Swiss LithoClast Trilogy

K181364 · E.M.S Electro Medical Systems S.A · FEO · Jun 20, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K181364
• Device Name: Swiss LithoClast Trilogy
• Applicant: E.M.S Electro Medical Systems S.A
• Product Code: FEO · Gastroenterology, Urology
• Decision Date: Jun 20, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Swiss LithoClast® Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.

Device Story

The Swiss LithoClast Trilogy is an intracorporeal lithotripter used by urologists to fragment and remove urinary tract stones. The system comprises a console, a reusable PEEK handpiece, and various stainless steel probes compatible with endoscopes. It operates in three modes: pneumatic (ballistic) lithotripsy, ultrasound lithotripsy, or a combined mode. The console generates energy via an electromagnetic field for ballistic shocks and a 24 kHz transducer for ultrasound vibrations. A two-step foot pedal controls energy delivery and suction. Suction is managed via an integrated peristaltic pump or an external vacuum system connected to a pinch valve. Stone fragments are collected in an optional stone catcher. The device is used in clinical settings. This submission specifically validates the use of hydrogen peroxide (H2O2) sterilization for the reusable handpiece, ensuring the device remains sterile for repeated clinical use.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, specifically sterilization validation performed in accordance with ISO 14937:2009 using the STERRAD 100NX sterilizer to confirm the efficacy of the H2O2 sterilization cycle.

Technological Characteristics

Console-based lithotripter with microprocessor control, touchscreen I/O, and LCD display. Handpiece housing is PEEK; probes are 316L stainless steel. Energy sources: electromagnetic field (ballistic) and 24 kHz ultrasonic transducer. Connectivity: RFID tag for probe identification. Sterilization: Pre-vacuum steam or H2O2 (STERRAD 100NX). Suction: Peristaltic pump or pinch valve. Power: 100-240 VAC.

Indications for Use

Indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.

Regulatory Classification

Identification

An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”

Predicate Devices

• Swiss LithoClast® Trilogy (K173234)

Submission Summary (Full Text)

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June 20, 2018

EMS Electro Medical Systems SA % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002

Re: K181364

Trade/Device Name: Swiss LithoClast Trilogy Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic Lithotripter Regulatory Class: II Product Code: FEO, FFK Dated: May 22, 2018 Received: May 23, 2018

Dear Sheila Hemeon-Heyer:

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.

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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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Timothy Martin -S 2018.06.20 19:26:41 -04'00'

Benjamin R. Fisher, Ph.D. Director 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

510(k) Number (if known) K181364

Device Name

Swiss LithoClast Trilogy

### Indications for Use (Describe)

The Swiss LithoClast Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☑</span> </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☐</span> </span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Special 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted per the requirements of 21 CFR 807.92.

| A. | 510(k) Applicant: | EMS Electro Medical Systems SA |
|----|-------------------|------------------------------------------|
| | | Ch. De la Vuarpillière 31 |
| | | 1260 Nyon, Switzerland |
| | | c/o Sonia Callegaro |
| | | Regulatory Affairs Group Leader - Medica |
| | | T: [phone] |
| | | Email: [e-mail] |

- Date Prepared: May 22, 2018 B.
#### D. Device Name and Classification Information:

| Trade Name: | Swiss LithoClast® Trilogy |
|----------------------|-------------------------------|
| Common Name: | Intracorporeal lithotripter |
| Classification Name: | Electrohydraulic lithotripter |
| Regulation: | 21 CFR 876.4480 |
| Product Code: | FEO, FFK |
| Review Panel: | 78 Gastroenterology / Urology |
| Class: | II |

- K173234, Swiss LithoClast® Trilogy E. Predicate Device(s):
#### F. Summary Device Description:

The Swiss LithoClast® Trilogy has three possible modes of operation: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy.

The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a twostep foot pedal.

Two models of the LithoClast Trilogy are available: one with a peristaltic pump and one with a pinch valve. Both versions can be used to suction stone fragments into the optional Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.

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#### G. Intended Use / Indication for Use:

The Swiss LithoClast® Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.

#### Technical Comparison with Predicate Device H.

The Swiss LithoClast® Trilogy described in this 510(k) has the same indications for use and technological specifications as previously described in K173234 (see below). The purpose of this Special 510(k) is to add the option of hydrogen peroxide (H2O2) sterilization using the Standard Cycle of the STERRAD 100NX sterilizer to the instructions for reprocessing the reusable handpiece.

| Characteristic | Swiss Lithoclast Trilogy<br>(K173234) | Swiss Lithoclast Trilogy<br>Proposed | Basis for SE |
|-------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------|
| Indications for use | Fragmentation and removal<br>of urinary tract calculi in the<br>kidney, ureter and bladder | Fragmentation and removal<br>of urinary tract calculi in the<br>kidney, ureter and bladder | Same |
| DEVICE COMPONENTS | | | |
| CONSOLE | | | |
| Microprocessor control | Yes | Yes | Same |
| I/O | Touchscreen input<br>LCD display | Touchscreen input<br>LCD display | Same |
| Dimensions | 172 mm (H) x 402 mm (W)<br>x 451 mm (D) | 172 mm (H) x 402 mm (W)<br>x 451 mm (D) | Same |
| Weight | 13.5 kg | 13.5 kg | Same |
| Power supply | 100-240 VAC, 50-60 Hz | 100-240 VAC, 50-60 Hz | Same |
| HANDPIECE | | | |
| Handpiece types | Single handpiece | Single handpiece | Same |
| Handpiece housing<br>material | PEEK | PEEK | Same |
| Sterilization | Re-usable, pre-vacuum,<br>steam | Re-usable, pre-vacuum,<br>steam or H2O2 | Substantially<br>equivalent |
| PROBES | | | |
| Probe types | Single probe provides both<br>ultrasound (vibration) and<br>ballistic (shock wave) | Single probe provides both<br>ultrasound (vibration) and<br>ballistic (shock wave) | Same |
| Probe material | Ultrasound: 316L stainless<br>steel | Ultrasound: 316L stainless<br>steel | Same |

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| Characteristic | Swiss Lithoclast Trilogy<br>(K173234) | Swiss Lithoclast Trilogy<br>Proposed | Basis for SE |
|----------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|--------------|
| Probe diameters | 1.1, 1.5, 1.9, 3.4 and 3.9<br>mm | 1.1, 1.5, 1.9, 3.4 and 3.9<br>mm | Same |
| RFID tag | Yes | Yes | Same |
| Sterilization | Provided EtO sterilized,<br>Multiple-use probes<br>validated for 4x steam<br>sterilization after first use | Provided EtO sterilized,<br>Multiple-use probes<br>validated for 4x steam<br>sterilization after first use | Same |
| FOOT PEDAL | Single pedal<br>Two-step for suction and<br>energy | Single pedal<br>Two-step for suction and<br>energy | Same |
| SUCTION | Options of pinch valve or<br>peristaltic pump on console | Options of pinch valve or<br>peristaltic pump on console | Same |
| STONE CATCHER | Optional component | Optional component | Same |
| OPERATING MODES | | | |
| ULTRASOUND MODE | Yes | Yes | Same |
| Transducer frequency | 24 kHz | 24 kHz | Same |
| Max. amplitude<br>Peak to peak | 60 μm | 60 μm | Same |
| Output power<br>adjustment | Adjustable from 10%-100%<br>(10% increments) | Adjustable from 10%-100%<br>(10% increments) | Same |
| BALLISTIC MODE | Yes | Yes | Same |
| Energy Type | Ballistic, generated by<br>electromagnetic field | Ballistic, generated by<br>electromagnetic field | Same |
| Output power<br>adjustment | Adjustable from 10%-100%<br>(10% increments) | Adjustable from 10%-100%<br>(10% increments) | Same |
| Operating modes | Multiple shot mode only | Multiple shot mode only | Same |
| Multiple shot repetition<br>rate | 1 to 12 Hz in 1 Hz<br>increments | 1 to 12 Hz in 1 Hz<br>increments | Same |

#### l. Basis for Substantial Equivalence

Substantial equivalence of the Trilogy handpiece when sterilized using H2O2 was demonstrated by validation in accordance with ISO 14937:2009 Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices. Sterilization validation was conducted using the STERRAD 100NX sterilizer on the Standard cycle and demonstrated the achievement of sterility assurance level (SAL) 10-6.

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#### J. Conclusion

The information and testing presented in this 510(k) demonstrate that the Swiss Lithoclast® Trilogy reusable handpiece, when sterilized using the STERRAD 100NX H2O2 sterilizer, is substantially equivalent to the handpiece when sterilized using steam.