The Swiss LithoClast® Trilogy offers three modes of lithotripsy: 1) ultrasound alone; 2) shock wave alone; or 3) combined ultrasound and shock wave.. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a dual-energy 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. The purpose of this 510(k) is to increased the number of validated reprocessing cycles for the reusable handpiece and add the option of a wireless foot pedal.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, the Swiss LithoClast® Trilogy, which is an electrohydraulic lithotriptor used for fragmenting and removing urinary tract calculi. The submission is to address two changes: the addition of an optional wireless foot pedal and an increase in the validated number of reprocessing cycles for the reusable handpiece from 60 to 100.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a single table labeled "Acceptance Criteria and Reported Device Performance" for the overall device's indication. Instead, it describes performance testing related to the changes being submitted in this 510(k). The implicit acceptance criteria are that the device with the changes performs equivalently to the predicate device and meets relevant safety and performance standards.

Characteristic	Acceptance Criteria	Reported Device Performance
Wireless Foot Pedal - Software Validation	The software in the wireless foot pedal and dongle must be validated commensurate with a moderate level of concern and compliant with IEC 62304 Edition 1.1 2015-06. All unit, integration, and system level tests must meet acceptance criteria.	All tests met the acceptance criteria and were passed, demonstrating compliance with IEC 62304.
Wireless Foot Pedal - Electrical Safety & EMC	The Swiss LithoClast Trilogy, when operated by the wireless foot pedal, must comply with IEC 60601-1:2005 + A1:2012 and IEC 60601-1-2:2014. The Wireless Foot Pedal Kit must also comply with EN 300 328 V2.2.2 (2019-07) and EN 62311:2008.	Demonstrated compliance with all specified electrical safety and EMC standards.
Wireless Foot Pedal - Device Performance Testing	The wireless foot pedal and dongle must meet the design input requirements for functional performance, battery performance, mechanical integrity, dongle connection/disconnection integrity, chemical resistance, expected use lifetime, and RF quality of service and coexistence.	All test results demonstrated that the wireless foot pedal and dongle meet the design input requirements.
Handpiece Lifetime Testing (Reprocessing Cycles)	Handpieces must meet performance specifications and be effective in clearing stones in a simulated use set-up within 20% of the time needed using new handpieces (at time 0) after 133 cleaning, disinfection, and steam sterilization cycles. This must demonstrate validation for 100 reprocessing cycles with 95% reliability and 95% confidence.	Performance testing confirmed that handpieces met performance specifications and were effective in clearing stones within 20% of the time needed by new handpieces after 133 reprocessing cycles. The conclusion was validation for 100 reprocessing cycles with 95% reliability and 95% confidence.

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

Wireless Foot Pedal Testing (Software, Electrical Safety, Device Performance): The document does not specify a distinct "test set" in terms of patient data or clinical samples for the wireless foot pedal. The testing described is primarily engineering and bench testing on the device hardware and software itself. Therefore, sample sizes would relate to the number of production units tested, but this detail is not provided.
Handpiece Lifetime Testing:
- Sample Size: Twenty (20) handpiece units were tested.
- Data Provenance: This was bench testing conducted by the manufacturer, not patient data. The country of origin of this data is not explicitly stated but would be from EMS Electro Medical Systems SA, Nyon, Switzerland, or a contract testing facility. This is prospective testing performed for the purpose of this submission.

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

This information is not applicable to the studies described. The "ground truth" for these tests relates to engineering specifications and performance benchmarks (e.g., successful software operation, compliance with electrical safety standards, stone clearance within a specified time). These are not studies involving human interpretation of data for which expert consensus would establish ground truth in a clinical context.

4. Adjudication Method for the Test Set:

Not applicable. There was no clinical test set requiring expert adjudication. The tests were objective engineering and performance verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The changes addressed in this 510(k) are related to an optional wireless foot pedal and increased reprocessing cycles for a handpiece, neither of which involves human readers interpreting cases or AI assistance in a diagnostic or interventional workflow that would necessitate an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The term "standalone" performance typically refers to the performance of an AI algorithm independent of human interaction. This submission does not involve an AI algorithm with such a function. The software validation mentioned for the wireless foot pedal assesses the functional correctness and safety of the embedded software, not its standalone performance in interpreting medical data.

7. The Type of Ground Truth Used:

Wireless Foot Pedal Testing: The ground truth was based on pre-defined engineering design input requirements and international standards for electrical safety, EMC, and wireless communication (e.g., functional performance specifications, battery life targets, compliance with IEC 60601 series, EN 300 328, EN 62311).
Handpiece Lifetime Testing: The ground truth was based on performance specifications for stone clearance (i.e., effectiveness in clearing stones in a simulated use set-up within 20% of new handpiece performance) and statistical reliability/confidence targets (95% reliability, 95% confidence for 100 cycles).

8. The Sample Size for the Training Set:

Not applicable. There is no AI model or algorithm being trained with a dataset mentioned in this 510(k) submission. The software validation is for embedded control software, not for an AI/ML component that learns from data.

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

Not applicable, as there was no training set for an AI/ML model.

Summary

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October 23, 2023

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

K230893 Re: 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 21, 2023 Received: September 21, 2023

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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K230893 - Sheila Hemeon-Heyer, MS, JD, FRAPS

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark J. Antonino -S

Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K230893

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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Traditional 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 Timothée Deblock Head of Quality T: +41 22 994 8516 Email: tdeblock@ems-ch.com
March 31, 2023 B. Date Prepared:

D. Device Name and Classification Information :

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

E. Predicate Device(s): Swiss LithoClast® Trilogy: K191124

F. Summary Device Description:

G. Intended Use / Indication for Use:

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

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H. Technical Comparison with Predicate Device

The Swiss LithoClast® Trilogy described in this 510(k) has the same indications for use and same technical characteristics as the predicate device. The purpose of this 510(k) is to add the option of a wireless foot pedal This is the only change to the predicate Swiss LithoClast Trilogy device.

The table below provides a side-by-side comparison of the new and predicate devices. A more detailed discussion of the differences is provided following the table.

Characteristic	Predicate SwissLithoClast Trilogy(K191124)	Proposed SwissLithoClast Trilogy	Basis for SE
Manufacturer	EMS Medical Systems S.A.	EMS Medical Systems S.A.	Same
Indications for use	Fragmentation and removalof urinary tract calculi in thekidney, ureter and bladder	Fragmentation and removalof urinary tract calculi in thekidney, ureter and bladder	Same
DEVICE COMPONENTS
CONSOLE
Microprocessor control	Yes	Yes	Same
I/O	Touchscreen inputLCD display	Touchscreen inputLCD display	Same
Dimensions	172 mm (H) x 402 mm (W)x 451 mm (D)	172 mm (H) x 402 mm (W)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 housingmaterial	PEEK	PEEK	Same
Sterilization	H2O2 or steam sterilizationSteri Holder provided toposition handpiece duringsteam sterilization	H2O2 or steam sterilizationSteri Holder provided toposition handpiece duringsteam sterilization	Same
# Reprocessing cycles	Up to 60	Up to 100	Different
PROBES
Probe types	Single probe provides bothultrasound (vibration) andballistic (shock wave)	Single probe provides bothultrasound (vibration) andballistic (shock wave)	Same
Characteristic	Predicate SwissLithoClast Trilogy(K191124)	Proposed SwissLithoClast Trilogy	Basis for SE
Probe material	Ultrasound: 316L stainlesssteel	Ultrasound: 316L stainlesssteel	Same
Probe diameters	1.1, 1.5, 1.9, 3.4 and 3.9mm	1.1, 1.5, 1.9, 3.4 and 3.9mm	Same
RFID tag	Yes	Yes	Same
Sterilization	Provided EtO sterilized,	Provided EtO sterilized,	Same
# Reprocessing cycles	Multiple-use probesvalidated for 4x steamsterilization after first use	Multiple-use probesvalidated for 4x steamsterilization after first use	Same
FOOT PEDAL	Single pedal, wiredTwo-step for suction andenergy	Single pedal, wired orwirelessTwo-step for suction andenergy	Different
SUCTION	Options of pinch valve orperistaltic pump on console	Options of pinch valve orperistaltic pump on console	Same
STONE CATCHER	Optional component	Optional component	Same
STERI HOLDER	Provided for positioning ofTrilogy handpiece duringsteam sterilization	Provided for positioning ofTrilogy handpiece duringsteam sterilization	Same
ULTRASOUND MODE	Yes	Yes	Same
Transducer frequency	Around 24 kHz	Around 24 kHz	Same
Max. amplitudePeak to peak	60 μm	60 μm	Same
Output poweradjustment	Adjustable from 10%-100%(10% increments)	Adjustable from 10%-100%(10% increments)	Same
BALLISTIC MODE	Yes	Yes	Same
Energy Type	Ballistic, generated byelectromagnetic field	Ballistic, generated byelectromagnetic field	Same
Output poweradjustment	Adjustable from 10%-100%(10% increments)	Adjustable from 10%-100%(10% increments)	Same
Operating modes	Multiple shot mode only	Multiple shot mode only	Same
Multiple shot repetitionrate	1 to 12 Hz in 1 Hzincrements	1 to 12 Hz in 1 Hzincrements	Same

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The only differences shown in the above table are:

1. an RF wireless foot pedal has been added as an option to the wired foot pedal; and
1. the validated number of reprocessing cycles for the reusable handpiece has been increased from 60 to 100.

The foot pedal (wired or wireless) is used to control delivery of the shock waves through the handpiece. The wireless foot pedal is operated by the user in the same way as the previously cleared wired foot pedal. Testing submitted in this 510(k)(summarized below) demonstrates that these two changes do not raise any new or different questions of safety or effectiveness compared to the prior version of the Swiss LithoClast Trilogy cleared under K191124.

l. Basis for Substantial Equivalence

The following categories of tests were conducted to provide performance data to support the substantial equivalence of the Swiss LithoClast Trilogy device with the proposed changes:

Software Validation

The wireless foot pedal is used to control the delivery of energy from a medical device that has a moderate level of concern. Therefore, the software in the wireless foot pedal and dongle is also considered to have a moderate level of concern. This 510(k) included software documentation commensurate with a moderate level of concern and compliant with IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes. The software was validated in at the unit, integration, and system levels (i.e., with the software integrated into the final device). All tests met the acceptance criteria and were passed.

Electrical Safety and EMC

The Swiss LithoClast Trilogy, operated by the wireless foot pedal, was tested and demonstrated to comply with the following standards:

IEC 60601-1:2005 + A1:2012 Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements ● for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

In addition, the Wireless Foot Pedal Kit was tested and demonstrated to comply with the following standards related to radiofrequency devices and RF wireless transmissions:

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EN 300 328 V2.2.2 (2019-07) Wideband Transmission Systems. Data Transmission ● Equipment Operating in the 24 GHz Band; Harmonised Standard for Access to Radio Spectrum
EN 62311:2008 Assessment of Electronic and Electrical Equipment Related to ● Human Exposure Restriction for Electromagnetic Fields (0 Hz to 300 GHz)

Device Performance Testing

Comprehensive testing was conducted to confirm that the performance of the wireless foot pedal and dongle meet the design inputs requirements. These tests were done to internal protocols and covered the following requirements:

Functional performance ●
Battery performance ●
Mechanical integrity testing ●
Dongle connection / disconnection integrity ●
Chemical resistance testing to cleaning and disinfection solutions
Expected use lifetime testing ●
RF quality of service and coexistence testing ●

All test results demonstrated that the wireless foot pedal and dongle meet the design input requirements.

Handpiece Lifetime Testing

Twenty handpiece units were subjected to 133 cleaning, disinfection, and steam sterilization cycles. Performance testing conducted after completion of these reprocessing cycles confirmed that the handpieces met the performance specifications and were effective in clearing stones in a simulated use set-up within 20% of the time needed using handpieces at time 0 (prior to the 133 reprocessing cycles), which met the test acceptance criteria. The conclusion of the testing was that the Swiss LithoClast Trilogy handpiece is validated for 100 reprocessing cycles with 95% reliability and 95% confidence.

J. Conclusion

The information presented in this 510(k) demonstrate that the Swiss Lithoclast® Trilogy incorporating the changes as described is substantially equivalent to the Swiss Lithoclast® Trilogy as cleared under K191124.

Regulation Number and Section

§ 876.4480 Electrohydraulic lithotriptor.

(a)
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.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”