Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study

Inclusion Criteria: * Individuals presenting with at least one kidney stone apparent on CT. * Stones must be within the upper urinary tract. * Stones are indicated for SWL treatment per the American Urology Association (AUA) 2016 guidelines.8 * Stones must be measured under CT to be within the AUA 2016 SWL guidelines (i.e. ≤ 10 mm for lower pole stones and ≤ 20 mm for non-lower pole stones). Exclusion Criteria: * Acute untreated urinary tract infection or urosepsis. * Uncorrected bleeding disorders or coagulopathies. * Pregnancy. * Uncorrected obstruction distal to the stone. * Patients receiving anticoagulants and who are unable or not willing to cease the medication for the Break Wave procedure. * Stones that are not echogenically visible or cannot be positioned within the Break Wave therapy focus. * Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.). * Patients unwilling to comply with the follow-up protocol, including post-procedure CT. * Individuals under 18 years of age. * Anatomic presentations preventing adequate positioning or delivery of the Break Wave pulse. * Calcified abdominal aortic aneurysms or calcified renal artery aneurysms. * Solitary kidney * Comorbidity risks which, in at the discretion of the physician, would make the patient a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.