Digital Diagnostic Mobile X-ray System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the left side of the image. To the right of the text is a symbol consisting of three stylized human profiles facing right, connected by flowing lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 15, 2016 Samsung Electronics Co., Ltd. % Chulsin Kim Regulatory Affairs Manager 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi-do 16677 REPUBLIC OF KOREA Re: K162278 Trade/Device Name: GM85 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL, MQB Dated: October 24, 2016 Received: October 26, 2016 Dear Chulsin Kim: 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. Michael 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K162278 Device Name GM85 Indications for Use (Describe) The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <div style="display:inline-block;"> <svg height="15px" width="15px"> <rect fill="white" height="15px" stroke="black" width="15px" x="0" y="0"></rect> <path d="M2,2 L13,13 M13,2 L2,13" stroke="black"></path> </svg> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <div style="display:inline-block;"> <svg height="15px" width="15px"> <rect fill="white" height="15px" stroke="black" width="15px" x="0" y="0"></rect> </svg> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (8/14) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the Samsung logo. The logo is in blue and features the word "SAMSUNG" in white, uppercase letters. The logo is tilted slightly upwards. 510(k) Premarket Notification - Traditional ## Section 5: 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92 - 1. Date: August 10, 2016 ## 2. Submitter - Company Name: SAMSUNG ELECTRONICS Co., Ltd. A. - Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16677, B. Republic of Korea ### 3. Primary Contact Person - Name: KIM, CHULSIN A. - B. Title: Regulatory Affairs Manager - C. Phone Number: +82-31-200-7661 - FAX Number: +82-31-200-1199 D. E-Mail:chulsin.kim@samsung.com ## 4. Secondary Contact Person - A. Name: Ninad Gujar - B. Title: Director, Regulatory & Quality - C. Phone Number: 978-564-8503 - D. FAX Number: 978-750-6677 E-Mail: ngujar@samsungneurologica.com ## 5. Proposed Device - A. Trade Name: GM85 - B. Device Name: GM85 - C. Common Name: Digital Diagnostic Mobile X-ray System - D. Classification Name: Mobile X-ray System - E. Product Code: IZL & MQB - Regulation: 21 CFR 892.1720 ட் ### 6. Predicate Devices | | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | |----------------------|-------------------------|-------------------------|----------------------------------------| | Device Name | GM60A-32S,<br>GM60A-40S | GC85A | ClearRead +Confirm | | Classification Name | MobileX-ray system. | Stationary X-ray System | System, Image Processing, Radiological | | Product Code | IZL | KPR | LLZ | | Regulation | 21 CFR 892.1720 | 21 CFR 892.1680 | 21CFR 892.2050 | | 510(K)# | K150097 | K160997 | K123526 | | 510(K) Decision Date | February 19, 2015 | April 02, 2015 | December 27, 2012 | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The font is sans-serif and bold, and the letters are evenly spaced. The blue oval is tilted slightly to the left. 510(k) Premarket Notification - Traditional #### 7. Device Description The GM85 Digital Mobile X-ray imaging System is the equipment that captures images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images. The SimGrid is an additional image processing software option which is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical anti-scatter grid of all kinds of anatomical regions. The SimGrid is available as options to be exclusively installed in S-station, which is a Samsung Digital X-ray operation S/W, while this post-image processing software does not depend on how the image is acquired, or with what acquisition device. The Tube & Line Enhancement (TLE) is that after generating a normal post processing image, pressing the TLE button will create a companion view. For making a better tube & line look in chest radiography, input raw image is processed by using stronger contrast and detail enhancement algorithm. This supports clearer visibility of tube & lines than normal post processing image. TLE is available as options to be exclusively installed in S-station, which is a Samsung Digital X-ray operation S/W, while this post-image processing software does not depend on how the image is acquired, or with what acquisition device. The Pediatric Exposure Management provides subdivided patient size and exposure conditions of chest and abdomen radiographs specially optimized for pediatric patients. It helps an optimal dose for radiographic procedures of pediatric patients by providing guidance of optimized exposure conditions according to patient's weight and procedures. #### 8. Intended Use The GM85 Digital Mobile X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. The SimGrid is a technology that enhances the visibility of major clinical equipment by compensating for the decrease in contrast that is caused by scatter radiation of all kinds of anatomical regions. The Tube & Line Enhancement enhances the visibility of tube and line to support radiologists or ICU clinicians who may need to find tubes and line on chest radiographs by trained professionals, such as physician, radiologists, and technicians. The Pediatric Exposure Management support radiologists to select suitable patient's size or take steps to serve an optimal exposure conditions to the lowest possible levels {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the Samsung logo. The logo is in blue and the word "SAMSUNG" is written in white, bold letters. The logo is slightly tilted. 510(k) Premarket Notification - Traditional especially for the pediatric patients. - 9. Summary of Technological characteristic of the proposed device compared with the predicate devices The proposed device, GM85, has same detectors and image processing as predicate devices so it does not have significant changes in image characteristics compare to the predicate device #1 & #2, GM60A and GC85A. SimGrid, optional post-image processing software, has same image processing technology as SimGrid of predicate device, SimGrid technology is possible to applying to all kinds of anatomical regions where scatter radiation cause the contrast decrease. Specific description is added to make it clear with the non-clinical data, because the description of the predicate device was not mentioned about the target anatomical regions specifically. Tube & Line Enhancement (TLE) and ClearRead +Confirm (K123526) are the same kind of function in that both include software with the ability to enhance visibility of tube and line. These are also provided in addition to the application and used to assistant tool for radiologist. Pediatric Exposure Management is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols. It follows same methodologies to define preset of patient size compare to preset of standard patient size from predicate device but specially optimized for pediatric patients. The gantry of GM85 is newly designed to enhance coverage of tube head and usability but it has same structures of battery powered system, wheel based movable body, builtin console, rotational collapsible column, extractable arm and rotational tube head as predicate device #1 GM60A so it does not have significant changes in acquiring radiographic images compare to predicate device #1 GM60A. Comparisons of the following technological characteristics were assessed and the results demonstrate the substantial equivalence to the predicates. A. Comparing with Predicate Device #1 and #2 The proposed device is shown as its parts are identical or equivalent with predicate device #1 or #2 while some differences are made as below, which does not show significant difference in safety and effectiveness. | Specifica<br>tion | Predicate Device #2 | Proposed Device | Predicate Device #1 | Discussi<br>on | |-------------------|----------------------------------|----------------------------------|----------------------------------|----------------| | Device<br>Name | GC85A | GM85 | GM60A-32S, 40S | | | Manufac<br>turer | SAMSUNG<br>ELECTRONICS co., ltd. | SAMSUNG<br>ELECTRONICS co., ltd. | SAMSUNG<br>ELECTRONICS co., ltd. | | | 510(k)<br>Number | K160997 | - | K150097 | | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the SAMSUNG logo. The logo is in a blue box with the word SAMSUNG in white letters. The logo is simple and recognizable. 510(k) Premarket Notification - Traditional | Appearances | | | | Difference(1) | |-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | Intended<br>Use | Image: GC85A digital X-ray imaging system | Image: GM85 Digital Mobile X-ray imaging System | Image: GM60A Digital Mobile X-ray Imaging System | Same | | | The GC85A digital X-ray imaging system is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | The GM85 Digital Mobile X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | The GM60A Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | | | Manufacturer Contents | Predicate Device #2 | GM85 | Predicate Device #1 | Discussion<br>n | | | |-----------------------|---------------------|--------------------------------------|--------------------------------------|----------------------------------|-----------------|---------------| | (2)Tube assembly | | | | | | | | Moving<br>Range | Horizontal | 1680~4180mm | 793~1355mm | 700~1250mm | Difference(2) | | | | Vertical | 1030~3030mm | 550~2030mm | 550~2020mm | Difference(2) | | | Tube | Target Angle | 12° | 14° | 12° 16° | Difference(3) | | | Collimator | | SDR-<br>OGCL80U<br>212X300X1<br>79mm | SDR-<br>OGCL83U<br>212X306<br>X179mm | SDR-OGCL40U<br>212 X 306 X 179mm | RALCO R221 DHHS | Difference(4) | | Manufacturer Contents | Predicate Device #2 | GM85 | Predicate Device #1 | Discussion | |---------------------------------------|---------------------|---------|---------------------|---------------| | (6) Software Feature | | | | | | SimGrid | SimGrid | SimGrid | - | Difference(5) | | Tube & Line<br>Enhancement(TLE) | - | TLE | - | Difference(6) | | Pediatric Exposure<br>Management(PEM) | - | PEM | - | Difference(7) | | S-Align | S-Align | S-Align | - | Difference(8) | | No | Differences | Explanation | |-----|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | (1) | Appearance | The gantry of GM85 is newly designed to enhance coverage of tube head<br>and usability but it has same structures of battery powered system, wheel<br>based movable body, built-in console, rotational collapsible column,<br>extractable arm and rotational tube head as predicate device #1 GM60A.<br>So it does not have significant changes in acquiring radiographic images<br>compare to predicate device #1, GM60A. | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the Samsung logo. The logo is in blue and white. The word "SAMSUNG" is written in white letters on a blue background. 510(k) Premarket Notification - Traditional | (2) | Moving Range | Extended coverage of proposed device GM85 can be more helpful to set<br>position than predicate device #1, GM60A. | |-----|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | (3) | Tube Target Angle | Tube target angle is maximized while focal spot is maintained 0.6/1.2mm<br>for proposed device GM85. Larger target angle increases X-ray beam<br>coverage and enhances usability. Tube target angle 14° of proposed<br>device GM85 does not have significant changes in image characteristics<br>compare to tube target angle between 12° and 16° of predicate device #1<br>GM60A. | | (4) | Collimator | Collimator (SDR-OGCL40U) of proposed device, GM85 has same design<br>compare to collimator (SDR-OGCL80U) of predicate device #2, GC85A but<br>collimator(SDR-OGCL40U) of proposed device, GM85 has some<br>mechanical changes to mount sub display unit on it from predicate device<br>#2 GC85A. So it does not have significant changes in performance<br>compare to predicate device #2 GC85A. | | (5) | SimGrid | SimGrid, optional post-image processing software, has same image<br>processing technology as SimGrid of predicate device #2 GC85A. SimGrid<br>technology is possible to applying to all kinds of anatomical regions where<br>scatter radiation cause the contrast decrease. Specific description is added<br>to make it clear with the non-clinical data, because the description of the<br>predicate device #2 was not mentioned about the target anatomical regions<br>specifically. | | (6) | Tube & Line<br>Enhancement (TLE) | Tube & Line Enhancement (TLE) is optional software to make an additional<br>image with enhanced tube and line besides original post processing image.<br>It focused on enhancement of tubes and lines regardless of patient size and<br>should be used only as an assistant tool. (Refer to the comparing with<br>predicate device #3) | | (7) | Pediatric Exposure<br>Management (PEM) | Pediatric Exposure Management is subdivided patient size and exposure<br>conditions especially for pediatric patients based on weight and protocols. It<br>follows same methodologies to define preset of patient size compare to<br>preset of standard patient size from predicate device but specially<br>optimized for pediatric patients. | | (8) | S-Align | S-Align of proposed device GM85 has same design but GM85 is operated<br>only in manual compare to predicate device GC85A and it doesn't<br>contribute adverse impacts to the device safety and performance. | ## B. Comparing with Predicate Device #3 | Specification | Predicate Device #3 | Proposed Device | Discussion | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | Device Name | ClearRead +Confirm | GM85 | - | | Manufacturer | Riverain Technologies, LLC | SAMSUNG ELECTRONICS co., ltd. | - | | 510(k) Number | K123526 | None | - | | S/W Feature<br>Name | ClearRead +Confirm 1.0 | Tube & Line Enhancement | - | | Intended Use | ClearRead +Confirnm is intended to<br>generate an enhanced secondary digital<br>radiographic image of the chest to<br>facilitate confirmation of line/tubes. The<br>enhanced AP or PA image of the chest<br>provides improved visibility of lines and<br>tubes. The ClearRead +Confirm image<br>provides adjunctive information and is not | Tube & Line Enhancement (TLE)<br>software generates a companion image<br>which can provide clear visibility of tubes<br>and lines in addition to the original chest<br>radiograph. Since the image generated<br>by TLE is intended to be used to assist | Difference(6) | {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, sans-serif font, set against a blue, oval-shaped background. The oval is tilted slightly, giving the logo a dynamic appearance. 510(k) Premarket Notification - Traditional | a substitute for the original PA/AP image.<br>This device is intended to be used by<br>trained professionals, such as<br>physicians, radiologists, and technicians,<br>on patients with lines and tubes and is<br>not intended to be used on pediatric | provided with the original diagnostic<br>chest radiograph. TLE software is<br>intended to be used by qualified/ trained<br>doctors or technicians on patients with<br>tubes and lines. | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | No | Differences | Explanation | |-----|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | (6) | Intended Use | Since TLE software amplify specific frequencies suitable for tubes and lines<br>partially, it does not depend on the size of patients. Therefore TLE software<br>can be used for all patients including the pediatric patient. So it does not have<br>significant changes in performance compare to predicate device #3. | ### C. Safety, EMC and Performance Data Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1,IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Wireless function was tested and verified followed by quidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards. #### D. Non-clinical data Non-clinical testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 62220-1. The proposed device has same detectors so it shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device #1 and #2. SimGrid software, 510(k) cleared before with predicate device #2 was evaluated with various phantoms at various exposure conditions demonstrating that SimGrid processing gives the better local contrast than images acquired without a grid at expanded anatomical regions. Tube & Line Enhancement(TLE) was evaluated with the phantom. After input image is acquired with chest phantom which is inserted tube line, the normal post image and TLE image are created. Then, the three images are compared in terms of the tube & line contrast. This evaluation proves that TLE processing gives the better tube and line visibility than original post processing. ### E. Clinical data In clinical data, phantom image evaluations were performed in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. They were evaluated by a professional radiologist and found to be equivalent to the predicate devices. Evaluated 30case of phantom image includes eight parts of the body. ### F. Conclusions The non-clinical and clinical data demonstrate that the proposed device is as safe, as {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the text "SAMSUNG ELECTRONICS Co., Ltd." in a bold, sans-serif font. The text is arranged on a single line, with the company name in all caps. The words "Co." and "Ltd." are abbreviated and separated by a comma. Image /page/9/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue oval shape. 510(k) Premarket Notification - Traditional effective, and performs as well as the legally marketed predicate devices #1, #2 and #3.