(28 days)
Not Found
No
The summary describes a lithotripsy device with pneumatic and ultrasound modes, controlled by a console and foot pedal. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for fragmentation and removal of urinary tract calculi, which is a therapeutic intervention.
No
Explanation: The device is indicated for "fragmentation and removal of urinary tract calculi," which describes a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines hardware components such as a console, handpiece, probes, foot pedal, and pump/valve system, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The Swiss LithoClast Trilogy is used to physically fragment and remove kidney stones within the body (in vivo). It's a surgical device used for treatment, not for diagnostic testing of samples.
- Intended Use: The intended use clearly states "fragmentation and removal of urinary tract calculi," which is a therapeutic procedure, not a diagnostic one.
The information provided describes a device used for a surgical intervention, not for analyzing biological samples for diagnostic purposes.
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 (comma separated list FDA assigned to the subject device)
FEO, FFK
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.
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)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ 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: +41 22 994 26 11 | ||
| Email: scallegaro@ems-ch.com |
- 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.
4
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
(K173234) | Swiss Lithoclast Trilogy
Proposed | Basis for SE |
|-------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------|
| 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 | Re-usable, pre-vacuum,
steam | Re-usable, pre-vacuum,
steam or H2O2 | Substantially
equivalent |
| PROBES | | | |
| Probe types | Single probe provides both
ultrasound (vibration) and
ballistic (shock wave) | Single probe provides both
ultrasound (vibration) and
ballistic (shock wave) | Same |
| Probe material | Ultrasound: 316L stainless
steel | Ultrasound: 316L stainless
steel | Same |
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| Characteristic | Swiss Lithoclast Trilogy
(K173234) | Swiss Lithoclast Trilogy
Proposed | Basis for SE |
|----------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|--------------|
| 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,
Multiple-use probes
validated for 4x steam
sterilization after first use | Provided EtO sterilized,
Multiple-use probes
validated for 4x steam
sterilization after first use | Same |
| FOOT PEDAL | Single pedal
Two-step for suction and
energy | Single pedal
Two-step for suction and
energy | Same |
| 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 |
| OPERATING MODES | | | |
| ULTRASOUND MODE | Yes | Yes | Same |
| Transducer frequency | 24 kHz | 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 |
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.