CardIQ Flow

{0}------------------------------------------------ February 14, 2020 GE Medical Systems SCS % Ms. Elizabeth Mathew Senior Regulatory Affairs Manager 283 rue de la Miniere Buc, 78530 FRANCE Re: K192277 Trade/Device Name: CardIQ Flow Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS Dated: January 14, 2020 Received: January 15, 2020 Dear Ms. Mathew: 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 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 {1}------------------------------------------------ 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, For Thalia T. Mills, Ph.D. Director. Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) #### K192277 Device Name CardIQ Flow Indications for Use (Describe) CardIQ Flow is an aiding tool for the clinicians to perform analysis of stationary, dynamic, or gated cardiac position emission tomography (PET) images. The measurements include perfusion, end-diastolic volumes, stroke volume, ejection fraction, myocardial mass, and transient ischemic dilatation. Also included is a feature that enables clinicians to visualize reformatted data and make a comparison between stress and rest series. Software is indicated for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g, Coronary Flow Reserve and their combination into the Coronary (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images by quantification of their severty. It is intended for use by trained professionals, such as nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training. The clinician remains ultimately responsible for the final assessment and diagnosis based on standard practices, clinical judgment and interpretation of cardiac images or quantitative data. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------|---------------------------------------------| | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo is presented in a blue color. ## GE Healthcare 510(k) Premarket Notification Submission ## 510(k) Summary K192277 In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | August 21, 2019 | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Medical Systems SCS<br>Establishment Registration Number - 9611343<br>283 rue de la Miniere<br>78530 Buc, France | | Primary Contact<br>Person: | Elizabeth Mathew<br>Senior Regulatory Affairs Manager<br>GE Healthcare, (GE Medical Systems, LLC)<br>3000 N Grandview Blvd.,<br>Waukesha, WI - 53188<br>Phone: (262) 424-7774<br>Email: Elizabeth.Mathew@ge.com | | Secondary Contact<br>Person: | Helen Peng<br>Sr. Regulatory Affairs Director<br>GE Healthcare, (GE Medical Systems, LLC)<br>3000 N Grandview Blvd.,<br>Waukesha, WI - 53188<br>Phone: 262-424-8222<br>Email: Hong.Peng@ge.com | | Proposed Device: | | | Device Name: | CardIQ Flow | | Common/Usual<br>Name: | CardIQ Flow | | Primary Regulation<br>number: | 21 CFR 892.1200 Emission computed tomography system | | Primary Product<br>Code: | KPS | | Secondary Regulation number: | 21 CFR 892.2050 Picture archiving and communications system | | Secondary Product<br>Code: | LLZ | | Classification: | Class II | {4}------------------------------------------------ GE Healthcare 510(k) Premarket Notification Submission | Primary Predicate Device: | | |-------------------------------------|------------------------------------------------------------| | Device Name: | HeartSee | | 510(k) number: | K171303 cleared on September 22, 2017 | | Regulation number/<br>Product Code: | 21 CFR 892.1200 Emission computed tomography system<br>KPS | | Classification: | Class II | | Manufacturer: | University of Texas Medical School at Houston, Texas | | Predicate Device: | | | Device Name: | FullCard Analysis | | 510(k) number: | K061587 cleared on June 23rd, 2006 | | Regulation number/<br>Product Code: | 21 CFR 892.1200 Emission computed tomography system<br>KPS | | Classification: | Class II | | Manufacturer: | GE Healthcare | Device Description: The basis for this submission is the introduction of a new software device, CardIQ Flow which integrates the functionalities of the predicate devices HeartSee and FullCard Analysis for the display and analysis of Cardiac PET images. It is built within the framework of the Volume Viewer (K041521) 3D platform, intended to aid clinicians in assessing the myocardial perfusion, myocardial perfusion, myocardial blood flow and wall motion. It is used for the evaluation of patients with known or suspected coronary artery or ischemic heart disease. This application can be used for: · Reformatting axial data to the standard axis of the heart. Axial data may have been reconstructed using iterative or FBP algorithms with scatter and attenuation correction, if available. • Analyzing the myocardial perfusion by the Vertical Long Axis (VLA), Horizontal Long Axis (HLA) and Short Axis (SA) obliques generated from the selected input data. · Comparing myocardial perfusion in rest and stress studies as well as metabolism in viability studies. - · Viewing wall motions via synchronized gated beating slices. - · Investigating the entire left ventricle in one 2D Polar Plot that displays all short axis slices. - · Comparing myocardial perfusion of corrected and uncorrected datasets. · Calculation and evaluation of Myocardial Blood Flow (MBF), Coronary Flow Reserve (CFR), and Coronary Flow Capacity (CFC). · Printing a report designed for referring physicians. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular shape. The circle is outlined with a decorative, swirling pattern. The logo is presented in a blue color. ### Intended use: CardIQ Flow is a fully integrated post-processing and analysis tool tailored for PET cardiac imaging. CardIQ Flow is designed to provide an easy-to-use and efficient tool aiding clinical interpretation for patients with suspected or known coronary artery disease (CAD) with quantification of their severity. ### Indications for use: CardIQ Flow is an aiding tool for the clinicians to perform analysis of sets of stationary, dynamic, or gated cardiac positron emission tomography (PET) images. The measurements include perfusion, end-diastolic & end-systolic volumes, stroke volume, ejection, myocardial mass, and transient ischemic dilatation. Also included is a feature that enables clinicians to visualize reformatted data and make a comparison between stress and rest series. Software is indicated for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images by quantification of their severity. It is intended for use by trained professionals, such as nuclear technicians, nuclear cardiology physicians, or cardiologists with appropriate training. The clinician remains ultimately responsible for the final assessment and diagnosis based on standard practices, clinical judgment and interpretation of cardiac images or quantitative data. Technological Characteristic: CardIO Flow employs the same technologies as those of the Predicates. HeartSee (K171303) is a software tool for cardiac positron emission tomography (PET) for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g. Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map for facilitating the interpretation of PET perfusion images in patients with suspected of known coronary artery disease. FullCard Analysis (K061587) is a post processing analysis software package designed to provide a totally integrated package including automated processing, visualization, quantification of parameters of myocardial perfusion and function, along with simple reporting capabilities. The parameters include perfusion, end-diastolic & end-systolic volumes, stroke volume, ejection fraction, myocardial mass, and transient ischemic dilatation. CardIQ Flow is a software which integrates together the functionalities from HeartSee and FullCard Analysis in order to be able to display and analyze Cardiac PET images. CardIQ Flow when compared to HeartSee has the same workflow leading to the computation of the CFC (ROI Deposition, blood flow and CFR computation). CardIQ Flow has based the computation of the different maps on HeartSee's 2D formulas, but has tuned them to 3D in order to augment the clinical review capabilities. Similar to HeartSee, the segmentation in CardIQ Flow can be {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a circular frame. The frame is decorated with swirling, wave-like elements, giving it a distinctive and recognizable appearance. The logo is presented in a blue color. # GE Healthcare 510(k) Premarket Notification Submission manually adjusted using dedicated tools so that the user can control where blood flow will be computed. CardIO Flow has the same workflow as FullCard Analysis and has incorporated the same formulas as FullCard Analysis to quantify the parameters (perfusion, end-diastolic & end-systolic volumes, stroke volume, ejection fraction, myocardial mass, and transient ischemic dilatation) of myocardial perfusion and function. As CardIQ Flow is built within Volume Viewer, CardIQ Flow inherits the below existing capabilities from Volume Viewer: - Display of the maps - Display of the statistics - Display of the CFC graph - ROI deposition - Report of the maps and statistics ### Comparison The table below summarizes the feature/technological comparison between the predicate device and the proposed device: | Specification | Primary<br>Predicate:<br>HeartSee<br>(K171303) | Predicate Device:<br>FullCard<br>Analysis<br>(K061587) | Proposed Device:<br>CardIQ Flow | Comparison | |----------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | Workflow for<br>computation<br>of Coronary<br>Flow Capacity<br>(CFC) | ROI Deposition,<br>Blood Flow and<br>Coronary Flow<br>Reserve (CFR)<br>computation | NA | ROI Deposition,<br>Blood Flow and<br>Coronary Flow<br>Reserve (CFR)<br>computation | Proposed device is<br>substantially<br>equivalent to the<br>Primary Predicate<br>Device - HeartSee | | Myocardium<br>Identification | HeartSee uses a<br>2D box to define<br>the myocardium. | Automatic 3D<br>Myocardium<br>Segmentation<br>algorithm. | Automatic 3D<br>Myocardium<br>Segmentation<br>algorithm. | Substantial Equivalent<br>to the predicate<br>devices. | | Map Output | 2D maps<br>Rendering | NA | 3D maps Rendering | Substantial Equivalent<br>to the Primary<br>Predicate Device –<br>HeartSee. | | Measurements | NA | The measurements<br>include perfusion,<br>end-diastolic &<br>end-systolic<br>volumes, stroke | The measurements<br>include perfusion,<br>end-diastolic &<br>end-systolic<br>volumes, stroke | Identical to Predicate<br>Device - FullCard<br>Analysis | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The frame is made up of swirling lines that resemble water droplets or stylized leaves. The logo is presented in a light blue color. # GE Healthcare 510(k) Premarket Notification Submission | | volume, ejection | volume, ejection | | | | |------------------------------------------------------------------------------------------------------------|-------------------------------|----------------------|-----|--|--| | | fraction. | fraction. | | | | | | myocardial mass, | myocardial mass, | | | | | | and transient | and transient | | | | | | ischemic | ischemic dilatation. | | | | | | dilatation. | | | | | | | | | | | | | | | | | | | | | | | | | | | Determination of Substantial Equivalence: | | | | | | | | | | | | | | CardIQ Flow has successfully completed the required design control activities per GE's quality | | | | | | | management system that complies to Quality System Regulations of 21CFR 820 and ISO 13485 | | | The | | | | following quality assurance measures have been applied to the development of the device: | | | | | | | | | | | | | | Risk Analysis and Mitigation<br>● | | | | | | | Requirements Reviews<br>● | | | | | | | Design Reviews<br>● | | | | | | | Performance testing (Verification, Validation)<br>● | | | | | | | ● | Safety testing (Verification) | | | | | | | | | | | | | The testing and results did not raise new questions of safety and effectiveness from those associated with | | | | | | | predicate devices and demonstrated that the CardIQ Flow performs subdistally equivalent to the predicate | | | | | | | devices. | | | | | | | | | | | | | | The substantial equivalence was also based on software documentation for a "Moderate" level of concern | | | | | | | device. | | | | | | | Conclusion | | | | | | | GE Healthcare considers CardIQ Flow to be as safe, as effective as the predicate devices, and is | | | | | | | substantially equivalent to the predicate devices. | | | | | |