QNA · Ultrasonic Urinary Stone Propulsion Device
Gastroenterology, Urology · 21 CFR 876.4690 · Class 2
Overview
| Product Code | QNA |
|---|---|
| Device Name | Ultrasonic Urinary Stone Propulsion Device |
| Regulation | 21 CFR 876.4690 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
An ultrasonic urinary stone propulsion device visualizes urinary stones in the upper urinary tract and delivers focused acoustic pulses to reposition the stones to facilitate their passage. The Stone Clear 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.
Classification Rationale
Class II. The device is subject to general controls and special controls as defined in 21 CFR 876.4690.
Special Controls
In combination with the general controls of the FD&C Act, the ultrasonic urinary stone propulsion device is subject to the following special controls: (1) Clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Data must evaluate the following: The device performance in repositioning urinary stones and facilitating their (i) passage: and (ii) Device and procedure related adverse events, including pain, discomfort, hematuria, and urinary obstruction. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: Acoustic output characteristics, including acoustic power and intensity, focal (i) geometry, and target accuracy; and Probe surface heating. (ii) (3) Performance testing must demonstrate the electromagnetic compatibility (EMC), electrical safety, and mechanical safety of the device in the intended use environment. (4) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (5) Performance data must validate the reprocessing instructions for the reusable components of the device. (6) Software verification, validation, and hazard analysis must be performed. (7) Labeling must include: The size of the stones treated with the device; (i) The acoustic properties of the device: (ii) (iii) Specific instructions on identifying an appropriate acoustic window; (iv) Summary of the clinical performance data conducted with the device; and (v) Reprocessing instructions.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN230082 | Stone Clear (SC-LP9-01) | Sonomotion, Inc. | Oct 30, 2024 | DENG |
Top Applicants
- Sonomotion, Inc. — 1 clearance
