(189 days)
The EL27-Compact is a device to be used together with EHL-probes from Walz Elektronik GmbH for disintegration of concernments in the upper and lower urinary tract and in gastroenterology, particularly in the bile duct.
The EL27-Compact is a device, designed to be used with Walz Elektronik GmbH disposable EHL-Probes for the fragmentation of concrements in the gastroenterology and urology.
A physician inserts and pushes the disposable EHL probe through the working channel of an endoscope and places the tip of the probe in front of the stone surrounded with saline solution. With pressing the footswitch, the device provides electric pulse energy in form of a high-voltage pulse. This pulse generates high pressure shockwaves that fragment hard stones.
The EL27-Compact is a table-top device and consists of the generator itself, the power cord, the footswitch, a probe cable for connection between the device and the EHL-probes.
This document describes the EL27-Compact, an electrohydraulic lithotriptor (EHL) device used for fragmenting concretions in the urinary tract and bile duct.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes performance testing conducted to demonstrate "equivalence to the predicate device" and "comparable effects." The acceptance criterion generally appears to be meeting relevant standards, achieving comparable performance to the predicate device in bench tests, and ensuring biocompatibility and electrical/EMC safety.
| Feature/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| EHL-Probes | ||
| Visual Inspection | Appearance within acceptable limits. | (Not explicitly stated, but implied as "successfully conducted" for other EHL-probe tests.) |
| Dimensions | Tolerances met. | (Not explicitly stated, but implied as "successfully conducted" for other EHL-probe tests.) |
| Insertion into Endoscope | Compatible with endoscopes. | (Not explicitly stated, but implied as "successfully conducted" for other EHL-probe tests.) |
| Shockwave Measurement | Comparable shockwave characteristics to predicate. | "Measuring the shockwaves" was performed. Conclusion is that "comparable effects could be achieved." |
| Withdrawing Force of Tip | Within acceptable limits for safe and effective use. | "Measuring withdrawing force of the tip of the probes" was performed. Conclusion is that "comparable effects could be achieved." |
| Electrode Consumption | Comparable electrode consumption. | "Measuring the electrode consumption" was performed. Conclusion is that "comparable effects could be achieved." |
| Biocompatibility | Compliance with ISO 10993-1. | "Successfully conducted previously according to ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing" for patient-contacting EHL-Probes. Confirmed "no changes that have impacted the established biocompatibility." |
| EL27-Compact (Generator) | ||
| Performance (Intensity Output) | Comparable performance across different intensity settings (Low, Medium, High) to the predicate device. | "The Test performed was to set up the 3 devices and connect them to 3Fr. Probes. Choosing the different intensities on the devices, pulses have been emitted on a piece of plasterboard. The distance of the probe to the plasterboard have been kept the same overall tests. The resulting holes in the plasterboard, which vary in depth caused by the chosen intensity, can be compared to another." Conclusion: "comparable effects could be achieved for applicable modes of operation." |
| Electrical Safety & Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 and IEC 60601-1:2005+AMD1:2012. | "Electrical safety and EMC performance testing have been confirmed to be in compliance with the relevant requirements." |
| Software Verification and Validation | Compliance with FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | "Software testing has been performed and documented accordingly to the FDA Guidance Document." |
| Overall Substantial Equivalence | Indications for use, principles of operation, fundamental technology, patient population, and procedures are identical to predicate. | "Indications for use, principles of operation, fundamental technology of the generator are identical to the predicate device... The indicated patient population and procedures are also identical to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes (number of probes, number of plasterboards, etc.) for each bench test. For the EL27-Compact intensity test, it mentions "the 3 devices" (presumably 3 EL27-Compact units) and "3Fr. Probes" (number of probes not specified per device).
- Data Provenance: The document implies that the data is from prospective bench testing conducted by Walz Elektronik GmbH ("The following performance testing was conducted..."). There is no information about the country of origin of the data beyond the manufacturer being in Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable as the study described is primarily bench testing against engineering specifications and predicate device performance, not a clinical study involving human assessment of ground truth.
4. Adjudication Method for the Test Set
This is not applicable as the study described is primarily bench testing, not a study requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or conducted. The submission focuses on demonstrating substantial equivalence through bench testing to a predicate device.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable. The EL27-Compact is a medical device that requires a human operator (physician) to operate. It is not an AI algorithm with standalone performance metrics.
7. Type of Ground Truth Used
The "ground truth" for the bench tests was based on:
- Engineering specifications and tolerances: For visual inspection, dimensions, insertion compatibility, and withdrawing force.
- Established biological safety standards (ISO 10993-1): For biocompatibility.
- Comparative physical effects: For shockwave measurement, electrode consumption, and the plasterboard penetration test (comparing the "resulting holes" to another, implicitly the predicate, or expected performance).
- Compliance with recognized electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2).
- Compliance with regulatory guidance for software verification and validation.
8. Sample Size for the Training Set
This is not applicable. The EL27-Compact is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
§ 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.”