(90 days)
The Circon AEH-4 Electrohydraulic Lithotripter (EHL) Probes are to be used with the Circon AEH-4 Electrohydraulic Lithotripter to fragment stones (calculi) in the urinary and biliary tracts.
Not Found
The provided document is an FDA 510(k) clearance letter for the CIRCON AEH-4 Electrohydraulic Lithotripter Probes. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about the acceptance criteria, study design, or performance data of the device.
Therefore, I cannot provide the requested information. The letter only confirms that the device can be marketed in the US based on its substantial equivalence to previously approved devices, but it does not include details on the specific studies conducted to establish that equivalence or any performance metrics.
§ 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.”