(206 days)
Not Found
No
The 510(k) summary describes a lithotripsy device with different energy modes and a wireless foot pedal. There is no mention of AI or ML in the intended use, device description, or performance studies. The software validation is for the wireless foot pedal and dongle, not for any AI/ML functionality.
Yes
The device is used for fragmentation and removal of urinary tract calculi, addressing a medical condition.
No
Explanation: The device is indicated for fragmentation and removal of urinary tract calculi, which is a treatment procedure, not a diagnostic one.
No
The device description clearly outlines hardware components including a console, handpiece, probes, and foot pedal, indicating it is not a software-only device. The 510(k) is for modifications to existing hardware (handpiece reprocessing and wireless foot pedal).
Based on the provided information, the Swiss LithoClast® Trilogy is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the fragmentation and removal of urinary tract calculi (stones) within the body (in the kidney, ureter, and bladder). IVDs are used to examine specimens outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a system that generates energy (ultrasound and shock waves) and delivers it through a handpiece and probes to break up stones inside the body. This is a therapeutic/surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
The device is clearly designed for a therapeutic procedure (lithotripsy) performed in vivo.
N/A
Intended Use / Indications for Use
The Swiss LithoClast® Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.
Product codes
FEO, FFK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney, ureter, and bladder (urinary tract calculi)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Validation: The software in the wireless foot pedal and dongle was validated at the unit, integration, and system levels according to IEC 62304 Edition 1.1 2015-06. All tests met acceptance criteria.
Electrical Safety and EMC: The device complied with IEC 60601-1:2005 + A1:2012 and IEC 60601-1-2:2014. The Wireless Foot Pedal Kit also complied with EN 300 328 V2.2.2 (2019-07) and EN 62311:2008.
Device Performance Testing: Comprehensive testing of the wireless foot pedal and dongle for functional performance, battery performance, mechanical integrity, dongle connection/disconnection integrity, chemical resistance, expected use lifetime, and RF quality of service/coexistence. All test results met design input requirements.
Handpiece Lifetime Testing: Twenty handpiece units were subjected to 133 cleaning, disinfection, and steam sterilization cycles. Performance testing confirmed that handpieces met specifications and were effective in clearing stones within 20% of initial time. The handpiece is validated for 100 reprocessing cycles with 95% reliability and 95% confidence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Handpiece Lifetime Testing: 95% reliability and 95% confidence for 100 reprocessing cycles.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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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).
1
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
2
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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3
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:
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.
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 Swiss
LithoClast Trilogy
(K191124) | Proposed Swiss
LithoClast Trilogy | Basis for SE |
|----------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------|
| Manufacturer | EMS Medical Systems S.A. | EMS Medical Systems S.A. | Same |
| Indications for use | Fragmentation and removal
of urinary tract calculi in the
kidney, ureter and bladder | Fragmentation and removal
of urinary tract calculi in the
kidney, ureter and bladder | Same |
| DEVICE COMPONENTS | | | |
| CONSOLE | | | |
| Microprocessor control | Yes | Yes | Same |
| I/O | Touchscreen input
LCD display | Touchscreen input
LCD 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 housing
material | PEEK | PEEK | Same |
| Sterilization | H2O2 or steam sterilization
Steri Holder provided to
position handpiece during
steam sterilization | H2O2 or steam sterilization
Steri Holder provided to
position handpiece during
steam sterilization | Same |
| # Reprocessing cycles | Up to 60 | Up to 100 | Different |
| PROBES | | | |
| Probe types | Single probe provides both
ultrasound (vibration) and
ballistic (shock wave) | Single probe provides both
ultrasound (vibration) and
ballistic (shock wave) | Same |
| Characteristic | Predicate Swiss
LithoClast Trilogy
(K191124) | Proposed Swiss
LithoClast Trilogy | Basis for SE |
| Probe material | Ultrasound: 316L stainless
steel | Ultrasound: 316L stainless
steel | Same |
| Probe diameters | 1.1, 1.5, 1.9, 3.4 and 3.9
mm | 1.1, 1.5, 1.9, 3.4 and 3.9
mm | Same |
| RFID tag | Yes | Yes | Same |
| Sterilization | Provided EtO sterilized, | Provided EtO sterilized, | Same |
| # Reprocessing cycles | Multiple-use probes
validated for 4x steam
sterilization after first use | Multiple-use probes
validated for 4x steam
sterilization after first use | Same |
| FOOT PEDAL | Single pedal, wired
Two-step for suction and
energy | Single pedal, wired or
wireless
Two-step for suction and
energy | Different |
| SUCTION | Options of pinch valve or
peristaltic pump on console | Options of pinch valve or
peristaltic pump on console | Same |
| STONE CATCHER | Optional component | Optional component | Same |
| STERI HOLDER | Provided for positioning of
Trilogy handpiece during
steam sterilization | Provided for positioning of
Trilogy handpiece during
steam sterilization | Same |
| ULTRASOUND MODE | Yes | Yes | Same |
| Transducer frequency | Around 24 kHz | Around 24 kHz | Same |
| Max. amplitude
Peak to peak | 60 μm | 60 μm | Same |
| Output power
adjustment | Adjustable from 10%-100%
(10% increments) | Adjustable from 10%-100%
(10% increments) | Same |
| BALLISTIC MODE | Yes | Yes | Same |
| Energy Type | Ballistic, generated by
electromagnetic field | Ballistic, generated by
electromagnetic field | Same |
| Output power
adjustment | 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 repetition
rate | 1 to 12 Hz in 1 Hz
increments | 1 to 12 Hz in 1 Hz
increments | Same |
5
6
The only differences shown in the above table are:
-
- an RF wireless foot pedal has been added as an option to the wired foot pedal; and
-
- 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:
7
- 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.