The document is a letter from the FDA regarding a 510(k) submission from Shanghai United Imaging Healthcare Co., Ltd. for their uMC 560i mobile C-arm X-ray system. The FDA determined the device is substantially equivalent to legally marketed predicate devices. Shanghai United Imaging Healthcare Co., Ltd. can now market the uMC 560i, subject to general controls and other applicable regulations and standards. The letter provides information on labeling requirements, adverse event reporting, and other regulations the sponsor must comply with regarding the device.
The document is a letter from the FDA regarding a 510(k) submission from Shanghai United Imaging Healthcare Co., Ltd. for their uMC 560i mobile C-arm X-ray system. The FDA determined the device is substantially equivalent to legally marketed predicate devices. Shanghai United Imaging Healthcare Co., Ltd. can now market the uMC 560i, subject to general controls and other applicable regulations and standards. The letter provides information on labeling requirements, adverse event reporting, and other regulations the sponsor must comply with regarding the device.
The document is a letter from the FDA regarding a 510(k) submission from Shanghai United Imaging Healthcare Co., Ltd. for their uMC 560i mobile C-arm X-ray system. The FDA determined the device is substantially equivalent to legally marketed predicate devices. Shanghai United Imaging Healthcare Co., Ltd. can now market the uMC 560i, subject to general controls and other applicable regulations and standards. The letter provides information on labeling requirements, adverse event reporting, and other regulations the sponsor must comply with regarding the device.
The document is a letter from the FDA regarding a 510(k) submission from Shanghai United Imaging Healthcare Co., Ltd. for their uMC 560i mobile C-arm X-ray system. The FDA determined the device is substantially equivalent to legally marketed predicate devices. Shanghai United Imaging Healthcare Co., Ltd. can now market the uMC 560i, subject to general controls and other applicable regulations and standards. The letter provides information on labeling requirements, adverse event reporting, and other regulations the sponsor must comply with regarding the device.
℅ Shumei Wang QM & RA VP No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, Shanghai 201807 CHINA
Re: K183144 Trade/Device Name: uMC 560i Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: November 27, 2018 Received: November 29, 2018
Dear Shumei Wang:
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 (reporting of medical device-related adverse events) (21 CFR 803) for 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-reporting- K183144 - Shumei Wang Page 2
combination-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-devices/medical-device-safety/medical-device-reporting- mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical- devices/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-devices/device-advice-comprehensive-regulatory- assistance/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,
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 Shanghai United Imaging Healthcare Co., Ltd. T e l: +86 (21) 67076888 Fax：+86 (21) 67076889 www.united-imaging.com
Trade Name: uMC 560i Common Name: Mobile C-arm X-Ray System Model(s): uMC 560i Regulatory Information Classification Name: Image-intensified fluoroscopic x-ray system Classification: Product Code: OWB, OXO, JAA Regulation Number: 21 CFR 892.1650 Review Panel: Radiology
4. Identification of Predicate Device(s)
Predicate Device 510(k) Number: K153244 Device Name: Cios Fusion Manufacturer: Siemens AG Regulatory Information Classification Name: Image-intensified fluoroscopic x-ray system Classification: II Product Code: OWB, OXO Regulation Number: 21 CFR 892.1650 Review Panel: Radiology Reference Device
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510(k) Number: K181560
Device Name: Cios Alpha Manufacturer: Siemens AG
Regulatory Information Classification Name: Image-intensified fluoroscopic x-ray system Classification: II Product Code: OWB, OXO Regulation Number: 21 CFR 892. 1650 Review Panel: Radiology
5. Device Description
uMC 560i is the first mobile C-arm X-ray system developed and produced by UIH Medical XR Business Unit. It is designed to meet medical institutions’ demands. To cover the most surgical imaging needs, it’s X-ray imaging of the anatomical structures of patient during clinical applications may include, but are not limited to: orthopedic, pain therapy, neurological, pediatric examinations and critical care. uMC 560i consists of C-arm, Monoblock, Anti-scatter Grid, CMOS flat panel detector, Collimator system, Exposure handswitch, Exposure footswitch, Connects cables for Monitor cart and C-arm mobiles stand, Monitor cart, Touchable control panel, HD monitor, Examination workstation. The powerful system performance brings a safe, fluent and efficient operation experience.
6. Indications for Use
The uMC 560i is intended to provide digital imaging of patients during diagnostic and surgical procedures. Examples of clinical application may include, but are not limited to: orthopedic, pain therapy, neurological, pediatric examinations and critical care. The visualization of such anatomical structures assists the clinician with clinical decisions. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
7. Performance Data
Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as it is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated Text) Medical electric for basic safety and essential performance (IEC 60601-1:2005, MOD). IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral
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Standard: Radiation protection in diagnostic X-ray equipment.
IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability. IEC 60601-2-28 Edition 2.0 2010-03 Medical electrical equipment –Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis. IEC 60601-2-43 Edition 2.1 2017-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures. IEC 60601-2-54 CONSOLIDATED VERSION Edition 1.1 2015-04 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes. IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Clinical Test Conclusion
The fluoroscopy sequences images and static images produced by the uMC 560i in clinical environment accompanied by exposure mode, exposure parameters and anatomical regions were provided in the clinical evaluation. Both dynamic and static images were reviewed by a board-certified clinical reviewer with a statement indicating that images are of diagnostic quality.
8. Substantially Equivalent (SE) Comparison
Table 1 Comparison of Device Functionality and Specification
ITEM Proposed Device Predicate Device Remark uMC 560i Siemens Cios Fusion (K153244) General Mobile Yes Yes Same Fluoroscopic C-arm Product Code OWB, OXO OWB, OXO Same Class II II Same Indications for The uMC 560i is intended to The Cios Fusion is a mobile X- Note 1 Use provide digital imaging of Ray System designed to patients during diagnostic and provide X-ray imaging of the surgical procedures. anatomical structures of patient Examples of clinical during clinical applications. application may include, but Clinical applications may
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are not limited to: orthopedic, include but are not limited to: pain therapy, neurological, interventional fluoroscopic, pediatric examinations and gastrointestinal, endoscopic, critical care. The urologic, pain management, visualization of such orthopedic, neurologic, anatomical structures assists vascular, cardiac, critical care the clinician with clinical and emergency room decisions. This device does procedures. The patient not support direct population may include radiographic film exposures pediatric patients. and is not intended for use in performing mammography. Specifications Imaging Pulsed Fluoroscopy Pulsed Fluoroscopy Note 2 Modes Spot Fluoroscopy Continuous Fluoroscopy Digital Radiography Digital Radiography X-ray Tube Stationary Anode Stationary Anode Same X-ray Yes Yes Same Generator and Tube Housing Assembly Monoblock Technology KV Range 40 kV – 110 kV 40 kV – 110 kV Same Max Power 3.5 kW 2.3 kW Note 3 Output Pulsed 0.1 mA - 30 mA 3 mA - 25 mA Note 4 Fluoroscopy Current Displays 34’’ TFT Flat Screen Color 19’’ TFT Flat Screen Color Note 5 Display Panel Display Panels Collimator Yes, Pd, Rectangular and Slot Yes, Pd, Rectangular and Slot Same Collimator Collimator SID 107.5 cm 102 cm Note 6 Removable Yes Yes Same Anti-scatter Grid Dose Area Yes Yes Same Product Monitor Cart Mandatory Monitor Cart Mandatory Monitor Cart Same User Interface Yes, Touch Panel Yes, Touch Panel Same Dose uFree Dose Management Siemens CARE Program Note 7 Optimization Technology DICOM Yes Yes Same Function
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2D Image Post Yes Yes Same
Processing Safety Electrical AAMI ANSI ES60601- Comply with AAMI/ANSI ES Same Safety 1:C1:2009/(R)2012 and 60601-1(IEC 60601-1:2005) A2:2010/(R)2012 EMC Comply with IEC60601-1-2 Comply with IEC60601-1-2 Same Biocompatibili Comply with ISO10993-5, Comply with ISO10993-5, Same ty ISO10993-10 ISO10993-10
Table 2 Comparison of Flat Panel Detector Specification
ITEM Proposed Device Reference Device Remark uMC 560i Siemens Cios Alpha (K181560) Specifications of Flat Panel Detector Image CMOS Flat Panel Detector CMOS Flat Panel Detector Same Receptor XINEOS 2222HS XINEOS 3030HS or XINEOS 2222HS DQE 75% 75% (XINEOS 2222HS) Same 72% (XINEOS 3030HS) Dynamic 96dB 96dB Same Range Modulation 60%@1lp/mm 60%@1lp/mm(XINEOS Same Transfer 2222HS) Function 58%@1lp/mm(XINEOS (MTF) 3030HS) Digitization 16bit 16bit Same Depth Field of View Square, 21.5 cm × 21.5 cm Square, 20 cm × 20 cm Note 8 (XINEOS 2222HS) Square, 30 cm × 30 cm (XINEOS 3030HS) Pixel Size 151.8 μm 152 μm Same Matrix Size 1416 × 1420 1416 × 1420 Same (XINEOS 2222HS) 1952×1952 (XINEOS 3030HS)
Table 3 Justifications of Differences
Note ID Justification uMC 560i and the predicate devices are all used for providing digital imaging of adults and pediatric during diagnostic and surgical procedures. Note 1 The difference is that uMC 560i is not intended to be used during interventional, which does not affect the clinical application of uMC 560i. The difference does not affect safety and effectiveness.
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Compared to predicate devices Siemens Cios Fusion (K153244),
uMC 560i does not provide continuous fluoroscopy, whose fundamental principle and clinical application are the same with pulsed fluoroscopy. The difference does not affect safety and effectiveness. uMC 560i also provides spot fluoroscopy, whose fundamental Note 2 principle is the same with pulsed fluoroscopy. The difference between spot fluoroscopy and pulsed fluoroscopy is that radiation stops automatically when meeting target grey level, but the image quality is the same with LIH of pulsed fluoroscopy. The difference does not affect safety and effectiveness. Note 3 3.5 kW has the ability to provide higher mA at lower kV levels allowing shorter pulse widths at variable frame rates to increase the image quality of moving objects by reducing or eliminating the movement during each single pulse. The difference in maximum power output does not affect safety and effectiveness. Note 4 The pulsed fluoroscopy current of predicate devices can be covered by uMC 560i’s in clinical application. And the maximum current of uMC 560i is larger than predicate devices, which will improve the image quality of large patient. The difference in pulsed fluoroscopy current does not affect safety and effectiveness. Note 5 The display with larger size will improve user experience, which does not affect safety and effectiveness. Note 6 The slight difference of SID does not affect clinical application. The difference does not affect safety and effectiveness. Note 7 uMC 560i and the predicate devices all provide dose optimization method. Even though the principle is different, the effectiveness of uFree can be proven by Section 21 Software Design Description (Chapter 3.3.8). The difference does not affect safety and effectiveness. Note 8 uMC 560i and the reference device (K181560) both use the same flat panel detector. uMC 560i has a larger effective imaging area than Cios Alpha. The slight difference of Field of View does not affect clinical application. The difference does not affect safety and effectiveness.
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9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety and effectiveness as the predicate device. The differences above between the proposed device and predicate device do not affect the intended use, technology characteristics, safety and effectiveness. And no issues are raised regarding to safety and effectiveness. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
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