(184 days)
The Storz Medical MODULITH® Model SLX F2 is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
The Storz Modulth® Lithotripter Model SLX-F2 is lithotripsy system comprised of a therapy source, an X-ray system, an ultrasound system and a patient table.
This document does not contain the specific information required to complete the table and answer the requested questions about acceptance criteria and a study proving device performance. The provided text is a 510(k) summary and an FDA clearance letter for a lithotripter device, the Storz Modulith® Lithotripter Model SLX-F2.
It states that the device is substantially equivalent to a predicate device (Storz Modulith® Lithotripter Model SLX) and that "The minor differences in design, dimensions and features between the Storz Modulith® Lithotripter Model SLX-F2 and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." This suggests that a direct performance study to establish new acceptance criteria was likely not performed for this 510(k) clearance, as the focus was on demonstrating equivalence to an already cleared device.
Therefore, I cannot provide details on:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or type of ground truth for a test set.
- Sample size or ground truth establishment for a training set.
The document only provides:
- Device Name: Storz Modulith® Lithotripter Model SLX-F2
- Indication for Use: Noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
- Device Description: A lithotripsy system comprising a therapy source, an X-ray system, an ultrasound system, and a patient table.
- Substantial Equivalence Statement: The device is substantially equivalent to the Storz Modulith® Lithotripter Model SLX.
§ 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.”)