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510(k) Data Aggregation

    K Number
    K222932
    Device Name
    INVOcell Intravaginal Culture System
    Manufacturer
    INVO Bioscience
    Date Cleared
    2023-06-22

    (269 days)

    Product Code
    OYO
    Regulation Number
    884.6165
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    DEN150008
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The INVOcell Culture Device is indicated for use in preparing, holding, and transferring human gametes or embryos during In Vitro Fertilization/Intravaginal Culture (IVF/IVC) and Intra-Cytoplasmic Sperm Injection Fertilization/ Intravaginal Culture (ICSI/VC) procedures. The INVOcell Culture Device is indicated for use with the INVOcell Retention Device. The INVOcell Culture Device is not indicated for incubation periods exceeding 120h.

    The INVOcell Retention Device is indicated for use with the INVOcell Culture Device to aid in retention of the INVOcell Culture Device in the vaginal cavity during the incubation period. The INVOcell Retention Device is not indicated for use exceeding 120h.

    Device Description

    The INVOcell Intravaginal Culture System consists of the INVOcell Culture Device and the INVOcell Retention Device.

    The INVOcell Culture Device is a radiation sterilized, single-use polystyrene container that holds and maintains the gametes and/or embryos during intravaginal culture for a maximum duration of 120 hours. The INVOcell Culture Device consists of three components: Inner Vessel, Outer Rigid Shell, and Retention Device.

    The Inner Vessel holds the culture medium along with the gametes and /or embryos. It has a rotating valve at its top, which allows for access to the chamber when loading and retrieving gametes/embryos and provides a seal during incubation. At the bottom of the Inner Vessel, there is a physical stop to limit the penetration depth of the retrieval catheter into the Inner Vessel to protect embryos during retrieval.

    The Outer Rigid Shell that is made of polystyrene, protects the Inner Vessel from the vaginal environment when the device is in use. The Inner Vessel fits into the bottom portion of the Outer Rigid Shell and is sealed in position by the top portion of the Outer Rigid Shell cap with a silicone O-ring, which provides a liquid-tight seal to prevent contamination of the Inner Vessel.

    The Retention Device aids in the retention of the INVOcell Culture Device during incubation in the vaginal cavity for a maximum duration of 120 hours. The Retention Device is single-use and provided non-sterile. It is a 70 mm diameter cup-shaped silicone retention device that includes holes to allow flow of vaginal secretions during use.

    AI/ML Overview

    The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the INVOcell Intravaginal Culture System.

    Here's the breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The information for "acceptance criteria" and "reported device performance" is primarily found in the "Summary of Non-Clinical Performance Testing" and "Summary of Clinical Performance Testing" sections, as well as the comparison table in Section VI.

    Acceptance Criterion (Non-Clinical)Reported Device Performance
    Mouse Embryo Assay (MEA): ≥80% embryos developed to expanded blastocyst at 120h (1-Cell MEA per 2021 FDA guidance)Met: ≥80% embryos developed to expanded blastocyst at 120h (Confirmed in "Shelf-Life Testing" section; implicitly met for the clinical efficacy as well)
    Seal Integrity Testing: No contamination inside and outside the vessel after 120h of incubation.Met: No contamination inside and outside the vessel after 120h of incubation.
    pH Stability: pH of test medium in device remained within the specified range after 120h of incubation.Met: pH of test medium in device remained within the specified range after 120h of incubation.
    Vessel Wall Optical Clarity: No obscured views after 120h of incubation.Met: No obscured views after 120h of incubation.
    Sterilization Validation: Gamma irradiation to achieve sterility.Met: The gamma irradiation sterilization methods for the predicate device (ISO 11137:2006) are being relied on.
    Packaging Integrity Testing: Qualify 6-year expiration date (bubble leak testing per ASTM F2096, seal strength testing per ASTM F88).Met: Packaging integrity tested after accelerated aging to support 6-year expiration date.
    Endotoxin (LAL):
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