(206 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 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. The purpose of this 510(k) is to increased the number of validated reprocessing cycles for the reusable handpiece and add the option of a wireless foot pedal.
This is a 510(k) premarket notification for a medical device, the Swiss LithoClast® Trilogy, which is an electrohydraulic lithotriptor used for fragmenting and removing urinary tract calculi. The submission is to address two changes: the addition of an optional wireless foot pedal and an increase in the validated number of reprocessing cycles for the reusable handpiece from 60 to 100.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a single table labeled "Acceptance Criteria and Reported Device Performance" for the overall device's indication. Instead, it describes performance testing related to the changes being submitted in this 510(k). The implicit acceptance criteria are that the device with the changes performs equivalently to the predicate device and meets relevant safety and performance standards.
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Wireless Foot Pedal - Software Validation | The software in the wireless foot pedal and dongle must be validated commensurate with a moderate level of concern and compliant with IEC 62304 Edition 1.1 2015-06. All unit, integration, and system level tests must meet acceptance criteria. | All tests met the acceptance criteria and were passed, demonstrating compliance with IEC 62304. |
| Wireless Foot Pedal - Electrical Safety & EMC | The Swiss LithoClast Trilogy, when operated by the wireless foot pedal, must comply with IEC 60601-1:2005 + A1:2012 and IEC 60601-1-2:2014. The Wireless Foot Pedal Kit must also comply with EN 300 328 V2.2.2 (2019-07) and EN 62311:2008. | Demonstrated compliance with all specified electrical safety and EMC standards. |
| Wireless Foot Pedal - Device Performance Testing | The wireless foot pedal and dongle must meet the design input requirements for functional performance, battery performance, mechanical integrity, dongle connection/disconnection integrity, chemical resistance, expected use lifetime, and RF quality of service and coexistence. | All test results demonstrated that the wireless foot pedal and dongle meet the design input requirements. |
| Handpiece Lifetime Testing (Reprocessing Cycles) | Handpieces must meet performance specifications and be effective in clearing stones in a simulated use set-up within 20% of the time needed using new handpieces (at time 0) after 133 cleaning, disinfection, and steam sterilization cycles. This must demonstrate validation for 100 reprocessing cycles with 95% reliability and 95% confidence. | Performance testing confirmed that handpieces met performance specifications and were effective in clearing stones within 20% of the time needed by new handpieces after 133 reprocessing cycles. The conclusion was validation for 100 reprocessing cycles with 95% reliability and 95% confidence. |
2. Sample Size Used for the Test Set and Data Provenance:
- Wireless Foot Pedal Testing (Software, Electrical Safety, Device Performance): The document does not specify a distinct "test set" in terms of patient data or clinical samples for the wireless foot pedal. The testing described is primarily engineering and bench testing on the device hardware and software itself. Therefore, sample sizes would relate to the number of production units tested, but this detail is not provided.
- Handpiece Lifetime Testing:
- Sample Size: Twenty (20) handpiece units were tested.
- Data Provenance: This was bench testing conducted by the manufacturer, not patient data. The country of origin of this data is not explicitly stated but would be from EMS Electro Medical Systems SA, Nyon, Switzerland, or a contract testing facility. This is prospective testing performed for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to the studies described. The "ground truth" for these tests relates to engineering specifications and performance benchmarks (e.g., successful software operation, compliance with electrical safety standards, stone clearance within a specified time). These are not studies involving human interpretation of data for which expert consensus would establish ground truth in a clinical context.
4. Adjudication Method for the Test Set:
Not applicable. There was no clinical test set requiring expert adjudication. The tests were objective engineering and performance verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The changes addressed in this 510(k) are related to an optional wireless foot pedal and increased reprocessing cycles for a handpiece, neither of which involves human readers interpreting cases or AI assistance in a diagnostic or interventional workflow that would necessitate an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The term "standalone" performance typically refers to the performance of an AI algorithm independent of human interaction. This submission does not involve an AI algorithm with such a function. The software validation mentioned for the wireless foot pedal assesses the functional correctness and safety of the embedded software, not its standalone performance in interpreting medical data.
7. The Type of Ground Truth Used:
- Wireless Foot Pedal Testing: The ground truth was based on pre-defined engineering design input requirements and international standards for electrical safety, EMC, and wireless communication (e.g., functional performance specifications, battery life targets, compliance with IEC 60601 series, EN 300 328, EN 62311).
- Handpiece Lifetime Testing: The ground truth was based on performance specifications for stone clearance (i.e., effectiveness in clearing stones in a simulated use set-up within 20% of new handpiece performance) and statistical reliability/confidence targets (95% reliability, 95% confidence for 100 cycles).
8. The Sample Size for the Training Set:
Not applicable. There is no AI model or algorithm being trained with a dataset mentioned in this 510(k) submission. The software validation is for embedded control software, not for an AI/ML component that learns from data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set for an AI/ML model.
§ 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.”