(231 days)
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.
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.
This document is a 510(k) summary for the SONOLITH® I-SYS Treatment Module and SONOLITH® I-SYS Table, an Extracorporeal Shock Wave Lithotripter. It focuses on the substantial equivalence to predicate devices and describes the technological characteristics, but does not contain information about a specific study designed to prove the device meets acceptance criteria.
The document details the device's technical specifications, especially its acoustic parameters. However, it does not provide:
- A table of acceptance criteria and reported device performance based on a study.
- Information on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Details about a multi-reader, multi-case comparative effectiveness study or a standalone algorithm-only performance study.
- The type of ground truth used in such studies.
- Sample size or ground truth establishment for a training set.
The document primarily serves to demonstrate that the SONOLITH® I-SYS is substantially equivalent to existing predicate devices (EDAP TMS France S.A. SONOLITH® Praktis and Dornier Medical Systems, Inc. DoLi S) for its intended use, which is to fragment stones in the kidney and ureter, and for urological diagnostics and endourological interventions. The acoustic measurements provided in the "Technological Characteristics" section are physical measurements of the device's output, not performance metrics against clinical acceptance criteria.
§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
Identification. An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.(b)
Classification. Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)