(28 days)
No
The provided text describes a lithotripsy device with different operational modes and components. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of AI/ML technology. The performance studies focus on sterilization validation, not algorithmic performance.
Yes
The device is used for the fragmentation and removal of urinary tract calculi, which is a direct treatment aimed at alleviating a medical condition.
No
The device is indicated for fragmentation and removal of urinary tract calculi, which is a treatment function, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a console, handpiece, probes, foot pedal, and pump/valve system, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fragmentation and removal of urinary tract calculi (stones) within the body (kidney, ureter, bladder). This is a therapeutic procedure performed directly on the patient.
- Device Description: The device description details a system for generating and delivering energy (pneumatic and ultrasound) to break up stones and potentially suction them out. This is a physical intervention.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device described is a surgical or therapeutic device used for lithotripsy, a procedure to break up stones within the urinary tract.
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 two-step 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 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)
Substantial equivalence of the Trilogy handpiece when sterilized using each of the H2O2 sterilizers 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 was conducted using the recommended sterilization parameters and demonstrated achievement of sterility assurance level (SAL) 10-6 for each sterilizer.
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.
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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October 9, 2018
EMS Electro Medical Systems SA % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002
Re: K182490 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 13, 2018 Received: September 14, 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 mav, 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 avare 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 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,
Glenn B. Bell -S
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)
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 Requlatory Affairs Group Leader - Medical T: +41 22 994 26 11 Email: scallegaro@ems-ch.com
- B. Date Prepared: September 11, 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 |
- E. Predicate Device(s): Swiss LithoClast® Trilogy: K181997
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 two-step 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
4
Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.
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 Swiss LithoClast® Trilogy described in this 510(k) has the same indications for use and technological specifications as previously described in K181364. The purpose of this Special 510(k) is to add the following five H2O2 sterilizers to the instructions for use for end-user resterilization of the reusable Trilogy handpiece:
- o STERIS V-PRO 1
- STERIS V-PRO 60 ●
- STERIS V-PRO maX ●
- STERRAD 100S Short o
- STERRAD NX Standard ●
These five are in addition to the instructions for use of the STERRAD 100NX H2O2 sterilizer that were added to the Trilogy instructions for use under Special 510(k) K181364.
l. Basis for Substantial Equivalence
Substantial equivalence of the Trilogy handpiece when sterilized using each of the H2O2 sterilizers 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 was conducted using the recommended sterilization parameters and demonstrated achievement of sterility assurance level (SAL) 10-6 for each sterilizer.
J. Conclusion
The information and testing presented in this 510(k) demonstrate that the Swiss Lithoclast® Trilogy and reusable handpiece, when sterilized using the recommended sterilization parameters for each of the H2O2 sterilizers, is substantially equivalent to the Swiss Lithoclast® Trilogy and reusable handpiece as previously cleared for marketing in the United States.