CORE M2 Vascular System

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April 6, 2017 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Volcano Corporation Courtney Moore Regulatory Affairs Specialist 3721 Vallev Centre Dr Ste 500 San Diego, California 92130 Re: K170385 Trade/Device Name: Core® M2 Vascular System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, DSA Dated: March 10, 2017 Received: March 13, 2017 Dear Courtney Moore: 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, 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 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 {1}------------------------------------------------ related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. Mude Jellm 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) K170385 Device Name CORE® M2 Vascular System #### Indications for Use (Describe) The CORE M2 Vascular System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. Type of Use (Select one or both, as applicable) | <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | |--------------------------------------------------------------------------------------| | <span style="font-size: 10pt;">☐ 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: | Volcano Corporation<br>3721 Valley Center Drive<br>San Diego, CA 92130 | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT/SUBMITTER: | Courtney Moore<br>Regulatory Affairs Specialist<br>Volcano Corporation<br>3721 Valley Center Drive<br>San Diego, CA 92130<br>Tel: (858) 764-1308<br>Fax: (858) 481-1027 | | DATE PREPARED: | March 10, 2017 | | DEVICE: | Volcano CORE® M2 Vascular System | | TRADE NAME: | Volcano CORE® M2 Vascular System | | COMMON NAME: | System, Imaging, Pulsed Echo, Ultrasonic | | CLASSIFICATION: | 21 CFR Part 892.1560<br>IYO: Ultrasonic Pulsed Echo Imaging System<br>21 CFR Part 870.2900<br>DSA: Patient Transducer and Electrical Cable<br>Class II Device | | PREDICATE DEVICE: | Volcano s5i/CORE and CORE Mobile Precision Guided<br>Therapy Systems (K153369) | | DEVICE DESCRIPTION: | The CORE M2 Vascular System is used for the qualitative<br>and quantitative evaluation of vascular morphology in the<br>coronary arteries and vessels of the peripheral vasculature.<br>It is also indicated as an adjunct to conventional<br>angiographic procedures to provide an image of vessel<br>lumen and wall structures. The system utilizes the acoustic<br>impedance of vascular structures to provide cross sectional<br>images from inside the vessel. The IVUS catheter uses a<br>transducer near the distal tip to emit and receive high<br>frequency sound waves. The system is then able to analyze<br>the signal that is received by the transducer to differentiate<br>between vessel structures to produce a 360° cross sectional<br>image. | {4}------------------------------------------------ The CORE M2 Vascular System consists of a cart mounted touchscreen PC Console, a patient interface module (PIM) for connecting the IVUS Imaging Catheter to the PC Console, and an optional Control Console as an alternative to the touchscreen for control of the CORE M2 System. #### INDICATIONS FOR USE: The CORE M2 Vascular System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ## COMPARISON OF CHARACTERISTICS: The CORE M2 System is a modification to the currently marketed CORE Mobile system. The CORE M2 system is designed to provide only IVUS imaging for the peripheral and coronary vasculature. The CORE M2 system interfaces with the same Digital IVUS Patient Interface Module and a subset of the Catheters that are used with the CORE Mobile System. The CORE M2 System is compatible with the following catheter models: - Eagle Eye Platinum, Model 85900P ● - . Eagle Eye Platinum Short Tip, Model 85900PST - Visions PV .014P. Model 85910P . - . Visions PV .035. Model 88901 and 81234 The CORE M2 System has employed a new User Interface Design, and uses different hardware and software for image signal processing to produce the IVUS images. ## PERFORMANCE DATA: The following performance data were provided in support of the substantial equivalence determination. ### Design Verification - Electrical safety and Electromagnetic Compatibility ● (EMC) testing were conducted on the CORE M2 system. The system complies with ANSI/AAMI ES60601-1:2005 + A2(R2012) + A1, IEC 60601-2-37:2007 standards for safety and IEC 60601-1-2:2014 standard for EMC. - Environmental Testing was conducted to verify the ● CORE M2 system's performance under the environmental conditions as defined in the product {5}------------------------------------------------ specifications. The CORE M2 system was subjected to a range of humidity, temperature, and varying levels of shock and vibration. The results of this testing demonstrate the CORE M2 System remains functional under the required environmental conditions. - Packaging testing was conducted on each of the . CORE M2 System packages, consisting of the Panel PC, Panel PC Assembly, Cart, and Patient Interface Module per FDA recognized standards ASTM D4332-14 and ASTM D4169-16. The results of this testing demonstrate that the CORE M2 System packaging design is sufficient for transit conditions. - Hardware Verification was performed on the CORE ● M2 System and each of its subassemblies to verify each meets its relevant product specifications. Testing was performed on the following: - o CORE M2 Panel PC - Image Acquisition Printed Circuit Assembly o - Mobile Cart o o CORE M2 System, fully assembled The results of this testing demonstrates the CORE M2 System and each of its subassemblies meet the defined product specifications. ## Software Verification and Validation Software verification and validation testing was conducted and documentation was provided as recommended by FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Unit, integration, and system level software testing was conducted on the CORE M2 v4.1 software, consisting of the application, firmware, and imaging library. The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator. The results of the software verification and validation demonstrate that the CORE M2 v4.1 software meets the defined software requirements. {6}------------------------------------------------ ## Simulated Use / Usability Validation Simulated Use/Usability Validation testing was conducted to ensure the CORE M2 System meets the user needs, satisfies the intended use, and demonstrates that users are able to use the device safely and effectively. The results of this validation demonstrate that the CORE M2 System meets the user needs. ## Image Validation An Image Validation was also conducted to confirm that the images acquired and displayed by the CORE M2 System are clinically acceptable for end users. The results of the image validation demonstrate that the CORE M2 system provides images which are clinically acceptable. ### Summary The results of the performance data for the CORE M2 System demonstrate substantial equivalence to the predicate device.