Portable X-ray System

{0}------------------------------------------------ March 16, 2018 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Rolence Enterprise, Inc. % Sterling Cheng General Manager 18-3 Lane 231 Pu Chung Rd., Chungli Taovuan, 32083 TAIWAN Re: K172928 Trade/Device Name: XR-01 Portable X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: February 22, 2018 Received: February 23, 2018 Dear Sterling Cheng: 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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-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 Ochs. 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) K172928 Device Name XR-01 Portable X-Ray System Indications for Use (Describe) The XR-01 Portable X-Ray System is intended to be used by trained dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and child subjects | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------|---------------------------------------------| | × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | SEQUENCE OF INSTRUCTIONS #### 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 "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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for ROLENCE. The logo consists of two stylized "R" letters intertwined on the left. To the right of the logo is the company name in both Chinese and English. The English name "ROLENCE" is in larger, bold font, while the Chinese name is above it in a smaller font. ### 510(k) Summary | Date 510(k) Summary prepared | 2018/2/1 | |------------------------------|--------------------------------------------------------------------------------------------| | Submitter Name | Rolence Enterprise Inc.<br>Address: 18-3 Lane 231 Pu Chung Rd., Chungli, Taoyuan<br>Taiwan | | Contact Person | Jui-Ya Lai<br>Regulatory Affairs Quality Assurance Associate Manager | | Telephone | +886-3-4631999 | | FAX | +886-3-4631997 | | Device Information | | | Type of 510(k) Submission | Traditional | | Trade or Proprietary Name | XR-01 Portable X-Ray System | | Common or Usual Name | Portable X-ray System | | Regulation Name | Extraoral source x-ray system | | Regulation Number | 872.1800 | | Product Code | EHD | | Class of Device | Class II | | Panel | Radiology | - 1. Comparison with predicate devices: | | Subject<br>Device | Primary<br>Predicate<br>Device | Reference Devices | | | Source to skin distance | 200 mm | 210 mm | 100 mm | > 100 mm (fixed by cone) | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-------------------------------------|-------------------------------------|-------------------------|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | XR-01<br>Portable X-Ray<br>System | Nomad Pro<br>Intraoral X-<br>Ray system | Port-X II | DX-3000<br>Portable X-Ray<br>System | | X-ray field Size | 60 mm round | 60 mm round | 70 mm round | 50 mm round | | Regulation Number | 872.1800 | 872.1800 | 872.1800 | 872.1800 | | User Interface | Up-down buttons for exposure time selection with timer display. Additionally, several user-selectable preset times with patient size, image receptor type and tooth selection icon on control panel. | Up-down buttons for exposure time selection, with timer display. Additionally, several user-selectable preset times with patient size, image receptor type, and tooth selection icons on an LCD display. | Up-down buttons for exposure time selection with timer display. Additionally, several user-selectable preset times with patient size and tooth selection icons on an LCD display. | Up-down buttons for exposure time selection with timer display. Additionally, several user-selectable preset times with patient size and tooth selection icons on an LCD display. | | Regulation Name | Extraoral<br>source x-ray<br>system | Extraoral<br>source x-ray<br>system | Extraoral<br>source x-ray<br>system | Extraoral<br>source x-ray<br>system | | Backscatter radiation protection | Available as optional accessory | 171.45 mm dia. Pb-filled acrylic plastic scatter shield | None | Available as optional accessory | | Regulatory Class | II | II | II | II | | Exposure Switch | Exposure button at front body | Trigger on Handset | Exposure button at x-ray control panel | Exposure button at front body | | Primary Product Code | EHD | EHD | EHD | MUH | | Tube head mounting | Handheld or on a tripod | Handheld | Handheld or on a tripod | Handheld | | Applicant Name | Rolence<br>Enterprise Inc. | Aribex Inc. | Genoray Co.,<br>Ltd. | Dexcowin Co.,<br>Ltd. | Electrical | Energy source | Rechargeable 25.2 V DC Lithium Polymer battery pack | Rechargeable 22.2 V DC Lithium Polymer battery pack | Rechargeable 22.2 V DC Lithium Polymer battery pack | Rechargeable 16.8 V DC Lithium Polymer battery pack | | 510(k) Number | - | K081664 | K063121 | K133007 | | Exposure time | 0.01 – 2.00 seconds in 0.01 steps | 0.02 - 1.00 seconds in 0.01 increments | 0.01 - 2.0 seconds in 46 steps | 0.05 - 1.35 seconds in 0.01 steps | | INTENDED USE | All four systems are intended as extraoral X-ray sources to be<br>used with intraoral image receptors for diagnostic imaging by<br>dentist or dental technicians. | | | | | mA | 2 mA fixed | 2.5 mA fixed | 2 mA fixed | 2 mA | | Mechanical Size (mm) | 174 x 178 x<br>257 | 266.7 x 133.35<br>x 304.8 | 197 x 147 x<br>145.5 | 139 x 163.5 x<br>66.5 | | kVp | 60 kVp fixed | 60 kVp fixed | 60 kVp fixed | 60 kvp | | | Waveform | Constant Potential (DC) | Constant Potential (DC) | Constant Potential (DC) | Constant Potential (DC) | | | | | | | | Duty Cycle | 1:30 | 1:60 | N/A | 1:60 | | | | | | | Applied Standards | | IEC 60601-1 | IEC/EN | UL/IEC | 21 CFR | | | | | | Rolence Enterprise Inc. No. 18-3, Lane 231, Pu chung Rd., Chungli, Taoyuan, 32083 Taiwan {4}------------------------------------------------ Rolence Enterprise Inc. No. 18-3, Lane 231, Pu chung Rd., Chungli, Taoyuan, 32083 Taiwan {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains a logo for a company called "ROLENCE". The logo consists of two stylized "R" letters, one in blue and one in white, placed next to each other. To the right of the "R" letters, the company name "ROLENCE" is written in blue, with some Chinese characters above it. The Chinese characters are likely the company name in Chinese. | EN 60601-1-2, 60601-1,<br>IEC 60601-1-<br>3,<br>IEC 60601-2-<br>65,<br>IEC 62133<br>21 CFR<br>1020.30,<br>21 CFR | IEC 60601-1-<br>3, IEC 60601-<br>2-7, 21 CFR<br>1020.30,<br>21 CFR<br>1020.31 | 60601-1,<br>EN 60601-1-2, IEC 60601-1-2 21 CFR<br>IEC 60601-2-<br> 7,<br>21 CFR<br>1020.30,<br>21 CFR<br>1020.31 | 1020.30,<br>1020.31 | |------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------| | 1020.31 | | | | ### Device Description XR-01, a portable X-ray system is mainly designed for dental diagnosis via X-ray exposure with intraoral image receptors, supplied with 25.2 V DC rechargeable Li-ion polymer battery. The portable X-ray system consist of an x-ray generator with an x-ray tube, device controller, beam limiting device, AC-DC power supply, charging unit and optional back scatter shield. ### Indication for Use The XR-01 Portable X-Ray System is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and child subjects. #### Performance Testing Subject device XR-01 complies with safety and performance standards which are in accordance with 21 CFR 1020.30 and 31. Performance test validate that accuracy, reproducibility, deviation and linearity of technical factors such as tube voltage, tube current and exposure time is meet the criteria. Safety tests in terms of HVL, leakage, x-ray field size meet Federal standard requirements. #### Standards and Guidance Documents #### Electrical Safety and EMC Standards - IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 ● - EN 60601-1-2:2015 - IEC 60601-1-3:2008 (Second Edition) + A1:2013 for use in conjunction with IEC 60601-1:2005 (Third Edition) + A1:2012 - IEC 60601-1-6:2010 (Third Edition) + A1:2013 - IEC 60601-2-65:2012 (First Edition) for use in conjunction with IEC 60601-1:2005 (Third edition) #### Battery Safety Standards - IEC 62133:2012 (Second Edition) #### Usability Standards - IEC 62366: 2007 (First Edition) + A1: 2014 #### Radiation Control - 21 CFR 1020.30 - 21 CFR 1020.31 {6}------------------------------------------------ ## Guidance - Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use - How to Prepare a Special 510(k) - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Pediatric Information for X-ray Imaging Device Premarket Notifications - Applying Human Factors and Usability Engineering to Medical Devices - . . . . 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 ## Conclusion The subject device and predicate devices have same intended use and principle of operation. Also, both of them met Federal regulations 21 CFR Part 1020.30, 1020.31 and international medical device safety standard. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Rolence Enterprise Inc. concludes that the Portable X-Ray System (XR-01) is safe and effective and substantially equivalent to predicate devices as described herein.