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510(k) Data Aggregation

    K Number
    K092033
    Device Name
    VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR
    Manufacturer
    Date Cleared
    2010-04-30

    (298 days)

    Product Code
    Regulation Number
    876.4480
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELMED USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This unit is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.
    Device Description
    The ELMED Vibrolith Plus® is intracorporeal lithotripter which joint together the ultrasonic lithotripter with aspiration system with the high efficiancy of the electro-pneumatic lithotripter. Three possible modes of operation are available using Vibrolith Plus such as; (1) pneumatic lithotripsy alone; (2) ultrasonic lithotripsy alone; (3) and combined pneumatic and ultrasonic lithotripsy. The system consists of two independent operating units in one housing, which allows for independent operation of the two modalities. Delivery of energy is controlled using a common two-pedal footswitch. The pneumatic part of the system works under the principle of collision of a bullet, accelerated by a medical compressed air supply from either a compressor or a central hospital supply. The compressed air provides the pressure pulse that drives the projectile within pneumatic handpiece toward the proximal end of the probe. This probe transmits the impact energy to the stone, resulting in fragmentation. By this electro-pneumatic ballistic energy, only the calculi is disintegrated, there is no effect on tissue. The pneumatic part can also be used in combination with aspiration system. The pneumatic probes can be inserted through the suction tube for simultaneous lithotripsy and suction. The ultrasonic lithotriptor works under the principle of vibration in the ultrasonic area by the piezo-ceramic crystals and transmites these vibrations to the stone with a steel probe inserted into the body by endoscopy. The endoscope is used to position the Vibrolith Plus® handpiece in the urethra under direct observation. The ultrasonic handpiece consists of an ultrasound transducer containing the piezoelectric elements, which are driven by a generator operating between 15-28 kHz. The resulting longitudinal waves are propagated along the ultrasound probe to the target stone. The ultrasound transducer and the probes are hollow, permitting simultaneous suction. Combined operation of the pneumatic and ultrasonic parts is desirable for certain hard kidney and bladder stones. In order to use the combined energy, the pneumatic and ultrasonic handpieces must be mounted together. In a combined operation, the probes must be length-adjusted so that the tip of the pneumatic probe is flush with the tip of the ultrasonic probe. The Vibrolith Plus® is designed to be used with general or spinal anesthesia. This design, together with the clinical data, offers a particular advantage for using Vibrolith Plus® in patients with renal, ureteral and bladder stones. This advantage may be most significant in patients who wish to remain physically active and for those who are in higher risk categories where serious side effects present a significant threat to their health and well being. For the application, probes with various lengths and in various diameters are available, which permits adaptation to the stone size as well as to the available lumen of the working channel. The ELMED Vibrolith is very similar to the Vibrolith Plus with the exception that the Vibrolith is only available with pneumatic lithotripsy.
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