VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. # September 2, 2020 Philips Image Guided Therapy Corporation % Rand Daoud Regulatory Affairs Specialist, 4 Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell, Washington 98021 Re: K200812 Trade/Device Name: VeriSight Intracardiac Echocardiography (ICE) Catheter, and VeriSight Pro ICE Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: August 13, 2020 Received: August 17, 2020 Dear Rand Daoud: 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. 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 located 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. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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 Fellman Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K200812 Device Name VeriSight/VeriSight Pro Intracardiac Echocardiography (ICE) Catheter #### Indications for Use (Describe) The VeriSight VeriSight Pro ICE 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. 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 style="padding-right: 20px;"> <span style="font-size: 16px;"></span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="font-size: 16px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ ## K200812 - 510(k) Summary #### Submitter Information: | Date Prepared | August 13, 2020 | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer Name<br>and Address | Philips Image Guided Therapy Corporation<br>2870 Kilgore Road<br>Rancho Cordova, CA 95670 | | Establishment Registration<br>Number | 2939520 | | Primary Contact/Submitter<br>Information | Rand Daoud<br>Regulatory Affairs Specialist, 4<br>TEL: 1-858-720-4049<br>EMAIL: rand.daoud@philips.com<br>Philips Image Guided Therapy Corporation<br>3721 Valley Center Dr.<br>Suite 500<br>San Diego, CA 92130 | #### Subject Device Information: | Trade Name | VeriSight Intracardiac Echocardiography Catheter,<br>VeriSight Pro Intracardiac Echocardiography Catheter | |------------------------|-----------------------------------------------------------------------------------------------------------| | Common Name | Intravascular Ultrasound Catheter | | Regulation Description | Diagnostic intravascular catheter | | Regulation Number | 870.1200 | | Product Code | OBJ | | Device Class | Class II | | Classification Panel | Cardiovascular | K170263 - Siemens AcuNav Diagnostic Ultrasound Predicate Device: Catheter 8F, 10F Reference Devices: K173618 - ACUSON AcuNav Volume ICE Catheter {4}------------------------------------------------ ### Subject Device Description: The Intracardiac Echocardiography (ICE) System comprises of the VeriSight Pro ICE Catheters, the ICE PIM, and the EPIQ Diagnostic Ultrasound System (cleared under K202216). The VeriSight/VeriSight Pro Intracardiac Echocardiography (ICE) catheters are sterile, disposable, and for single use only. The catheter's distal end has an ultrasound transducer providing 2D and/or 3D imaging capabilities. A handle, located at the proximal end of the catheter, has two steering wheels that can be manually operated to control four-way articulation of the distal segment in anterior, posterior, left and right directions. The catheter has a 9 French (F) shaft and a usable length of 90 cm. The VeriSight and VeriSight Pro ICE Catheters are identical in all regards (material, processing, assembly and packaging). The VeriSight ICE catheter provides 2D ultrasound imaging capabilities. The VeriSight Pro ICE catheter provides 2D and/or 3D ultrasound imaging capabilities, depending on the model and configuration of the EPIQ ultrasound system it connects to. The catheters are compatible with ancillary equipment such as sheaths and introducers. The catheters are sterilized via Ethylene Oxide. The catheters connect to the Philips EPIQ Diagnostic Ultrasound System via a patient interface module (PIM); the connection between the catheter and the PIM is located outside the sterile field. The catheters will not operate if connected to any other imaging system. These catheters are for exclusive use with Philips EPIQ 7C, CVx, and CVxi series of ultrasound systems, cleared under K202216. #### Indications for Use: VeriSight/ VeriSight Pro ICE catheter: The VeriSight/ VeriSight Pro ICE catheter is intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. {5}------------------------------------------------ #### Predicate Device Comparison: Technological Comparison Table: Comparison of the proposed VeriSight/VeriSight Pro ICE Catheters to the currently marketed predicate device, the AcuNav Diagnostic Ultrasound Catheter 8F, 10F. | Standard<br>Feature | VeriSight/VeriSight<br>Pro ICE Catheters<br>K200812<br>(Proposed Device) | AcuNav Diagnostic<br>Ultrasound Catheter<br>K170263<br>(Predicate Device) | ACUSON AcuNav<br>Volume ICE Catheter<br>K173618<br>(Reference Device) | |------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications<br>for Use | The VeriSight/VeriSight<br>Pro ICE catheter is<br>intended for intra-<br>cardiac and intra-<br>luminal visualization of<br>cardiac and great<br>vessel anatomy and<br>physiology as well as<br>visualization of other<br>devices in the heart.<br>The catheter is<br>intended for imaging<br>guidance only, not<br>treatment delivery,<br>during cardiac<br>interventional<br>percutaneous<br>procedures. | The catheter is intended<br>for intra-cardiac and<br>intra-luminal<br>visualization of cardiac<br>and great vessel<br>anatomy and physiology<br>as well as visualization<br>of other devices in the<br>heart of adult and<br>pediatric patients. The<br>catheter is intended for<br>imaging guidance only,<br>not treatment delivery,<br>during cardiac<br>interventional<br>percutaneous<br>procedures. | The catheter is intended<br>for intra-cardiac and<br>intra-luminal<br>visualization of cardiac<br>and great vessel<br>anatomy and physiology<br>as well as visualization<br>of other devices in the<br>heart of adult and<br>pediatric patients. The<br>catheter is intended for<br>imaging guidance only,<br>not treatment delivery,<br>during cardiac<br>interventional<br>percutaneous<br>procedures. | | Catheter | Intracardiac | Intracardiac | Intracardiac | | Type<br>Single-Use | Echocardiography<br>Yes | Echocardiography<br>Yes | Echocardiography<br>Yes | | Duration of<br>Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Limited (≤ 24 hours) | | Scientific | Ultrasound Imaging | Ultrasound Imaging | Ultrasound Imaging | | Technology | Frequency | Frequency | Frequency | | Compatible<br>with<br>Previously-<br>cleared<br>Ultrasound<br>Systems? | Yes | Yes | Yes | | Number of | 840 | 64 | Unknown | | Standard<br>Feature | VeriSight/VeriSight<br>Pro ICE Catheters<br>K200812<br>(Proposed Device) | AcuNav Diagnostic<br>Ultrasound Catheter<br>K170263<br>(Predicate Device) | ACUSON AcuNav<br>Volume ICE Catheter<br>K173618<br>(Reference Device) | | Ultrasound<br>Transducer<br>Elements | | | | | Nominal<br>Center<br>Frequency<br>[MHz] | 7 MHz | 6.5 MHz | Unknown | | Operating<br>principles | Catheter with<br>ultrasound sensors<br>that is used with an<br>imaging system to<br>display to provide high-<br>resolution real-time<br>visualization of cardiac<br>structures, continuous<br>monitoring of catheter<br>location within the<br>heart | Catheter with<br>ultrasound sensors that<br>is used with an imaging<br>system to display to<br>provide high-resolution<br>real-time visualization of<br>cardiac structures,<br>continuous monitoring<br>of catheter location<br>within the heart | Catheter with<br>ultrasound sensors that<br>is used with an imaging<br>system to display to<br>provide high-resolution<br>real-time visualization of<br>cardiac structures,<br>continuous monitoring<br>of catheter location<br>within the heart | | Image<br>Technique to<br>Visualize<br>Device | Fluoroscopy | Fluoroscopy | Fluoroscopy | | Catheter<br>Diameter | 9F | 8F, 10F | 12.5F | | Sheath<br>Compatibility | 10F | 9F, 11F | >12.5F | | Catheter<br>Working<br>Length | 90cm | 90cm | 90 cm | | Imaging<br>Modes | VeriSight:<br>• 2D (B-Mode)<br>• M-Mode<br>• Pulse wave Doppler<br>• Continuous wave<br>Doppler<br>• Color Doppler<br><br>VeriSight Pro: | • 2D (B-Mode)<br>• M-Mode<br>• Pulse wave Doppler<br>• Continuous wave<br>Doppler<br>• Color Doppler | • 2D (B-Mode)<br>• M-Mode<br>• Pulse wave Doppler<br>• Continuous wave<br>Doppler<br>• Color Doppler Volume<br>• 3D | | Standard<br>Feature | VeriSight/VeriSight<br>Pro ICE Catheters<br>K200812<br>(Proposed Device) | AcuNav Diagnostic<br>Ultrasound Catheter<br>K170263<br>(Predicate Device) | ACUSON AcuNav<br>Volume ICE Catheter<br>K173618<br>(Reference Device) | | | • 2D (B-Mode) | | | | | • M-Mode | | | | | • Pulse wave Doppler | | | | | • Continuous wave<br>Doppler | | | | | • Color Doppler | | | | | • Live 3D | | | | | • Live 3D color | | | | Acoustic<br>Output Track | Track 3 | Track 3 | Track 3 | | Safety and<br>EMC<br>Compliance | EN/IEC 60601-1<br>IEC 60601-2-37<br>EN/IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-2-37<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-2-37<br>IEC 60601-1-2 | | Accessories | Philips ICE PIM | Sterile Cover, Swiftlink<br>Catheter Connector | Sterile Cover, Swiftlink<br>Catheter Connector | Page 3 of 6 {6}------------------------------------------------ {7}------------------------------------------------ The Technological Comparison Table above provides a detailed comparison demonstrating that both the VeriSight/VeriSight Pro ICE Catheters and the predicate AcuNav Diagnostic Ultrasound Catheter share the same intended use and similar indications for use, same principle of operation for primary function (ultrasonic imaging), the same mechanism of action for achieving actuation, similar physical form of the catheter, and the same clinical operation and the device life cycle (sterile, single use disposable). Hence, the VeriSight Pro ICE Catheters are substantially equivalent to the predicate device, the Siemens AcuNav Diagnostic Ultrasound Catheter 8F, 10F cleared under K170263. Any differences between the subject and predicate devices were evaluated through design verification and validation testing, which did not raise new questions of safety and/or effectiveness and support a determination of substantial equivalence. ### Reference Device Comparison: The ACUSON AcuNav Volume ICE Catheter (K173618), is identified as a reference device and shares the same operating principles and technological characteristics, specifically when related to Philips VeriSight Pro ICE catheter's 3D imaging modalities. {8}------------------------------------------------ #### Summary of Non-Clinical Performance Testing: The VeriSight/VeriSight Pro ICE Catheters have been evaluated for performance and technological characteristics by completion of the following design verification and validation tests: - Visual inspection - Dimensional - Actuation characteristics - Tip deflection ● - Torsional shaft - Tensile tests - Deliverability - Saline imaging ● - Particulate - Usability - Preclinical Animal testing - Biocompatibility - Sterilization - Packaging and Shelf Life Validation - System testing with EPIQ System - Electrical Safety, EMC and acoustic output testing with EPIQ System The VeriSight and VeriSight Pro Catheters comply with the following voluntary standards for Electrical Safety, EMC and Acoustic Outputs: - . Electrical Safety and EMC Requirements for Medical Equipment - > EN IEC 60601-1 - A EN IEC 60601-1-2 - EN IEC 60601-2-37, Diagnostic Ultrasound Safety Standards ● - IEC 62359, Ultrasonics - Field characterization ### Summary of Clinical Performance Testing: The VeriSight/VeriSight Pro ICE catheters use the same scientific technology, operating principles and shares similar indications for use as the predicate device. Therefore, clinical data is not required to establish substantial equivalence. ### Conclusion: The VeriSight/VeriSight Pro ICE catheters, when connected to the EPIQ Diagnostic Ultrasound System, use the same scientific technology, operating principles and indications for use as the predicate device. Based on results of non-clinical testing, and the information submitted in this 510(k) Premarket Notification, the subject VeriSight/VeriSight Pro ICE Catheters are substantially equivalent to currently marketed devices.