(441 days)
The Storz Modulith® Lithotripter Models SLK is manufactured by Storz Indication: Medical AG are indicated for the therapeutic use in the treatment of ureteric calculi in lithotripsy procedures.
Storz Modulith® Lithotripter Model SLK is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
The lithotripter models described in this submission are intended for use by qualified surgeons during a variety of lithotripsy surgical procedures.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Storz Modulith® Lithotripter Model SLK, a device indicated for the therapeutic use in the treatment of ureteric calculi in lithotripsy procedures.
The information provided confirms:
- Device Identification: Storz Modulith® Lithotripter Model SLK.
- Indication for Use: Therapeutic use in the treatment of ureteric calculi in lithotripsy procedures, and noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
- Regulatory Status: Substantial equivalence to legally marketed predicate devices, classifying it as a Class II device.
However, the document does not include details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test sets.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone (algorithm-only) performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document primarily focuses on the administrative and regulatory approval for marketing the device based on substantial equivalence, rather than providing details of specific performance studies against defined acceptance criteria.
§ 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.”)