(86 days)
The Genestone Exel (XL) Extracorporeal Shock Wave Lithotripter is indicated for use in the non-invasive disintegration of kidney (renal pelvis and renal calyceal) and upper ureteral stones between 5 and 20 mm in size.
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This document is a 510(k) clearance letter for the Genestone Exel (XL) Extracorporeal Shockwave Lithotripter. It acknowledges that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria or a study proving the device meets those criteria.
A 510(k) clearance evaluates substantial equivalence to a predicate device, not necessarily new performance data against specific acceptance criteria. To find the information you requested, one would typically need to review the original 510(k) submission document itself, which is not provided here.
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§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
Identification. An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.(b)
Classification. Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)