(231 days)
K003529, 10(h) 1873
Not Found
No
The document describes a lithotripter and associated imaging systems (X-ray and Ultrasound) with standard control mechanisms. There is no mention of AI, ML, or any related concepts in the device description, intended use, or the sections specifically checked for AI/ML mentions and training/test data.
Yes
The device is described as a "lithotripter" that is "intended to fragment stones in the kidney...and the ureter." This clearly indicates a therapeutic function, as it directly treats a medical condition by breaking up stones.
Yes
The "Endourology table I-sys table" component of the system is explicitly stated as intended for "urological diagnostics". Additionally, the device uses X-ray and Ultrasound for localization of stones, which are imaging modalities used in diagnosis.
No
The device description clearly details multiple hardware components including a lithotripter generator, X-ray subsystem, ultrasound subsystem, and a patient support table. It is a physical medical device with integrated software for control and operation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fragment stones in the kidney and ureter using extracorporeal shock wave lithotripsy (ESWL) and for urological diagnostics and endourological interventions. This is a therapeutic and diagnostic procedure performed directly on the patient's body.
- Device Description: The device is a lithotripter that generates shock waves to break up stones. It uses X-ray and Ultrasound imaging for localization and guidance. These are imaging modalities used to visualize structures within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze such specimens.
The device is a therapeutic and diagnostic medical device used for procedures performed directly on the patient, not for in vitro analysis of biological samples.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
78 LNS, MMZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, Ultrasound
Anatomical Site
kidney (renal pelvis and renal calyces), ureter (upper, middle and lower ureter)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Shock Wave Characteristics, however, were measured using IEC 61846.
The following table shows the synthesis of the acoustics' measurements realized with the ellipsoid Diatron IV and an electrode of type TMS 220830B.
| Acoustic parameter | DIATRON IV |
|---|---|
| Min / Typical / Max | |
| Peak-positive acoustic pressure (MPa) | 111 / 126 / 129(1) |
| Peak-negative acoustic pressure. (MPa) |
§ 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.”)
0
JUL 2 7 2009
PG / IF 3
11.3 A "510(K) Summary"
- Sponsor/manufacturing Information a)
| Sponsor's name: | EDAP TMS France S.A. | |
|---|---|---|
| Contact person: | Mr Bruno PAGES, Quality & Regulatory Affairs Director | |
| Address of sponsor: | 4 rue du Dauphiné | |
| 69120 Vaulx-en-Velin | ||
| France | ||
| Telephone number : | (011) 33 4 72 15 31 50 | |
| Facsimile number : | (011) 33 4 72 15 31 51 | |
| Manufacturer name: | EDAP TMS France S.A. | |
| Contact person: | Mr Bruno PAGES, Quality & Regulatory Affairs Director | |
| Address of manufacturer: | 4, rue du Dauphiné | |
| 69120 Vaulx-en-Velin | ||
| France | ||
| Telephone number : | (011) 33 4 72 15 31 50 | |
| Facsimile number : | (011) 33 4 72 15 31 51 |
Proposed Device b)
| Common name of the Medical Device | Extracorporeal Shock Wave Lithotripter and
Accessories |
|-----------------------------------|-------------------------------------------------------------|
| Trade / Proprietary Name | SONOLITH® I-SYS Module |
| CFR Number | 21 CFR 876.5990
(Extracorporeal shock wave lithotripter) |
| Regulatory Class | Class II (Special Controls) |
| Product Code | 78 LNS |
| Common name of the Medical Device | Endo-Urology Table and Accessories |
| Trade / Proprietary Name | SONOLITH® I-SYS Table |
| CFR Number | 21 CFR 876.4890
(Urological table and accessories) |
| Regulatory Class | Class II (Special Controls) |
| Product Code | MMZ |
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Image /page/0/Picture/11 description: The image contains a large, bold number "4" on the left side of the frame. To the right of the number, there are two small dots, one slightly above the other. The background is plain and light, providing contrast to the dark number and dots.
1
Predicate Device(s) c)
Device # 1 - EDAP TMS France S.A.SONOLITH® Praktis, marketed via 510(k) nº K003529. Device # 2 - Dornier Medical Systems, Inc. DoLi S, marketed via 510(k) 0° 10(h) 1873
ರು) 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.
2
Reply 17
a) 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 is intended for urological diagnostics, endourological interventions (e.g. TURP) extracorporeal lithotir for artistion with the diagnostic and therapeutic module of the platform.
b) Technological Characteristics
Shock Wave Characteristics are presented in the following table for minimum, typical and maximum shock wave generator output settings. The hydrophone used to conduct the testing complies with FDA's 1991 SWL Guidance Document. The Shock Wave Characteristics, however, were measured using IEC 61846.
The following table shows the synthesis of the acoustics' measurements realized with the ellipsoid Diatron IV and an electrode of type TMS 220830B.
| Acoustic parameter | DIATRON IV |
|---|---|
| Min / Typical / Max | |
| Peak-positive acoustic pressure (MPa) | 111 / 126 / 129(1) |
| Peak-negative acoustic pressure. (MPa) |