Jumong Series

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 13, 2016 SG HealthCare Co., Ltd. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114 Re: K150816 Trade/Device Name: Jumong Series Stationary Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB Dated: March 20, 2015 Received: March 27, 2015 Dear Mr. Kamm: This letter corrects our substantially equivalent letter of May 8, 2015 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 {1}------------------------------------------------ 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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. Michael D'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) K150816 Device Name Jumong Series Stationary Radiographic Systems ### Indications for Use (Describe) The Jumong Series Stationary Radiographic System is 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) | | |-----------------------------------------------------------------------------------------------------|-----------------------------------------------| | <span style="font-family: Arial, sans-serif;">☑</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}------------------------------------------------ ## 510(K) Summary, 510(k) K150816 Submitter: SG Healthcare Co., Ltd. 753 ITECO, 150 Jojeong-Daero, Hanam-Si, Gyeonggi-Do, 465-736 Korea Tel : +82-70-7011-6161 FAX : +82-31-737-4954 Contact: YOSEP PARK, sales@sghealthcare.com Date Prepared: April 11, 2015 #### 1. Identification of the Device: Proprietary-Trade Name: Jumong Series Stationary Radiographic System Classification Name: Stationary X-Ray System, Product codes KPR and MQB Common/Usual Name: Diagnositc X-Ray System Device Class: II per regulation 21CFR 892.1680 #### 2. Equivalent legally marketed device: K133782, Sedecal Nova FA DR System, Sedecal SA. - 3. Indications for Use The Jumong Series is 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. - 4. Description of the Device: This device represents a new combination of an already cleared solid state digital x-ray acquisition panel with software and diagnostic x-ray compnents required to make a complete system. Film cassettes may be employed in place of the digital panel. The purchaser can select from one of four configurations. Please see the photos below. The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Varian (RAD-14), and the collimator is the Ralco R225 ACS DHHS. 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 and IEC 60601-1-2. All major components are either UL or CSA listed. - Safety and Effectiveness, comparison to predicate device. This combination device has the same 5. 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}------------------------------------------------ | Characteristic | Sedecal Nova FA K133782 | SG Healthcare, Co. Ltd., Jumong Series<br>Stationary Radiographic System | |---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use: | Sedlecal "NOVA FA DR System" is<br>intended for use by a qualified, trained<br>doctor or technician on both adult and<br>pediatric subjects for taking diagnostic<br>radiographic exposures of the skull,<br>spinal column, chest. abdomen,<br>extremities, and other body parts.<br>Applications can be performed with<br>the patient sitting, standing, or lying in<br>the prone or supine position. Not for<br>mammography. | Jumong Series is intended for use by a<br>qualified, trained doctor or technician on<br>both adult and pediatric subjects for taking<br>diagnostic radiographic exposures of the<br>skull, spinal column, chest. abdomen,<br>extremities, and other body parts.<br>Applications can be performed with the<br>patient sitting, standing, or lying in the<br>prone or supine position. Not for<br>mammography. | | Configuration<br>of Digital<br>Panels | Battery or AC operated wireless IEEE<br>802.11n or Wired Ethernet | SAME | | Digital Panel<br>Models and<br>their clearance<br>numbers | CXDI Canon Detector 401C/401C<br>Compact (K103591)<br>CXDI Canon Detector 55C (K091436)<br>CXDI Canon Detector 501C<br>(K111682) | Vieworks<br>K122865 Vivix-S Wireless<br>K122866 Vivix-S With Vxvue<br>K120020 Vivix-S | | Image<br>acquisition<br>panel<br>specifications | 3,320 x 3,408 125 µm (401C) or<br>2,208 x 2,688 pixels 160 µm (55C)<br>2,800 x 3,408 Pixels 125 µm (501C) | FXRD-1717SA, FXRD-1717SB)<br>3,072 x 3,072, 140µm or<br>FXRD-1417SA, FXRD-1417SB)<br>2560 x 3072, 140μm<br>Wireless: FXRD-1417WA, FXRD-<br>1417WB, 2560 x 3072, 140μm | | DICOM | DICOM 3 | DICOM 3 | | WiFi Wireless<br>IEEE802.11n<br>(All others are<br>Ethernet<br>Tethered.) | Not applicable, but compatible with<br>all Canon panels, including wireless. | K122865 Vivix-S Wireless | | Image<br>acquisition<br>software | CANON cleared in K111682 | Vieworks as cleared in K122866 Vivix-S<br>With Vxvue | | Power Source | AC Line. various voltages available | SAME | | Characteristic | Sedecal Nova FA K133782 | SG Healthcare, Co. Ltd., Jumong Series Stationary Radiographic System | | Photos | Image: Sedecal Nova FA K133782 | Image: Jumong M<br>Image: Jumong General<br>Image: Junong E | | Alternate<br>configuration | Sedecal X-Plus LP Plus, K090238<br>Sedecal | Image: Jumong U | | Generator | Sedecal SHF | CPI CMP 200DR | | Collimator | Ralco R225 | Ralco R225 | | Characteristic | Sedecal Nova FA K133782 | SG Healthcare, Co. Ltd., Jumong Series<br>Stationary Radiographic System | | Performance<br>Standard | FDA 21CFR1020.30-31 | SAME | | Electrical safety | Electrical Safety per IEC-60601. UL listed | SAME | {5}------------------------------------------------ {6}------------------------------------------------ - 7. Summary of non-clinical testing: We performed integration testing. The results of a 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 | | 60601-1-3: | IEC | Collateral Standard Radiation protection in<br>diagnostic X ray equipment | 2008 | 2008 | | 60601-1-6 | IEC | Collateral standard: Usability | 2010 3ed.<br>+A1:2013 | 2010-2013 | | 60601-2-28 | IEC | Particular requirements for the basic safety and<br>essential performance of X-ray tube assemblies<br>for medical diagnosis | 2010, 2ed | 2010 | | 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 | | 62366 | IEC | Application of usability engineering to medical<br>devices | 2007-1ed | 2007 | | 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 SG Healthcare that the "Jumong Series" is as safe and effective as the predicate device, has few technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device.