SONOLITH I-MOVE

K111808 · Edap Tms France · LNS · Aug 1, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K111808
• Device Name: SONOLITH I-MOVE
• Applicant: Edap Tms France
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Aug 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

SONOLITH® i-move is an extracorporeal shock wave lithotripter (ESWL) for stone fragmentation. Device uses Diatron V generator; emits electrical discharge at first focus (F1) of truncated ellipsoid; shock waves reflect off inner wall to concentrate at second focus (F2) where stone is located. Features include electrode with highly conductive solution, acoustic coupling membrane, and real-time pressure servo control. Requires integration with dedicated table (TEU or ESWL_L8) and imaging system (Ultrasound/X-ray C-arm). Operated by clinicians in hospital/clinic settings. Imaging guides stone localization; shock waves fragment calculi; fragments passed naturally. Benefits include non-invasive stone treatment.

Clinical Evidence

Confirmatory clinical study conducted at 2 sites with 24 patients. Study established labeling adequacy, device functionality, system ergonomics, and effectiveness/safety for urinary stone fragmentation. Bench testing included electrical safety (IEC 60601-1, 60601-1-1, 60601-2-36), EMC (IEC 60601-1-2), shock wave characterization (IEC 61846), localization accuracy (+/- 2 mm), and road testing for transportability.

Technological Characteristics

ESWL lithotripter; Diatron V generator; truncated ellipsoid shock wave generation; real-time pressure servo control; acoustic coupling membrane. Integrated with TEU or ESWL_L8 tables and X-ray/Ultrasound imaging. Complies with IEC 60601-1, IEC 60601-1-1, IEC 60601-2-36, IEC 60601-1-2, and IEC 61846.

Indications for Use

Indicated for patients requiring fragmentation of kidney (renal pelvis and calyces) and ureteral (upper, middle, lower) stones via extracorporeal shock wave lithotripsy.

Regulatory Classification

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.

Special Controls

*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.”)

Predicate Devices

• Sonolith® Praktis (K003529)
• Sonolith® I-sys treatment module and Sonolith® Isys table (K083614)
• EDAP LT.02 Shock Wave Lithotripter (P880042)
• Twinheads® TH-101 ESWL (K030346)

Submission Summary (Full Text)

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#### 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<br>4 rue du Dauphiné<br>69120 Vaulx-en-Velin<br>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<br>4, rue du Dauphiné<br>69120 Vaulx-en-Velin<br>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<br>Accessories |
|-----------------------------------|-------------------------------------------------------------|
| Trade / Proprietary Name | SONOLITH® i-move Module |
| CFR Number | 21 CFR 876.5990<br>(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<br>(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

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#### 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

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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:

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| Test | Relevant standards or<br>Guidance | Conclusions |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical safety testing | IEC 60601-1, "Medical<br>Electrical Equipment - Part 1:<br>General Requirements for<br>Safety"<br>IEC 60601-1-1, "Medical<br>Electrical Equipment - Part 1:<br>General Requirements for<br>Safety; Safety Requirements<br>for Medical Electrical<br>Systems"<br>IEC 60601-2-36, "Medical<br>electrical equipment - Part 2:<br>Particular requirements for<br>the safety of equipment for<br>extracorporeally induced<br>lithotripsy" | The certified laboratory has<br>concluded that the device in<br>its full configuration is in<br>compliance with the<br>standards. |
| Electromagnetic compatibility<br>testing | IEC 60601-1-2, "Medical<br>Electrical Equipment - Part<br>1-2: General Requirements<br>for Safety - Collateral<br>standard: Electromagnetic<br>Compatibility" | The certified laboratory has<br>concluded that the device in<br>its full configuration is in<br>compliance with the<br>standard. |
| Shock Wave characterization<br>measurements | IEC 61846, (1998),<br>"Ultrasonics - Pressure pulse<br>lithotripters - Characteristics<br>of fields" | The results, in reference to<br>the details of the<br>measurements and<br>calculations, given in<br>relevant part of 510(k)<br>application, are found similar<br>to the predicate devices<br>characteristics. |
| X-ray and ultrasound<br>localization accuracy testing | Section 8.B of the FDA's<br>Guidance for the Content of<br>Premarket Notifications<br>(510(k)s) for Extracorporeal<br>Shock Wave Lithotripters<br>indicated for the<br>Fragmentation of Kidney and<br>Ureteral Calculi (August 9,<br>2000) | The tests performed with the<br>Sonolith i-move has resulted<br>in localization accuracy of<br>+/- 2 mm for both X-ray and<br>Ultrasound systems. |
| Test | Relevant standards or<br>Guidance | Conclusions |
| Road testing | Section 8.C of the FDA's<br>Guidance for the Content of<br>Premarket Notifications<br>(510(k)s) for Extracorporeal<br>Shock Wave Lithotripters<br>indicated for the<br>Fragmentation of Kidney and<br>Ureteral Calculi (August 9,<br>2000) | The test was performed on a<br>mobile/transportable version<br>of the treatment module<br>associated with a patient<br>support, an X-ray C-arm<br>system and external<br>Ultrasound System. The test<br>showed no significant<br>differences in performance<br>specifications before and<br>after road test. |
| Confirmatory clinical testing | primary objective of the<br>Section 8.D of the FDA's<br>Guidance for the Content of<br>Premarket Notifications<br>(510(k)s) for Extracorporeal<br>Shock Wave Lithotripters<br>indicated for the<br>Fragmentation of Kidney and<br>Ureteral Calculi (August 9,<br>2000) | The confirmatory clinical<br>study (2 clinical sites, 24<br>patients) established the<br>labeling adequacy, the<br>device functioning and the<br>system ergonomics as well<br>as the effectiveness and<br>safety of the Sonolith i-move<br>in patients with urinary<br>stones. |

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# f) Conclusion

The SONOLITH® i-move Module and the Tables (ESWL_L8 and TEU) are substantially equivalent to the predicate devices.

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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

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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 [phone] or [phone] 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

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#### 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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