Swiss LithoClast Trilogy
Device Facts
| Record ID | K173234 |
|---|---|
| Device Name | Swiss LithoClast Trilogy |
| Applicant | E.M.S Electro Medical Systems S.A |
| Product Code | FEO · Gastroenterology, Urology |
| Decision Date | Jan 10, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4480 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for 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 electrohydraulic lithotripter used by urologists in clinical settings to fragment and remove urinary tract stones. The system comprises a console, a reusable handpiece, and various probes compatible with standard endoscopes. It delivers energy via three modes: pneumatic lithotripsy, ultrasound lithotripsy, or a combined mode. The device uses an electromagnetic field to generate ballistic energy and a transducer for ultrasound vibration. A two-step foot pedal controls energy delivery and suction. The console features a touchscreen interface and integrates with an optional stone catcher and external vacuum or internal peristaltic pump for fragment removal. An RFID system tracks probe usage history. By combining ultrasound and ballistic energy in a single probe, the device enables efficient stone fragmentation and clearance, potentially reducing procedure time and improving patient outcomes compared to single-modality systems.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included stone fragmentation and clearance time using artificial Begostones, tissue perforation testing on pig bladder, reusable handpiece/probe qualification, electrical safety, electromagnetic compatibility, biocompatibility (cytotoxicity, sensitization, reactivity, systemic toxicity, pyrogenicity), sterilization validation (ISO 11135), and software verification/validation (IEC 62304).
Technological Characteristics
Console-based electrohydraulic lithotripter; 24 kHz ultrasound transducer; electromagnetic ballistic energy source. Handpiece housing: PEEK. Probes: 316L stainless steel. Dimensions: 135mm x 360mm x 420mm. Connectivity: RFID for probe tracking. Power: 100-240 VAC. Sterilization: Reusable probes (EtO/steam). Software: Microprocessor-controlled with touchscreen I/O.
Indications for Use
Indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder in patients requiring lithotripsy.
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® Master (K012445)
Submission Summary (Full Text)
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January 10, 2018
E.M.S. Electro Medical Systems SA % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst. MA 01002
Re: K173234
Trade/Device Name: Swiss LithoClast Trilogy Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic Lithotripter Regulatory Class: II Product Code: FEO, FFK Dated: October 4, 2017 Received: October 5, 2017
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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) K173234
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) | |
|-------------------------------------------------|---------------------------------------------|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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## 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: +41 22 994 26 11 |
| | | Email: scallegaro@ems-ch.com |
- B. Date Prepared: January 9, 2018
#### D. Device Name and Classification Information:
| Trade Name: | Swiss LithoClast® Trilogy |
|----------------------|-------------------------------|
| Classification Name: | Electrohydraulic Lithotripter |
| Regulation: | 21 CFR 876.4480 |
| Product Code: | FEO, FFK |
| Review Panel: | 78 Gastroenterology / Urology |
| Class: | II |
- E. K012445, Swiss LithoClast® Master Predicate Device(s):
#### F. Summary Device Description:
The Swiss LithoClast® Trilogy is a modified version of the Swiss LithoClast® Master, previously cleared under K012445. As with the predicate device, three possible modes of operation are available: 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.
#### H. Technical Comparison with Predicate Device
The table below provides a side-by-side comparison of the modified device to the predicate device.
| Characteristic | Ems Swiss Lithoclast<br>Master (K012445) | Ems Swiss Lithoclast<br>Trilogy | Basis for SE |
|----------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Indications for use | Fragmentation of urinary<br>tract calculi in the kidney,<br>ureter and bladder | Fragmentation and removal<br>of urinary tract calculi in the<br>kidney, ureter and bladder | Substantially<br>equivalent |
| DEVICE COMPONENTS | | | |
| CONSOLE | | | |
| Microprocessor control | Yes | Yes | Same |
| I/O | Rotary knobs/switches<br>LCD display | Touchscreen input<br>LCD display | Substantially<br>equivalent |
| Dimensions | 135 mm (H) x 371 mm (W)<br>x 432 mm (D) | 135 mm (H) x 360 mm (W)<br>x 420 mm (D) | Substantially<br>equivalent |
| Weight | 10.5 kg | 13.5 kg | Substantially<br>equivalent |
| Power supply | 100-240 VAC, 50-60 Hz | 100-240 VAC, 50-60 Hz | Same |
| HANDPIECE | | | |
| Handpiece types | Separate handpieces for<br>ultrasound and pneumatic | Single handpiece | Single handpiece<br>delivers both<br>energy types |
| Handpiece housing<br>material | PEEK | PEEK | Same |
| Sterilization | Re-usable, pre-vacuum,<br>steam | Re-usable, pre-vacuum,<br>steam | Same |
| PROBES | | | |
| Probe types | Separate probes for<br>ultrasound (vibration) and<br>ballistic (shock wave) | Single probe provides both<br>ultrasound (vibration) and<br>ballistic (shock wave) | Single probe<br>delivers both<br>energy types |
| Probe material | Ultrasound: 316L stainless<br>steel<br>Ballistic: 304 stainless<br>steel | Ultrasound: 316L stainless<br>steel | Same as for<br>ultrasound probe |
| Characteristic | Ems Swiss Lithoclast<br>Master (K012445) | Ems Swiss Lithoclast<br>Trilogy | Basis for SE |
| Probe diameters | Pneumatic: 0.8, 1.0, 1.6,<br>2.0 and 3.2 mm<br>Ultrasound: 3.3 and 3.8<br>mm | 1.1, 1.5, 1.9, 3.4 and 3.9<br>mm | Equivalent range |
| RFID tag | None | Yes | Enables console<br>to track probe<br>type and use<br>history |
| 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 | Dual side-by-side<br>Two-step for suction and<br>ultrasound | Single pedal<br>Two-step for suction and<br>energy | Only one pedal<br>needed due to<br>integrated<br>energy |
| SUCTION | Pinch valve on console,<br>compatible with EMS<br>LithoVac | Options of pinch valve or<br>peristaltic pump on console | Substantially<br>equivalent |
| STONE CATCHER | Optional component | Optional component | Same product |
| OPERATING MODES | | | |
| ULTRASOUND MODE | Yes | Yes | Same |
| Transducer frequency | 24 kHz | 24 Hz | Same |
| Max. amplitude<br>Peak to peak | 60 μm | 60 μm | Same |
| Output power<br>adjustment | Adjustable from 0%-100%<br>(10% increments) | Adjustable from 10%-100%<br>(10% increments) | Substantially<br>equivalent |
| BALLISTIC MODE | Yes | Yes | Same |
| Energy Type | Ballistic, generated by<br>compressed air | Ballistic, generated by<br>electromagnetic field | Different energy<br>source |
| Output power<br>adjustment | Adjustable from 0%-100%<br>(10% increments) | Adjustable from 10%-100%<br>(10% increments) | Substantially<br>equivalent |
| Operating modes | Single shot or multiple shot<br>modes | Multiple shot mode only | Single shot<br>mode eliminated<br>as rarely used |
| Multiple shot repetition<br>rate | 1 to 12 Hz in 1 Hz<br>increments | 1 to 12 Hz in 1 Hz<br>increments | Same |
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#### l. Basis for Substantial Equivalence - Bench Testing
The following FDA guidance documents were followed for this 510(k):
- . "Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters," Nov. 30, 1998
- . "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," May 11, 2005
- "Off-The-Shelf Software Use in Medical Devices," Sept. 9, 1999
- "Radio Frequency Wireless Technology in Medical Devices," August 14, ● 2013
- . "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,"" June 16, 2016
- . "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," January 21, 2016
Testing submitted in this 510(k) to support substantial equivalence included the following:
- Fragmentation and stone clearance time using the dual energy Trilogy handpiece and probes and artificial Begostones
- Tissue perforation testing on pig bladder tissue ●
- Reusable handpiece qualification testing .
- Reusable probe qualification testing
- Electrical safety testing to IEC 60601-1:2005 +A1:2012 (ed. 3.1) ●
- Electromagnetic compatibility testing to IEC 60601-1-2:2014 (ed. 4.0) ●
- Biocompatibility testing to ISO 10993-1 including: .
- Cytotoxicity: ISO 10993-5:2009 o
- Sensitization: ISO 10993-10:2010 o
- Intracutaneous reactivity in rabbits: ISO 10993-10:2010 O
- Acute Systemic Toxicity in Mice: ISO 10993-11:2006 O
- Endotoxin (LAL) test: USP39 <85> 2016, USP39 <161> 2016 o
- Material-mediated Pyrogenicity: ISO 10993-11:2006, USP <151> o Pyrogen Test
- . Sterilization validation to ISO 11135:2014
- Shipping and handling testing to ISTA 1E and ISTA 2A ●
- Package and sterility testing after 2X EtO sterilization and accelerated ● aqing including:
- o Visual inspection to ASTM F1886:2016
- Seal peel and seal tensile strength tests to EN 868-5:2009 O
- Seal integrity test to ASTM F1929:2015 O
- Dye penetration test for pinholes to EN 868-5:2009 o
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- Sterility tests to ISO 11737-2:2009 o
- Functional tests of the Trilogy probes after aging .
- Software verification and validation to IEC 62304:2006
#### J. Conclusion
The information and testing presented in this 510(k) demonstrate that the modified Swiss LithoClast device, called the Trilogy, is substantially equivalent to the predicate Swiss LithoClast device, called the Master. The modified device has the same intended use, equivalent indications for use, and same fundamental scientific technology as compared to the predicate device. The test data submitted in the 510(k) demonstrate that the modified device is as safe and as effective as the predicate device and, therefore, can be found substantially equivalent.
