(28 days)
The Swiss LithoClast Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.
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.
This document describes a Special 510(k) submission for the Swiss LithoClast® Trilogy device. The primary purpose of this submission is to add hydrogen peroxide (H2O2) sterilization as an option for reprocessing the reusable handpiece, in addition to the previously validated steam sterilization. Therefore, the acceptance criteria and study described below specifically pertain to the validation of this new sterilization method for the handpiece.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| For the Handpiece: Successful validation of H2O2 sterilization method to achieve a sterility assurance level (SAL) of 10-6 in accordance with ISO 14937:2009 using the STERRAD 100NX sterilizer on the Standard cycle, ensuring the device remains safe and effective.** | Sterilization validation was conducted using the STERRAD 100NX sterilizer on the Standard cycle. The study demonstrated the achievement of sterility assurance level (SAL) 10-6 for the Swiss LithoClast® Trilogy reusable handpiece. This indicates the new sterilization method effectively renders the handpiece sterile to the required standard without compromising its functionality or safety. The submission concludes 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." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" in terms of a number of handpieces tested for the H2O2 sterilization validation. However, sterilization validation studies typically involve:
* Multiple samples (e.g., biological indicators, inoculated devices) within each test run to demonstrate the killing of a specified number of microorganisms.
* Multiple replicate cycles (e.g., three consecutive successful cycles) to prove reproducibility.
The data provenance is related to the performance of the Swiss LithoClast® Trilogy reusable handpiece when subjected to H2O2 sterilization. Given that this is a Special 510(k) for a manufacturing change (adding a sterilization method), the data would be prospective and generated specifically for this validation study. The location of the test facilities or the country of origin of the data is not specified beyond the applicant being EMS Electro Medical Systems SA in Nyon, Switzerland.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve "experts" establishing a ground truth in the same way clinical diagnostic studies do. The "ground truth" for sterilization validation is fundamentally defined by the successful inactivation of biological indicators (BIs) or inoculated devices, as measured by standard microbiological assays (e.g., lack of growth). The expertise lies in:
* Microbiologists and sterilization engineers who design, execute, and interpret the validation studies according to ISO 14937 and other relevant standards.
* Regulatory affairs personnel who ensure compliance with medical device regulations.
The document does not specify the number or qualifications of these individuals, as this is standard practice in such validation studies.
4. Adjudication Method for the Test Set
Not applicable for a sterilization validation study. The outcome (sterile or not sterile, SAL achieved or not achieved) is determined by objective laboratory testing (microbiological culture results) rather than expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not a diagnostic device or a device whose performance is assessed by human readers. It is a device sterilization validation.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This is not an AI/algorithm-based device. "Standalone performance" in this context would refer to the device's functional integrity and sterility post-sterilization, which is inherently part of the validation.
7. The Type of Ground Truth Used
The ground truth used for this sterilization validation is microbiological sterility testing. This involves:
* Inoculating representative devices or biological indicators (BIs) with a known, resistant microorganism (e.g., Geobacillus stearothermophilus for H2O2 sterilization).
* Processing these inoculated items through the sterilization cycle.
* Aseptic retrieval and culture of the BIs or device samples to determine if any viable microorganisms remain.
* The "ground truth" is established by the lack of microbial growth (kill) conforming to the specified SAL (10-6).
8. The Sample Size for the Training Set
Not applicable. This is a sterilization validation study, not a machine learning study that would use training sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of validation. The ground truth (sterility) is established through standardized microbiological testing methods as described in point 7.
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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.
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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.
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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.
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 TrilogyProposed | Basis for SE |
|---|---|---|---|
| Indications for use | Fragmentation and removalof urinary tract calculi in thekidney, ureter and bladder | Fragmentation and removalof urinary tract calculi in thekidney, ureter and bladder | Same |
| DEVICE COMPONENTS | |||
| CONSOLE | |||
| Microprocessor control | Yes | Yes | Same |
| I/O | Touchscreen inputLCD display | Touchscreen inputLCD 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 housingmaterial | PEEK | PEEK | Same |
| Sterilization | Re-usable, pre-vacuum,steam | Re-usable, pre-vacuum,steam or H2O2 | Substantiallyequivalent |
| PROBES | |||
| Probe types | Single probe provides bothultrasound (vibration) andballistic (shock wave) | Single probe provides bothultrasound (vibration) andballistic (shock wave) | Same |
| Probe material | Ultrasound: 316L stainlesssteel | Ultrasound: 316L stainlesssteel | Same |
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| Characteristic | Swiss Lithoclast Trilogy(K173234) | Swiss Lithoclast TrilogyProposed | Basis for SE |
|---|---|---|---|
| Probe diameters | 1.1, 1.5, 1.9, 3.4 and 3.9mm | 1.1, 1.5, 1.9, 3.4 and 3.9mm | Same |
| RFID tag | Yes | Yes | Same |
| Sterilization | Provided EtO sterilized,Multiple-use probesvalidated for 4x steamsterilization after first use | Provided EtO sterilized,Multiple-use probesvalidated for 4x steamsterilization after first use | Same |
| FOOT PEDAL | Single pedalTwo-step for suction andenergy | Single pedalTwo-step for suction andenergy | Same |
| SUCTION | Options of pinch valve orperistaltic pump on console | Options of pinch valve orperistaltic 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. amplitudePeak to peak | 60 μm | 60 μm | Same |
| Output poweradjustment | Adjustable from 10%-100%(10% increments) | Adjustable from 10%-100%(10% increments) | Same |
| BALLISTIC MODE | Yes | Yes | Same |
| Energy Type | Ballistic, generated byelectromagnetic field | Ballistic, generated byelectromagnetic field | Same |
| Output poweradjustment | 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 repetitionrate | 1 to 12 Hz in 1 Hzincrements | 1 to 12 Hz in 1 Hzincrements | 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.
§ 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.”