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 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).

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance Study for SONOLITH® i-move Module

The SONOLITH® i-move module is an Extracorporeal Shock Wave Lithotripter (ESWL) intended to fragment kidney and ureteral stones. The following information details the acceptance criteria and the studies conducted to demonstrate the device's performance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally inferred from the "Relevant standards or Guidance" column, and the reported performance is from the "Conclusions" column in the provided summary.

Acceptance Criteria (Inferred from Standards/Guidance)	Reported Device Performance
Compliance with Electrical Safety Standards (IEC 60601-1, -1-1, -2-36)	Device in full configuration is in compliance with the standards.
Compliance with Electromagnetic Compatibility (IEC 60601-1-2)	Device in full configuration is in compliance with the standard.
Shock Wave Characterization similar to predicate devices (IEC 61846)	Results found similar to the predicate devices' characteristics.
X-ray Localization Accuracy (Section 8.B of FDA Guidance)	Localization accuracy of +/- 2 mm for X-ray systems.
Ultrasound Localization Accuracy (Section 8.B of FDA Guidance)	Localization accuracy of +/- 2 mm for Ultrasound systems.
No significant performance differences after road testing (Section 8.C of FDA Guidance)	No significant differences in performance specifications before and after road test.
Clinical effectiveness and safety for fragmenting urinary stones (Section 8.D of FDA Guidance)	Confirmatory clinical study established labeling adequacy, device functioning, system ergonomics, effectiveness, and safety in patients with urinary stones.

2. Sample Size Used for the Test Set and Data Provenance

For the Confirmatory Clinical Testing:

Sample Size: 24 patients
Data Provenance: Not explicitly stated, but the study was conducted at "2 clinical sites." The country of origin is not specified, but the sponsor/manufacturer is EDAP TMS France. The study appears to be prospective given the nature of "confirmatory clinical testing."

The other performance tests (Electrical safety, EMC, Shock Wave characterization, Localization accuracy, Road testing) do not typically involve patient data and were conducted in certified laboratories or under controlled engineering environments.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

For the Confirmatory Clinical Testing:
The document does not explicitly state the number of experts or their qualifications for establishing ground truth in the clinical study. It refers to a "confirmatory clinical study" but does not detail the methodology for determining ground truth (e.g., stone fragmentation success, safety events).

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for any of the tests, particularly the clinical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any effect size information regarding human readers improving with AI assistance. This device is an ESWL lithotripter, which is a therapeutic device, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance

The concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable in the context of this device. The SONOLITH® i-move is a physical medical device designed to fragment stones, not a software algorithm with a diagnostic output. Its operation inherently involves a human urologist.

7. Type of Ground Truth Used

For the Confirmatory Clinical Testing:
The ground truth would have been based on clinical outcomes data related to stone fragmentation, device functioning (as observed by clinicians), system ergonomics, and patient safety (e.g., adverse events, complications). While not explicitly detailed, it would likely involve imaging follow-ups to confirm stone fragmentation and clinical assessments for safety and effectiveness.

For the Localization Accuracy Testing:
The ground truth would have been established using physical measurements or phantoms with known target locations, against which the device's targeting accuracy was measured.

8. Sample Size for the Training Set

The document does not mention a training set as this device is not an AI/machine learning algorithm that requires a training phase. It's a physical medical device.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

Summary

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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 Poudrette4 rue du Dauphiné69120 Vaulx-en-VelinFrance
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 Poudrette4, rue du Dauphiné69120 Vaulx-en-VelinFrance
Telephone number :	(011) 33 4 72 15 31 50

「『 ﺮ

a) Proposed Device

Common name of the Medical Device	Extracorporeal Shock Wave Lithotripter andAccessories
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

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Device Description c)

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.

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 orGuidance	Conclusions
Electrical safety testing	IEC 60601-1, "MedicalElectrical Equipment - Part 1:General Requirements forSafety"IEC 60601-1-1, "MedicalElectrical Equipment - Part 1:General Requirements forSafety; Safety Requirementsfor Medical ElectricalSystems"IEC 60601-2-36, "Medicalelectrical equipment - Part 2:Particular requirements forthe safety of equipment forextracorporeally inducedlithotripsy"	The certified laboratory hasconcluded that the device inits full configuration is incompliance with thestandards.
Electromagnetic compatibilitytesting	IEC 60601-1-2, "MedicalElectrical Equipment - Part1-2: General Requirementsfor Safety - Collateralstandard: ElectromagneticCompatibility"	The certified laboratory hasconcluded that the device inits full configuration is incompliance with thestandard.
Shock Wave characterizationmeasurements	IEC 61846, (1998),"Ultrasonics - Pressure pulselithotripters - Characteristicsof fields"	The results, in reference tothe details of themeasurements andcalculations, given inrelevant part of 510(k)application, are found similarto the predicate devicescharacteristics.
X-ray and ultrasoundlocalization accuracy testing	Section 8.B of the FDA'sGuidance for the Content ofPremarket Notifications(510(k)s) for ExtracorporealShock Wave Lithotriptersindicated for theFragmentation of Kidney andUreteral Calculi (August 9,2000)	The tests performed with theSonolith i-move has resultedin localization accuracy of+/- 2 mm for both X-ray andUltrasound systems.
Test	Relevant standards orGuidance	Conclusions
Road testing	Section 8.C of the FDA'sGuidance for the Content ofPremarket Notifications(510(k)s) for ExtracorporealShock Wave Lithotriptersindicated for theFragmentation of Kidney andUreteral Calculi (August 9,2000)	The test was performed on amobile/transportable versionof the treatment moduleassociated with a patientsupport, an X-ray C-armsystem and externalUltrasound System. The testshowed no significantdifferences in performancespecifications before andafter road test.
Confirmatory clinical testing	primary objective of theSection 8.D of the FDA'sGuidance for the Content ofPremarket Notifications(510(k)s) for ExtracorporealShock Wave Lithotriptersindicated for theFragmentation of Kidney andUreteral Calculi (August 9,2000)	The confirmatory clinicalstudy (2 clinical sites, 24patients) established thelabeling adequacy, thedevice functioning and thesystem ergonomics as wellas the effectiveness andsafety of the Sonolith i-movein patients with urinarystones.

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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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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

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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

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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.

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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.”)