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510(k) Data Aggregation

    K Number
    K152717
    Device Name
    Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit
    Manufacturer
    WILLIAM A. COOK AUSTRALIA PTY, LTD.
    Date Cleared
    2016-05-06

    (228 days)

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

    WILLIAM A. COOK AUSTRALIA PTY, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sydney IVF Blastocyst Cryopreservation Kit is intended for use in assisted reproduction technologies for cryopreservation of blastocysts. Sydney IVF Blastocyst Thawing Kit is intended for use in assisted reproduction technologies for thawing of cryopreserved blastocysts.
    Device Description
    The Sydney IVF Blastocyst Cryopreservation and Thawing Kits are intended for cryopreservation and thawing of human blastocysts. The Sydney IVF Blastocyst Cryopreservation and Thawing Kits provide users with the ability to cryopreserve supernumerary embryos created during the in vitro fertilization procedure and then to thaw them for use at a future point in time. The Sydney IVF Blastocyst Cryopreservation Kit consists of three solutions containing increasing concentrations of cryoprotectant (both glycerol and sucrose are used). These buffers were designed to be used sequentially in order to remove water from embryos prior to cryopreservation. The removal of water prevents ice crystal formation inside the embryo thereby limiting damage and improving viability. It contains 12 mg/mL Human Serum Albumin (HSA) and 0.01mg/mL Gentamicin. Sydney IVF Blastocyst Cryopreservation Kit is designed for use with Sydney IVF Blastocyst Thawing Kit. The Sydney IVF Blastocyst Thawing Kit consists of four solutions with decreasing concentrations of cryoprotectants (sucrose) which are used sequentially throughout the thawing process. It contains 12 mg/mL Human Serum Albumin (HSA) and 0.01mg/mL Gentamicin. It is designed for use with Sydney IVF Blastocyst Cryopreservation Kit. Sydney IVF Blastocyst Cryopreservation and Thawing Kits are provided in glass vials with Fluorotec® coated rubber stoppers held in place with a tamper evident seal. Sydney IVF Blastocyst Cryopreservation Kit is packaged in a carton box containing 3 x 20mL solutions per kit. The Sydney IVF Blastocyst Thawing Kit is packaged in a carton box containing 4 x 20mL solutions per kit.
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    K Number
    K152904
    Device Name
    SYDNEY IVF EMBRYO BIOPSY MEDIUM
    Manufacturer
    WILLIAM A. COOK AUSTRALIA PTY, LTD.
    Date Cleared
    2015-12-03

    (63 days)

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

    WILLIAM A. COOK AUSTRALIA PTY, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sydney IVF Embryo Biopsy Medium is intended for use in assisted reproduction technologies to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis.
    Device Description
    Sydney IVF Embryo Biopsy Medium is bicarbonate based, free of calcium and magnesium to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis of the embryo. Embryos are placed in this medium for approximately five minutes to break down gap junctions between blastomeres. One or two blastomeres are removed, and the embryo is then returned to Cleavage Medium or Blastocyst Medium for further culture. Sydney IVF Embryo Biopsy Medium contains Human Serum Albumin (5 mg/mL) and Gentamicin (0.01 mg/mL). The device is available as a 20 mL fill only. The Sydney IVF Embryo Biopsy Medium is provided in glass vials with Fluorotec® coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices.
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    K Number
    K143724
    Device Name
    COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit
    Manufacturer
    WILLIAM A. COOK AUSTRALIA PTY, LTD.
    Date Cleared
    2015-08-27

    (241 days)

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

    WILLIAM A. COOK AUSTRALIA PTY, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blastocyst Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with Blastocyst Warming Kit (K-SIBW-5000). Blastocyst Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using COOK Sydney IVF Vitrification Kit (K-SIBV-5000) for ART procedures.
    Device Description
    COOK Sydney IVF Blastocyst Vitrification and Warming Kits are intended for the vitrification and warming of human blastocysts as part of human ART procedures. The COOK Sydney IVF Blastocyst Vitrification and Warming Kits provide users with the ability to cryopreserve supernumerary embryos created during the in vitro fertilization procedure and then to re-warm them for use at a future point in time. The COOK Sydney IVF Blastocyst Vitrification Kit (K-SIBV-5000) consists of a series of 2-[4-(2-hydroxyethyl)piperazin1-yl] ethanesulfonic acid (HEPES)-buffered, physiological solutions containing increasing concentrations of functional cryoprotectants to which the embryo is sequentially exposed during cryopreservation. The first three solutions in the kit are all based upon the same formulation (known as "Cryobase buffer"), which is a 10 mM HEPES buffered media containing 20 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. The fourth solution in the kit is dimethyl sulfoxide (DMSO) and does not contain HSA or Gentamicin. The DMSO is provided for the practitioner to add to Solution 2 and Solution 3 of the vitrification kit, as described in the Instructions for Use. COOK Sydney IVF Blastocyst Warming Kit (K-SIBW-5000) consists of three solutions which are used sequentially throughout the warming process. The three media in the kit are all based upon the same formulation of Cryobase buffer, a 10 mM HEPES buffered media containing 20 mg/mL HSA and 0.01 mg/mL Gentamicin. The COOK Sydney IVF Blastocyst Vitrification and Warming Kits are single use, sterile (aseptic filtration) devices. These solutions contact the blastocyst during the vitrification and re-warming process. The solutions are removed by washing prior to embryo transfer back to the patient and are therefore non-patient contacting.
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    K Number
    K141365
    Device Name
    OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN
    Manufacturer
    WILLIAM A. COOK AUSTRALIA PTY, LTD.
    Date Cleared
    2014-08-07

    (76 days)

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

    WILLIAM A. COOK AUSTRALIA PTY, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cook Otrieva™ Tapered Ovum Aspiration Needles are used for laproscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles.
    Device Description
    This device is intended for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles. The needle is passed through a transvaginal ultrasound transducer or placed through a cannula for a laparoscopic procedure to advance into the ovarian follicle. The main body of the cannula is 17 gage, which tapers to 20 gage at the distal tip. Although the outer diameter of the needle tapers, a constant 0.60 mm internal diameter is maintained. The Otrieva™ needles are available in two lengths: 30cm and 35cm. The needles are provided with an aspiration tube of 90 cm length and a vacuum tube with a length of 50 cm. The tubing is connected to a silicone bung. The materials used in the device include: stainless steel, polycarbonate, PTFE, silicone, FEP and copolyester.
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    K Number
    K082363
    Device Name
    COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS
    Manufacturer
    WILLIAM A. COOK AUSTRALIA PTY, LTD.
    Date Cleared
    2009-04-29

    (254 days)

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

    WILLIAM A. COOK AUSTRALIA PTY, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    'Cook Sydney IVF Blastocyst Vitrification Kit' is intended for the vitrification of Human blastocysts for ART procedures. This kit is designed for use with Cook Sydney IVF Blastocyst Vitrification Warming Kit 'Cook Sydney IVF Blastocyst Warming Kit' is intended for the recovery of Human blastocysts that have undergone vitrification using Cook Sydney IVF Blastocyst Vitrification Kit for ART procedures. Blastocyst Warming Kit is intended for the recovery of human blastocysts that have Diastooyst Warming This Internet Sydney IVF Blastocyst Vitrification Kit (K-SIBV-5000) for ART procedures. Blastocyst Vitrification Kit is intended for the vitrification of human blastocysts for assisted Diastooyot . This sit is designed for use with Blastocyst Warming Kit (K-SIBW-5000)
    Device Description
    Cook Sydney IVF Blastocyst Vitrification and Warming Kits are intended for the vitrification, containment and re-warming of human blastocysts as part of human ART procedures. Vitrification involves the rapid freezing of the embryo and is defined as the solidification of a solution at a temperature below its glass transition temperature by extreme elevation in viscosity using high cooling rates (15 000 to 30 000 °C/min) rather than crystallisation. The Cook Sydney IVF Vitrification and Warming Kits are comprised of HEPES buffered solutions containing physiological salts and the cryoprotectants ethylene glycol, DMSO and trehalose.
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