ACUSON AcuNav Volume Intracardiac Echocardiography Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION". December 19, 2017 Siemens Medical Solutions USA, Inc. Hyunjung Lee Regulatory Technical Specialist 685 East Middlefield Road Mountain View, California 94043 Re: K173618 Trade/Device Name: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: November 21, 2017 Received: November 22, 2017 Dear Hyunjung Lee: 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 (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. The general controls provisions of the Act include requirements for annual registration. Iisting 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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerelv. M.A. Hillebrenner for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K173618 #### Device Name ACUSON AcuNav Volume Intracardiac Echocardiography Catheter Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------|------------------------------------------------------------------| | <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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." {3}------------------------------------------------ ## 510(k) Summary ## SPONSOR'S NAME & ADDRESS Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mt. View, CA 94043 ## OFFICIAL CORRESPONDENT HyunJung Lee Regulatory Technical Specialist Phone: (425) 281-5061 Email: hyunjung.lee@siemens-healthineers.com ### SUBMISSION DATE November 21, 2017 #### TRADE NAME ACUSON AcuNav Volume Intracardiac Echocardiography Catheter #### COMMON NAME Ultrasound Catheter #### CLASSIFICATION NAME/PRODUCT CODE Diagnostic Intravascular Catheter/ OBJ ### CLASSIFICATION Class II, 21 CFR 870.1200 ### PREDICATE DEVICE #K163478, ACUSON AcuNav Volume ICE Catheter ### DESCRIPTION OF MODIFIED DEVICE The ACUSON AcuNav Volume ICE Catheter is a 12.5F 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. Modifications include the clarification to the indications for use statement and the update of labeling. There are no new indications for use in this modification. {4}------------------------------------------------ ### 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. ### SUBSTANTIAL EQUIVALENCE CONCLUSION The ACUSON AcuNav Volume ICE catheter is substantially equivalent to the company's own previously cleared AcuNav Volume ICE catheter (K163478) with regard to both intended use and technological characteristics. Both the subject catheters and the predicate catheters function in the same manner as all diagnostic ultrasound catheters. | Feature / Characteristic | AcuNav Volume ICE<br>This Submission | AcuNav Volume ICE<br>K163478 | |---------------------------|--------------------------------------|------------------------------| | Indications for Use: | | | | ■ Cardiac | √ | √ | | ■ Pediatric | √ | √ | | ■ Intra-luminal | √ | √ | | ■ Intra-cardiac | √ | √ | | Patient Contact Materials | ISO 10993-1 | ISO 10993-1 | #### 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, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The device complies with the following voluntary standards: - I UL 60601-1, Safety Requirements for Medical Equipment - l IEC 60601-2-37 Diagnostic Ultrasound Safety Standards - I AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment - I AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound - I Safety and EMC Requirements for Medical Equipment - o EN/EC 60601-1 - o EN/IEC 60601-1-2 - I ISO 10993-1 Biocompatibility Cleared patient contact materials and mechanical safety are unchanged. {5}------------------------------------------------ #### A SUMMARY DISCUSSION OF THE CLINICAL TESTS SUBMITTED, REFERENCED, OR RELIED ON FOR A DETERMINATION OF SUBSTANTIAL EQUIVALENCE. Because the ACUSON AcuNav Volume ICE catheter in this submission uses the same technology, patient contact materials 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. Changes to the currently cleared AcuNav Volume ICE catheter include 1) a clarification to the indications for use statement and 2) update on labeling. There are no new Indications for Use in this device modification. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 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 the opinion of Siemens Medical that the ACUSON AcuNav Volume ICE Catheter is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.