Rezum System

{0}  September 3, 2026 Boston Scientific Yuki Yamashita Regulatory Affairs Specialist III 100 Boston Scientific Way Marlborough, Massachusetts 01752 Re: K262460 Trade/Device Name: Rezum System Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and accessories Regulatory Class: II Product Code: KNS Dated: July 17, 2026 Received: July 17, 2026 Dear Yuki Yamashita: 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: Center for Devices and Radiological Health (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, the Food and Drug Administration (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} K262460 - Yuki Yamashita 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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} K262460 - Yuki Yamashita 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 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} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262460 | ? | | Please provide the device trade name(s). | | ? | | Rezum System | | | | Please provide your Indications for Use below. | | ? | | The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men ≥ 50 years of age with a prostate volume 30 cm3 ≤ 150 cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} K262460 Page 1 of 3 # 510(k) Summary ## A. Submitter Information ### Address: Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 USA ### Contact Person: Yuki Yamashita Regulatory Affairs Specialist +1 (508) 382-9142 Yuki.Yamashita@BSCI.com B. Date of 510(k) Summary Preparation: July 17, 2026 ## C. Subject Device | Trade Name | Rezūm System | | --- | --- | | Common Name | Vapor Ablation Device | | Classification Name | Unit, electrosurgical, endoscopic (with or without accessories) | | Regulation Name | Endoscopic electrosurgical unit and accessories | | Regulation Number | 21 CFR 876.4300 | | Classification | Class II | | Product Code | KNS | ## D. Predicate Device | Trade Name | Rezūm System | | --- | --- | | Common Name | Vapor Ablation Device | | Regulation Name | Endoscopic electrosurgical unit and accessories | | Regulation Number | 21 CFR 876.4300 | | Classification | Class II | | Product Code | KNS | | 510(k) Submitter/Holder | Boston Scientific Corporation | | 510(k) #/Clearance Date | K250584/Cleared June 11, 2025 | Page 1 of 3 {5} K262460 Page 2 of 3 ### E. Device Description The Rezüm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezüm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure. Following thermal therapy for BPH, small pieces of coagulated tissue may slough off and be expelled via urination. This sloughing process may continue for a few months post-procedure depending on the rate of healing. The Rezüm System consists of the following: - Rezüm Console – reusable, non-sterile capital equipment, provided with one power cord - Rezüm Delivery Device Kit – sterile, single-use kit containing the following disposable components: - One sterile Delivery Device with cable and tubing - One sterile syringe - One sterile spike adaptor - One sterile water vial ### F. Intended Use/Indications for Use The Rezüm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men ≥ 50 years of age with a prostate volume 30 cm³ ≤ 150 cm³. The Rezüm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe. ### G. Technological Characteristics Compared to the Predicate The fundamental technology, operating principle, and performance remain unchanged. The proposed device modifications are limited to the Rezum Console; the Rezum Delivery Device remains unchanged. The minor differences in technological characteristics include: - Software, firmware, and hardware changes associated with needle deployment - Change to the software operating system - Graphical user interface (GUI) enhancements - Addition of mounting capability and a Mobility Pole ### H. Performance Data Non-clinical performance testing included the following: Page 2 of 3 {6} K262460 Page 3 of 3 - Electromagnetic Compatibility (EMC): Assessed and tested per IEC 60601-1-2 and FDA guidance Electromagnetic Compatibility (EMC) of Medical Devices - EMT (Electrical, Mechanical, Thermal) Safety: Assessed and tested per IEC 60601-1 - System and Hardware Design Verification - Human Factors: Summative usability evaluation per IEC 62366-1 and FDA guidance Applying Human Factors and Usability Engineering to Medical Devices - Software Verification and Validation: Validated and verified per IEC 62304 - Cybersecurity: Assessed and tested per FDA guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions All non-clinical performance testing were executed with passing results, demonstrating that the subject device meets all design, performance, and user requirements, remains suitable for its intended use, and the proposed modifications do not affect the safe and effective use of the device by the intended users in the intended use environment. # I. Conclusion The subject device is substantially equivalent to the predicate. The intended use and indications for use of the subject device are the same as the predicate. The minor differences in technological characteristics do not raise different types of questions of safety or effectiveness. The fundamental technology, operating principle, and performance remain unchanged. Non-clinical performance testing demonstrates the safety and effectiveness of the subject device for its intended use. Page 3 of 3