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510(k) Data Aggregation
K Number
K111808Device Name
SONOLITH I-MOVE
Manufacturer
Date Cleared
2011-08-01
(35 days)
Regulation Number
876.5990Why did this record match?
Applicant Name (Manufacturer) :
EDAP TMS FRANCE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sonolith® i-move is intended to fragment stones in the kidney (renal pelvis and renal calyces) and the ureter (upper, middle and lower ureter).
The ESWL L8 table is intended for extracorporeal shock wave lithotripsy (ESWL) procedures in conjunction with the diagnostic and therapeutic module of the platform.
The TEU table is intended for urological diagnostics, endourological procedures and extracorporeal shock wave lithotripsy (ESWL) procedures in conjunction with the diagnostic and therapeutic module of the platform.
Device Description
The SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle consists in delivering pulsed pressure waves which are focalized on the stone to be treated, at fixed frequency or patient synchronized frequency.
The SONOLITH® i-move ESWL generator Diatron V uses a patented electrode including a reservoir with a highly conductive solution. This electrode type is the same for the previous generator Diatron IV and III used in clinics and hospitals for several years.
A membrane mounted on the top of the generator ensures the acoustical coupling between the generator and the patient's skin. Moreover, the generator benefits from a real time pressure servo control device.
The shock wave generation consists of emitting an electrical discharge at the first focus (F1) of the truncated ellipsoid. The shock wave generated is bent back by the ellipsoid's inner wall to be precisely concentrated at the second focus (F2). The highly conductive liquid incorporated into the electrode guarantees a very high stability of the electrical arc at F1 ensuring very low dispersion at F2.
The SONOLITH® i-move has to be coupled with, at least, one table dedicated at minimum, ESWL application, and one imaging system (Ultrasound scanner and/or X-ray C-arm). The two tables (TEU and ESWL_L8) are presented in the part hereafter (e: Intended Use).
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