Medical image processing software

{0}------------------------------------------------ Image /page/0/Picture/0 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 and 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. August 11, 2022 Hangzhou Deepwise & league of PHD Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 CHINA Re: K220910 Trade/Device Name: Medical image processing software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: July 7, 2022 Received: July 11, 2022 Dear Ray Wang: 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. 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Sincerely, Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220910 Device Name Medical image processing software #### Indications for Use (Describe) The DW-CACTAS is a medical image processing software, combining digital image processing and visualization tools (multiplanar reconstruction (MPR) think, maximum intensity projection(MP) thin/thick, inverted MIP thinkthick, volume rendering technique (VRT), curved planar reformation (CPR)), this software is used for post-processing of coronary CT angiography images. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div><span style="font-family: Arial;"></span><span style="font-family: Symbol;"> </span><span style="font-family: Arial;">Prescription Use (Part 21 CER 801 Subpart D)</span></div> | <div><span style="font-family: Arial;"></span><span style="font-family: Symbol;"></span><span style="font-family: Arial;">Over-The-Counter Use (21 CFR 801 Subpart C)</span></div> | # 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}------------------------------------------------ The assigned 510(k) Number: K220910 # 510(k) Summary This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) Number: K220910 - 1. Date of Preparation: 08/10/2022 - 2. Sponsor #### Hangzhou Deepwise & league of PHD Technology Co.,Ltd. Room 705, Building 8, 1818-2 Wenyi West Road, Yuhang District, 311121, Hangzhou City, Zhejiang Province, China Contact Person: Hailong Xu Position: QA manager Tel: +86-13521047585 Fax: +86-0571-88075727 Email: xuhailong@deepwise.com - 3. Submission Correspondent ### Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com - Proposed Device Identification 4. Trade Name: Medical image processing software Common Name: System, X-Ray, Tomography, Computed Regulatory Information: Classification: II Product Code: JAK Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Review Panel: Radiology {4}------------------------------------------------ Indication For Use Statement: The DW-CACTAS is a medical image processing software, combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection(MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation i (CPR)), this software is used for post-processing of coronary CT angiography images. - Predicate Device Identification ર. 510(k) Number: K173637 Product Name: Syngo.CT Coronary Analysis Manufacturer: Siemens Medical Solutions USA, Inc. #### 6. Device Description Medical image processing software (DW- CACTAS) is a network system management and image processing software based on local storage service. The software obtains image data from medical image equipment through image network transmission and storage technology, and stores data in the server. Through the information system management function module and image processing module, medical institution can transmit, store, query, browse, manage and process image data. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection(MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), the DW- CACTAS is used for post-processing of coronary CT angiography images. The data transmission of the software follows the HTTP transmission protocol and DICOM network protocol, and supports the DICOM3.0 standard data transmission interface. The medical image storage format is DICOM. - Non-Clinical Test Conclusion 7. Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - > Bench Testing for the Software Test Report - > IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes - > NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set - Clinical Test Conclusion 8. No clinical study is included in this submission. {5}------------------------------------------------ | ITEM | Proposed Device<br>Medical image processing software | Predicate Device K173637<br>syngo.CT Coronary Analysis | Remark | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Software Operating<br>Platform | Linux Ubuntu 16.04 | SOMARIS/8 VB30 | Analysis 1 | | Indications for Use | The DW-CACTAS is a medical<br>image processing software,<br>combining digital image processing<br>and visualization tools (multiplanar<br>reconstruction (MPR) thin/thick,<br>maximum intensity<br>projection(MIP) thin/thick,<br>inverted MIP thin/thick, volume<br>rendering technique (VRT), curved<br>planar reformation (CPR)), this<br>software is used for<br>post-processing of coronary CT<br>angiography images. | syngo.CT Coronary Analysis is an<br>image analysis software package for<br>evaluating cardiac CT angiography<br>(CTA) volume data sets. Combining<br>digital image processing and<br>visualization tools (multiplanar<br>reconstruction (MPR) thin/thick,<br>maximum intensity projection<br>(MIP) thin/thick, inverted MIP<br>thin/thick, volume rendering<br>technique (VRT), curved planar<br>reformation (CPR)), evaluation<br>tools (coronary vessel centerline<br>calculation, stenosis calculation and<br>plaque analysis) and reporting tools<br>(lesion location, lesion<br>characteristics and key images), the<br>software package is designed to<br>support the physician in confirming<br>the presence or absence of<br>physician-identified coronary<br>lesions and evaluation,<br>documentation and follow-up of any<br>such lesion. These<br>visualization/evaluation tools allow<br>for characterization (geometry<br>(length, lumen diameter, cross<br>section area, stenosis grade) and<br>appearance (HU values)) of<br>coronary lesions and lesion size<br>over time, helping the physician to<br>assess the changes in their growth.<br>It is also designed to help the<br>physician classify conspicuous<br>regions of tissue. | SAME | | Visualization and | Image List | Basic Visualization and Navigation | Analysis 2 | | Segmentation<br>Tools | | Tools | | | | Myocardium segmentation in VR<br>image | Automatic Organ Segmentation | | | | Blood vessel centerline calculation | Automatic Vessel Tracing | | | | 3D VR image of Image browsing<br>and processing functions | 3D Vessel Visualization Tools | | | | 2D VR image of Image browsing<br>and processing functions | 2D Vessel Visualization Tools | | | | Blood vessel positioning | Vessel Navigation Tools | | | | Blood vessel identification | Vessel Definition Tools | | | | Blood vessel measurement and<br>centerline calculation | Vessel Evaluation Tools | | | | VR/CPR/lumen/Xsection image<br>creation | Result Image Creation | | | | / | Integrated Reporting | Analysis 3 | | Archiving and<br>Reporting | User Interface | User Interface | SAME | | | Archiving/Storing | Archiving/Storing | SAME | | | Communication | Communication | SAME | #### Substantially Equivalent (SE) Comparison 9. {6}------------------------------------------------ ## Analysis 1: The proposed device is different with the predicate device on Software Operating Platform, but the intended use is the same, for this risk we have conducted the software testing, the test results show that our products can meet the intended use and the difference does not raise any risk. # Analysis 2: We are not sure whether the proposed device and the predicate device are exactly the same on Visualization and Segmentation Tools, because we can't get the algorithm for predicate device, but the intended use is the same. For this uncertain deficiency we have conducted the software testing, the test results show that our products can meet the intended use, and compared to the predicate, the uncertain deficiency does not raise any risk. # Analysis 3: The proposed device is different with the predicate device on Visualization and Segmentation Tools, the proposed device won't generate report, but this difference would not affect its safety and effectiveness. The proposed device is used by professionals with medical imaging diagnosis experience, according to the medical imaging experience of professionals, combined with the patient's medical history and the patient's own physical condition for diagnosis. The proposed device has better performance to the predicate device. Both proposed device and predicate device are safe and effective, so we consider which is same with the predicate device and this difference does not raise any risk. #### 10. Performance Data {7}------------------------------------------------ #### Non-Clinical Testing Summary Non-clinical tests (integration and functional) were conducted for DW- CACTAS during product development. Performance tests were conducted to test the functionality of DW- CACTAS. The modifications described in this Premarket Notification were supported with verification/validation testing. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence. Hangzhou Deepwise & league of PHD Technology Co.,Ltd. claims conformance to the following performance standards: | Product Area | Title of Standard | Publication<br>Date | Standards Development<br>Organization | |--------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------| | Radiology | NEMA PS 3.1 - 3.20 Digital Imaging and<br>Communications in Medicine (DICOM) Set | 06/27/2016 | NEMA | | Software | IEC 62304 Edition 1.1 Medical device<br>software - Software life cycle processes | 2015-06 | IEC | | Software/<br>Informatics | Medical devices - Application of risk<br>management to medical devices | 2019-12 | ISO | | General I<br>(QS/RM) | IEC 62366-1 Edition 1.1 Medical devices -<br>Part 1: Application of usability engineering<br>to medical devices | 2020-06 | IEC | ## Non-Clinical Performance (Bench) Testing The function of the software meets the expected functional requirements. According to the DICOM standard communication protocol, it establishes a communication with the PACS system, obtains medical image data through network communication, and can realize the transmission, browsing, query and processing of medical images. #### Software Verification and Validation Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document " Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claim of substantial equivalence. Medical image processing software conforms to the Cybersecurity requirements by implementing a {8}------------------------------------------------ process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices issues on October 2, 2014" is included within this submission. #### General Safety and Effectiveness Concerns The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. Medical image processing software is designed to fulfill the requirements of the applicable safety and performance standards as listed above. ## 11. Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.