(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.
§ 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.”