PowerDR

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words. Radiology Information Systems, Inc. % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114 August 16, 2019 ### Re: K191504 Trade/Device Name: PowerDR™ Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, MQB Dated: June 3, 2019 Received: June 6, 2019 Dear Mr. Kamm: 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/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 mediation-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. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191504 Device Name PowerDR™ Indications for Use (Describe) The PowerDR Digital X-ray Imaging System is indicated for use as an X-ray imaging modality to acquire, process, display, quality assure and store digital medical X-ray images. The PowerDR Digital X-ray Imaging System is indicated for use in general radiographic and fluoroscopic examinations of any anatomy for adult, pediatric, and neonatal patients. It is not indicated for use in mammography. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ 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}------------------------------------------------ 510(k) Summary 510(k) Number K191504 Image /page/3/Picture/1 description: The image shows the logo for RADinfo SYSTEMS. The logo consists of the text "RADinfo SYSTEMS" in bold black letters, with the word "RADinfo" being larger than the word "SYSTEMS". Below the text is the tagline "Delivering Solutions that Meet Your Vision" in a smaller, lighter font. To the right of the text is a blue circular graphic with a stylized letter "R" inside. Radiology Information Systems, Inc. 43676 Trade Center Place, Ste 100 Dulles, VA 20166 Ph: 703-713-3313 Fx: 703-713-3343 www.radinfosystems.com Contact/Prepared by: Chen-Tai Ma Ph.D. Contact Title CEO and President Date Prepared: August 9, 2019 - 1. Identification of the Device: Trade/Device Name: PowerDR™ Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA, MQB - 2. Equivalent legally marketed device: K130318, Varian Medical Systems, X-Ray Products-InfiMed Trade/Device Name: Nexus DRF Digital X-ray Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA, MQB - 3. Indications for Use (intended use) The PowerDR™ Digital X-ray Imaging System is indicated for use as an Xray imaging modality to acquire, process, display, quality assure and store digital medical X-ray images. The PowerDR™ Digital X-ray Imaging System is indicated for use in general radiographic and fluoroscopic examinations of any anatomy for adult, pediatric, and neonatal patients. It is not indicated for use in mammography. (Rx Only) - 1. Description of the Device: The PowerDR™ Console Application is a digital medical X-ray imaging system consisting of an X-Ray detector, computer hardware and the PowerDR™ software. The User supplies the X-Ray generator. The PowerDR™ Console Application is intended to enable a procedure of medical image acquisition, processing, display, quality assurance, and storage. The software interfaces to an X-Ray detector from variety of vendors to acquire raw pixel data. Its image-processing algorithms transform raw pixel data into diagnostic quality images and image sequences to aid the medical professional in diagnosis. For temporary storage, image data can be stored on the local computer. For long term storage, image data can be stored on a portable media device or a remote PACS (Picture Archive and Communication System) server. The PowerDR™ Digital X-ray Imaging System is intended for use in general radiographic and fluoroscopic examinations of any anatomy for adult, pediatric, and neonatal patients. It is not intended for use in mammography. The system can be sold with or without a computer, and with or without a compatible, previously cleared, digital receptor panel. The computer requirements are: Intel Core i5-8500, 6 Core, 9MB Cache, 3.0GHz, 4.1Ghz Turbo w/ HD Graphics 630, Win 10 Pro 64, 8x DVD+/-RW 9.5mm Optical Disk Drive, (2) 3.5 inch 1TB 7200rpm SATA Hard Disk Drives RAID 1, 8GB RAM, Intel Integrated Graphics, 22" display monitor 1920x1080 at 60 Hz. If the customer buys only the software, they are required to install and keep up to date one of the anti-virus programs cited in our User Manual. In addition the device conforms to the applicable provisions EPRC regulations, 21 CFR 1020.30, 1020.31, and 21 CFR 1020.32. {4}------------------------------------------------ - 4. Safety and Effectiveness, comparison to predicate device. The results of image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate devices. All of the proposed panels have previously received FDA 510(k) clearances. ## 5. Substantial Equivalence Chart | Characteristic | Predicate Device | Proposed Device | | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | Identification | K130318, Varian Medical Systems, X- Ray<br>Products-InfiMed , Trade/Device Name:<br>Nexus DRF Digital X-ray Imaging System | RADinfo SYSTEMS, Digital X-ray Imaging<br>Products, Trade/Device Name:<br>PowerDR™ Console Application | | | Intended Use: | The InfiMed i5 Digital X-ray Imaging<br>System is a high resolution digital imaging<br>system intended to replace conventional<br>film techniques, or existing digital systems,<br>in multipurpose or dedicated applications<br>specified below. The i5 Digital X-ray<br>Imaging System enables an operator to<br>acquire, display, process, export images to<br>portable media, send images over a<br>network for long term storage and<br>distribute hardcopy images with a laser<br>printer. | The PowerDR™ Digital X-ray Imaging<br>System is indicated for use to acquire,<br>process, display, quality assure and store<br>digital medical X-ray images. The<br>PowerDR™ Digital X-ray Imaging System is<br>indicated for use in general radiographic<br>and fluoroscopic examinations of any<br>anatomy for adult, pediatric, and neonatal<br>patients. It is not indicated for use in<br>mammography.<br>(similar) | | | Description | Digital image software application | Same | | | Where used | Radiology department and medical<br>imaging center use in general<br>radiographic examinations and<br>applications. For the RF/DSA application,<br>the InfiMed i5 Digital X-ray Imaging<br>System is intended for use where general<br>fluoroscopy, interventional fluoroscopy or<br>angiography imaging procedures are<br>performed. | Radiology department and medical imaging<br>center use in general radiographic<br>examinations and applications. For the<br>RF/DSA application, the PowerDR™ Digital<br>X-ray Imaging System is intended for use<br>where general fluoroscopy, interventional<br>fluoroscopy or angiography imaging<br>procedures are performed. SAME | | | image<br>processing | Image processing algorithms enable the<br>operator to bring out diagnostic details<br>difficult to see using conventional imaging<br>techniques. | The image processing software, used<br>with a cleared DR device, provides<br>diagnostic quality images to aid<br>physicians with diagnosis. | | | image Storage | Images can be stored locally for temporary<br>storage. | Same | | | Image data<br>source | A variety of image receptors from<br>commercially available flat panel<br>detectors. | Same | | | Configuration | Digital Panel, a connected personal<br>computer, and installed application<br>software. | Same | | | Primary Digital<br>Panel | Varex/PaxScan 4343CB flat panel<br>detector | Multiple panels supported: Pixium;<br>Careray; Varex/XRPad2. Only FDA cleared<br>panels are supported. See detailed list<br>below. | | | Characteristic | Predicate Device | Proposed Device | | | System<br>Software | Installed on a Microsoft Windows PC<br>(Windows 10 64 bit) | Same | | | Image<br>data<br>format | The input and output image pixel data is<br>the raster data. The photometric<br>representation of the image pixel data is<br>provided. | Same | | | Image<br>presentation | Enhanced Visualization Processing<br>(EVP) | Same | | | Application<br>software | Enhanced GUI for easy navigation | Same | | | Tracking<br>Xray dose | Dose recording from generator | Same | | | Fluoro<br>image<br>processing | Advanced contrast and edge<br>enhancement | Same | | | MutiRad image | Support last image hold and review<br>previous frames | Same | | | Dose and<br>processing<br>Auto optimized | Based on selected Fluoro frames rate<br>and magnification | Same | | | Quality<br>Assurance | Support various quality assurance<br>tools | Same | | | DICOM 3.0<br>Conformance | Yes | Yes | | | IHE<br>Integration<br>profile | Yes | Yes | | | Power source<br>(for required<br>computer) | 120 VAC | Same | | | Computer<br>Platform | Windows 10® 64 bit operating<br>system | Same, see computer requirements in<br>description above. | | | Manufacturer | Model Number | Static/Dynamic<br>Note: All Dynamic<br>panels can take Static<br>Images. | 510(k) Number | | Thales Pixium | RAD 4343 | Static | K133139 | | Thales Pixium | RAD 4143 | Static | K133139 | | Thales Pixium | RF 4343 | Dynamic | K150306 | | Thales Pixium | 3543 EZ | Static | K141440 | | Thales Pixium | 2430 EZ | Static | K141440 | | Careray | CareView 750C | Static | K163019 | | Careray | CareView 750Cw | Static | K163019 | | Careray | CareView 1500 L | Static | K153058 | | Careray | CareView 1500C | Static | K153058 | | Careray | CareView 1500Cw | Static | K150929 | | Careray | CareView 1500P | Static | K162178 | | Careray | CareView 1800L | Static | K153492 | | Careray | CareView 1800Cw | Static | K172581 | | Varex | XRpad2 4336 | Dynamic | K161966 | | Varex | XRpad2 3025 | Dynamic | K161942 | {5}------------------------------------------------ - 6. Summary of Bench Testing Conducted: This is a software product installed on a PC using Windows 10® 64 bit operating system which interfaces with FDA cleared digital x-ray receptor panels. All compatible digital panels have already received FDA clearances. See list below Risk Analysis and software validation was conducted in accordance with FDA guidance documents. All panels had been tested in accordance with the FDA guidance on Solid State Imaging Devices via their previous clearances. We employed these FDA guidance documents in the development of this software product: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Guidance for Industry and FDA Staff MAY 2005; AND Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff OCTOBER 2014. We also employed FDA recommendations in our labeling regarding imaging the pediatric population: Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Druq Administration Staff, November 2017. The user manual states: "Use special care when imaging patients outside the typical adult size range. Children are more radiosensitive than adults." {6}------------------------------------------------ Each available digital receptor panel has undergone a rigorous verification and validation procedure prior to addition to our line-up. ## List of Tested Panels - 7. Summary of Clinical Testing: Clinical testing was not necessary to establish substantial equivalence. All digital panels employed have received previous FDA clearance. - 8. Conclusion: After analyzing bench testing and risk analysis and compliance to the DICOM standard, it is the conclusion of Radiology Information Systems, Inc. that the PowerDR™ Digital X-ray Imaging System is as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.