XmaruView V1 (Xmaru Chiroview, Xmaru Podview)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. April 30, 2019 Rayence Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025 Re: K190866 Trade/Device Name: XmaruView V1 (Xmaru Chiroview, Xmaru Podview) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 29, 2019 Received: April 3, 2019 Dear Mr. Kim: 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 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190866 Device Name XmaruView V1 Xmaru Chiroview Xmaru Podview #### Indications for Use (Describe) Xmaru View V1(Xmaru Chiroview or Xmaru Podview) software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, and measurements. Ymaru View V (Xmaru Chiroview or Xmaru Podview) is not approved for mammography and is meant to be used by qualified medical personnel only. Xmaru Chiroview or Xmaru Podview) is complying with DICOM standards to assure optimum communications between network systems. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: overline;">X</span> 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}------------------------------------------------ # 1. 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. #### Date 510K summary prepared: April 9, 2019 Submitter's Name, address, telephone number, a contact person: | Submitter's Name : | Rayence Co., Ltd. | |-------------------------|---------------------------------------------------------| | Submitter's Address: | 14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea | | Submitter's Telephone: | +82-31-8015-6459 | | Contact person: | Mr. Kee Dock Kim / RA Team Manager / +82-31-8015-6459 | | Official Correspondent: | Dave Kim (davekim@mtech-inc.net) | | Address: | 8310 Buffalo Speedway, Houston, TX 77025 | | Telephone: | +713-467-2607 | | Fax: | +713-583-8988 | Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known: | Type of 510k Submission: | Special | |----------------------------|----------------------------------------------------------------------------------------| | Trade/proprietary name: | XmaruView V1 (Xmaru Chiroview or Xmaru Podview) | | Common Name: | Medical Image Processing Software | | Regulation number: | 21 CFR 892.2050 | | Classification Name: | Picture archiving and communications system | | Product Code: | LLZ | | Predicate device (K160579) | | | Manufacturer: | Rayence Co., Ltd. | | Device Name : | XmaruView V1 (Xmaru Chiroview or Xmaru Podview) and<br>Xmaru PACS | | 510(k) Number: | K160579 (Decision Date - Apr 08, 2016) | | Common Name: | Medical Image Processing Software | | Regulation number: | 21 CFR 892.2050 | | Classification Name : | Picture archiving and communications system | | Product Code: | LLZ | | Reference device (K153464) | | | Manufacturer: | FUJIFILM Medical Systems U.S.A., Inc. | | Device Name : | FDR D-EVO Flat Panel Detector System (DR-ID600) with<br>improved virtual grid software | | 510(k) Number: | K153464 (Decision Date – Apr 08, 2016) | | Common Name: | Flat Panel Digital Detector System | | Regulation number: | 21 CFR 892.1680 | | Classification Name : | Stationary X-ray system | | Product Code: | MQB | {4}------------------------------------------------ # 2. Device Description XmaruView V1 is a software program designed to provide image acquisition, processing and operational management functions for Digital Radiography. XmaruView V1 performs connects with Flat-Panel Detectors and Generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. XmaruView V1 provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography. Image /page/4/Figure/4 description: The image shows a diagram of the XmaruView V1 software architecture. The diagram is divided into three main sections: Viewer Window, Main Window, and External Connection. The Viewer Window section includes modules for image acquisition, post-image processing, thumbnail list, image display, and a side toolbar. The Main Window section is divided into two tabs: Study List and Worklist, each containing modules for study management and data management. # 3. Indication for use XmaruView V1(Xmaru Chiroview or Xmaru Podview) software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, and measurements. XmaruView V1(Xmaru Chiroview or Xmaru Podview) is not approved for mammography and is meant to be used by qualified medical personnel only. XmaruView V1(Xmaru Chiroview or Xmaru Podview) is complying with DICOM standards to assure optimum communications between network systems. # 4. The Main Functions of XmarView V1 The major functions of XmaruView V1 are as follows. - Automatic acquisition of patient information and photo-taking a shot through the -DICOM Worklist. - Auto Query that searches the Worklist server at every designated interval, facilitating to handle newly added works rapidly and efficiently. - Display an acquired image within a very short period of time after taking an image. - - Reduce input time for patient information by automatically applying the preset Image -Processing Parameter, ROI, Marker, LUT etc. according to different body parts. - Enables a user to take images simultaneously while conducting a variety of functions, including DICOM image transmission, printing, and Worklist search. - Provides a variety of image editing functions, including Contrast, Invert, Flip, Rotate, ROI, and -Windowing. - Grid ON function is to reduce the effects of scatter radiation and to enhance contrast for image . - Enable a user to edit images upon acquisition - Image management functions: test creation, modify and delete of information, move and {5}------------------------------------------------ delete of image, and image storage management. - Supports DICOM 3.0 and image transmission to the PACS server, print and Worklist jobs. - #### 5. Interoperation products XmaruView V1 are compatible with the following detectors and generators: - -Rayence's Detector - -Generator - EDITOR HFe 501(Spellman) 1 - CMP200(CPI) - SYNERGY(SUMMIT) - System - - SU-3000/RU-3000(SYFM) . #### 6. Substantial Equivalence XmaruView V1 SW and the predicate device(K160579), XmaruView V1 image viewer software are substantially equivalent, having the same indications for use and functionalities such as image processing, windowing, zoom, rotation, contrast, brightness, inverting view, annotation, DICOM worklist, DICOM store and DICOM print. The differences are hardware operation environment and Grid ON processing parameter. Both subject device and predicate device are categorized as the product code LLZ; equivalence between the subject and predicate device is evident. The differences between the subject and predicate device are as follows: The proposed device, XmaruView V1 is an upgrade version of the predicate device (K160579). XmaruView V1 SW is updated with Grid ON function to enhance contrast for image, Grid On function is related to Virtual grid where physical grid is not used. Grid On is a software algorithm designed to improve image contrast in general radiographic images by reducing the effects of scatter radiation. primarily for exams acquired without a grid. However. Grid On function should be turned off to acquire images with a real grid. The difference is not significant since they are additional features for user convenience and do not raise new safety or effectiveness concerns. Based on the validation submitted in this 510(k) submission, we conclude that the proposed device is substantially equivalent to the predicate device. # 7.Summary of Performance Testing - 1) The complete system configuration has been assessed and tested by the manufacturer and passed all testing acceptance criteria. The software validation test was designed to evaluate all input functions, output functions, and actions performed by XmaruView V1. Each operational mode and the processes are documented in the Software Validation Report. The validation testing verified and validated the risk analysis and individual performance results were within the predetermined acceptance criteria. - 2) Safety and Performance Data: The SW validation and risk analysis based on FMEA were conducted. The risks identified have been mitigated and any residual risks were evaluated and accepted. - IEC 62304 Medical device software Software life-cycle processes : 2006 - ISO 14971 Medical Devices Application of risk management to medical device : 2007 # 8. Conclusions None of the modifications alter the Indications for Use in a significant way, nor the fundamental scientific technology, and do not introduce a fundamentally new scientific technology. Therefore, it is determined that the XmaruView V1 described in this submission is substantially equivalent to the predicate device.