML algorithms that require training sets.

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

    Not applicable, as there is no training set for these physical devices.

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