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510(k) Data Aggregation

    K Number
    K051304
    Device Name
    ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM
    Date Cleared
    2005-06-03

    (15 days)

    Product Code
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIENCE SURGICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic. The OIS provides real-time, high-resolution images of the intraocular anatomy and is, therefore, useful in evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, and glaucoma. It can also be used during ophthalmic surgery to monitor the changes in anatomical structures such as the anterior angle, Schlemm's canal and related outflow structures of the eye, for glaucoma management.
    Device Description
    The Ophthalmic Imaging System (OIS) is an ultrasound system designed for noninvasive imaging of the anterior segment of the eye through the use of standard ultrasound imaging pulse-echo techniques. The system consists of a handpiece containing a high-frequency transducer, connected to interfacing electronics in the Transducer Interface Module (TIM) which is in turn connected to a personal computer with video display. Software developed by iScience Surgical runs on the computer controlling the system and generating the image. The OIS is used with a sterile disposable tissue interface (Imaging Gel Cap) which is attached to the handpiece for direct contact with the eye during imaging. The OIS may also be used with a sterile Sheath Adapter Assembly for sterile field applications.
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    K Number
    K050716
    Device Name
    ISCIENCE SURGICAL VISCOINJECTOR
    Date Cleared
    2005-04-21

    (31 days)

    Product Code
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISCIENCE SURGICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iScience Surgical Ophthalmic Viscoinjector is a manually operated device for precision delivery of small amounts of viscous fluid such as a sterile viscoelastic solution pre-packaged in a cartridge, for example Healon, HealonGV and Healon5 manufactured by Advanced Medical Optics Inc., and Ocucoat manufactured by Bausch and Lomb.
    Device Description
    The iScience Surgical Ophthalmic Viscolnjector consists of a holder for a viscoelastic The loolorios bargreates a manually operated screw driven plunger. For use, a cantridge of viscoelastic solution is placed into the body of the Ophthalmic Viscolnjector. A needle inside the Ophthalmic Viscolnjector pierces the septum of the viscoelastic cartridge as it is seated within the body cavity. The cap from the Ophthalmic Cannage as it is connected to the body to secure the cartridge of viscoelastic solution inside the Viscolnjector. The thumbwheel is rotated clockwise thereby advancing the screw driven plunger to deliver viscoelastic solution. The end of the screw has a bushing that contacts the stopper in the viscoelastic cartridge. As the screw is advanced at a controlled rate the stopper displaces fluid out through the needle that has pierced the septum. The opposite, blunt end of the needle is embedded in a male Luer lock connector. This connector may be mated to a female Luer connector and the viscoelastic solution delivered. Markings on the thumbwheel, cap, and body of the Viscolnjector are provided to assist in determining the number of complete or partial thumbwheel rotations and thus relate to the amount of fluid delivered.
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    K Number
    K041108
    Device Name
    ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA
    Date Cleared
    2004-06-22

    (55 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISCIENCE SURGICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iScience Surgical Ophthalmic Microcannula is indicated for fluid infusion and aspiration, as well as illumination, during surgery.
    Device Description
    The iScience Surgical Ophthalmic Microcannula, or iTRACK, is a flexible microcannula designed to allow atraumatic cannulation of spaces in the eye such as the anterior chamber and posterior segment, for infusion and aspiration of fluids during surgery, including saline and viscoelastics. The microcannula incorporates an optical fiber to allow transmission of light to the microcannula tip for surgical illumination and guidance.
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