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510(k) Data Aggregation

    K Number
    K200680
    Device Name
    Synvitro Hyadase
    Manufacturer
    Origio a/s, a CooperSurgical Company
    Date Cleared
    2020-07-17

    (123 days)

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

    Origio a/s, a CooperSurgical Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SynVitro® Hyadase is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
    Device Description
    SynVitro® Hyadase is a modified version of the prior cleared SynVitro® Hyadase device and is used for removal of cumulus and corona radiata cells surrounding the oocytes (denudation) prior to intracytoplasmic sperm injection (ICSI). SynVitro® Hyadase is a clear non-viscous hyaluronidase enzyme solution contained in a 2 ml transparent plastic bottles (containing 1 ml solution) with caps and provided in cardboard boxes containing five bottles. This product has a one-year shelf-life when stored as recommended and can be used for up to seven days after opening.
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    K Number
    K200815
    Device Name
    VitriGuard
    Manufacturer
    ORIGIO a/s
    Date Cleared
    2020-06-25

    (87 days)

    Product Code
    MQK
    Regulation Number
    884.6160
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORIGIO a/s

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VitriGuard is intended for use as a cryopreservation storage device in vitrification procedures and indicated to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos.
    Device Description
    VitriGuard is a sterile, single-use device that is intended for use as a cryopreservation storage device in vitrification procedures. The device consists of a two-piece polystyrene assembly that includes a hexagonal-shaped stick and cap. As part of the vitrification procedure, the oocytes or embryos are loaded on the tip of the stick is capped prior to plunging the device in liquid nitrogen and for subsequent storage. The tip has a trough area for loading, maintaining and securing oocytes or embryos. The stick and cap include a taper design that create a seal when assembled. Black markings at the end of the stick and the tip of the device provide visual aid for proper device orientation. All VitriGuard devices have a blue cap and the sticks are available in eight (8) translucent colors: clear, blue, green, yellow, lime green, purple, orange and pink.
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    K Number
    K180740
    Device Name
    VitriGuard
    Manufacturer
    ORIGIO a/s
    Date Cleared
    2018-05-04

    (43 days)

    Product Code
    MQK, MOK
    Regulation Number
    884.6160
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORIGIO a/s

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VitriGuard is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
    Device Description
    VitriGuard is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. It is single-use, disposable, and provided sterile. The device consists of a two-piece polystyrene assembly that includes a hexagonalshaped stick and cap. As part of the vitrification procedure, the embryos to be stored are loaded on the tip, and capped prior to plunging the device in liquid nitrogen and for subsequent storage. The tip has a trough area for loading, maintaining, and securing the embryos. The stick and cap include a taper design that creates a seal when assembled. Markings at the end of the stick and the tip of the device provide visual aid for proper device orientation.
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    K Number
    K173624
    Device Name
    ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)
    Manufacturer
    Origio a/s
    Date Cleared
    2018-03-02

    (98 days)

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

    Origio a/s

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ORIGIO® Handling™ is intended for in vitro procedures involving handling and micromanipulation of gametes and embryos outside the CO2 incubator. Indication includes oocyte retrieval including follicle flushing, gamete (oocyte/sperm) and embryo washing, and micromanipulation procedures including Intra Cytoplasmic Sperm Injection (ICSI), assisted hatching and trophectoderm biopsy.
    Device Description
    ORIGIO® Handling™ is a non-viscous, ready-to-use solution providing supporting conditions for human gametes and embryos during in vitro Assisted Reproduction Technology (ART) procedures taking place outside the CO2 incubator. This product can also be used for oocyte retrieval including follicle flushing. ORIGIO® Handling™ consists of amino acids, glucose, physiological salts, calcium lactate, sodium pyruvate, vitamins, sodium bicarbonate MOPS/HEPES, human serum albumin, and gentamicin sulfate. This product is supplied with phenol red (Cat. No. 8311) or without phenol red (Cat. No. 8310). ORIGIO® Handling™ is a single-use device that is aseptically filled into sterilized bottles (60 and 125 ml) and has a sterility assurance level (SAL) of 103. The product is stored at 2-8℃, and if not warmed, the product can be used for up to seven days after bottle opening. Prior to use, ORIGIO® Handling™ must be pre-warmed to 37℃, except for sperm washing procedures where the product is pre-warmed to room temperature before use.
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    K Number
    K172197
    Device Name
    SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS
    Manufacturer
    ORIGIO a/s
    Date Cleared
    2017-10-13

    (84 days)

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

    ORIGIO a/s

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product is intended for in vitro culture of human embryos following fertilization until Day 5/6 of development. The media can also be used for embryo transfer.
    Device Description
    SAGE 1-Step™ GM-CSF with HSA and SAGE 1-Step™ GM-CSF with SPS are assisted reproduction embryo culture media products consisting agents, physiological salts, energy substrates, amino acids, antibiotics, protein supplements (HSA or SPS), and granulocyte-macrophage colony-stimulating factor (GM-CSF, 2 ng/ml). These devices are aseptically filtered (sterility assurance level of 10 %), and supplied in 3 ml glass vials. They are tested for pH, osmolality, embryotoxicity, endotoxin, sterility, and GM-CSF concentration and potency before lot release. These devices have a shelf-life of 16 weeks, and can be used for up to seven days after vial opening when stored at 2-8°C.
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    K Number
    K161547
    Device Name
    Transem and EchoGen Embryo Transfer Catheters
    Manufacturer
    ORIGIO A/S
    Date Cleared
    2017-03-09

    (279 days)

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

    ORIGIO A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transem and EchoGen™ are catheters with angled or spherical tips for embryo transfer into the uterine cavity in the treatment of infertility. The Transem Stylets are intended to assist the insertion of the Transem or EchoGen™ catheters where the passage through the cervix is impeded.
    Device Description
    The Transem and EchoGen™ are Embryo Transfer Catheters with various angled or spherical tips and various lengths. The EchoGen™ variants are designed to be visible under ultrasound imaging. Stylets to aid in the insertion of the embryo catheters are also available.
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    K Number
    K162833
    Device Name
    VitriGuard
    Manufacturer
    ORIGIO A/S
    Date Cleared
    2017-02-16

    (128 days)

    Product Code
    MQK
    Regulation Number
    884.6160
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORIGIO A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VitriGuard is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
    Device Description
    VitriGuard is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. The VitriGuard device is composed of a two-piece polystyrene assembly that includes a hexagonal shaped stick and cap. As part of the vitrification procedure, the embryos to be stored are loaded on the tip, also referred to as the leaf, and capped with a pre-cooled cap for subsequent storage following vitrification. The leaf has a trough area for loading. maintaining, and securing the embryos. The stick and cap include a taper design that creates a hermetic seal, forming a closed system. Markings at the stick and the tip of the device provide visual aid for proper device orientation. The device is provided sterile and is for single use only. The VitriGuard has been designed as a cryopreservation storage device to maintain the integrity of human 4-8 cell and blastocyst stage embryos throughout the cooling. storage, and warming processes.
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    K Number
    K153267
    Device Name
    ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
    Manufacturer
    ORIGIO A/S
    Date Cleared
    2016-07-22

    (253 days)

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

    ORIGIO A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ORIGIO® Sperm Wash is intended for washing of spermatozoa, the isolation of motile viable sperm by swim-up method, dilution of ORIGIO gradients, and holding sperm for IUI procedure ORIGIO® Gradient™ 100, ORIGIO® Gradient™ 90 and ORIGIO® Gradient™ 40/80 are for separation of motile sperm from the ejaculate by the density gradient method.
    Device Description
    ORIGIO® Sperm Wash and ORIGIO® Gradient™ devices are for separation of motile sperm from semen and handling of sperm. These devices are based on the same formulation, but differ in the content of Human Serum Albumin (HSA), NaCl, bicarbonate, and silane silica. The silane silica generates the density, thus it is an ingredient in the ORIGIO® Gradient™ devices only and is not present in ORIGIO® Sperm Wash. All subject devices, except ORIGIO® Gradient™ 100, contain gentamicin and HSA. The subject devices are aseptically filtered, colorless solutions. ORIGIO® Gradient™ devices are viscous while ORIGIO® Sperm Wash is non-viscous. They are contained in transparent polyethylene terephthalate glycol (PETG) bottles with high density polyethylene (HDPE) closures, available in card board boxes, individually labeled and with instruction for use provided as a package insert.
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    K Number
    K152932
    Device Name
    BlastGen
    Manufacturer
    ORIGIO A/S
    Date Cleared
    2016-02-29

    (147 days)

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

    ORIGIO A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BlastGen™ is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage. BlastGen™ can also be used for embryo transfer.
    Device Description
    BlastGen™ is based on ORIGIO® Sequential Blast™ (K133387) with the supplement of Leukine (Sargramostim) granulocyte macrophage colony-stimulating factor (GM-CSF). BlastGen™ is a colorless, non-viscous solution contained in 3mL transparent glass bottles with white polypropylene caps, available in a single piece card board box, individually labeled and with instruction for use provided as a package insert. BlastGen™ is a ready to use by professionals for assisted reproduction. BlastGen™ is quality control tested before release for pH, sterility, Mouse Embryo Assay, endotoxin, osmolality, GM-CSF concentration (by ELISA), GM-CSF potency (TF-1 cell assay) and human serum albumin (HSA) concentration (by ELISA).
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    K Number
    K140317
    Device Name
    EMBRYOGEN
    Manufacturer
    ORIGIO A/S
    Date Cleared
    2014-06-16

    (126 days)

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

    ORIGIO A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EmbryoGen® is for culture of human embryos until the 2-8 cell stage. EmbryoGen® can also be used for embryo transfer at day 2 or 3.
    Device Description
    EmbryoGen® (1204) is a modification of EmbryoGen® (1203) (K120136), where the base medium has been changed from EmbryoAssist® (K080473) to the new ORIGIO Sequential Cleav™ (K133912) medium. EmbryoGen® (1204) contains GM-CSF (Granulocyte macrophage- colony stimulating factor), in the same concentration as EmbryoGen® (1203). EmbryoGen® (1204) is an aseptically filtered, colorless, non viscous solution, which is ready to use by professionals within assisted reproduction. EmbryoGen® (1204) is contained in 3 ml transparent glass bottles with white polypropylene caps, available in a single piece card board box, individually labeled and with instruction for use provided as a package insert.
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