ACUNAV Luxera 4D ICE Catheter

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 10, 2026 Siemens Medical Solutions USA, Inc. Bongsoo Cho Senior Regulatory Affairs Professional 22010 S. E. 51st St. Issaquah, Washington 98029 Re: K261696 Trade/Device Name: ACUNAV Luxera 4D ICE Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: August 11, 2026 Received: August 11, 2026 Dear Bongsoo Cho: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261696 - Bongsoo Cho Page 2 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" (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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K261696 - Bongsoo Cho Page 3 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, MARCO CANNELLA -S Marco Cannella PhD Acting Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular 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. | K261696 | ? | | Please provide the device trade name(s). | | ? | | ACUNAV Luxera 4D ICE Catheter | | | | Please provide your Indications for Use below. | | ? | | The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. | | | | 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} Siemens Medical Solutions USA, Inc. Ultrasound Division K261696 Special 510(k) ACUNAV Luxera 4D ICE Catheter ### 510k Summary This summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21CFR §807.92(c). ### SPONSOR'S NAME & ADDRESS Siemens Medical Solutions USA, Inc. 22010 S.E. 51st Street Issaquah, WA 98029, USA ### OFFICIAL CORRESPONDENT Bongsoo Cho Regulatory Affairs Professional Phone: (425) 606-9346 Email: bongsoo.cho@siemens-healthineers.com ### SUBMISSION DATE May 21, 2026 ### TRADE NAME ACUNAV Luxera 4D ICE Catheter ### COMMON NAME Ultrasound Catheter ### CLASSIFICATION NAME/PRODUCT CODE Diagnostic Intravascular Catheter/ OBJ ### CLASSIFICATION Class II, 21 CFR 870.1200 ### PREDICATE DEVICE #K212959, ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter ### DESCRIPTION OF MODIFIED DEVICE The ACUNAV Luxera 4D ICE catheter is a 13.5F catheter with 90 cm of usable length and four-way steering that provides real-time three-dimensional ultrasound images of anatomical structures and devices, in addition to conventional real-time two-dimensional images. ### INDICATIONS FOR USE The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. Page 1 of 3 {5} K261696 Siemens Medical Solutions USA, Inc. Ultrasound Division Special 510(k) ACUNAV Luxera 4D ICE Catheter # SUBSTANTIAL EQUIVALENCE CONCLUSION The ACUNAV Luxera 4D ICE catheter is substantially equivalent to the company's own previously cleared ACUSON AcuNav Volume Intracardiac Echocardiography catheter(K212959) with regard to both intended use and technological characteristics. The Indications for Use and Intended Uses of the submission device remain unchanged from the predicate catheter device as cleared under K212959. Both the subject catheter and the predicate catheter function in the same manner as all diagnostic ultrasound catheters. | ATTRIBUTES | AACUNAV Luxera 4D ICE Catheter *This Submission* | ACUSON AcuNav Volume ICE catheter *Predicate (K212959)* | | --- | --- | --- | | **BACKGROUND** | | | | Device name | ACUNAV Luxera 4D ICE Catheter | ACUSON AcuNav Volume ICE catheter | | 510(k) | Subject of this 510(k) submission | K212959 | | Manufacturer | Siemens Medical Solutions USA, Inc. 22010 S.E. 51st Street Issaquah, WA 98029, USA | Siemens Medical Solutions USA, Inc. 22010 S.E. 51st Street Issaquah, WA 98029, USA | | Manufacturing Facility | Siemens Healthineers Ltd. 2nd, 3rd and 4th Venture Bld., Pohang Technopark, 394, Jigok-ro, Nam-gu, Pohang-si, Gyeongsangbuk-Do, Republic of Korea | Siemens Healthineers Ltd. 2nd, 3rd and 4th Venture Bld., Pohang Technopark, 394, Jigok-ro, Nam-gu, Pohang-si, Gyeongsangbuk-Do, Republic of Korea | | Indications for Use | The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. | The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. | | **INDICATIONS FOR USE** | | | | Cardiac | X | X | | Pediatric | X | X | | Intra-luminal | X | X | | Intra-Cardiac | X | X | | **PRINCIPLE OF OPERATION** | | | | Mechanism of Distal tip Orientation (steering control) | Manual Control knobs on the handle provide bidirectional steering capabilities in 2 planes, left/right and posterior /anterior. | Manual Control knobs on the handle provide bidirectional steering capabilities in 2 planes, left/right and posterior /anterior. | | **MECHANICAL DESIGN CHARACTERISTICS** | | | | Tip Dimensions | 13.5F | 12.5F | | Insertable Length | 90 cm | 90 cm | | Acoustic Array | 96 channel on ASIC | 192 channel Vector | | Function of handle | The handle houses the steering mechanism that enables deflection of the distal tip | The handle houses the steering mechanism that enables deflection of the distal tip | | **OTHER DESIGN CHARACTERISTICS** | | | Page 2 of 3 {6} K261696 Siemens Medical Solutions USA, Inc. Ultrasound Division Special 510(k) ACUNAV Luxera 4D ICE Catheter | ATTRIBUTES | AACUNAV Luxera 4D ICE Catheter *This Submission* | ACUSON AcuNav Volume ICE catheter *Predicate (K212959)* | | --- | --- | --- | | Radiopacity | Yes | Yes | | Biocompatibility | Compliant to ISO 10993-1 | Compliant to ISO 10993-1 | | Adhesives | N/A - no patient contacting materials have adhesives associated. Internal sub-assemblies inside the handle are bonded using adhesives | N/A - no patient contacting materials have adhesives associated. Internal sub-assemblies inside the handle are bonded using adhesives | | Sterilization Method | EtO | EtO | | Single Use | Yes | Yes | | Shelf life | 1 year | 1 year | # A BRIEF DISCUSSION OF NONCLINICAL TESTS SUBMITTED, REFERENCED, OR RELIED ON IN THE 510(K) FOR A DETERMINATION OF SUBSTANTIAL EQUIVALENCE. The device has been evaluated for acoustic output, biocompatibility, sterilization, packaging, shelf life as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The device complies with the following voluntary standards: - ISO 14971 risk management to medical devices - ANSI/AAMI ES 60601-1 Safety Requirements for Medical Equipment - IEC 60601-1-2 EMC requirements for Medical Equipment - IEC 60601-2-37 Diagnostic Ultrasound Safety Standards - ISO 10993-1 Biocompatibility - ISO 11135, Sterilization of health-care products - Ethylene oxide - ISO 11607-1 and ISO 11607-2, Packaging for terminally sterilized medical devices # A SUMMARY DISCUSSION OF THE CLINICAL TESTS SUBMITTED, REFERENCED, OR RELIED ON FOR A DETERMINATION OF SUBSTANTIAL EQUIVALENCE. Because the ACUNAV Luxera 4D ICE catheter in this submission uses the same intended use, technology and principles as the predicate device, clinical data is not required to establish substantial equivalence. # SUMMARY Intended use and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2016 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is opinion of Siemens Medical Solutions USA, Inc. that ACUNAV Luxera 4D ICE catheter is substantially equivalent with the respect to safety and effectiveness to the device currently cleared for market. Page 3 of 3