Multi4 System

{0} FDA U.S. FOOD & DRUG ADMINISTRATION June 27, 2025 Multi4 Medical AB % Erin Gontang Senior Consultant RQM+ 2790 Mosside Blvd, Suite #800 Monroeville, Pennsylvania 15146 Re: K250522 Trade/Device Name: Multi4 System Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and accessories Regulatory Class: II Product Code: FAS, GEI, KQT, FJL, FBK Dated: February 21, 2025 Received: June 4, 2025 Dear Erin Gontang: 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} K250522 - Erin Gontang 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} K250522 - Erin Gontang 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} 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. Submission Number (if known) K250522 Device Name Multi4 System Indications for Use (Describe) The Multi4 System is intended for use by trained urologists for endoscopically controlled tissue resection and coagulation, and removal of bladder tumors (TURBT) via suction channel under controlled flow conditions following resection using a monopolar resectoscope. The Multi4 System is also intended to deliver injectable materials into the urinary bladder wall during transurethral endoscopic procedures. 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} K250522 Page 1 of 5 ^{}[] 510(k) Summary K250522 DATE PREPARED June 4, 2025 MANUFACTURER AND 510(k) OWNER Multi4 Medical AB Lasarettsgatan 2 SE-553 18 Jönköping Sweden Telephone: +46 736 929 000 Official Contact: Miden Melle-Hannah, MD, PhD, CEO REPRESENTATIVE/CONSULTANT Erin Gontang, PhD Allison Komiyama, PhD, RAC RQM+ Telephone: +1 (412) 899-7422 Email: egontang@rqmplus.com DEVICE INFORMATION Trade/Proprietary Name: Multi4 System Classification Name: Electrode, Electrosurgical, Active, Urological Regulation Number: 21 CFR 876.4300 Common Name: Endoscopic electrosurgical unit and accessories; Electrosurgical cutting and coagulation device; Endoscope and accessories Device Class: Class II Product Code: FAS, KQT, GEI, FBK, FJL Classification Panel: Gastroenterology/Urology Premarket Review: Reproductive, Gynecology and Urology Devices (DHT3B) PREDICATE DEVICE IDENTIFICATION The Multi4 System is substantially equivalent to the following predicates: | 510(k) Number | Predicate Device Name / Manufacturer | Predicate | | --- | --- | --- | | K191341 | Veloxion System / Corinth MedTech, Inc. | Primary | | K192498 | Single Use Injection / Olympus Medical Systems | Secondary | The predicate devices have not been subject to a design related recall. {5} K250522 Page 2 of 5 MULTI # DEVICE DESCRIPTION The Multi4 System is an electrosurgical system used during urethral resection procedures of adult patients. The system, intended to remove and collect tissue from the bladder, includes a single-use electrosurgical instrument, known as the Multi4 B, as well as the reusable Multi4 Pump. The Multi4 Pump administers energy from an external electrosurgical unit to the handheld Multi4 B instrument, which has electrosurgical functions and allows for fluid transport and tissue sample collection. The Multi4 B instrument accesses the bladder through the working channel of a commercially available cystoscope. The Multi4 System is a prescription device intended for use in professional healthcare facilities by healthcare professionals (HCPs). # INDICATIONS FOR USE STATEMENT The Multi4 System is intended for use by trained urologists for endoscopically controlled tissue resection and coagulation, and removal of bladder tumors (TURBT) via suction channel under controlled flow conditions following resection using a monopolar resectoscope. The Multi4 System is also intended to deliver injectable materials into the urinary bladder wall during transurethral endoscopic procedures. # SUMMARY OF NON-CLINICAL TESTING The following testing was performed to evaluate the safety and effectiveness of the Multi4 System. - Software Verification and Validation Testing performed per IEC 62304, and documentation provided per FDA's Guidance for Industry and FDA Staff: Content of Premarket Submissions for Device Software Functions (Issued June 14, 2023). - Sterility Testing - Packaging Testing - Shelf-life Testing - Biocompatibility Testing - Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity - Electrical Safety & EMC: - IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-2 - Integrity Testing - Functional Testing - Cut and coagulation, aspiration, irrigation, injection - Dimensional Inspection and Testing - Simulated Use Testing # EQUIVALENCE TO PREDICATE DEVICE The subject device has a similar design and dimensions and uses similar or identical materials as the devices cleared in K191341 and K192498. The subject device also has the same intended use and similar technological characteristics as the devices cleared in K191341 and K192498. Based on the testing performed, including biocompatibility, sterilization validation, packaging validation, shelf-life validation, EMC and electrical safety and EMC testing, software verification and validation testing, and non-clinical performance bench testing, it can be concluded that the subject device does not raise different questions of safety or effectiveness compared to the predicate devices. The testing performed demonstrates that the subject device is as safe and effective as the {6} K250522 Page 3 of 5 ^{}[] predicate devices, and the similar indications for use, technological characteristics, and performance characteristics for the proposed Multi4 System are assessed to be substantially equivalent to the predicate devices. The Multi4 System is substantially equivalent to the predicate devices based on the information summarized here: | | Subject Device | Predicate Device | Predicate Device | | --- | --- | --- | --- | | Device Name | Multi4 System | Veloxion System | Single Use Injector | | Manufacturer Name | Multi4 Medical AB | Corinth MedTech, Inc. | Olympus Medical Systems Corp. | | 510(k) Number | K250522 | K191341 | K192498 | | Regulation | 21 CFR 876.1500 - Endoscope and accessories 21 CFR 876.4370 - Gastroenterology-urology evacuator 21 CFR 878.4400 - Electrosurgical cutting and coagulation device and accessories 21 CFR 876.4300 - Endoscopic electrosurgical unit and accessories | 21 CFR 876.1500 - Endoscope and accessories 21 CFR 876.4370 - Gastroenterology-urology evacuator 21 CFR 878.4400 - Electrosurgical cutting and coagulation device and accessories | 21 CFR 876.1500 - Endoscope and accessories | | Regulation | Endoscope and accessories | Endoscope and accessories | Endoscope and accessories | | Product Code(s) | FJL - Resectoscope KQT - Evacuator, Gastro-Urology GEI - Electrosurgical, Cutting & Coagulation & Accessories FAS - Electrode, Electrosurgical, Active, Urological FBK - Endoscopic Injection Needle, Gastroenterology-Urology | FJL - Resectoscope KQT - Evacuator, Gastro-Urology GEI - Electrosurgical, Cutting & Coagulation & Accessories | FBK - Endoscopic Injection Needle, Gastroenterology-Urology | | Classification | Class II | Class II | Class II | | Indications for Use Statement | The Multi4 System is intended for use by trained urologists for endoscopically controlled tissue resection and coagulation, and removal of bladder tumors (TURBT) via suction channel under controlled flow conditions following resection using a monopolar resectoscope. The Multi4 System is also intended to deliver injectable materials into the urinary bladder wall during transurethral endoscopic procedures. | The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas and bladder tumors (TURBT) via suction channel under continuous flow conditions following resection using a bipolar resectoscope. | This instrument has been designed to be used with an Olympus endoscope to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures. | {7} K250522 Page 4 of 5 MAFF | Device Description | The Multi4 System consists of the following components: • Multi4 Pump (with Integrated Fluid Control) o Footswitch • Multi4 B o Resectoscope & Needle o Simple4tainer (For collection of gross resected tissue pieces for pathology) | The Veloxion System consists of the following components: • Veloxion Controller (with Integrated Fluid Control) o Footswitch • Veloxion Resectoscope • Veloxion Fluid Set • Waste Management Tubing • Tissue Catch (For collection of gross resected tissue pieces for pathology) | The Single Use Injector has been designed to be used with an Olympus endoscope to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures. The Single Use Injector device is provided in a sterile package. | | --- | --- | --- | --- | | Target Population | Adults | Adults | Adults | | Sterile/ Non-sterile | Sterile; Gamma | Sterile; Unknown | Sterile; Unknown | | Use Environment | Healthcare Facilities | Healthcare Facilities | Healthcare Facilities | | Energy Type; Monopolar or Bipolar | Radiofrequency; Monopolar | Radiofrequency; Bipolar | N/A | | RF Function | Cut, Coagulation | Cut, Coagulation | N/A | | Control of cavity pressure? | The urologist manages the irrigation and fluid control during the procedure. | The device uses a pressure monitor to evaluate cavity pressure during the procedure. | N/A | | Irrigation Fluid | Water | Saline | N/A | | Pump | Dual Action (Irrigation, Aspiration) | Dual Action (Irrigation, Aspiration) | N/A | | Testing | Biocompatibility Testing Sterility Testing Packaging Testing Shelf-life Testing EMC/Electrical Safety Testing Software V&V Testing Performance Testing – Bench and Simulated Use | Biocompatibility Testing Sterility Testing Packaging Testing Shelf-life Testing EMC/Electrical Safety Testing Software V&V Testing Performance Testing – Bench and Simulated Use | Biocompatibility Testing Sterility Testing Packaging Testing Shelf-life Testing Performance Testing – Bench | | Functional Testing | Cut & Coagulation Aspiration Irrigation Injection | Cut & Coagulation Aspiration Irrigation Pressure Control | Injection | | Needle Width | 27G | N/A | 27G | | Needle Working Length | 716 mm | N/A | 971 mm | | Needle Length | 11 mm (maximum) | N/A | 4 mm | | Tip Shape of Needle | Lancet Point | N/A | Lancet Point | {8} K250522 Page 5 of 5 Multi4 ## CONCLUSION Based on the testing performed, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices. The Multi4 System is considered safe and effective for its intended use. The similar technological characteristics and performance characteristics for the Multi4 System are assessed to be substantially equivalent to the predicate devices.