Models 2200DR and 1600DR Digital Stationary Radiographic Systems

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, wave-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 4, 2015 Beijing Polycon Medical Engineering Company % Daniel Kamm, P.E. Principal Engineer Kamm and Associates 8870 Ravello Court NAPLES FL 34114 Re: K151219 Trade/Device Name: Models 2200DR and 1600DR Digital Stationary Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MOB Dated: June 24, 2015 Received: June 30, 2015 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Robert A Ochs Robert Ochs. Ph.D. Acting 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) K151219 Device Name Models 2200DR and 1600DR Digital Stationary Radiographic Systems #### Indications for Use (Describe) The Models 2200DR and 1600DR Digital Stationary Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest. abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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) K151219 Submitter: Beijing Polycon Medical Engineering Company Building 9, Fu Wai Liang Jia Dian Street Hai Dian Qu , Beijing 100142, P.R. China Tel: 8610-8811-0881 Fax: 8610-88148957 Date Prepared: June 13, 2015 Contact: Xiangchen Liu, President #### 1. Identification of the Device: Proprietary-Trade Name: Models 2200DR and 1600DR Digital Stationary Radiographic Systems Classification Name: Stationary X-Ray System, Product codes KPR and MQB Common/Usual Name: Digital Diagnositc X-Ray System Device Class: II per regulation 21CFR892.1680 - 2. Equivalent legally marketed device: KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems, K143257, MedicaTech USA. Classification Name: Stationary X-Ray System. Product codes KPR and MOB Common/Usual Name: Digital Diagnositc X-Ray System Device Class: II per regulation 21CFR892.1680 - Indications for Use The Models 2200DR and 1600DR are intended for use by a qualified/trained doctor or 3. technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest. abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography. - Description of the Device: This device represents a new combination of an already cleared solid state digital 4. x-ray acquisition panel and software with the diagnostic x-ray compnents required to make a complete system. The digital panel is the Toshiba wired flat panel detector FDX-4343R, 17 in x 17in. (Cleared in K 143257 as well as other submissions.) The system has been tested with only this model of flat panel detector. The purchaser can select either a "C" arm configuration (1600DR) or an overhead tube crane configuration (2200DR). Please see the photos below. The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Toshiba (E7252X Series), and the collimator is the Ralco R302A. The system complies with the CDRH Radiological Health performance standard in the Code of Federal Regulations, as well as the voluntary IEC standards IEC 60601-1-2, and IEC60601-2-54. The systems include an AEC feature. - 5. Safety and Effectiveness, comparison to predicate device. This combination device has the same indications for use and very similar technological characteristics as the predicate device, and employs already 510(k) cleared digital panels and software. - 6. Substantial Equivalence Chart: Please see the next page. {4}------------------------------------------------ | Characteris<br>tic | KrystalRad 1100 and<br>KrystalRad 3000 Digital<br>Stationary Radiographic<br>Systems, K143257,<br>MedicaTech USA. | Models 2200DR and 1600DR<br>Digital Stationary<br>Radiographic Systems,<br>Beijing Polycon Medical<br>Engineering Company | Difference and Analysis | |-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended<br>Use: | KrystalRad Series is intended<br>for use by a qualified/trained<br>doctor or technician on both<br>adult and pediatric subjects for<br>taking diagnostic radiographic<br>exposures of the skull, spinal<br>column, chest. abdomen,<br>extremities, and other body<br>parts. Applications can be<br>performed with the patient<br>sitting, standing, or lying in<br>the prone or supine position.<br>Not for mammography. | Models 2200DR and 1600DR<br>Digital Stationary<br>Radiographic Systems are<br>intended for use by a<br>qualified/trained doctor or<br>technician on both adult and<br>pediatric subjects for taking<br>diagnostic radiographic<br>exposures of the skull, spinal<br>column, chest. abdomen,<br>extremities, and other body<br>parts. Applications can be<br>performed with the patient<br>sitting, standing, or lying in<br>the prone or supine position.<br>Not for mammography.<br>(SAME) | NO DIFFERENCE | | Configurati<br>on of<br>Digital<br>Panels | Battery or AC operated<br>wireless IEEE 802.11n or<br>Wired Ethernet | AC operated Wired Ethernet<br>only. | Difference: There is no<br>chance of wireless<br>interference with the Polycon<br>implementation. | | Digital<br>Panel<br>Models and<br>their<br>clearance<br>numbers | Vieworks/Medicatech<br>FXRD-1717SA/SB,<br>FXRD-1417SA/SB and<br>FXRD-1417WA/WB<br>(K130337)<br>Toshiba: FDX4343R/RPW,<br>FDX3543RP and<br>FDX3543RPW (Del Medical:<br>K140825; O&R: K131121;<br>Sedecal: K130883);<br>PerkinElmer: XRpad 4336<br>MED (K140551) | Toshiba: FDX4343R<br>Cleared in the Predicate<br>Device, K143257 | NO DIFFERENCE | | Image<br>acquisition<br>panel<br>specificatio<br>ns | FXRD-1717SA/SB: 3,072 x<br>3,072, 140μm<br>FXRD-1417SA/SB: 2560 x<br>3072, 140μm<br>FXRD-1417WA/WB: 2560 x<br>3072, 140μm<br>FDX4343R/RPW:<br>3008×3072, 143 μm<br>FDX3543RP: 2448×2984, 143<br>μm<br>FDX3543RPW: 2466×3040,<br>140μm<br>XRpad 4336 MED:<br>3556×4320, 100 μm | FDX4343R 3008×3072, 143<br>μm | NO DIFFERENCE | | Characteris<br>tic | KrystalRad 1100 and<br>KrystalRad 3000 Digital<br>Stationary Radiographic<br>Systems, K143257,<br>MedicaTech USA. | Models 2200DR and 1600DR<br>Digital Stationary<br>Radiographic Systems,<br>Beijing Polycon Medical<br>Engineering Company | Difference and Analysis | | AEC | YES | YES | NO DIFFERENCE | | DICOM | DICOM 3 | DICOM 3 | NO DIFFERENCE | | Image<br>acquisition<br>software | CrystalRad as cleared in<br>K130377 | ECOM Software | DIFFERENT SOFTWARE:<br>Software was as cleared in:<br>K130883. That submission<br>used the same Toshiba panel,<br>FDX4343R We verified<br>proper operation of the<br>ECOM software via Clinical<br>Testing. | | Power<br>Source | AC Line, various voltages<br>available | SAME | NO DIFFERENCE | | Photo | Krystalrad 3000 | 2200DR | NO DIFFERENCE | | Alternate<br>configurati<br>on | KrystalRad 1100 | 1600DR | NO DIFFERENCE | | Generator | CPI CMP 200DR | CPI CMP 200DR | NO DIFFERENCE | | Collimator | Ralco R302A | Ralco R302A | NO DIFFERENCE | | Tube Head | Toshiba | Toshiba | NO DIFFERENCE | | Performance<br>Standard | FDA 21CFR1020.30-31 | SAME | NO DIFFERENCE | | Electrical<br>safety | Electrical Safety per IEC-60601.<br>UL listed | SAME | NO DIFFERENCE | {5}------------------------------------------------ {6}------------------------------------------------ - Summary of non-clinical testing: We performed integration testing and risk analysis. The results of a 7. review of bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device. The device conforms to US Performance Standards. The device conforms to this list of voluntary standards: | Standards<br>No. | Standards<br>Organization | Standards Title | Version | Date | |-------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------| | 60601-1 | IEC | Safety of Electrical Medical Equipment | 2005 + A1<br>(2012) | 2005 + A1<br>(2012) | | 60601-1-2 | IEC | Electromagnetic Compatibility | 2007 | 2007 | | 60601-2-54 | IEC | Particular requirements for the basic safety and<br>essential performance of X-ray equipment for<br>radiography and radioscopy | 2009 1ed | 2009 | | PS 3.1 - 3.18<br>(2009) | NEMA | Digital Imaging and Communications in<br>Medicine (DICOM) Set (This applies to the<br>Digital Panel) | 3 | 2009 | - 8. Summary of clinical testing: Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (e.g., use of previously cleared detectors) but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended. - 9. Conclusion: After analyzing software integration validation, safety testing data, and clinical images, it is the conclusion of Beijing Polycon that the "Models 2200DR and 1600DR Digital Stationary Radiographic Systems" are as safe and effective as the predicate device, have few technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device.