Break Wave

{0} FDA U.S. FOOD & DRUG ADMINISTRATION January 12, 2026 SonoMotion Inc. Emily Hergenreiter VP - Clinical Affairs 1600 W Hillsdale Blvd Suite 105 San Mateo, California 94402 Re: K252913 Trade/Device Name: Break Wave Regulation Number: 21 CFR 876.5990 Regulation Name: Extracorporeal Shock Wave Lithotripter Regulatory Class: II Product Code: LNS Dated: December 8, 2025 Received: December 9, 2025 Dear Emily Hergenreiter: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K252913 - Emily Hergenreter Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See {2} K252913 - Emily Hergenreter Page 3 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Mark R. Kreitz -S for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K252913 | | | Device Name Break Wave | | | Indications for Use (Describe) The Break Wave device is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper and lower ureter). | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} K252913 Page 1 of 4 Break Wave 510(k) Premarket Notification Property of SonoMotion, Inc. # 510(K) SUMMARY ## 1. SUBMITTER INFORMATION | Applicant Name: | SonoMotion, Inc. | | --- | --- | | Applicant Address: | 1600 W Hillsdale Blvd Suite 105 San Mateo, CA 94402 | | Primary Correspondent: | Emily Hergenreter, VP – Clinical Affairs SonoMotion 925-594-9600 emily.hergenreter@sonomotion.com | | Secondary Correspondent: | Oren Levy, CEO SonoMotion 415-672-2631 oren.levy@sonomotion.com | | Date Prepared | September 11, 2025 | ## 2. DEVICE INFORMATION | Proprietary Trade Name: | Break Wave | | --- | --- | | Common Name: | Extracorporeal Shock Wave Lithotripter | | Classification Name: | Lithotripter, Extracorporeal Shock-Wave, Urological | | Product Code: | LNS | | Regulatory Class: | Class II | | Regulation Number: | 21 CFR 876.5990 | | Panel: | Gastroenterology/Urology | ## 3. PREDICATE DEVICE The Break Wave device is substantially equivalent to the Piezolith 3000 Triple-focus extracorporeal lithotripter (K072538, Product Code: LNS). ## 4. DEVICE DESCRIPTION The Break Wave device is designed for the extracorporeal fragmentation of calculi located in the kidney and ureter. The primary components include a diagnostic ultrasound imaging workstation, imaging probe(s), high voltage signal generator, and piezoelectric acoustic source (therapy probe). The generator controls and drives the therapy probe, which delivers the acoustic pulses required for breaking stones. A lens is used to focus the acoustic waves to the target stone, 510(k) Summary Page 1 of 4 {5} K252913 Page 2 of 4 Break Wave 510(k) Premarket Notification Property of SonoMotion, Inc. creating stresses within the stone that result in stone fracture. Repeated application of the acoustic waves breaks the stone into small fragments that can pass spontaneously. The imaging workstation and associated ultrasound imaging probe provide the user interface and real-time image guidance for the Break Wave procedure. The imaging and therapy probe are coaxially aligned, with the imaging probe docking into the housing of the therapy probe. The probe assembly is designed to couple directly to the patient's skin and be held in place with a mechanical arm or hand-held. Since the therapy probe has a fixed focus, multiple therapy probes are included to target stones over a range of skin-to-stone distances. The Break Wave device is a portable lithotripter the size of a diagnostic ultrasound system, and the user operates the device similarly to operating a diagnostic ultrasound system. The user applies ultrasound coupling gel to the therapy/imaging probes, places the probe assembly against the patient's skin, and scans the abdomen to locate the stone(s) using standard ultrasound imaging techniques. Once the stone is identified and positioned within the target zone, the operator presses and releases the foot pedal to activate therapy. The operator monitors the fragmentation of the stone in real-time via the coaxial aligned imaging probe. The operator has the option to stop the therapy at any time by pressing and releasing the foot pedal a second time. Treatment may continue with up to 30 minutes of therapy. The device can be used without the need for patient sedation. ## 5. INTENDED USE/INDICATIONS FOR USE The Break Wave device is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper and lower ureter). The Indication for Use for the Break Wave device is the same as the predicate device. ## 6. TECHNOLOGICAL CHARACTERISTICS COMPARISON The SonoMotion Break Wave device has similar technological characteristics as the predicate device. The differences between the Break Wave and predicate device do not introduce new or different questions of safety or effectiveness. ### Similar Technological Characteristics The Break Wave device maintains the following similar technological characteristics as the predicate device: - Function: focus acoustic waves into the body to non-invasively fragment urinary calculi. - Primary system components: high voltage generator, acoustic wave source, control console, and imaging/localization system. - Acoustic wave source: piezoelectric - Imaging/localization system: continuous, in-line ultrasound 510(k) Summary Page 2 of 4 {6} K252913 Page 3 of 4 Break Wave 510(k) Premarket Notification Property of SonoMotion, Inc. - Device configuration: transportable ## Technological Differences The Break Wave device achieves the same function as the predicate device with the following technological differences: - Lower amplitude, longer duration acoustic wave pulse - Higher acoustic pulse rate - Smaller therapy probe head that uses an acoustic lens for focusing - Therapy probe head that can be hand-held or fixated using a mechanical arm - Direct coupling of the probe head to the patient’s skin without a water filled membrane - Does not require an integrated system table or water circulation system ## 7. PERFORMANCE DATA ### Non-Clinical Performance Data The following safety and performance requirements for medical devices and extracorporeal shock wave lithotripsy devices were met in support of this premarket notification. Testing is consistent with the predicate device and supports substantial equivalence. - Basic Safety and Essential Performance, Electrical Safety, and EMC - IEC 60601-1 - IEC 60601-1-2 - Reprocessing - ANSI AAMI ST98:2022 - SWL Special Controls - IEC 61846 - IEC 60601-2-36 - Biocompatibility - ISO 10993-1 - Usability - IEC 62366 - Software Verification and Validation Testing - IEC 62304 Additional verification and validation testing was performed to ensure the device met all its design specifications. 510(k) Summary Page 3 of 4 {7} K252913 Page 4 of 4 Break Wave 510(k) Premarket Notification Property of SonoMotion, Inc. ## Clinical Performance Data The Break Wave device was evaluated in a prospective, open-label, single-arm clinical investigation of safety and effectiveness involving 64 subjects. The study was conducted across 10 sites including 7 sites in the U.S. and 3 sites in Canada with over 70% of the subjects enrolled from the U.S. sites. The study included participants 18 years of age and older with a stone in the upper urinary tract that was larger than 4 mm and up to and including 10 mm. Safety events were evaluated through direct contact with the subject at 14 ± 4 days post-procedure and through review of the subject’s medical records 90 days post-procedure. Effectiveness was evaluated by post-procedure CT or KUB imaging at 10 ± 2 weeks post-procedure. Subjects could undergo a maximum of one retreatment if a fragment larger than 4 mm and associated with the original stone target was identified on post-index procedure imaging. Study success was based on satisfying two (2) co-primary non-inferiority endpoints for safety and effectiveness compared to current SWL outcomes. Both the primary effectiveness and safety endpoints were met. The Break Wave device achieved a 70% cumulative success rate for the fragmentation of upper urinary tract stones with 30% of stones in the lower pole and 38% of stones with Hounsfield units greater than 1000. No device- or procedure-related clinically significant hematoma, urinary tract sepsis, or cardiac arrhythmia events were reported. Ninety-six percent of adverse events were mild (83%) or moderate (13%) and consistent with those anticipated with shock wave lithotripsy devices. Only one procedure related serious adverse event was reported, which was consistent with known lithotripsy risks and was managed per standard of care. Eighty-four percent (84%) of adverse events resolved within the first week post-procedure. Procedures were performed without sedation or general anesthesia in all cases; all subjects were awake and responsive during the procedure. This study demonstrates that the different technological characteristics of the Break Wave device do not introduce new questions of safety or effectiveness. ## 8. CONCLUSION The Break Wave device meets the FDA requirements stated in “Guidance for the Content of Premarket Notifications 510(k)s for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi” (issued on Aug. 9, 2000) for substantial equivalence. The Break Wave device has the same intended use and many similar characteristics as the predicate device. The non-clinical and clinical data provided in support of this premarket notification demonstrate that the minor technological differences do not raise any new or different questions of safety and effectiveness and the Break Wave device is therefore substantially equivalent to the predicate device. 510(k) Summary Page 4 of 4