(97 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 is a modified version of the Swiss LithoClast® Master, previously cleared under K012445. As with the predicate device, three possible modes of operation are available: 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 is a 510(k) premarket notification for the Swiss LithoClast Trilogy, a medical device for fragmenting and removing urinary tract calculi. It is a submission to the FDA to demonstrate the substantial equivalence of the new device to a previously cleared predicate device (Swiss LithoClast Master).
Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
Note: This document describes a medical device (Electrohydraulic Lithotripter), not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical acceptance criteria and study aspects for AI/SaMD (like human reader studies, ground truth establishment for AI, training set details, and specific metrics like sensitivity/specificity for diagnostic AI) are not applicable here. The "study" in this context refers to bench testing and validation to show the physical device performs as intended and is safe.
The core of this 510(k) submission is to demonstrate substantial equivalence to a predicate device. This means showing the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating that the new device (Swiss LithoClast Trilogy) performs equivalently to the predicate device (Swiss LithoClast Master) across various characteristics and safety requirements. The "performance" is shown through the technical comparison and bench testing results.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in a separate table with "reported performance" like one would see for an AI model's diagnostic accuracy. Instead, the acceptance is based on demonstrating that the new device's characteristics and performance fall within acceptable ranges or are equivalent to the predicate.
Here's how we can extract the implicit acceptance criteria and reported "performance" based on the technical comparison and bench testing:
| Characteristic/Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate (fragmentation of urinary tract calculi) | "Fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder" (Substantially equivalent, with added "removal") |
| Device Components: | ||
| - Console (Microprocessor, I/O, Dimensions, Weight, Power Supply) | Equivalent/Acceptable ranges compared to predicate. Must not introduce new safety concerns. | All deemed "Same" or "Substantially equivalent" to predicate, with noted differences (e.g., touchscreen vs. rotary knobs, slight dimension/weight changes). |
| - Handpiece (Types, Material, Sterilization) | Equivalent/Improved functionality without compromising safety; same material, same sterilization. | Single handpiece delivers both energy types (improvement); Same PEEK material; Same re-usable, pre-vacuum, steam sterilization. |
| - Probes (Types, Material, Diameters, RFID, Sterilization) | Single probe delivering both energy types; same material for ultrasound probe; equivalent diameter range; RFID tag acceptable; Same sterilization. | Single probe provides both ultrasound/ballistic; Same 316L stainless steel for ultrasound probe; Equivalent range of diameters (1.1-3.9mm vs. 0.8-3.8mm); RFID tag for tracking (acceptable addition); Same sterilization. |
| - Foot Pedal | Improved user interface without compromising control or safety. | Single pedal, two-step for suction and energy (simplified); Substantially equivalent. |
| - Suction | Equivalent functionality and safety. | Options of pinch valve or peristaltic pump; Substantially equivalent. |
| - Stone Catcher | Same functionality. | Optional component; Same product. |
| Operating Modes: | ||
| - Ultrasound Mode (Frequency, Amplitude, Output Power) | Same frequency/amplitude; acceptable output power adjustment range. | 24 kHz frequency; 60 μm max amplitude; Adjustable from 10%-100% (Substantially equivalent). |
| - Ballistic Mode (Energy Type, Output Power, Operating Modes, Repetition Rate) | Energy type difference must be demonstrated safe and effective; acceptable output power; justified mode changes; same repetition rate. | Different energy source (electromagnetic field vs. compressed air) - demonstrated safe/effective via testing; Adjustable from 10%-100% (Substantially equivalent); Multiple shot mode only (single shot eliminated as rarely used); 1-12 Hz repetition rate (Same). |
| Bench Testing (Safety/Performance) | Meets relevant international standards and performance metrics for all tests. | All listed tests were performed and results deemed acceptable to support substantial equivalence: - Fragmentation and stone clearance time (using Begostones) - Tissue perforation testing (on pig bladder) - Reusable handpiece/probe qualification - Electrical safety (IEC 60601-1) - EMC (IEC 60601-1-2) - Biocompatibility (ISO 10993-1, -5, -10, -11, etc.) - Sterilization validation (ISO 11135) - Shipping & handling (ISTA 1E, 2A) - Package & sterility after aging (ASTM F1886, EN 868-5, ASTM F1929) - Functional tests of probes after aging - Software verification and validation (IEC 62304) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly quantifiable in terms of "patient cases" as this is a device for physical intervention, not an AI/diagnostic software. The "test set" here refers to the materials and units used in the bench tests:
- Artificial "Begostones" for fragmentation and stone clearance time. Specific number not stated.
- Pig bladder tissue for tissue perforation testing. Specific number/amount not stated.
- Reusable handpieces and probes for qualification testing. Specific numbers not stated.
- Units used for electrical safety, EMC, biocompatibility, sterilization validation, shipping/handling, package/sterility, and functional tests after aging. These would be specific numbers of device components or completed devices as required by the respective standards.
- Data Provenance: This is all prospective bench testing conducted in a lab setting rather than retrospective patient data.
- Country of Origin: The applicant is EMS Electro Medical Systems SA, located in Nyon, Switzerland. The testing would have been conducted by the manufacturer or by third-party labs contracted by the manufacturer, following international standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This concept is not applicable to this type of device submission. There is no "ground truth" established by experts in the context of diagnostic accuracy, as this is a therapeutic device. The "ground truth" for the device's functionality is established by objective engineering measurements against defined performance specifications and validation against relevant international standards.
4. Adjudication Method for the Test Set
This concept is not applicable. Adjudication (e.g., 2+1, 3+1 for resolving discrepancies in expert interpretations) is used in studies with human interpretation, typically for diagnostic accuracy. For bench testing, results are measured objectively against predefined acceptance criteria, and any deviations would be handled through and engineering non-conformance and investigation process, not adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance on various cases) is specific to AI/SaMD, especially in diagnostic imaging. The Swiss LithoClast Trilogy is a therapeutic device (a lithotripter used to break up kidney stones), not a diagnostic AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, this is not applicable. The device is a physical electrohydraulic lithotripter, not an algorithm. Bench testing demonstrates its standalone physical performance according to specifications and safety standards.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective physical measurements and adherence to engineering specifications and international standards. Examples include:
- Physical performance metrics: Stone fragmentation efficiency, stone clearance time, maximum amplitude, energy output levels.
- Safety standards: Electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993 series), sterility (ISO 11135), tissue perforation limits.
- Functional validation: Probes functioning correctly after aging, software performing as designed (IEC 62304).
The "ground truth" isn't a medical outcome like disease presence (pathology) or patient outcomes data, but rather that the device, when used as intended, performs its function safely and effectively according to its design and established benchmarks (like the predicate device and industry standards).
8. The Sample Size for the Training Set
This concept is not applicable. "Training set" refers to data used to train a machine learning algorithm. This is a physical medical device. Its "training" is in its design, engineering tolerances, and manufacturing processes, which are validated through testing.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable for the same reason as point 8. There is no concept of a "training set" or "ground truth" for training in the context of a conventional medical device's physical design and performance.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
January 10, 2018
E.M.S. Electro Medical Systems SA % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst. MA 01002
Re: K173234
Trade/Device Name: Swiss LithoClast Trilogy Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic Lithotripter Regulatory Class: II Product Code: FEO, FFK Dated: October 4, 2017 Received: October 5, 2017
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible and well-defined.
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K173234
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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 |
- B. Date Prepared: January 9, 2018
D. Device Name and Classification Information:
| Trade Name: | Swiss LithoClast® Trilogy |
|---|---|
| Classification Name: | Electrohydraulic Lithotripter |
| Regulation: | 21 CFR 876.4480 |
| Product Code: | FEO, FFK |
| Review Panel: | 78 Gastroenterology / Urology |
| Class: | II |
- E. K012445, Swiss LithoClast® Master Predicate Device(s):
F. Summary Device Description:
The Swiss LithoClast® Trilogy is a modified version of the Swiss LithoClast® Master, previously cleared under K012445. As with the predicate device, three possible modes of operation are available: 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.
H. Technical Comparison with Predicate Device
The table below provides a side-by-side comparison of the modified device to the predicate device.
| Characteristic | Ems Swiss LithoclastMaster (K012445) | Ems Swiss LithoclastTrilogy | Basis for SE |
|---|---|---|---|
| Indications for use | Fragmentation of urinarytract calculi in the kidney,ureter and bladder | Fragmentation and removalof urinary tract calculi in thekidney, ureter and bladder | Substantiallyequivalent |
| DEVICE COMPONENTS | |||
| CONSOLE | |||
| Microprocessor control | Yes | Yes | Same |
| I/O | Rotary knobs/switchesLCD display | Touchscreen inputLCD display | Substantiallyequivalent |
| Dimensions | 135 mm (H) x 371 mm (W)x 432 mm (D) | 135 mm (H) x 360 mm (W)x 420 mm (D) | Substantiallyequivalent |
| Weight | 10.5 kg | 13.5 kg | Substantiallyequivalent |
| Power supply | 100-240 VAC, 50-60 Hz | 100-240 VAC, 50-60 Hz | Same |
| HANDPIECE | |||
| Handpiece types | Separate handpieces forultrasound and pneumatic | Single handpiece | Single handpiecedelivers bothenergy types |
| Handpiece housingmaterial | PEEK | PEEK | Same |
| Sterilization | Re-usable, pre-vacuum,steam | Re-usable, pre-vacuum,steam | Same |
| PROBES | |||
| Probe types | Separate probes forultrasound (vibration) andballistic (shock wave) | Single probe provides bothultrasound (vibration) andballistic (shock wave) | Single probedelivers bothenergy types |
| Probe material | Ultrasound: 316L stainlesssteelBallistic: 304 stainlesssteel | Ultrasound: 316L stainlesssteel | Same as forultrasound probe |
| Characteristic | Ems Swiss LithoclastMaster (K012445) | Ems Swiss LithoclastTrilogy | Basis for SE |
| Probe diameters | Pneumatic: 0.8, 1.0, 1.6,2.0 and 3.2 mmUltrasound: 3.3 and 3.8mm | 1.1, 1.5, 1.9, 3.4 and 3.9mm | Equivalent range |
| RFID tag | None | Yes | Enables consoleto track probetype and usehistory |
| 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 | Dual side-by-sideTwo-step for suction andultrasound | Single pedalTwo-step for suction andenergy | Only one pedalneeded due tointegratedenergy |
| SUCTION | Pinch valve on console,compatible with EMSLithoVac | Options of pinch valve orperistaltic pump on console | Substantiallyequivalent |
| STONE CATCHER | Optional component | Optional component | Same product |
| OPERATING MODES | |||
| ULTRASOUND MODE | Yes | Yes | Same |
| Transducer frequency | 24 kHz | 24 Hz | Same |
| Max. amplitudePeak to peak | 60 μm | 60 μm | Same |
| Output poweradjustment | Adjustable from 0%-100%(10% increments) | Adjustable from 10%-100%(10% increments) | Substantiallyequivalent |
| BALLISTIC MODE | Yes | Yes | Same |
| Energy Type | Ballistic, generated bycompressed air | Ballistic, generated byelectromagnetic field | Different energysource |
| Output poweradjustment | Adjustable from 0%-100%(10% increments) | Adjustable from 10%-100%(10% increments) | Substantiallyequivalent |
| Operating modes | Single shot or multiple shotmodes | Multiple shot mode only | Single shotmode eliminatedas rarely used |
| Multiple shot repetitionrate | 1 to 12 Hz in 1 Hzincrements | 1 to 12 Hz in 1 Hzincrements | Same |
{5}------------------------------------------------
{6}------------------------------------------------
l. Basis for Substantial Equivalence - Bench Testing
The following FDA guidance documents were followed for this 510(k):
- . "Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters," Nov. 30, 1998
- . "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," May 11, 2005
- "Off-The-Shelf Software Use in Medical Devices," Sept. 9, 1999
- "Radio Frequency Wireless Technology in Medical Devices," August 14, ● 2013
- . "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,"" June 16, 2016
- . "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," January 21, 2016
Testing submitted in this 510(k) to support substantial equivalence included the following:
- Fragmentation and stone clearance time using the dual energy Trilogy handpiece and probes and artificial Begostones
- Tissue perforation testing on pig bladder tissue ●
- Reusable handpiece qualification testing .
- Reusable probe qualification testing
- Electrical safety testing to IEC 60601-1:2005 +A1:2012 (ed. 3.1) ●
- Electromagnetic compatibility testing to IEC 60601-1-2:2014 (ed. 4.0) ●
- Biocompatibility testing to ISO 10993-1 including: .
- Cytotoxicity: ISO 10993-5:2009 o
- Sensitization: ISO 10993-10:2010 o
- Intracutaneous reactivity in rabbits: ISO 10993-10:2010 O
- Acute Systemic Toxicity in Mice: ISO 10993-11:2006 O
- Endotoxin (LAL) test: USP39 <85> 2016, USP39 <161> 2016 o
- Material-mediated Pyrogenicity: ISO 10993-11:2006, USP <151> o Pyrogen Test
- . Sterilization validation to ISO 11135:2014
- Shipping and handling testing to ISTA 1E and ISTA 2A ●
- Package and sterility testing after 2X EtO sterilization and accelerated ● aqing including:
- o Visual inspection to ASTM F1886:2016
- Seal peel and seal tensile strength tests to EN 868-5:2009 O
- Seal integrity test to ASTM F1929:2015 O
- Dye penetration test for pinholes to EN 868-5:2009 o
{7}------------------------------------------------
- Sterility tests to ISO 11737-2:2009 o
- Functional tests of the Trilogy probes after aging .
- Software verification and validation to IEC 62304:2006
J. Conclusion
The information and testing presented in this 510(k) demonstrate that the modified Swiss LithoClast device, called the Trilogy, is substantially equivalent to the predicate Swiss LithoClast device, called the Master. The modified device has the same intended use, equivalent indications for use, and same fundamental scientific technology as compared to the predicate device. The test data submitted in the 510(k) demonstrate that the modified device is as safe and as effective as the predicate device and, therefore, can be found substantially equivalent.
§ 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.”