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510(k) Data Aggregation

    K Number
    K141434
    Device Name
    SATURN 5 LASER
    Manufacturer
    RESEARCH INSTRUMENTS LTD.
    Date Cleared
    2015-02-18

    (264 days)

    Product Code
    MRX
    Regulation Number
    884.6200
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESEARCH INSTRUMENTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in assisted reproduction procedures to ablate or thin the zona pellucida of an oocyte or embryo to facilitate assisted hatching or recovery of cells for pre-implantation genetic diagnosis (blastomeres). The device can also be used on blastocyst stage embryos for biopsy of trophectoderm cells for pre-implantation diagnosis procedures, and blastocyst collapse prior to vitrification procedures.
    Device Description
    The Saturn 5 is the latest generation of ART laser systems manufactured by Research Instruments Limited. It is offered in two versions, the fixed and the active models and is designed to enable laser assisted hatching (LAH), laser assisted biopsy (LAB) and related procedures in assisted reproduction clinics. The system has been designed to be fitted to most commercially available inverted microscopes e.g. Olympus, Nikon and is also used with a PC and camera to provide an optical system and means of firing the laser. A foot pedal for firing the laser is available as an optional extra. The Saturn system comprises hardware, software and firmware. Hardware components include a control unit, armoured fibre optic patch lead, special 40x objective, a mirror module, motor module (active models only), IR filter and foot pedal (optional). This Saturn 5 system delivers two lasers; the main ablation laser and the pilot laser. Both laser beams are launched from the end of a fibre optic and collimated by an achromatic collimator. Saturn 5, RI Viewer software controls the movement of the laser, fires the laser and allows the user to take measurements and store images.
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    K Number
    K133257
    Device Name
    BIOPSY PIPETTES
    Manufacturer
    RESEARCH INSTRUMENTS LTD.
    Date Cleared
    2014-05-16

    (205 days)

    Product Code
    MQH
    Regulation Number
    884.6130
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESEARCH INSTRUMENTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biopsy pipettes are used in assisted reproduction techniques (ART) for the removal of blastomere(s) from embryos or polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic materials in the biopsied cell(s).
    Device Description
    The Biopsy pipette is part of the RI Pipettes range. Other pipettes available in this range include ICSI Injection, ICSI Holding, and Assisted Hatching pipettes. Biopsy pipettes are offered in a range - ID sizes - 14μm, 20μm, 25μm, 30μm, 40μm . - bend angles 0°, 15°, 20°, 25°, 30°, 35°, 40°, 45° . - . tip profiles - flat , non-spiked (bevelled), spiked All pipettes in this range are manufactured from very fine borosilicate glass, packed individually into a Twista-Pak (primary packaging) and sealed in a medical pouch. They are then batch sterilised by gamma irradiation.
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    K Number
    K112413
    Device Name
    RI MSC (MIGRATION SEDIMENTATION CHAMBER)
    Manufacturer
    RESEARCH INSTRUMENTS LTD.
    Date Cleared
    2012-07-13

    (326 days)

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

    RESEARCH INSTRUMENTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RI MSC is intended to prepare sperm by migration-sedimentation method for the assisted reproduction techniques of intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI).
    Device Description
    The Research Instruments Migration Sedimentation Chamber (RI MSC) is sterile, non-pyrogenic proven by Limulus Amebocyte Lysate and non-toxic to sperm proven by Human Sperm Survival Assay (HSSA). The RI MSC is disposable and labelled for single use, individually packaged in medical pouches and sold in boxes of twenty (x20) units. The RI MSC is manufactured from medical grade polystyrene and its surfaces are untreated. It is injection moulded as a completed unit, housing a central well with a surrounding gallery. The cylinder is 74 mm in height with a top OD of 16.5 mm and fluid capacity of 6 ml (approx) if completely filled; however, during recommended procedures it accommodates 1-2 ml of culture medium. The RI MSC facilitates the migration sedimentation technique. The migration sedimentation technique utilizes the innate 'swimming' ability of sperm to separate vigorous, A-motile sperm from non-motile or abnormal sperm and ejaculate debris.
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    K Number
    K083208
    Device Name
    SATURN ACTIVE LASER SYSTEM
    Manufacturer
    RESEARCH INSTRUMENTS LTD.
    Date Cleared
    2009-08-25

    (298 days)

    Product Code
    MRX
    Regulation Number
    884.6200
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESEARCH INSTRUMENTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Saturn Active is a Laser System is to be used to drill a small tangential hole in, or to thin, the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome such as: Advanced maternal age Prior failed IVF Cryopreserved embryos Abnormal zona pellucida morphology
    Device Description
    The Saturn Active Laser System is a device that images, targets, and controls the power and pulse duration of a laser beam to ablate a small tangential hole in, or thin, the Zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.
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    K Number
    K060764
    Device Name
    SATURN 3 LASER SYSTEM
    Manufacturer
    RESEARCH INSTRUMENTS LTD.
    Date Cleared
    2007-03-12

    (356 days)

    Product Code
    MRX
    Regulation Number
    884.6200
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESEARCH INSTRUMENTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Saturn 3 Laser System is to be used to drill a small tangential hole in, or to thin, the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as: Advanced maternal age, Prior failed IVF, Cryopreserved embryos, Abnormal zona pellucida morphology.
    Device Description
    The Saturn 3 Laser System is a device that images, targets, and controls the power and pulse duration of a laser beam used to ablate a small tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.
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    K Number
    K003142
    Device Name
    MICROMANIPULATOR
    Manufacturer
    RESEARCH INSTRUMENTS LTD.
    Date Cleared
    2000-11-22

    (43 days)

    Product Code
    MQJ
    Regulation Number
    884.6150
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESEARCH INSTRUMENTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991261
    Device Name
    ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET
    Manufacturer
    RESEARCH INSTRUMENTS LTD.
    Date Cleared
    1999-08-05

    (114 days)

    Product Code
    MQH
    Regulation Number
    884.6130
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESEARCH INSTRUMENTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ICSI injection micropipettes are used for injecting spermatozoa into the . cytoplasm of an oocyte during intracytoplasmic sperm injection (ICSI). - - Holding micropipettes are used to anchor the oocyte under vacuum during . intracytoplasmic sperm injection (ICSI). - Assisted hatching micropipettes are used to direct Tyrode's solution onto the . zona of an oocyte, thus creating a hole and enabling the oocyte to hatch. - Denuding pipettes are used to strip the cumulus from oocytes prior to . intracytoplasmic sperm injection (ICSI).
    Device Description
    ICSI injection micropipette (spiked and non-spiked) ICSI holding micropipette Assisted hatching / zona drilling micropipette Denudation pipette
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