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510(k) Data Aggregation

    K Number
    K240523
    Device Name
    VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
    Manufacturer
    Shenzhen VitaVitro Biotech Co., Ltd.
    Date Cleared
    2024-11-15

    (266 days)

    Product Code
    MQE
    Regulation Number
    884.6100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen VitaVitro Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VitaVitro Single Lumen Oocyte Retrieval Needle is intended for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures. VitaVitro Double Lumen Oocyte Retrieval Needle is intended for ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
    Device Description
    The Oocyte Retrieval Needle is composed of a stainless steel needle protective sleeve, needle handle, suction catheter, silicone plug, vacuum catheter and taper joint. The device includes both dual lumen (ORND) and single-lumen needles (ORNS). Three models are available: ORNS-17G, ORNS-18G and ORND-17G. The oocyte retrieval needles are available in 17 or 18 gauge sizes and two lengths: 33 and 35 cm. The needles are provided with a suction catheter of 100 cm length and a vacuum catheter with a length of 35 cm, and the ORND-17G also includes a flushing catheter of 100 cm length. Needles have an echogenic tip that enhances the visualization of the needle tip under ultrasound. This product is a disposable, sterile medical device, sterilized by ethylene oxide.
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    K Number
    K240307
    Device Name
    VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
    Manufacturer
    Shenzhen VitaVitro Biotech Co., Ltd.
    Date Cleared
    2024-08-16

    (196 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen VitaVitro Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VitaVitro Embryo Transfer Catheter is used to place in vitro fertilized (IVF) embryos into the uterine cavity
    Device Description
    The VitaVitro Embryo Transfer Catheters are sterile (ethylene oxide), single use catheters used to deliver in vitro fertilized embryos to the uterine cavity. They have a three-year shelf-life. The device includes five catheter models that are composed of a transfer catheter and a guide catheter (some with obturator). The 172 mm length Guide catheters have OD 2.4 mm for straight (Models ET-SI and ET-S) and OD 2.2 mm for the curved version type (Model ET-A). The curved version type (Model ET-A) has an additional adjustable positioner which aids in positioning the device to the targeted depth within the uterine cavity during a procedure. Both types have a rounded/blunt tip and marker bands at the distal tip to aid in catheter placement. The guide catheter is delivered through the cervix first and is used to guide the insertion of the transfer catheter holding the embryos into the uterine cavity. The 240 mm transfer catheter with an OD 0.95 mm is loaded with embryos prior to delivery through the guide catheter and into the uterine cavity. A syringe (not provided with catheters) is connected to the connector of the transfer catheter and is used to deliver the embryos into the uterine cavity. The 200 mm obturator with OD 1.3 mm is an optional accessory for the device. It has a rounded/blunt closed tip. The obturator is used to provide additional support (increase rigidity) during guide catheter placement and to assess the placement of the device prior to conducting an actual embryo transfer procedure.
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    K Number
    K191063
    Device Name
    1-Step Culture Medium
    Manufacturer
    Shenzhen VitaVitro Biotech Co., Ltd.
    Date Cleared
    2019-08-23

    (123 days)

    Product Code
    MQL, MOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen VitaVitro Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for the in vitro culture of human embryos following fertilization until Day 5/6 of development.
    Device Description
    VitaVitro® 1-Step Culture Media product intended for the in vitro culture of embryos from fertilization until day 5/6 of development. It is an aseptically filtered, bicarbonate-buffered media containing physiological salt solutions, gentamicin, and human serum albumin. It is ready to use after warming to 37°C and equilibration in a CO2 environment.
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