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510(k) Data Aggregation

    K Number
    K013471
    Device Name
    DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER
    Date Cleared
    2002-04-29

    (193 days)

    Product Code
    Regulation Number
    876.5990
    Why did this record match?
    Applicant Name (Manufacturer) :

    E.S.W.L. PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Delta™ 2000 Series Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
    Device Description
    The DELTA lithotripter utilizes well known spark gap technology. To generate a shock wave utilizing this method, an electrical discharge is created between two electrodes submerged in water. This sudden discharge of the enormous amount of energy lasts less than 1 microsecond. During this time an evaporation of water surrounding the gap between the electrodes occurs. The evaporation causes an instant expansion of vapor which produces a shock wave. In an extracorporeal lithotripter, the two wire electrodes are embedded in a plastic tube filled with insulating material. On one end of the tube the tips of the wire are bent towards each other with a small gap between them. A source of electrical energy is connected to each wire on the other end of this tubular structure. This electrode assembly is placed inside an ellipsoidal reflector in such a way that the gap between the two conductors coincides with the first focal point of the reflector. The reflector is filled with water and covered with a thin elastic membrane. After discharging the energy, reflected shock waves are transmitted to the second focal point through noncompressible medium, such as water in the reflector and in human tissue. The energy generated at the first focal point is recaptured at the second focal point of the ellipsoidal reflector with only minimal losses. When the second focal point is positioned on the treatment area such as the kidney stone inside the body, the repeated impact of the shock waves on the stone, at various energy levels, causes its disintegration.
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