(35 days)
Not Found
No
The summary describes a lithotripter with different energy modes and a console for setting parameters. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device's operation.
Yes
The device is indicated for fragmentation and removal of urinary tract calculi, addressing a medical condition and restoring normal function.
No
The device description indicates it is an intracorporeal lithotripter used for "fragmentation and removal of urinary tract calculi". Its function is therapeutic (breaking and removing stones), not diagnostic (identifying or characterizing disease).
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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Swiss LithoClast Trilogy is an intracorporeal lithotripter. This means it is a device used inside the body to break up stones (calculi) in the urinary tract. It uses pneumatic and/or ultrasound energy to fragment the stones.
- Intended Use: The intended use is for the fragmentation and removal of urinary tract calculi. This is a therapeutic procedure performed directly on the patient's body, not a diagnostic test performed on a sample outside the body.
The device description and intended use clearly indicate that this is a surgical/therapeutic device, not an in vitro diagnostic device.
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® Triloqy is an intracorporal lithotripter with 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
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)
Substantial equivalence of the engineering change to the Trilogy handpiece was demonstrated by validation of the change in accordance with the EMS risk management and design change control procedures. Summaries of the risk analysis and validation testing were provided in this 510(k). No new risks or change in the device risk level were identified. The revised handpiece met the acceptance criteria of the validation testing.
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.
Swiss LithoClast® Trilogy, K181364
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.”
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August 30, 2018
EMS Electro Medical Systems SA % Sheila Hemeon-Heyer, JD, RAC President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002
Re: K181997 Trade/Device Name: Swiss LithoClast Trilogy Regulation Number: 21 CFR& 876.4480 Regulation Name: Electrohydraulic Lithotripter Regulatory Class: II Product Code: FEO, FFK Dated: July 30, 2018 Received: August 1, 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. 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 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.
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) 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 medical devices and radiation-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.
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) K181997
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: B. July 24, 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 |
Swiss LithoClast® Trilogy, K181364 E. Predicate Device(s):
F. Summary Device Description:
The Swiss LithoClast® Triloqy is an intracorporal lithotripter with 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.
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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
This Special 510(k) is submitted to describe an engineering modification to improve the durability of the reusable handpiece. There have been no changes to the indications for use, principles of operation, or technological specifications of the Swiss LithoClast® Trilogy system.
l. Basis for Substantial Equivalence
Substantial equivalence of the engineering change to the Trilogy handpiece was demonstrated by validation of the change in accordance with the EMS risk management and design change control procedures. Summaries of the risk analysis and validation testing were provided in this 510(k). No new risks or change in the device risk level were identified. The revised handpiece met the acceptance criteria of the validation testing.
J. Conclusion
The information and testing presented in this 510(k) demonstrate that the modified Swiss Lithoclast® Trilogy system is substantially equivalent to the predicate Swiss Lithoclast® Trilogy system.