(28 days)
The CyberWand Hollow Semi-Flexible Ureteral probe is designed to be used only with the CyberWand System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.
The CyberWand Dual Ultrasonic Lithotripsy System is an electromechanical device used to fragment and aspirate calculi. The system consists of the generator unit, transducer handpiece, footswitch, probe sets and cleaning stylets.
The Semi-Flexible Probe is constructed entirely of stainless steel and is packaged with a stainless steel cleaning stylet. The probe has a working length of 58.5 cm and an outer diameter of 1.65 mm; it is is intended to be used primarily with semi-rigid or ridged scopes (cystoscopes, nephroscopes and ureteroscopes) which have a working channel between 5 and 7 French in diameter.
The probe is for provided non-sterile and is for single-patient use.
The provided text is related to a 510(k) submission for the Cybersonics CyberWand® Lithotripter and its Hollow Semi-Flexible Ureteral Probe. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting extensive clinical studies to establish new safety and effectiveness criteria as would be typical for novel devices.
Therefore, many of the requested items (e.g., acceptance criteria for clinical performance, sample size for test sets with ground truth, MRMC studies, training set details) are not applicable or not present in the provided 510(k) summary because the device is a modified version of an already cleared predicate device. The focus is on demonstrating that the modifications do not raise new questions of safety and effectiveness and that the modified device performs as intended.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not provide specific quantitative acceptance criteria or detailed reported device performance in a table format for clinical efficacy. The device is a "modified probe" intended to be equivalent to a predicate. The "acceptance criteria" here refer more to meeting functional and performance requirements for a medical device rather than clinical outcome measures as you might find for a diagnostic AI.
| Acceptance Criteria Type | Details from Submission |
|---|---|
| Functional & Performance Requirements | "To verify that device design met its functional and performance requirements, representative samples of the device underwent durability and stone breakage testing in accordance with Cybersonics Design Control processes and the risk assessment." (Specific metrics are not provided in this summary.) |
| Substantial Equivalence | "Cybersonics considers the modified probes to be equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified for clinical efficacy. The summary mentions "representative samples of the device" for durability and stone breakage testing, implying in-vitro or bench testing, not a clinical test set with patient data.
- Data Provenance: Not applicable for a clinical test set. The functional and performance testing would have been conducted internally by Cybersonics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the provided summary discusses a physical medical device (lithotripter probe) and its functional performance, not an AI or diagnostic device that requires expert-established ground truth on a test set of patient data.
4. Adjudication method for the test set
- This is not applicable for the same reasons as point 3.
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 is relevant for diagnostic devices, especially those incorporating AI, where human readers interpret patient cases. This submission is for a surgical instrument.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable. The device is a human-operated surgical instrument, not an algorithm.
7. The type of ground truth used
- For the functional and performance testing, the "ground truth" would be the engineering specifications and performance standards established by Cybersonics for durability and stone breakage. This is not clinical ground truth like pathology or outcome data.
- For the overall submission, the "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
8. The sample size for the training set
- This is not applicable as there is no AI algorithm being developed or trained for this device.
9. How the ground truth for the training set was established
- This is not applicable as there is no AI algorithm or training set discussed.
§ 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.”