(190 days)
The Lite-Med LM-9300 ELMA Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle and lower ureteral stones by extracorporeal shock wave lithotripsy (ESWL).
The Lite-Med LM-9000 ELMA is an Electromagnetic Extracorporeal Shock Wave Lithotripter that effectively treats urinary calculi. It is routinely used for the fragmentation of kidney and ureteral stones and offers a good combination of clinical performance, flexibility and affordability. The standard LM-9300 ELMA system consists of a shockwave generator, an operator interface (industrial computer with dual monitors), a water circulation subsystem and a patient handling subsystem. For the Extracorporeal Shock Wave Lithotripsy (ESWL) operation to be fully functional, one or two more subsystems are necessary. The first is a C-arm X-ray fluoroscopy device and the second is an ultrasound imaging unit. Normally one of the imaging devices is sufficient. For most advanced ESWL designs such as LM-9300 ELMA both X-ray and ultrasound are used for patient positioning and monitoring purposes.
Shock waves are generated on the basis of a principle similar to that used in loudspeakers. An electrical impulse is sent through an inductance coil, generating a magnetic field which repulses a metallic membrane. The acoustic impulse created by this repulsion is focused by an acoustic lens to form a shock wave. A water circulation subsystem is used to provide transmission of shockwaves and cooling of the generator.
Here's an analysis of the provided text to extract the acceptance criteria and study details for the LM-9300 ELMA Lithotripter:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a typical quantitative pass/fail format for a diagnostic device. Instead, it describes performance based on the clinical outcome of stone fragmentation. The key performance indicator is the "stone-free ratio."
| Acceptance Criteria Category (Implied) | Reported Device Performance (LM-9300 ELMA) |
|---|---|
| Clinical Effectiveness (Stone-Free) | Averaged stone-free ratio at one month after treatment: 80% |
| Effectiveness (Residual Fragments) | Effectiveness (fragments |
§ 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.”)