Nexus DR Digital X-ray Imaging System with stitching

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December 7, 2018 Varex Imaging Corporation Michael Ryn Regulatory Affairs Analyst 121 Metropolitan Drive Liverpool, New York 13088 Re: K183212 Trade/Device Name: Nexus DR Digital X-ray Imaging System with stitching Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: November 15, 2018 Received: November 19, 2018 Dear Michael Ryn: 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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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. Michael D. O'Hara For Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | | |-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <b>Indications for Use</b> | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020<br>See PRA Statement below. | | 510(k) Number (if known) | K183212 | | Device Name | Nexus DR Digital X-ray Imaging System (with Stitching) | | Indications for Use (Describe) | The Varex Nexus DR Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software.<br><br>The Varex Nexus DR Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography). | | Type of Use (Select one or both, as applicable) | <div> <span> <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </span> <span> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </span> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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](mailto: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." | FORM FDA 3881 (7/17) | Page 1 of 1 | |----------------------|-------------| |----------------------|-------------| PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made up of three vertical lines in different colors: blue, yellow, and green. To the right of the "V" is the word "VAREX" in blue, block letters. Below "VAREX" is the word "IMAGING" in smaller, gray letters. Varex Imaging Corporation 121 Metropolitan Drive Liverpool, NY 13088- USA www.vareximaging.com # Section 3: 510(k) Summary Date Prepared: November 13, 2018 | Contact Person: | Michael Van Ryn<br>Regulatory Affairs Manager | |-----------------------|----------------------------------------------------------------------------| | Telephone: | 315-234-6853 | | Fax: | 315-234-6801 | | Submitter Name: | Varex Imaging Corporation<br>121 Metropolitan Drive<br>Liverpool, NY 13088 | | Subject Device | | | Trade Name: | DR ^TM Digital X-ray Imaging System (with Stitching) | | Common Name: | Digital Radiographic System | | Regulation: | 21 CFR 892.1680 | | Classification Name: | Stationary X-ray System | | Class: | II | | Primary Product Code: | MQB | Primary Predicate Device | Trade Name: | DR TM Digital X-ray Imaging System<br>(with PaxScan 4343RC and PaxScan 4343Rv3) | |-----------------------|---------------------------------------------------------------------------------------------| | Common Name: | Digital Radiographic System | | Regulation: | 21 CFR 892.1680 | | Classification Name: | Stationary X-ray System | | Class: | II | | Primary Product Code: | MQB | | 510(k) Number: | K172951 | Reference Predicate Device: | Trade Name: | InfiStitch for i5 TM Digital X-Ray Imaging System | |-----------------------|---------------------------------------------------------------| | Common Name: | Digital Radiographic System | | Regulation: | 21 CFR 892.1680 | | Classification Name: | Stationary X-ray System | | Class: | II | | Primary Product Code: | JAA, MQB | | 510(k) Number: | K101833 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made up of three vertical lines in blue, yellow, and green, followed by the text "VAREX" in blue. Below "VAREX" is the word "IMAGING" in smaller, blue letters. ## Device Description: The Varex DRTM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The DR-m Digital X-ray Imaging System is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform. The modified device consists of an X-ray imaging receptor, computer, monitor, and the digital imaging software and the optional Stitching software. The Varex DR™ Digital X-ray Imaging System is a configurable product platform designed to allow Varex to leverage the common components of digital X-ray imaging systems from which the following medical modalities can be served: General Radiography (excluding fluoroscopy, angiography, and mammography). The DR™ Digital X-ray Imaging System is then configured to function on a computer with modality specific components, functionality and capabilities to complete the specific product package. Like the predicate device, the modified DR™ Digital X-ray Imaging System is in a class of devices that all use similar technology to acquire digital radiographic images. These devices convert X-rays into visible light that shines onto a TFT array, which converts the visible light into a digital electronic signal. This process is ultimately used for the same purpose as Radiographic film, to create an X-ray image. Identical to the predicate device, the modified device is capable of interfacing with flat panel detectors in vTrigger Mode or RAD Mode utilizing an external I/O box to interface with compatible X-ray generators, in non-integrated mode. The modified device also retains the ability to apply the grid suppression feature. However, the modified device allows the operator to generate sequential radiographic images and electronically join them to create a single electronic image (a leg from hip to foot, for example). Stitching is a post-processing feature that allows the user to merge up to four (4) DICOM images and does not alter the original images. Using a digital flat panel detector, and a non-integrated generator, the Nexus DR Digital X-ray Imaging System (with Stitching) is capable of acquiring multiple digital radiographic images, processing and then displaying them in a high quality single image format to visualize long bones or other anatomical features such as the spine. The Nexus DR Digital X-ray Imaging System can then store the images on the local computer, archive them to CD/DVD media, transfer them to Hard Copy format via DICOM printers, or transfer them to PACS reviewing stations in DICOM format. ## Indications for Use: The Varex DR™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The DR™ Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software. The Varex DR™ Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography). {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made up of four vertical lines in different colors: blue, blue, yellow, and green. To the right of the "V" is the text "VAREX" in blue. Below the word "VAREX" is the word "IMAGING" in a smaller font size and in black. ## Technological Characteristics Comparison: The DR™ Digital X-ray Imaging System (with Stitching) supports the same modality as the predicate device with similar components or imaging concepts, has the same Indications for Use as the predicate device, and delivers equivalent image quality as the predicate device. The comparison chart below reveals that functions performed by the predicate device are performed by the modified device for the DR application. Therefore, the modified device is substantially equivalent to the predicate device. However, the modified device, DRTM Digital X-ray Imaging System, has the additional ability electronically join up to four (4) DICOM images into a single electronic image. All other features and functions remain unchanged. The DR™ Digital X-ray Imaging System (with Stitching) operating in RAD Mode (Panel Acquisition Mode) is designed to communicate with X-ray generators that provide Select, Prep and Request signals. The DR™ Digital X-ray Imaging System (with Stitching) utilizes an external I/O box to interface with compatible X-ray generators; not integrated. If an X-ray generator does not provide Select, Prep and Request signals, vTrigger Mode (AED) is used; thus no connection to the generator is required. | Feature/Item | Nexus DR™<br>Digital X-ray Imaging<br>System (PaxScan<br>4343RC and<br>4343Rv3) | InfiStitch for i5™<br>Digital X-Ray<br>Imaging System | Nexus DR™<br>Digital X-ray Imaging<br>System (Stitching) | |------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------| | Device Type | Primary Predicate<br>Device | Reference Predicate<br>Device | Subject Device | | 510 (k) Number | K161459 | K101833 | TBD | | Flat Panel<br>Detector | Varian PaxScan<br>4343RC/4343Rv3 | Similar | Same | | Detector<br>Material | a-Si sensor array with<br>CsI or Gd2O2S:TB<br>scintillator | Same | Same | | Detector<br>Dimensions | 17" x 17" | Same | Same | | Pixel<br>Size | 139 x 139 microns | Similar | Same | | Detector<br>Element Matrix | 3072 x 3072 | Similar | Same | | Dynamic<br>Range | 16 bits | Same | Same | | Uniform<br>Density | 1.52 | Same | Same | | Feature/Item | Nexus DR™ Digital X-ray Imaging System (PaxScan 4343RC and 4343Rv3) | InfiStitch for i5™ Digital X-Ray Imaging System | Nexus DR™ Digital X-ray Imaging System (Stitching) | | Device Type | Primary Predicate Device | Reference Predicate Device | Subject Device | | 510 (k) Number | K161459 | K101833 | TBD | | Spatial Resolution | 3.2 lp/mm | Similar | Same | | Sensitivity | 540 @ 1.1uGy/frame<br>1206 @ 3.9uGy/frame<br>4290 @ 10uGy/frame<br>12804@ 30uGy/frame<br>(16-bit subject panel) | Similar | Same | | Signal to Noise Ratio | 73 @ 2.8uGy/frame<br>117 @ 7uGy/frame<br>174 @ 17uGy/frame<br>285 @ 50uGy/frame | Similar | Same | | Modulation Transfer Function | 0.551 @ 1cycle/mm<br>0.234 @ 2cycles/mm<br>0.099 @ 3cycles/mm | Similar | Same | | Detective Quantum Efficiency | 0.232 @ 1cycle/mm<br>0.15 @ 2cycles/mm<br>0.07 @ 3cycles/mm | Similar | Same | | External Connectivity | DICOM<br>3.0 Compatible | Same | Same | | Operator Console | Graphical User Interface | Same | Same | | Image Processor | Intel CPU Based PC | Same | Same | | Image Storage | Hard Drive | Same | Same | | Operating System | Windows 10 | Similar | Same | | Total Image Processing Time | 10 seconds per image | Same | Same | | Power Requirements | 110/120V,<br>230/240V,<br>50/60 Hz | Same | Same | | Stitching | No | Yes | Yes | ## Comparison Chart: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made up of three vertical lines in blue, yellow, and green. To the right of the "V" is the word "VAREX" in blue, with the word "IMAGING" in smaller, gray letters below it. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made up of four vertical lines in different colors, followed by the text "VAREX" in a dark blue sans-serif font. Below the word "VAREX" is the word "IMAGING" in a smaller, lighter font. #### Non-clinical Tests Discussion: Non-clinical Data submitted is consistent with FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State Xray Imaging Devices" available at the website http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc m073781.pdf. Validation was completed in accordance with the Validation Protocols included with this submission. Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria. In conclusion, all release criteria have been met and the Nexus DR™ Digital X-ray Imaging System (with Stitching) is as safe and effective as the predicate devices and does not raise different questions of safety and effectiveness. ### Clinical Tests Discussion: Previously acquired sequential radiographic images from the Reference Predicate Device (InfiStitch for i5™ Digital X-Ray Imaging System) were used to establish, at a minimum, substantial equivalency for images processed by the Subject Device (Nexus DR™ Digital X-ray Imaging System (with Stitching)). Based on the image comparison study performed; images provided by the Subject Device (DR™ Digital X-ray Imaging System (with Stitching)) along with bench testing results provide enough evidence to demonstrate that the Subject Device (DR™ Digital X-ray Imaging System (with Stitching)) is as safe and effective as the predicate devices and does not raise different questions of safety and effectiveness. #### Standards and Guidance Documents: Electrical Safety and EMC Standards The modified device conforms to these consensus standards and has passed all relevant required testing: - AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012; ● Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - . IEC 60601-1-2 Edition 3: 2007-03: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests (2007) ## Data Storage and Exchange Standards The DRTM Digital X-ray Imaging System is designed to meet American College of Radiology / American College of Cardiology / National Electrical Manufacturers Association DICOM. Version 3.0, Parts 1 through 8, Part 10 (Media Storage and File Formats), Part 11 (Media Storage Applications Profiles) and Part 12 (CD-R Annex): - . NEMA PS 3.1 - 3.20; Digital Imaging and Communications in Medicine (DICOM) Set (2011) ## Radiation Control The DRTM Digital X-ray Imaging System meets the requirements of the Radiation Performance Standards of 21 CFR Subchapter J. applicable Sections 21 CFR 1020.30. 1020.31 and 1020.32. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made up of four vertical lines in different colors: blue, yellow, green, and blue. To the right of the "V" is the text "VAREX" in a dark blue sans-serif font. Below "VAREX" is the word "IMAGING" in a smaller, lighter blue sans-serif font. aging Corporation Any video monitors chosen for this application meet the requirements of the Radiation Performance Standards of 21 CFR Subchapter J, applicable Section 21 CFR 1020.10. Optical disk storage devices (reader and writer) comply with Radiation Performance Standards of 21 CFR Subchapter J, applicable Section 21 CFR 1040.10. ### Guidance The following guidance documents were considered and utilized in the development of the modified device. Applicable identified requirements derived from these guidance documents have been met. - Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices ● - How to Prepare a Special 510(k) - Guidance for Content of Premarket Submissions for Software Contained in Medical Devices ● - Deciding When to Submit a 510(k) for a Change to and Existing Device - Pediatric Information for X-ray Imaging Device Premarket Notifications - Applying Human Factors and Usability Engineering to Medical Devices - Use of Symbols in Medical Device Labeling - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices ● - Refuse to Accept Policy for 510(k)s - eCopy Program for Medical Device Submissions - Global Unique Device Identification Database (GUDID) ## Conclusion: Based upon the results of Verification and Validation testing, the DR™ Digital X-Ray Imaging System (Stitching) has no new indications for use, has no significant technological differences, and is as safe and effective as, does not raise different questions of safety and effectiveness and is therefore substantially equivalent to the above listed current legally marketed predicate device.