(30 days)
No
The 510(k) summary describes a lithotripsy device with different energy modes and a suction system, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used for fragmentation and removal of urinary tract calculi, which is a therapeutic intervention.
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 hardware components such as a console, handpiece, probes, foot pedal, and pump/valve systems, indicating it is a physical medical device, not software-only.
Based on the provided information, the Swiss LithoClast® Trilogy is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the fragmentation and removal of urinary tract calculi (stones) within the body. This is a therapeutic procedure performed directly on the patient.
- Device Description: The device description details a system that generates and delivers energy (ultrasound and shock waves) to break up stones. This is a physical intervention, not a diagnostic test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Swiss LithoClast® Trilogy is a surgical/therapeutic device used for treatment.
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
FFK, FEO
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.
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)
Performance testing was conducted to verify that use of the Steri Holder during steam sterilization has no adverse impact on the handpiece sterile barrier system (pouch or wrap) during the steam sterilization process. The purpose of the Steri Holder is for user convenience to hold the handpiece with the lumen in the vertical position during sterilization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.”
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May 29, 2019
EMS Electro Medical Systems SA % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst. MA 01002
Re: K191124
Trade/Device Name: Swiss LithoClast® Trilogy Regulation Number: 21 CFR 876.4480 Regulation Name: Electrohydraulic lithotriptor Regulatory Class: Class II Product Code: FFK, FEO Dated: April 29, 2019 Received: April 29, 2019
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.
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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 803) for devices or post-marketing 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,
for Glenn B. Bell, Ph.D. Assistant Division 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
Enclosure
2
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 CER 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 Timothée Deblock Head of Quality T: +41 22 994 8516 Email: tdeblock@ems-ch.com
- B. Date Prepared: April 29, 2019
D. Device Name and Classification Information:
| Trade Name: | Swiss LithoClast® Trilogy |
|---|---|
| Common Name: | Intracorporeal Lithotripter |
| Classification Name: | Electrohydraulic Lithotripter |
| Regulation Number: | 21 CFR 876.4480 |
| Product Code: | FFK, FEO |
| Review Panel: | 78 Gastroenterology / Urology |
| Class: | II |
- Predicate Device(s): Swiss LithoClast® Trilogy: K182490 E.
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.
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
The Swiss LithoClast® Trilogy described in this 510(k) has the same indications for use and technological specifications as the predicate device. The purpose of this Special 510(k) is to add a new device accessory, called the Steri Holder Trilogy, which is a stainless steel basket used to hold the Trilogy handpiece in a vertical position during steam sterilization at the end-user facility.
l. Basis for Substantial Equivalence
Performance testing was conducted to verify that use of the Steri Holder during steam sterilization has no adverse impact on the handpiece sterile barrier system (pouch or wrap) during the steam sterilization process. The purpose of the Steri Holder is for user convenience to hold the handpiece with the lumen in the vertical position during sterilization.
J. Conclusion
The information presented in this 510(k) demonstrate that the Swiss Lithoclast® Trilogy and reusable handpiece, when sterilized while positioned in the Steri Holder accessory, is substantially equivalent to the Swiss Lithoclast® Trilogy and reusable handpiece as previously cleared for marketing in the United States.