GC85A

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 6, 2016 Samsung Electronics Co., Ltd. % Mr. Chulsin Kim Regulatory Affairs Manager 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi-do 443-742 REPUBLIC OF KOREA Re: K160997 Trade/Device Name: GC85A Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: April 7, 2016 Received: April 11, 2016 Dear Mr. 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 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) K160997 Device Name GC85A Indications for Use (Describe) 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. | | Type of Use (Select one or both, as applicable) | | |--|-------------------------------------------------|--| |--|-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ 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: April 07, 2016 ### 2. Submitter - Company Name: SAMSUNG ELECTRONICS Co., Ltd. A. - Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, 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: Regulatory Affairs Manager - C. Phone Number: 978-564-8503 - FAX Number: 978-750-6677 D. E-Mail: ngujar@samsungneurologica.com #### 5. Proposed Device - A. Trade Name: GC85A - B. Device Name: GC85A - C. Common Name: Digital Diagnostic X-ray System - D. Classification Name: System, X-ray, Stationary - E. Product Code: KPR - Regulation: 21 CFR 892.1680 ட் #### 6. Predicate Devices | | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | |------------------------|----------------------------|--------------------------------------------|-----------------------------| | Device Name | GC85A | FDR D-EVO FLAT<br>PANEL DETECTOR<br>SYSTEM | DRX-EVOLUTION | | Classification<br>Name | Stationary X-ray<br>System | Stationary x-ray<br>system. | Stationary x-ray<br>system. | | Product Code | KPR | MQB | KPR | | Regulation | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 | | 510(K)# | K150165 | K141765 | K141837 | | 510(K) | April 02, 2015 | October 03, 2014 | March 11, 2015 | {4}------------------------------------------------ 510(k) Premarket Notification - Traditional Decision Date ### 7. Device Description The GC85A digital X-ray imaging system is used to capture images by transmitting Xray 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 a post-image processing software option which is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical antiscatter grid. The Bone Suppression Image (BSI) is a post-image processing software option which provides companion images to assist diagnosis in addition to the images obtained from normal diagnosis protocol. The BSI software option suppresses bone anatomy to enhance visualization of chest pathology in a companion image that is delivered in addition to the original diagnostic image. The SimGrid and BSI are available as options to be exclusively installed in S-station, which is a Samsung Digital X-ray operation S/W, since this post-image processing software does not depend on how the image is acquired, or with what acquisition device. #### 8. Intended Use 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 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 when the portable grid is not used for portable images. Bone Suppression is a technology that helps to create images with good lung field visibility by removing part of the ribs and clavicle with S/W algorithms. It is used as diagnosis assistance for areas that the image reader is interested in, such as soft tissues and lesions in the lung field. ### 9. Summary of Technological characteristic of the proposed device compared with the predicate devices The proposed device, GC85A, has the same technological characteristics as its original predicate device, GC85A (K150165), and adds two post-image processing software features, SimGrid and BSI(Bone Suppression Image), and other minor software features such as S-Align & S-Guide, and hardware such as a collimator and a weight distribution cap. All features do not have significant change in materials, energy source or technological characteristics compared to the predicate devices #1, 2 & 3. #### A. Comparing with Predicate Device #1 | Specification | Predicate Device #1 | Proposed Device | Discussion | |---------------|---------------------|-----------------|------------| |---------------|---------------------|-----------------|------------| {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the SAMSUNG logo. The logo is in white text on a blue background. The logo is tilted slightly to the right. 510(k) Premarket Notification - Traditional | Device Name | GC85A | GC85A | - | | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|---------------| | Manufacturer | SAMSUNG ELECTRONICS<br>co., ltd. | SAMSUNG ELECTRONICS<br>co., ltd. | - | | | 510(k)<br>Number | K150165 | None | - | | | Appearances | Image: x-ray | Image: x-ray | Same | | | Intended Use | The GC85A digital X-ray<br>imaging system is intended<br>for use in generating<br>radiographic images of<br>human anatomy by a<br>qualified/trained doctor or<br>technician. This device is not<br>intended for mammographic<br>applications. | The GC85A Digital X-ray<br>Imaging System is intended<br>for use in generating<br>radiographic images of<br>human anatomy by a<br>qualified/trained doctor or<br>technician. This device is not<br>intended for mammographic<br>applications. | Same | | | Collimator | *NOTE: SDR-OGCL80U was cleared with K150165 | | | | | Model<br>Names | SDR-OGCL80U | SDR-<br>OGCL80U | SDR-<br>OGCL83U | | | Overall<br>size(mm) | H212 X W300<br>X D179 | H212 X<br>W300<br>X D179 | H212 X<br>W306<br>X D179 | Difference(1) | | Weight Distribution Cap | | | | | | Model Name | None | SDR-OGWD80U<br>W x L x H(mm):<br>505x553x37.4 | | Difference(2) | | Software Features | | | | | | Feature<br>Names | None | S-Align & S-Guide | | Difference(3) | | No | Differences | Explanation | |-----|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | (1) | Collimator<br>Overall Size | The new SDR-OGCL83U collimator has 6mm wider width than the<br>predicate device's collimator. It does not contribute adverse<br>impacts to the device safety and performance. | | (2) | Weight<br>Distribution Cap | As an accessory, it is introduced to prevent the detector from being<br>damaged by excessive force, which does not contribute adverse<br>impacts to the device safety and performance. | | (3) | S-Align & S-<br>Guide | S-Align is to display the tilt angle of the portable detector, and S-<br>guide is to display the values (stitching areas) required for image<br>capturing. Both don't contribute adverse impacts to the device<br>safety and performance. | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the SAMSUNG logo. The logo is in white text on a blue oval background. The text is in a bold, sans-serif font. 510(k) Premarket Notification - Traditional B. Comparing with Predicate Device #2 | B. Comparing with Predicate Device #2 | | | | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | Specification | Predicate Device #2 | Proposed Device | Discussion | | Device Name | FDR D-EVO FLAT PANEL<br>DETECTOR SYSTEM | GC85A | - | | Manufacturer | FUJIFILM Medical Systems<br>U.S.A Inc. | SAMSUNG ELECTRONICS<br>co., ltd. | - | | 510(k)<br>Number | K141765 | None | - | | Intended Use | The Wireless/Wired FDR D-<br>EVO flat panel detector<br>system is intended to<br>capture for display<br>radiographic images of<br>human anatomy. It is<br>intended for use in general<br>projection radiographic<br>applications including<br>pediatric and neonatal<br>exams wherever<br>conventional film/screen or<br>CR systems may be used.<br>The FDR D-EVO is not<br>intended for mammography,<br>fluoroscopy, tomography,<br>and angiography<br>applications. | The GC85A Digital X-ray<br>Imaging System is intended<br>for use in generating<br>radiographic images of<br>human anatomy by a<br>qualified/trained doctor or<br>technician. This device is not<br>intended for mammographic<br>applications. | Difference(1) | | S/W Feature<br>Name | Virtual Grid Software | SimGrid | - | | S/W<br>description | The Virtual Grid Software is<br>designed to improve image<br>contrast in general<br>radiographic images by<br>reducing the effects of<br>scatter radiation, primarily<br>for exams acquired without a<br>grid | The SimGrid is a technology<br>that enhances the visibility of<br>major clinical equipment by<br>compensating for the<br>decrease in contrast that is<br>caused by scatter radiation<br>when the portable grid is not<br>used for portable images | Same | | No | Differences | Explanation | |-----|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | (1) | Intended Use | The intended use of both devices is different, but the s/w feature's application is same as the post-image processing software, which does not contribute adverse impacts to the device safety and performance. | ### C. Comparing with Predicate Device #3 | Specification | Predicate Device #3 | Proposed Device | Discussion | |---------------|---------------------|-----------------|------------| | Device Name | DRX-EVOLUTION | GC85A | - | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters against a blue background. The logo has a slightly curved shape, with the top and bottom edges of the blue background curving inward. 510(k) Premarket Notification - Traditional | Manufacturer | FUJIFILM Medical Systems<br>U.S.A Inc. | SAMSUNG ELECTRONICS<br>co., ltd. | - | No | Differences | Explanation | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-----|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k)<br>Number | K141837 | None | - | (1) | Intended Use | The intended use of both devices is different, but the s/w feature's<br>application is same as the post-image processing software, which<br>does not contribute adverse impacts to the device safety and<br>performance. | | Intended Use | The device is a permanently<br>installed diagnostic x-ray<br>system for general<br>radiographic x-ray imaging<br>including tomography. The<br>tomography feature is not to<br>be used for imaging pediatric<br>patients. | The GC85A Digital X-ray<br>Imaging System is intended<br>for use in generating<br>radiographic images of<br>human anatomy by a<br>qualified/trained doctor or<br>technician. This device is not<br>intended for mammographic<br>applications. | Difference(1) | | | | | S/W Feature<br>Name | Bone Suppression | Bone Suppression Image | - | | | | | S/W<br>description | Bone Suppression can<br>improve visibility of lung<br>nodules and other pathology<br>by suppressing the<br>appearance of posterior ribs<br>and clavicles. | Bone Suppression is a<br>technology that helps to<br>create images with good<br>lung field visibility by<br>removing part of the ribs and<br>clavicle with S/W algorithms.<br>It is used as diagnosis<br>assistance for areas that the<br>image reader is interested<br>in, such as soft tissues and<br>lesions in the lung field. | Same | | | | #### 10. 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 guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards. #### 11. 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 {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded rectangle. #### 510(k) Premarket Notification - Traditional DQE measurements from the predicate device #1. SimGrid software was evaluated with various phantoms at various exposure conditions to demonstrate that SimGrid processing gives the better local contrast than images acquired without a grid. The qualitative side including usefulness was validated by a radiographer using clinical images which was proved in 'Clinical data' section. #### 12. Clinical data In clinical data, clinical 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. BSI software was evaluated with various kinds of clinical images, such as with various sizes of patients at various exposure conditions, by a professional radiologist. Overall quality of the bone suppressed images was found to be useful as diagnosis assistance for areas that the reader is interested in, such as soft tissues and lesions in the lung field. #### 13. Conclusions The non-clinical and clinical data demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed devices.