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510(k) Data Aggregation

    K Number
    K213293
    Device Name
    V-HEPES PLUS
    Manufacturer
    Vitromed Langenfeld
    Date Cleared
    2022-09-14

    (348 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K142991
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    V-HEPES PLUS is intended for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity.

    Device Description

    V-HEPES PLUS is a medium for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity. The medium is aseptically filtered and provided in a volume of 100 mL in pre-sterilized PETG bottles. V-HEPES PLUS has a shelf-life of 12 months when stored at 2-8°C and can be used for up to seven days after bottle opening.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the V-HEPES PLUS device, based on the provided FDA 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Specification)Reported Device Performance (V-HEPES PLUS (K213293))Predicate Device (K142991)
    SterilityNo growthSterile (SAL 10-3)
    pH7.0-7.47.2-7.4
    Osmolality (mOsm/kg)257-273260-270
    Mouse Embryo Assay (MEA)1-Cell MEA: ≥80% developed to expanded blastocysts at 96 h after 120-minute exposure1-Cell MEA: ≥80% developed to expanded blastocysts at 96 h after one-hour exposure
    Endotoxin (EU/mL).
    • pH, Osmolality, Endotoxin: Quantitative measurements against specified ranges/limits, per established laboratory methods (e.g., USP for Endotoxin).
    • Mouse Embryo Assay (MEA): Defined by the percentage of embryos reaching the expanded blastocyst stage within a specified timeframe, according to FDA guidance.
    • Appearance: Visual inspection against an objective description ("Pink rose color, no precipitates").
    • Biocompatibility: Results of standardized in vitro (cytotoxicity) and in vivo (sensitization, irritation) tests as per ISO 10993 standards.

    8. The Sample Size for the Training Set

    This question is not applicable. The V-HEPES PLUS is a biological medium, not an AI model or algorithm that requires a "training set."

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

    This question is not applicable, as there is no training set for this device.

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