RealNow

{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. YIWEI Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O.box 120-119 Shanghai. 200120 CHINA Re: K213891 February 24, 2023 Trade/Device Name: RealNow Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: January 29, 2023 Received: January 30, 2023 Dear Diana Hong: 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 {1}------------------------------------------------ 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 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. Jessica Lamb Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: 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) K213891 Device Name RealNow ## Indications for Use (Describe) RealNow is an image processing software package to be used by trained professionals including physicians. The software runs on a standard "off-the-shelt" computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, analysis and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM compliant imaging devices. RealNow provides viewing, analysis and communication capabilities for functional and dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated in the standard DICOM format and may be viewed on existing radiological imaging viewers. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------|--| | <span style="padding-right: 5px;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | | | <span style="padding-right: 5px;">☐</span> 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}------------------------------------------------ # 510(k) Summary This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: K213891 - 1. Date of Preparation: 2/23/2023 - 2. Sponsor Identification ## YIWEI Medical Technology Co., Ltd Room 1001, MaiKelong Building, No. 6, Gaoxin South 6th Road, Dist.Gaoxin, Yuehai Street, Dist.Nanshan, Shenzhen, 518057, China. Establishment Registration Number: Not registered yet. Contact Person: Eric Ke Position: Management Representative Tel: +86-0755-82333762 Email: rick.ke@drbrain.com.cn - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person) ## Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net {4}------------------------------------------------ #### 4. Identification of Proposed Device Trade Name: RealNow Common Name: Picture Archiving Communications System ### Regulatory Information Classification Name: Picture archiving and communications system Classification: II; Product Code: LLZ; Regulation Number: 21CFR 892.2050 Review Panel: Radiology; ### Indication for Use: RealNow is an image processing software package to be used by trained professionals, such as physicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, analysis and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM compliant imaging devices. RealNow provides viewing, analysis and communication capabilities for functional and dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated in the standard DICOM format and may be viewed on existing radiological imaging viewers. ### Device Description RealNow image analysis includes calculation of the following perfusion related parameters: - Cerebral Blood Flow (CBF) - Cerebral Blood Volume (CBV) - Mean Transit Time (MTT) - · Residue function time-to-peak (TMax) - · Arterial Input Function (AIF) The primary users of RealNow are medical imaging professionals who analyze dynamic CT perfusion studies. The results of image analysis produced by RealNow should be viewed through appropriate diagnostic viewers when used in clinical decision making. - Identification of Predicate Device న. {5}------------------------------------------------ 510(k) Number: K121447 Product Name: RAPID Manufacturer: iSchemaView, Inc. #### Non-Clinical Test Conclusion 6. The software verification and validation testing was conducted on the proposed device CTP images (Real-World Evidence) are paired uploaded to RealNow and RAPID for perfusion analysis. The parametric maps from the subject device's output have been directly compared to the Rapid outputs in the additional study. The RealNow resulting CBF maps were compared on a pixel by pixel basis to the "ground truth" RAPID CBF maps. Intraclass Correlation Coefficient of the all the pixel values per scan was calculated to assess correlation, of the CBF estimates to the reference values. Volumetry from our device's out to RAPID on the same patient data have been statistically analyzed using MedCalc, and Bland-Altman analysis statistics been performed. For each scan, parametric map is considered acceptable when the ICC is greater than 0.75, which ICC was calculated per scan from all the voxels within the brain tissue. All Proportion of Acceptable (CBF Parameter Maps, CBV Parameter Maps, MTT Parameter Maps, Tmax Parameter Maps, ) more than the 90% (p=0.0009, p=0.0009, p=0.0196.).The assessment revealed bias is not significant for Rapid_Volume (CBF<20%) Vs RealNow_Volume (CBF<20%) \ Rapid_Volume (CBF<30%) Vs RealNow Volume (CBF<30%).The assessment revealed a negative bias in Tmax abnormality (mean Rapid Volume being smaller than mean Tmax volumetry) that increased as the average volume increased. For Proposed Device RealNow mismatch analysis, mismatch volume has been established within the following accuracy parameters:< 50 ml for mismatch volumes (total data); < 25 ml for mismatch volumes (stroke data). Good correlation in behavior between Rapid and RealNow volumetry was found. Altogether, good agreement and correlation in behavior between Rapid and RealNow was found. The outputs of the subject device are essentially the same as the outputs of the previously cleared RAPID. Subject device is essentially useful for CT brain perfusion and analysis, the same as the previously cleared RAPID. #### 7. Clinical Test Conclusion No clinical study is included in this submission. {6}------------------------------------------------ ### 8. Summary of Technological Characteristics | ITEM | Proposed Device | Predicate Device<br>K121447 | Remark | |----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Product name | RealNow | RAPID | / | | Product Code | LLZ | LLZ | Same | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same | | Class | II | II | Same | | Indication for Use | RealNow is an image processing software package to be used by trained professionals, such as physicians. The software runs on a standard “off-the-shelf” computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, analysis and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM compliant imaging devices.<br><br>RealNow provides viewing, analysis and communication capabilities for functional and dynamic imaging datasets that are acquired with CT Perfusion imaging protocols.<br><br>Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated in the standard DICOM format and may be viewed on | iSchemaView's RAPID is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard “off-the-shelf” computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, analysis of brain images. Data and images are acquired through DICOM compliant imaging devices.<br><br>iSchemaView's RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets that are acquired with CT Perfusion imaging and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT).<br><br>The DWI Module is used to visualize local water diffusion properties from the analysis of | Different | | | | | | | | existing radiological imaging<br>viewers. | diffusionweighted MRI data. | | | PACS Functionality | | The Dynamic Analysis Module is<br>used for visualization and analysis<br>of dynamic imaging data,<br>showing properties of changes in<br>contrast over time. This<br>functionality includes calculation<br>of parameters related to tissue<br>flow (perfusion) and tissue blood<br>volume. | | | Basic PACS<br>Functions | Yes | Yes | Same | | Computer<br>Platform | Standard "Off-the-Shelf" PC<br>Workstation or VMWare | Standard "Off-the-Shelf" PC<br>Workstation or VMWare | Same | | DICOM<br>Compliance | Yes | Yes | | | Functional<br>Overview | RealNow is a software package<br>that provides for the visualization<br>and study of changes of tissue<br>perfusion in digital images<br>captured by CT. RealNow allows<br>viewing and quantification | RAPID is a software package that<br>provides for the visualization and<br>study of changes of tissue<br>perfusion in digital images<br>captured by CT. RAPID allows<br>viewing and quantification<br>PAPID also has DWI Module to<br>visualize local water diffusion<br>properties from the analysis of<br>diffusionweighted MRI data. | Different | | Data<br>Acquisition | Acquires medical image data<br>from DICOM compliant imaging<br>devices and modalities. | Acquires medical image data from<br>DICOM compliant imaging<br>devices and modalities. | Same | | Data/Image<br>Types | Computed Tomography (CT) | Computed Tomography (CT)<br>Magnetic Resonance Imaging<br>(MRI) | Different | | Acquisition and Modalities Features for Tissue Perfusion | | | | | CT | CT Perfusion (CTP) | CT Perfusion (CTP) | Same | | Computed Parameter Maps for perfusion CT | | | | | Perfusion CT | Cerebral Blood Flow (CBF) | Cerebral Blood Flow (CBF) | Same | | | Cerebral Blood Volume (CBV) | Cerebral Blood Volume (CBV) | Same | | | Mean Transit Time (MTT) | Mean Transit Time (MTT) | Same | | | Tissue residue function time to | Tissue residue function time to | Same | | | peak (TMax) | peak (TMax) | Same | | Measurements/Tools | | | | | CT Tools | Arterial Input Function (AIF) | Arterial Input Function (AIF) | Same | | | Brain mask | Brain mask | Same | | | Export perfusion files to PACS<br>and<br>DICOM file systems | Export perfusion files to PACS<br>and<br>DICOM file systems | Same | | | Acquire, transmit, process, and<br>store medical images. | Acquire, transmit, process, and<br>store medical images. | Same | # Table 1 Comparison of Technology Characteristics {7}------------------------------------------------ {8}------------------------------------------------ - Substantially Equivalent (SE) Conclusion 9. The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device K121447.