AccuICAS

{0}------------------------------------------------ February 28, 2023 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: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health and Human Services seal. The right side of the logo features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. ArteryFlow Technology Co., Ltd. % Ashley Fu RA Specialist 459 Oianmo Road, Suite C1-501, Binjiang District, Hangzhou, ZHEJIANG 310051 CHINA Re: K221711 Trade/Device Name: AccuICAS Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II Product Code: QHA, LLZ Dated: January 17, 2023 Received: January 18, 2023 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. 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. 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Sincerely, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K221711 Device Name AccuICAS #### Indications for Use (Describe) AcculCAS is software intended to be used for performing calculations in X-ray angiographic innages of the intracranial vessels. AcculCAS enables neurointerventionalists to obtain quantifications of one or more lesions in the analyzed intracranial vessel segment. In particular, AccuICAS provides: · Ouantitative results of intracranial vessel segments based on a 3D reconstructed model: · Dimensions of the intracranial vessels and lesions; · Quantification of the pressure gradient (PG) and pressure ratio (PR) in intracranial vessels. AcculCAS is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of intracranial vessels in X-ray angiographic images. When the quantified results provided by AcculCAS 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) 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. 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 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: Jianping Xiang, PhD, General Manager Email: jianping.xiang@arteryflow.com Secondary correspondent: Ashley Fu, RA Specialist Email: fang.fu@arteryflow.com Date of preparation: February 28, 2023 ### 2. Device Information Trade/ Device Name: AcculCAS 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: ArteryFlow Technology Co., Ltd. Device Name: AccuFFRangio Regulatory Class: Class II Regulation Number: 892.1600 Classification Product Code: QHA Subsequent Product Code: LLZ 510(k) number: K210093 ### 4. Device Description {4}------------------------------------------------ ArteryFlow AcculCAS 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. AcculCAS is composed of the following analysis workflows: Image Loading, Frame Selection, Vessel Reconstruction and Hemodynamics Calculation for visualization of the target intracranial vessel segment, quantification of morphological parameters and pressure drop of the intracranial vessel segment. AcculCAS is only for quantitative imaging output but not for diagnosis. AcculCAS calculates the pressure gradient (PG) and pressure ratio (PR) value for the intracranial vessel. To obtain these values for a specific lesion in an intracranial vessel, the user needs to start with Frame Selection using the same vessel under different angulation. In each of these images, a classic 2D intracranial vessel contour detection is performed, after which a reconstruction of the intracranial vessel segment is obtained in 3D space. Based on the 3D reconstruction and patients' mean arterial pressure, the corresponding pressure gradient (PG) and pressure ratio (PR) value at each position can be calculated. AcculCAS enables neurointerventionalists to obtain accurate anatomical quantifications of one or more lesions in the analyzed intracranial vessel segment, and to assess the best viewing angles which can be helpful for optimal visualization of the lesion. AcculCAS's outputs mainly include quantitative dimension results of intracranial vessel and lesions segments based on a 3D reconstructed model and quantification of the pressure gradient (PG) and pressure ratio (PR) in intracranial vessels. Besides, other information provided to the end user also belongs to the outputs, such as display of reference vessels and lesions, display of target vessel lumen contour, 3D reconstructed model of intracranial vessels, the diameter stenosis distribution and PG/PR distributions. #### 5. Indications for Use AcculCAS is software intended to be used for performing calculations in X-ray angiographic images of the intracranial vessels. AcculCAS enables neurointerventionalists to obtain quantifications of one or more lesions in the analyzed intracranial vessel segment. In particular, AcculCAS provides: - Quantitative results of intracranial vessel seqments based on a 3D reconstructed model: - Dimensions of the intracranial vessels and lesions; - Quantification of the pressure gradient (PG) and pressure ratio (PR) in intracranial vessels. AcculCAS is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of intracranial vessels in X-ray angiographic images. When the quantified results provided by AcculCAS are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible {5}------------------------------------------------ clinicians. # 6. 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 | AccuICAS | AccuFFRangio | | Manufacturer | ArteryFlow Technology Co., Ltd. | ArteryFlow Technology Co., Ltd. | | 510(k) No. | - | K210093 | | 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 /<br>Indications for use | Indications for Use<br>AccuICAS is software intended to<br>be used for performing<br>calculations in X-ray angiographic<br>images of the intracranial<br>vessels. AccuICAS enables<br>neurointerventionalists to obtain<br>quantifications of one or more<br>lesions in the analyzed<br>intracranial vessel segment. In<br>particular, AccuICAS provides:<br>Quantitative results of<br>intracranial vessel segments<br>based on a 3D reconstructed<br>model;Dimensions of the<br>intracranial vessels and<br>lesions;Quantification of the<br>pressure gradient (PG) and<br>pressure ratio (PR) in<br>intracranial vessels.AccuICAS is indicated for use in<br>clinical settings where validated<br>and reproducible quantified<br>results are needed to support the<br>assessment of intracranial<br>vessels in X-ray angiographic | AccuFFRangio is software<br>intended to be used for<br>performing calculations in X-ray<br>angiographic images of the<br>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<br>pressure drop in coronary<br>vessels.AccuFFRangio is indicated for<br>use in clinical settings where<br>validated and reproducible<br>quantified results are needed to<br>support the assessment of | | | | | | | images.<br>When the quantified results<br>provided by AccuICAS are used<br>in a clinical setting on X-ray<br>images of an individual patient,<br>the results are only intended for<br>use by the responsible clinicians. | coronary vessels in X-ray<br>angiographic images, for use on<br>individual patients with coronary<br>artery disease.<br>When the quantified results<br>provided by AccuFFRangio are<br>used in a clinical setting on X-ray<br>images of an individual patient,<br>the results are only intended for<br>use by the responsible clinicians. | | | <b>Technological Characteristics</b> | | | Data type | ● X-ray angiographic data in<br>DICOM format (vendor-<br>independent) | ● X-ray angiographic data in<br>DICOM format (vendor-<br>independent) | | Import of patient<br>data | ● Automatically load<br>information from patient's<br>DICOM file;<br>● Manual through keyboard | ● Automatically load<br>information from patient's<br>DICOM file;<br>● Manual through keyboard | | Image display | ● 2D X-ray image visualization<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 hemodynamics<br>parameter value (PG/PR)<br>with vessel longitudinal<br>position;<br>● Hemodynamics parameter<br>value (PG/PR) is colored on<br>the 3D reconstructed vessel<br>segment model. | ● 2D X-ray image visualization<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<br>is colored on the 3D<br>reconstructed vessel<br>segment model. | | Centerline<br>and<br>contour definition | ● Manual and semi-automatic<br>centerline definition based<br>on contour detection of<br>vessel;<br>● Contour correction and<br>restriction | ● Manual and semi-automatic<br>centerline definition based<br>on contour detection of<br>vessel;<br>● Contour correction and<br>restriction | | Image<br>assessment | ● Manual and automatic<br>calibration;<br>● Vessel dimensions | ● Manual and automatic<br>calibration;<br>● Vessel dimensions | | | assessment;<br>• Pressure drop calculation in<br>intracranial vessel | assessment;<br>• Pressure drop calculation in<br>coronary vessel | | Storage of results | • Printout<br>• Images<br>• PDF | • Printout<br>• Images<br>• PDF | | Software<br>operation<br>environment | • Linux Ubuntu 18.04, 64-bit<br>version<br>• Microsoft Windows 10, 64-bit<br>version<br>• MacOS 11.4, 64-bit version | • Linux Ubuntu16.04 and<br>18.04, 32 and 64-bit version<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 | # Table 1 General Comparison {6}------------------------------------------------ {7}------------------------------------------------ AcculCAS is a quantitative imaging output device as the predicate devices. AcculCAS share the same intended use of performing calculations in X-ray angiographic images with the predicate device AccuFFRangio (K210093). Both products could enable medical professionals to obtain quantifications of one or more lesions based on a 3D reconstructed model and dimensions of vessels. The main outputs of both are morphological parameters and hemodynamics parameters. Besides, AcculCAS has same software algorithms and technical characteristics with predicate device AccuFFRangio (K210093). The minor gaps exist in lesion location of indications for use, intended patient population and software operating environment. However, the differences are not critical to the intended use of the device, and do not affect the safety and effectiveness of the device when used as labeled. ### 7. Performance Data Software 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 report and especially the requirements coverage matrix of AcculCAS providing traceability between requirements, design and the tests successfully executed. All outputs of the device have undergone validation to ensure that they support the intended use of the device: - The segmentation and reconstruction outputs were verified through the verification of the lumen and reference lumen contours and the verification of 3D model. - Morphological parameters output by AcculCAS was verified using three brass phantoms and a dozen clinical data. - The diameter stenosis distribution, as well as the PG and PR distributions, were verified using data from several clinical patients with stenosis lesions. {8}------------------------------------------------ - Hemodynamics calculation was validated by comparing the calculated results with the measured results. The comparison showed good correlation and agreement between the calculated and measured pressure gradients (PG) and pressure ratios (PR). All of these tests met the predefined criteria, indicating that the AcculCAS algorithm is accurate, and the device is clinically acceptable. #### 8. Conclusion Based on the information provided in this submission, AcculCAS shares same intended use, software algorithms and technical characteristics with the predicate device AccuFFRangio (K210093). Verification and validation testing have produced results consistent with design input requirements. During the development, potential hazards were controlled by a risk management report, including risk analysis, risk mitigation and validation. ArteryFlow Technology concludes that AcculCAS, intended only for quantitative imaging output but not for diagnosis, is as safe and effective as its predicate device. The difference between the subject and predicate devices do not raise new questions of safety and effectiveness.