(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.
§ 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.”