Swiss LithoClast Trilogy

K182490 · E.M.S Electro Medical Systems S.A · FEO · Oct 9, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K182490
• Device Name: Swiss LithoClast Trilogy
• Applicant: E.M.S Electro Medical Systems S.A
• Product Code: FEO · Gastroenterology, Urology
• Decision Date: Oct 9, 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

Swiss LithoClast® Trilogy is an intracorporeal lithotripter used for fragmentation and removal of urinary tract calculi. System comprises a console for parameter control/energy generation, a reusable handpiece, and various probe sizes compatible with standard endoscopes. Operation modes include pneumatic lithotripsy, ultrasound lithotripsy, or combined pneumatic and ultrasound. Energy delivery is managed via a two-step foot pedal. Two console versions exist: one with an integrated peristaltic pump and one utilizing a pinch valve requiring an external vacuum system. Both configurations support suctioning stone fragments into an optional Stone Catcher. The device is intended for clinical use by healthcare professionals. This specific submission expands the validated H2O2 sterilization methods for the reusable handpiece to include additional STERIS and STERRAD systems.

Clinical Evidence

Bench testing only. Validation of sterilization efficacy for the reusable handpiece was performed in accordance with ISO 14937:2009 for the specified H2O2 sterilizers, achieving a sterility assurance level (SAL) of 10^-6.

Technological Characteristics

Intracorporeal lithotripter; pneumatic and ultrasound energy sources. System includes console, reusable handpiece, and probes. Connectivity: external vacuum system (pinch valve model). Sterilization: H2O2 gas plasma (validated for STERIS V-PRO 1, 60, maX; STERRAD 100S, NX, 100NX).

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 (K181997)

Reference Devices

• Swiss LithoClast® Trilogy (K181364)

Submission Summary (Full Text)

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October 9, 2018

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

Re: K182490 Trade/Device Name: Swiss LithoClast® Trilogy Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic Lithotriptor Regulatory Class: II Product Code: FEO, FFK Dated: September 13, 2018 Received: September 14, 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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,

# Glenn B. Bell -S

for 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)

K182490

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) |
|-------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 Requlatory Affairs Group Leader - Medical T: [phone] Email: [e-mail]
- B. Date Prepared: September 11, 2018

#### 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 |

- E. Predicate Device(s): Swiss LithoClast® Trilogy: K181997
#### 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 two-step 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

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Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.

#### 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.

#### H. Technical Comparison with Predicate Device

The Swiss LithoClast® Trilogy described in this 510(k) has the same indications for use and technological specifications as previously described in K181364. The purpose of this Special 510(k) is to add the following five H2O2 sterilizers to the instructions for use for end-user resterilization of the reusable Trilogy handpiece:

- o STERIS V-PRO 1
- STERIS V-PRO 60 ●
- STERIS V-PRO maX ●
- STERRAD 100S Short o
- STERRAD NX Standard ●

These five are in addition to the instructions for use of the STERRAD 100NX H2O2 sterilizer that were added to the Trilogy instructions for use under Special 510(k) K181364.

#### l. Basis for Substantial Equivalence

Substantial equivalence of the Trilogy handpiece when sterilized using each of the H2O2 sterilizers 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 was conducted using the recommended sterilization parameters and demonstrated achievement of sterility assurance level (SAL) 10-6 for each sterilizer.

#### J. Conclusion

The information and testing presented in this 510(k) demonstrate that the Swiss Lithoclast® Trilogy and reusable handpiece, when sterilized using the recommended sterilization parameters for each of the H2O2 sterilizers, is substantially equivalent to the Swiss Lithoclast® Trilogy and reusable handpiece as previously cleared for marketing in the United States.