(281 days)
CIRCON ACMI's AEH-3 Electrohydraulic Lithotripter and Probes are intended to be used to fragment stones (calculi) in the urinary and biliary tracts, including the kidney, ureter, bladder, urethra, and common bile duct.
The CIRCON ACMI AEH-3 Electrohydraulic Lithotripter is a bipolar electronic device. When used with its flexible probes, the system is capable of fragmenting calculi so that fragments can be removed without requiring major surgery. In the presence of recommended irrigant solutions, sparks produced by activating the AEH-3 generator produce a series of high amplitude hydraulic shock waves that initiate fragmentation. These shock waves have no adverse effect on tissue because of tissue flexibility, as long as the probe does not come in contact with the tissue surface.
This 510(k) summary for the CIRCON ACMI AEH-3 Electrohydraulic Lithotripter and Probes does not include any information about acceptance criteria or a study proving the device meets those criteria.
The document focuses on establishing substantial equivalence to legally marketed predicate devices, outlining the device's intended use, and describing its basic working mechanism.
Therefore, I cannot provide the requested information based on the provided text. The summary only states that the device is "substantially equivalent" to other devices legally marketed for the same intended uses, implying that its performance is considered acceptable based on the predicate devices.
§ 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.”