(35 days)
Not Found
No
The summary describes a lithotripter based on established ESWL technology and does not mention any AI or ML components in its operation, control, or image processing. The focus is on the physical principles of shock wave generation and localization accuracy.
Yes
The device is described as a lithotripter intended to fragment stones in the kidney and ureter using extracorporeal shock wave lithotripsy (ESWL), which is a therapeutic procedure.
No
Explanation: The device, Sonolith® i-move, is described as a lithotripter intended to fragment stones. While it uses imaging for localization, its primary function is therapeutic (fragmenting stones) rather than diagnostic (identifying or characterizing disease). The tables associated with it mention "diagnostic and therapeutic module" and "urological diagnostics," but these refer to the broader platform or components, not the Sonolith® i-move itself as a diagnostic device.
No
The device description clearly outlines hardware components such as a lithotripter generator, electrode, membrane, and tables (TEU and ESWL_L8), which are integral to its function. It is a physical medical device that utilizes shock waves.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for fragmenting stones in the kidney and ureter using extracorporeal shock wave lithotripsy (ESWL). This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details the physical principle of generating and focusing shock waves to break up stones within the body. It describes the components involved in this process, such as the generator, electrode, membrane, and coupling with imaging systems and tables.
- 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 perform any such analysis of biological specimens.
The device is a therapeutic medical device used for a non-invasive procedure to treat kidney and ureter stones.
N/A
Intended Use / Indications for 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.
Product codes
LNS, MMZ
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, X-ray
Anatomical Site
kidney (renal pelvis and renal calyces) and the 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: Electrical safety testing
- Sample Size: Not Found
- AUC: Not Found
- MRMC: Not Found
- Standalone Performance: Not Found
- Key Results: The certified laboratory has concluded that the device in its full configuration is in compliance with the standards.
- Study Type: Electromagnetic compatibility testing
- Sample Size: Not Found
- AUC: Not Found
- MRMC: Not Found
- Standalone Performance: Not Found
- Key Results: The certified laboratory has concluded that the device in its full configuration is in compliance with the standard.
- Study Type: Shock Wave characterization measurements
- Sample Size: Not Found
- AUC: Not Found
- MRMC: Not Found
- Standalone Performance: Not Found
- Key Results: The results, in reference to the details of the measurements and calculations, given in relevant part of 510(k) application, are found similar to the predicate devices characteristics.
- Study Type: X-ray and ultrasound localization accuracy testing
- Sample Size: Not Found
- AUC: Not Found
- MRMC: Not Found
- Standalone Performance: Not Found
- Key Results: The tests performed with the Sonolith i-move has resulted in localization accuracy of +/- 2 mm for both X-ray and Ultrasound systems.
- Study Type: Road testing
- Sample Size: Not Found
- AUC: Not Found
- MRMC: Not Found
- Standalone Performance: Not Found
- Key Results: The test was performed on a mobile/transportable version of the treatment module associated with a patient support, an X-ray C-arm system and external Ultrasound System. The test showed no significant differences in performance specifications before and after road test.
- Study Type: Confirmatory clinical testing
- Sample Size: 2 clinical sites, 24 patients
- AUC: Not Found
- MRMC: Not Found
- Standalone Performance: Not Found
- Key Results: The confirmatory clinical study (2 clinical sites, 24 patients) established the labeling adequacy, the device functioning and the system ergonomics as well as the effectiveness and safety of the Sonolith i-move in patients with urinary stones.
Key Metrics
localization accuracy of +/- 2 mm for both X-ray and Ultrasound systems.
Predicate Device(s)
K003529, K083614, P880042, K030346
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
11.3 510(K) Summary
AUG - 1 2011
Sponsor/manufacturing Information
| Sponsor's name: | EDAP TMS France |
|---|---|
| Contact person: | Mr Bruno PAGES, Quality & Regulatory Affairs Director |
| Address of sponsor: | Parc d'activité la Poudrette |
| 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 |
| Contact person: | Mr Bruno PAGES, Quality & Regulatory Affairs Director |
| Address of manufacturer: | Parc d'activité la Poudrette |
| 4, rue du Dauphiné | |
| 69120 Vaulx-en-Velin | |
| France | |
| Telephone number : | (011) 33 4 72 15 31 50 |
「『 ﺮ
a) Proposed Device
| Common name of the Medical Device | Extracorporeal Shock Wave Lithotripter and
Accessories |
|-----------------------------------|-------------------------------------------------------------|
| Trade / Proprietary Name | SONOLITH® i-move 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® Tables : TEU and ESWL_L8 |
| CFR Number | 21 CFR 876.4890
(Urological table and accessories) |
| Regulatory Class | Class II (Special Controls) |
| Product Code | MMZ |
- b) Predicate Device(s)
ﻪ،
Device # 1 - EDAP TECHNOMED Inc. Sonolith® Praktis. K003529. Device # 2 - EDAP TMS France SA. Sonolith® I-sys treatment module and Sonolith® Isys table. K083614.
Device # 3 - EDAP International Corp. EDAP LT.02 Shock Wave Lithotripter. P880042. Device # 4 - FMD, LLC.Twinheads® TH-101 ESWL. K030346
1
Device Description c)
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).
d) Intended Use
The Sonolith® i-move is intended to fragment stones in the kidney (renal pelvis and renal calvces) 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.
e) Summary of Studies
In accordance with FDA's Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters indicated for the Fragmentation of Kidney and Ureteral Calculi (August 9, 2000), EDAP TMS France conducted the following types of performance testing:
2
| Test | Relevant standards or
Guidance | Conclusions |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical safety testing | IEC 60601-1, "Medical
Electrical Equipment - Part 1:
General Requirements for
Safety"
IEC 60601-1-1, "Medical
Electrical Equipment - Part 1:
General Requirements for
Safety; Safety Requirements
for Medical Electrical
Systems"
IEC 60601-2-36, "Medical
electrical equipment - Part 2:
Particular requirements for
the safety of equipment for
extracorporeally induced
lithotripsy" | The certified laboratory has
concluded that the device in
its full configuration is in
compliance with the
standards. |
| Electromagnetic compatibility
testing | IEC 60601-1-2, "Medical
Electrical Equipment - Part
1-2: General Requirements
for Safety - Collateral
standard: Electromagnetic
Compatibility" | The certified laboratory has
concluded that the device in
its full configuration is in
compliance with the
standard. |
| Shock Wave characterization
measurements | IEC 61846, (1998),
"Ultrasonics - Pressure pulse
lithotripters - Characteristics
of fields" | The results, in reference to
the details of the
measurements and
calculations, given in
relevant part of 510(k)
application, are found similar
to the predicate devices
characteristics. |
| X-ray and ultrasound
localization accuracy testing | Section 8.B of the FDA's
Guidance for the Content of
Premarket Notifications
(510(k)s) for Extracorporeal
Shock Wave Lithotripters
indicated for the
Fragmentation of Kidney and
Ureteral Calculi (August 9,
2000) | The tests performed with the
Sonolith i-move has resulted
in localization accuracy of
+/- 2 mm for both X-ray and
Ultrasound systems. |
| Test | Relevant standards or
Guidance | Conclusions |
| Road testing | Section 8.C of the FDA's
Guidance for the Content of
Premarket Notifications
(510(k)s) for Extracorporeal
Shock Wave Lithotripters
indicated for the
Fragmentation of Kidney and
Ureteral Calculi (August 9,
2000) | The test was performed on a
mobile/transportable version
of the treatment module
associated with a patient
support, an X-ray C-arm
system and external
Ultrasound System. The test
showed no significant
differences in performance
specifications before and
after road test. |
| Confirmatory clinical testing | primary objective of the
Section 8.D of the FDA's
Guidance for the Content of
Premarket Notifications
(510(k)s) for Extracorporeal
Shock Wave Lithotripters
indicated for the
Fragmentation of Kidney and
Ureteral Calculi (August 9,
2000) | The confirmatory clinical
study (2 clinical sites, 24
patients) established the
labeling adequacy, the
device functioning and the
system ergonomics as well
as the effectiveness and
safety of the Sonolith i-move
in patients with urinary
stones. |
3
f) Conclusion
The SONOLITH® i-move Module and the Tables (ESWL_L8 and TEU) are substantially equivalent to the predicate devices.
4
Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES." The text is in all caps and is in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally. The background is white.
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three wing-like strokes and two wave-like strokes below, representing human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG - 1 2011
EDAP TMS France % Mr. Howard M. Holstein Consultant Hogan Lovells US LLP Columbia Square - 555 Thirteenth Street, NW WASHINGTON DC 20004
Re: K111808
Trade/Device Name: SONOLITH® i-move module and SONOLITH® TABLES : ESWL L8 and TEU Regulation Number: 21 CFR§ 876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS, MMZ Dated: June 24, 2011 Received: June 27, 2011
Dear Mr. Holstein:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related
5
Page 2
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Huchal Lemur MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
K111808 510(k) Number (if known) :
Device Name : SONOLITH® i-move module and SONOLITH® TABLES : ESWL L8 and TEU
Indications for 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.
Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
Concurrence of CORH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K111808
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