Stone Clear (SC-LP9-01)
SonoMotion, Inc.Stone Clear is a medical device that uses ultrasound imaging to locate urinary stones in the upper urinary tract and applies focused ultrasound pulses to reposition these stones, helping patients pass them more easily after lithotripsy treatment. It provides real-time image guidance and therapy, improving stone management and patient outcomes.
Intended Use
The Stone Clear ultrasonic propulsion device is indicated for the repositioning of residual stone fragments post-lithotripsy that are located in the upper urinary tract of adult patients to facilitate passage, where any individual fragment is less than or equal to 5 mm.
Technology
The device consists of a commercially available ultrasound imaging system integrated with a proprietary signal generator and therapy probe. The coaxially aligned imaging and therapy probes allow real-time image guidance while delivering focused ultrasound pulses to reposition stones. The system includes specialized software to synchronize imaging and therapy, controlled via a user interface and foot pedal.
Performance
Safety and effectiveness were demonstrated through non-clinical bench testing (acoustic power, targeting accuracy, probe safety), biocompatibility studies, and animal testing showing no tissue injury under worst-case parameters. Clinical trials showed an 83.3% stone passage rate in treated patients compared to 4.5% in controls, with no serious adverse events related to the device. The device met FDA special controls including software validation and electromagnetic compatibility.
Device Timeline
- 1
Submission
12/7/2023
10 months - 2
FDA Approval
10/30/2024
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