SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)

Exclusion Criteria

• •1. Subject has an acute untreated urinary tract infection or urosepsis.
• •2. Subject has an uncorrected bleeding disorder or coagulation abnormality.
• •3. Subject is confirmed to be or suspected to be pregnant.
• •4. Subject has a urinary tract obstruction distal to the stone.
• •5. Subject is receiving anticoagulants and is unable or not willing to cease the medication for the Break Wave procedure
• •6. Subject has stones that are not echogenically visible with ultrasound.
• •7. Subject belongs to a vulnerable group (prisoner, etc.).
• •8. Patients unwilling to comply with the follow-up protocol, including post-procedure radiographic imaging.
• •9. Subject is under 18 years of age.
• •10. Subject's anatomy limits ability to focus on or deliver Break Wave to the target stone (e.g. viable acoustic window).
• •11. Subject has a calcified abdominal aortic aneurysm or calcified renal artery aneurysms.
• •12. Subject has a solitary kidney.
• •13. Subject has a comorbidity risk(s) which, at the discretion of the physician, would make the subject a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.
• •14. Subject is unable to read or comprehend the consent form.