AccuFFRangio

{0}------------------------------------------------ September 10, 2021 Image /page/0/Picture/1 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. ArteryFlow Technology Co., Ltd. % Ashley Fu International Registeration Engineer 459 Oianmo Road, Suite C1-501, Binjiang District Hangzhou. Zhejiang 310051 CHINA ## Re: K210093 Trade/Device Name: AccuFFFRangio Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: Class II Product Code: QHA, LLZ Dated: August 12, 2021 Received: August 16, 2021 ## Dear Ashley Fu: 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. 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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) K210093 Device Name AccuFFRangio Indications for Use (Describe) AccuFFRangio is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease. When the quantified results provided by AccuFFRangio are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## 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}------------------------------------------------ # Tab #06 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. ## 1. Submitter's Information Submitter: ArteryFlow Technology Co., Ltd. Address: 459 Qianmo Road, Suite C1-501, Binjiang District, 310051 Hangzhou City, Zhejiang Province, China Phone Number: +86-571-86772567 Primary correspondent: XIANG Jianping, PhD, General Manager Email: jianping.xiang@arteryflow.com Secondary correspondent: Ashley Fu, Registration engineer Email: fang.fu@arteryflow.com Date of preparation: January 05, 2021 ## 2. Device Information Trade/ Device Name: AccuFFRangio Common Name: Radiological Image Processing Software Regulatory Class: Class II Regulation Description: Angiographic X-ray system Regulation number: 892.1600 Classification Product Code: QHA Subsequent Product Code: LLZ ### 3. Predicate Device Information Manufacturer: Medis medical imaging systems bv Device Name: QANGIO XA 3D Regulatory Class: Class II Regulation Number: 892.1600 Classification Product Code: QHA Subsequent Product Code: LLZ 510(k) number: K182611 ### 4. Device Description {4}------------------------------------------------ ArteryFlow® AccuFFRangio is designed as a stand-alone software package to run on a PC. This software can read traditional x-ray angiographic images with DICOM format from the local file directory. The AccuFFRangio is composed of the following analysis workflows: Image Loading, Frame Selection, Vessel Reconstruction, QCA Vessel Quantification, and AccuFFRangio Calculation for visualization of the target coronary segment, quantification of the stenosis and pressure drop of the coronary seqment. The AccuFFRangio parameter is only for quantitative imaging output but not for diagnosis and the AccuFFRanigo product has a moderate level of concern. The user can calculate the pressure drop and AccuFFRangio (FFR) value for the coronary vessel. To obtain these values for a specific lesion in a coronary vessel, the user has to start with Frame Selection using two angiographic images from different views. In each of these images, a classic 2D coronary contour detection is performed, after which a reconstruction of the coronary segment is obtained in 3D space. Based on the 3D reconstruction and user input of the aortic pressure, the pressure drop and AccuFFRangio value can be calculated. AccuFFRangio enables interventional cardiologists to obtain accurate anatomical quantifications of one or more lesions in the analyzed coronary segment, and to assess the best viewing angles which can be helpful for optimal visualization of the lesion during percutaneous coronary intervention (PCI) treatment. Results can be displayed and generated by the software, which contains patient information, imaging of actual and reference vessel boundaries, dimensions of the vessel sizing, pressure drop, and AccuFFRangio value. The results can be export in PDF format. This functionality is independent of the type of vendor acquisition equipment. #### 5. Intended Use AccuFFRangio is software intended to be used for performing calculations in X-ray angiographic images of the coronary arteries. AccuFFRangio enables interventional cardiologists to obtain quantifications of one or more lesions in the analyzed coronary vessel segment. In particular, AccuFFRangio provides: - Quantitative results of coronary vessel segments based on a 3D reconstructed model; - Dimensions of the cardiovascular vessels and lesions; - Quantification of the pressure drop in coronary vessels. #### 6. Indication for Use AccuFFRangio is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease. When the quantified results provided by AccuFFRangio are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians. {5}------------------------------------------------ # 7. Technological Characteristic Comparison A comparison of the technological characteristics of the predicate and subject device is given in the table below. | Item | New device | Predicate device | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | AccuFFRangio | QANGIO XA 3D | | Manufacturer | ArteryFlow Technology Co., Ltd. | Medis medical imaging systems bv | | 510(k) No. | - | K182611 | | Product Code | QHA, LLZ | QHA, LLZ | | Regulation No. | 892.1600 | 892.1600 | | Class | II | II | | Level of Concern<br>of the software | Moderate | Moderate | | Intended Use and Indications for Use | | | | Intended Use | AccuFFRangio is software<br>intended to be used for performing<br>calculations in X-ray angiographic<br>images of the coronary arteries.<br>AccuFFRangio enables<br>interventional cardiologists to<br>obtain quantifications of one or<br>more lesions in the analyzed<br>coronary vessel segment. In<br>particular, AccuFFRangio<br>provides:<br>Quantitative results of<br>coronary vessel segments<br>based on a 3D reconstructed<br>model;Dimensions of the<br>cardiovascular vessels and<br>lesions;Quantification of the pressure<br>drop in coronary vessels. | QANGIO XA 3D is software<br>intended to be used for performing<br>calculations in X-ray angiographic<br>images of the coronary arteries.<br>QANGIO XA 3D enables<br>interventional cardiologists and<br>researchers to obtain<br>quantifications of one or more<br>lesions in the analyzed coronary<br>vessel segment. In particular,<br>QANGIO XA 3D provides:<br>Quantitative results of<br>coronary vessel segments<br>based on a 3D reconstructed<br>model;Dimensions of the<br>cardiovascular vessels and<br>lesions;Quantification of the pressure<br>drop in coronary vessels. | | Indication for use | AccuFFRangio is indicated for use<br>in clinical settings where validated<br>and reproducible quantified results<br>are needed to support the<br>assessment of coronary vessels in<br>X-ray angiographic images, for use<br>on individual patients with<br>coronary artery disease | QANGIO XA 3D is indicated for<br>use in clinical settings where<br>validated and reproducible<br>quantified results are needed to<br>support the assessment of<br>coronary vessels in X-ray<br>angiographic images, for use on<br>individual patients with coronary | | | | | | | When the quantified results<br>provided by AccuFFRangio are<br>used in a clinical setting on X-ray<br>images of an individual patient, the<br>results are only intended for use by<br>the responsible clinicians. | artery disease.<br>When the quantified results<br>provided by QANGIO XA 3D are<br>used in a clinical setting on X-ray<br>images of an individual patient, the<br>results are only intended for use by<br>the responsible clinicians. | | Technological Characteristics | | | | Data type | ● X-ray angiographic data in<br>DICOM format<br>(vendor-independent) | ● X-ray angiographic data in<br>DICOM format<br>(vendor-independent) | | Import of patient<br>data | ● Automatically load information<br>from patient's DICOM file;<br>● Manual through keyboard | ● Automatically load information<br>from patient's DICOM file;<br>● Manual through keyboard | | Image display | ● 2D X-ray image visualization<br>with embedded ECG signal;<br>● 3D reconstruction of the<br>vessel segment based on 2<br>X-ray images;<br>● Graph for actual and<br>reference vessel diameter<br>with vessel longitudinal<br>position;<br>● Graph for AccuFFRangio<br>(FFR) value with vessel<br>longitudinal position;<br>● AccuFFRangio (FFR) value is<br>colored on the 3D<br>reconstructed vessel segment<br>model. | ● 2D X-ray image visualization<br>with embedded ECG signal;<br>● 3D reconstruction of the<br>vessel segment based on 2<br>X-ray images;<br>● Graph for actual and<br>reference vessel diameter<br>with vessel longitudinal<br>position;<br>● Graph for QFR (FFR) value<br>with vessel longitudinal<br>position;<br>● QFR (FFR) value is colored<br>on the 3D reconstructed<br>vessel segment model. | | Centerline and<br>contour definition | ● Manual and semi-automatic<br>centerline definition based<br>contour detection of coronary<br>vessel;<br>● Contour correction and<br>restriction | ● Manual and semi-automatic<br>centerline definition based<br>contour detection of coronary<br>and peripheral vessel;<br>● Contour correction and<br>restriction | | Image assessment | ● Manual and automatic<br>calibration;<br>● Vessel dimensions<br>(diameters, areas, lengths);<br>● Automatic stenosis<br>assessment;<br>● Pressure drop calculation in<br>coronary vessel | ● Manual and automatic<br>calibration;<br>● Vessel dimensions<br>(diameters, areas, lengths);<br>● Automatic stenosis<br>assessment;<br>● Pressure drop calculation in<br>coronary vessel | | | | | | FFR calculation | AccuFFRangio provides a<br>quantification parameter called<br>AccuFFRangio. | QANGIO XA 3D provides a<br>quantification parameter called<br>QFR. | | Storage of results | ● Printout<br>● Images<br>● PDF | ● Printout<br>● Images<br>● PDF | | Different technological Characteristics | | | | Gap 1 | With ECG display in the image<br>pane | ECG display in a separate pane | | Gap 2 | The vessel is colored by stenosis<br>percentage in red to blue | The vessel is colored by stenosis<br>percentage in red to white | | Gap 3 | When visualizing the reconstructed<br>vessel segment, there is a body<br>icon to show the relative position<br>for the vessel segment. | In QAngio XA 3D, there is a box<br>icon to show the relative position<br>for the vessel segment. | | | Image: vessel segment | Image: vessel segment | | Gap 4 | In the calculated vessel FFR<br>distribution, users can easily point<br>the position by the curser and the<br>specific AccuFFRangio value will<br>show up. | In QAngio XA 3D, the user needs<br>to move four "checking disk" and<br>look at the FFR value in the<br>left-bottom window. | | Gap 5 | Software operation environment:<br>● Microsoft Windows 7, SP1,<br>32 and 64-bit version<br>● Microsoft Windows 8.1, 32<br>and 64-bit version<br>● Microsoft Windows 10, 32<br>and 64-bit version<br>● Linux Ubuntu16.04 and<br>18.04, 32 and 64-bit version | Software operation environment:<br>● Microsoft Windows 7, SP1,<br>32 and 64-bit version<br>● Microsoft Windows 8.1, 32<br>and 64-bit version<br>● Microsoft Windows 10, 32<br>and 64-bit version<br>● Microsoft Windows Server<br>2008 R2, SP1, 64-bit version<br>● Microsoft Windows Server<br>2012 R2, 64-bit version<br>● Microsoft Windows Server<br>2016, 64-bit version | # Table 1 General Comparison {6}------------------------------------------------ {7}------------------------------------------------ AccuFFRangio has the same intended use and indications for use as the predicate devices QANGIO XA 3D (K182611). The basic features in technological characteristics are the same, such as same types of data format, same method for importing patient data, similar {8}------------------------------------------------ display of image, same definition for centerline and contour, same method for Image assessment, same output for 3D reconstruction and the calculation of the pressure drop, etc. AccuFFRanqio is a quantitative imaging output device, like the QANGIO XA 3D. Though above five differences concerning the display pattern (gap 1), display interface (gap 2-3), specific operate method on showing result (gap 4) and software operating system (gap 5) do exist, they do not affect the function and safety of AccuFFRangio. #### 8. Performance Data System requirements – derived from the intended use and indications for use – as well as risk control measures are verified by system testing. All requirements are tested and all results of the tests performed are summarized in the software test statement and especially the requirements coverage matrix of AccuFFRangio providing traceability between requirements and the tests successfully executed. The main functionality (including 3D vessel reconstruction, the calculation of the pressure drop and AccuFFRangio) have all been validated: - 3D vessel reconstruction: A phantom study had been implemented by using three different types stenosis of brass model. This phantom test was to evaluate the accuracy of the 3D quantitative coronary angiography (QCA) of AccuFFRangio software. The following software technical parameters were validated, namely, lesion length accuracy, diameter stenosis accuracy, area stenosis accuracy, minimal lumen diameter accuracy and reference diameter accuracy. This demonstrated that the quantitative coronary angiography for coronary vessel have similar performance compare to the predicate device QAngio XA 3D (K182611). - AccuFFRanqio calculation: To confirm the performance of the pressure drop and AccuFFRangio (FFR) calculation in the coronary vessel, a series of X-ray angiographic dataset with known pressure drops were analyzed. The functionality of pressure drop and AccuFFRangio calculation for the new device is based on 3D reconstruction out of two angiographic images. The results, including accuracy, sensitivity, specificity, positive predictive value and negative predictive value for per-vessel were calculated. The results demonstrated that the quantification of AccuFFRangio in coronary vessel have similar performance compare to the QFR by the predicate device QAngio XA 3D (K182611). #### 9. Conclusion AccuFFRangio product manufactured by our company shares the same intended use, and indications for use with QAnqio XA 3D by Medis. Testing, validation and verification have produced results consistent with design input requirements. AccuFFRangio is a software-only device for which there are no applicable mandatory performance standards. During the development, potential hazards were controlled by a risk management report, including risk analysis, risk mitigation, verification and validation. ArteryFlow technology concludes that the AccuFFRangio is only for quantitative imaging {9}------------------------------------------------ output but not for diagnosis, and it is a safe and effective medical device as its predicate device. The use of AccuFFRangio does not change the intended use of X-ray angiography acquisition, nor does the use of this software results in any new potential hazards.