Search Results
Found 1 results
510(k) Data Aggregation
K Number
K083614Device Name
SONOLITH I-SYS LITHOTRIPER
Manufacturer
Date Cleared
2009-07-27
(231 days)
Product Code
Regulation Number
876.5990Why did this record match?
Applicant Name (Manufacturer) :
TECHNOMED MEDICAL SYSTEMS, SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sonolith I sys is intended to fragment stones in the kidney (renal pelvis and renal calyces) and the ureter (upper, middle and lower ureter)
The Endourology table I-sys table is intended for urological diagnostics, endourological interventions (e.g. TURP) extracorporeal lithotripsy in conjunction with the diagnostic and therapeutic module of the platform.
Device Description
The SONOLITH® I-SYS medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotipsy). 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-SYS ESWL generator Diatron IV uses a patented electrode including a reservoir with a highly conductive solution. This electrode type is the same for the previous generator Diatron III used in clinics and hospitals for several years.
A silicone 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) Jocated at 264.62 mm above F1. 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.
An X-ray subsystem is fully integrated as standard in the whole versions of the main treatment module (MIS) of the Sonolities i-Sys system. Each X-ray subsystem is manufactured and controlled before integration in the lithotripsy platform. Two size of image intensifier are available,one with a 23cm (9") Image Intensifier and the other one with a 31cm (12") Image Intensifier.
On the Sonolith® I-Sys range, the only authorized X-ray modes of operation are:
- o Continuous Fluoroscopy.
- o Pulsed Fluoroscopy.
- o Snapshot
The Ultrasound sub-system can be used with the Sonolith® I-sys in two versions. The first one is an external U/S scanner mounted on a trolley (including electronic rack, screen, operator interfaces). The second one, using the same electronic system, is integrated in the main treatment module of the Sonolith® I-sys. The U/S imaging allows the operator to follow in real time and non stop the localization of the calculus, because the ultrasound diagnosis is considered harmless for the patient.
The patient's support Table (TiS) is designed to allow 4 different working modes:
- Used during a Lithotripsy procedure with a treatment module like the Sonolith® I-SYS MIS,
- Used during a Lithotripsy procedure with a treatment module like the Sonolith® Prakts. .
- 2 modes for endo-urology uses with the patient right or left oriented. .
In any configuration, the local user interfaces can be a remote control keypad (hand button box) or a footswitch pedal. Both are controlling all the movements of the table.
Ask a Question
Ask a specific question about this device
Page 1 of 1