GR40CW

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION". July 20, 2018 Samsung Electronics Co., Ltd. % Jaesang Noh Senior Professional, Regulatory Affairs 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do 16677 REPUBLIC OF KOREA Re: K181631 Trade/Device Name: GR40CW Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: June 15, 2018 Received: June 20, 2018 Dear Jaesang Noh: 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 (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-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, Hole 2. Nils 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) K181631 Device Name GR40CW Indications for Use (Describe) The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications. | X Prescription Use (Part 21 CFR 801 Subpart D)<br>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<br>time to review instructions, search existing data sources, gather and maintain the data needed and complete<br>and review the collection of information. Send comments regarding this burden estimate or any other aspect<br>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." Type of Use (Select one or both, as applicable) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/3/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold, sans-serif font. The text is placed on a blue, rounded, oval-shaped background. # 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: June 15, 2018 ## 2. Submitter - A. Company Name: SAMSUNG ELECTRONICS Co., Ltd. - B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16677, Republic of Korea ## 3. Primary Contact Person - A. Name: JAESANG NOH & CHUNSIN KIM - B. Title: Requlatory Affairs, Senior Professional - C. Phone Number: +82-2-2193-2444 & +82-2-2193-2437 - D. FAX Number: +82-31-200-6401 - E. E-Mail: jaesang.noh@samsung.com & chulsin.kim@samsung.com ## 4. Secondary Contact Person - A. Name: Genci Omari - B. Title: Manager, Regulatory Affairs - C. Phone Number: 978-564-8602 - D. FAX Number: 978-560-0602 - E. E-Mail: gomari@samsungneurologica.com #### 5. Proposed Device - A. Trade Name: GR40CW - B. Device Name: GR40CW - C. Common Name: Retrofit Kit - D. Regulation Name: Stationary x-ray system - E. Product Code: MQB - F. Regulation: 21 CFR 892.1680 #### 6. Predicate Devices | | Predicate Device #1 | Predicate Device #2 | |----------------------|----------------------------------|-------------------------------------------| | Manufacturer | SAMSUNG ELECTRONICS<br>Co., Ltd. | SAMSUNG ELECTRONICS<br>Co., Ltd. | | Device Name | GR40CW | GM85 | | Common Name | Retrofit Kit | Digital Diagnostic Mobile X-ray<br>System | | Regulation Name | Stationary x-ray system | Mobile X-ray System | | Product Code | MQB | IZL | | Regulation | 21 CFR 892.1680 | 21 CFR 892.1720 | | 510(k) Number | K180543 | K171119 | | 510(k) Decision Date | May 24, 2018 | May, 12, 2017 | {4}------------------------------------------------ 510(k) Premarket Notification - Traditional ## 7. Device Description The GR40CW digital X-ray imaging system consists of Detector, Power supply box, Battery pack, Battery charger, Access point, CIB(Control Interface Box), Workstation, Barcode scanner, Main cable and software for image acquisition and image processing and does not include the X-ray generator. This system is used to capture 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 GR40CW digital X-ray imaging system was previously cleared with K180543, and through this premarket notification, we would like to add more configurations in the previously cleared GR40CW as three detectors are newly added, and some software features called as SimGrid, S-Enhance, BSI (Bone Suppression Image), Remote View and manual Stitching are newly added as stated below. SimGrid software option, cleared with K171119. is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical anti-scatter grid. BSI software option suppresses bone anatomy and S-Enhance is renamed from Tube & Line Enhancement (TLE), which was cleared before with the predicate device GM85 at K171119, to enhance visibility of tubes and lines and provide enhanced images separately from original images. In this submission, the scope of S-Enhance is expanded from tubes and lines on chest images to foreign body (e.g. tubes, lines and needles) and urinary stones on chest, abdomen, and L-spine. And Manual Stitching to capture a body part that is larger than the detector's by capturing multiple images and Remote View function to remote access to view the current image on the workstation through a web browser. It was determined that the level of concern for the software contained in the GR40CW digital X-ray imaging system was Moderate in accordance with the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Device". #### Integration Information This is a retrofit system consisting of Detectors, Power supply box, Battery charger, Access point, CIB (Control Interface Box), Workstation, Barcode scanner and Main cable. This retrofit system is designed to generate a digital image while using the current analogue X-ray system by upgrading only the part of an analogue cassette film to the digital panel(detector), and does not get involved in controlling X-ray radiation related parameters, which is still controlled by the existing X-ray system. The GR40CW retrofit system can be applied to the existing analogue X-ray system by two ways (CIB and AED modes). 1) In CIB mode, CIB is only connected to a signal line of a hand switch for passively detecting the signal, as On or Off, coming out from the hand switch to the X-ray Generator Console, to make the digital detector ready to active or inactive to receive Xray radiation. 2) In AED (Automatic Exposure Detection) mode, without CIB, the detector is sensing of radiation exposure. Once it recognizes the exposure, it become active right away to receive X-ray radiation. This whole process is independently operated from the existing {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed on a blue, rounded, rectangular background. 510(k) Premarket Notification - Traditional analogue X-ray system. Image /page/5/Figure/3 description: The image shows two integration diagrams, one for CIB mode and one for AED mode, of a GR40CW Retrofit Kit with an existing X-ray system. The CIB mode diagram shows the GR40CW Retrofit Kit consisting of a detector, workstation, and CIB, connected to the existing X-ray system, which includes an X-ray generator console and a hand switch. The AED mode diagram shows the GR40CW Retrofit Kit consisting of a detector and workstation, connected to the existing X-ray system, which includes an X-ray generator console and a hand switch. The diagrams illustrate the flow of signals and the components involved in each mode. In conclusion, this retrofit kit does not either require a modification / alteration or control in the part of X-ray radiation control of the current X-ray system in anyway. ## 8. Intended Use The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used. This device is not intended for mammographic applications. ## 9. Summary of Technological characteristic of the proposed device compared with the predicate device The proposed device GR40CW apply the software feature as S-Enhance, which were cleared with K171119, to GR40CW product which was cleared with K180543 without changes in technical characteristics, materials, energy sources and biocompatibility such as X-ray Tube Assembly except of detector. Optional three detectors which were improved durability and dust/water-resistance are added to GR40CW. Comparisons of technological characteristics were executed and demonstrate the substantial equivalence to the predicate. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the SAMSUNG logo. The logo is in a blue oval shape. The word "SAMSUNG" is written in white letters inside the oval. 510(k) Premarket Notification - Traditional #### A. Comparing with Predicate Device | Specification | Predicate<br>Device #1 | Proposed<br>Device | Predicate<br>Device #2 | Discussion | |---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Device Name | GR40CW | GR40CW | GM85 | | | Manufacturer | SAMSUNG<br>ELECTRONICS<br>Co., Ltd. | SAMSUNG<br>ELECTRONICS<br>Co., Ltd. | SAMSUNG<br>ELECTRONICS<br>Co., Ltd. | | | 510(k) Number | K180543 | None | K171119 | | | Appearances | Image: GR40CW Digital X-ray Imaging System | Image: GR40CW Digital X-ray Imaging System | Image: GM85 Digital Mobile X-ray imaging System | Same as PD#1 | | Intended Use | The GR40CW<br>Digital X-ray<br>Imaging System<br>is intended for<br>use in general<br>projection<br>radiographic<br>applications<br>wherever<br>conventional<br>screen-film<br>systems or CR<br>systems may be<br>used. This<br>device is not<br>intended for<br>mammographic<br>applications. | The GR40CW<br>Digital X-ray<br>Imaging System<br>is intended for<br>use in general<br>projection<br>radiographic<br>applications<br>wherever<br>conventional<br>screen-film<br>systems or CR<br>systems may be<br>used. This<br>device is not<br>intended for<br>mammographic<br>applications. | The GM85<br>Digital Mobile X-<br>ray imaging<br>System is<br>intended for use<br>in generating<br>radiographic<br>images of<br>human anatomy<br>by a<br>qualified/trained<br>doctor or<br>technician. This<br>device is not<br>intended for<br>mammographic<br>applications. | Same as PD#1 | | Manufacturer<br>Contents | GR40CW<br>(K180543) | GR40CW | GM85<br>(K171119) | Discussion | | | | | | |--------------------------|-------------------------------------------|--------------------------------------------------------------------------------|-------------------------------|------------------|------------------|------------------|-------------|---------|--| | (1) Detector | | | | | | | | | | | Name | S4335-WV<br>S4335-W<br>S4343-W<br>S3025-W | S4335-WV<br>S4335-W<br>S4343-W<br>S3025-W<br>S4335-AWV<br>S4335-AW<br>S4343-AW | S4335-W<br>S4343-W<br>S3025-W | Difference(1) | | | | | | | | S433<br>5-W | S43<br>35-<br>WV | S434<br>3-W | S433<br>5-<br>AW | S43<br>35-<br>AW | S434<br>3-<br>AW | S4335-<br>W | S4343-W | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the SAMSUNG logo. The logo is in a blue box with the word "SAMSUNG" in white letters. The letters are bold and sans-serif. # SAMSUNG ELECTRONICS Co., Ltd. 510(k) Premarket Notification - Traditional | Manufacturer<br>Contents | GR40CW<br>(K180543) | GR40CW | | | GM85<br>(K171119) | | Discussion | | | |----------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------|---------------------------------|---------------------------------------------------------------------------------------------|---------------------------------|---------------------------------|---------------------------------------------------------------------------------------------|------------------------------|---------------------| | | | | V | | | | | | | | Detector Type | CsI | Gd2O2S | CsI | CsI | Gd2O2S | CsI | CsI | Same as PD#1 | | | | Indirect | Indirect | Indirect | Indirect | Indirect | Indirect | Indirect | Same as PD#1 | | | Detector Area | 14"X 17"(<br>345 mm<br>X425m m) | 14"X 17"(<br>345 mm<br>X425m m) | 17"X 17"(<br>425 mm<br>X425m m) | 14"X 17"(<br>345 mm<br>X425m m) | 14"X 17"(<br>345 mm<br>X425m m) | 17"X 17"(<br>425 mm<br>X425m m) | 14"X17"<br>(345mm<br>X425m m) | 17"X17"<br>(425mmX<br>425mm) | Same as PD#1 | | Number of pixels | 2466X3<br>040 | 2466X3<br>040 | 3036X3<br>040 | 2466X3<br>040 | 2466X3<br>040 | 3036X3<br>040 | 2466X3<br>040 | 3036X30<br>40 | Same as PD#1 | | Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | 140 | 140 | Same as PD#1 | | High Contrast<br>Limiting<br>Resolution<br>(LP/mm) | 3.57 | 3.5 | 3.57 | 3.57 | 3.5 | 3.57 | 3.57 | 3.57 | Same as PD#1 | | Communication | Wire d /<br>Wireless | Wire d /<br>Wireless | Wire d /<br>Wireless | Wire d /<br>Wireless | Wire d /<br>Wireless | Wire d /<br>Wireless | Wired /<br>Wireless | Wired /<br>Wireless | Same as PD#1 | | Dust/Water-<br>resistance | IPx1 | | | IP54 | | | IPx1 | | Difference(1)<br>-1 | | Max.load<br>capacity | 150 kg for uniform load,<br>100 kg for local load (40 mm in<br>diameter disk at the center) | | | 400 kg for uniform load,<br>200 kg for local load (40 mm in<br>diameter disk at the center) | | | 150 kg for uniform load,<br>100 kg for local load<br>(40 mm in diameter disk at the center) | | Difference(1)<br>-2 | | Manufacturer<br>Contents | GR40CW<br>(K180543) | GR40CW | GM85<br>(K171119) | Discussion | |--------------------------|---------------------|-------------|-------------------|-----------------| | (2) Software Features | | | | | | | - | SimGrid | SimGrid | Same as<br>PD#2 | | | - | S-Enhance | TLE | Difference(2) | | Feature<br>Names | S-Share | S-Share | S-Share | Same | | | - | BSI | BSI | Same as<br>PD#2 | | | - | Remote View | | Difference(3) | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue background. The logo is simple and recognizable, and it is associated with the Samsung brand. 510(k) Premarket Notification - Traditional | Manufacturer<br>Contents | GR40CW<br>(K180543) | GR40CW | GM85<br>(K171119) | Discussion | |--------------------------|---------------------|------------------|-------------------|---------------| | | - | Manual Stitching | - | Difference(4) | | No | Differences | Explanation | |-----------|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | (1)-<br>1 | Dust/Water-resistance | The new detectors which are added to the GC85A device<br>have better dust/water-resistance than the predicate<br>device's dust/water-resistance and this change does not<br>contribute any adverse impact to the device's safety and<br>effectiveness. | | (1)-<br>2 | Max.load capacity | The new detectors which are added to the GC85A device<br>have higher max load capacity than the predicate device's<br>max load capacity and this change does not contribute any<br>adverse impact to the device's safety and effectiveness. | | (2) | S-Enhance | S-Enhance is renamed from Tube & Line Enhancement<br>(TLE), which was cleared with K171119, is to enhance<br>visibility of tubes and lines and provide enhanced images<br>separately from original images. This software feature is<br>applied to the GC85A with the scope of application for S-<br>Enhance, which is expanded from tubes and lines on chest<br>images to foreign body (e.g. tubes, lines and needles) and<br>urinary stones on chest, abdomen and L-spine images.<br>This change is considered low risk and does not contribute<br>any adverse impact to the device's safety and<br>effectiveness. | | (3) | Remote View | The function of Remote View, which allows remote access<br>to view the current image on the workstation through a<br>web browser, is applied to the GR40CW and this change<br>does not contribute any adverse impact to the device's<br>safety and effectiveness. | | (4) | Manual Stitching | Manual Stitching can capture a body part that is larger<br>than the detector's area by capturing multiple images. This<br>function is considered low risk and does not contribute any<br>adverse impact to the device's safety and effectiveness. | #### Safety, EMC and Performance Data B. Electrical, mechanical, environmental safety and performance testing were conducted according to standard ES 60601-1(2012), and EMC testing was conducted according to IEC 60601-1-2(2007). Wireless function was tested and verified followed by the guidance for Radio frequency Wireless Technology in Medical Devices. All test results were satisfying with the standards. #### C. 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 shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device. {9}------------------------------------------------ 510(k) Premarket Notification - Traditional #### D. Clinical data Phantom image evaluations for the new detector and S-Enhance were performed in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. Anthropomorphic phantom images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (note X-ray flat-panel detector similar to the predicate detector) but they provide further evidence in addition to the performance data to show that the complete system works as intended. They were evaluated by professional radiologists and found to be equivalent to the predicate devices. There is no significant difference in the average score considering the standard deviation of image quality evaluation between the proposed device and the predicate device and it is confirmed that S-Enhance is able to generate a companion image which provide clear visibility for foreign bodies such as lines, and needles, and urinary stones in chest, abdomen, and L-spine protocol in addition to the original images. Therefore, these changes do not affect either the safety or the effectiveness, compared to the predicated device. #### E. Conclusions The results of the non-clinical data & clinical data demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed devices. Image /page/9/Picture/7 description: The image shows the Samsung logo. The logo is in blue and the word "SAMSUNG" is written in white, uppercase letters. The logo is in a slightly tilted oval shape.