GUA60A, GU60A-65

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a wing or a flame. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 17, 2015 SAMSUNG ELECTRONICS Co., Ltd. % ChulSin Kim Regulatory Affairs Manager 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do 443-742 REPUBLIC OF KOREA Re: K151685 Trade/Device Name: GU60A & GU60A-65 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: June 23, 2015 Received: June 24, 2015 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, Robert A Ochs Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. ## 510(k) Number (if known) K151685 Device Name GU60A, GU60A-65 Indications for Use (Describe) The GU60A & GU60A-65 Digital X-ray Imaging Systems are 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov "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}------------------------------------------------ SAMSUNG ELECTRONICS Co., Ltd. 510(k) Premarket Notification - Traditional Image /page/3/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in bold, white letters. The word is placed inside of a blue, oval shape that is tilted slightly. ## 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 19, 2015 #### 2. Submitter - A. Company Name: SAMSUNG ELECTRONICS Co., Ltd. - B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, Republic of Korea #### 3. Primary Contact Person - A. Name: ChulSin Kim - Title: Regulatory Affairs Manager B. - ﻥ Phone Number: +82-31-200-7661 - D. FAX Number: +82-31-200-1199 E-Mail: chulsin.kim@samsung.com #### 4. Secondary Contact Person - A. Name: Ninad Guiar - B. Title: Regulatory Affairs Manager - Phone Number: 978-564-8503 ﻥ - FAX Number: 978-750-6677 D. - E-Mail: ngujar@samsungneurologica.com #### 5. Proposed Devices - Trade Names: GU60A & GU60A-65 A. - B. Device Names: GU60A & GU60A-65 - ﻥ Common Name: Digital Diagnostic X-ray System - D. Classification Name: Stationary X-ray System - ட் Requlation: 21 CFR 892.1680 - ட் Product Code: KPR #### Predicate Device 6. - Manufacturer: SAMSUNG ELECTRONICS Co., Ltd. A. - B. Device Name: XGEO GU60A - ﻥ Common Name: Digital Diagnostic X-ray System - D. Classification Name: Stationary X-ray System - ட் Regulation: 21 CFR 892.1680 - F. Product Code: KPR - G. 510(k) Number: K140332 - 510(k) Decision Date: May 28,2014 H. #### 7. Device Description The GU60A & GU60A-65 digital X-ray imaging systems are to be used to take and store image for diagnosis of patients. It consists of HVG(High voltage generator), U-arm positioner, Detector, X-ray tube, Collimator, AEC(Auto Exposure Control), DAP(Dose Area Product), CIB(Control Interface Box), Remote controller, Grid, Barcode scanner and Auto-stitching stand. These systems are 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 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) {4}------------------------------------------------ # SAMSUNG ELECTRONICS Co., Ltd. Image /page/4/Picture/1 description: The image shows the text "510(k) Premarket Notification - Traditional". The text is written in a simple, sans-serif font and is left-aligned. The text is likely a title or heading for a document or presentation related to medical device regulation. Image /page/4/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is inside of a blue, oval shape that is tilted slightly. server, and can be used for reading images. - 8. Intended Use No Differences The GU60A & GU60A-65 Digital X-ray Imaging Systems are 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. - 9. Summary of Technological characteristic of the proposed device compared with the predicate device The proposed GU60A & GU60A-65 add two detectors (S4335-W & S3025-W), already cleared with K150165, to the list of detector of predicate device XGEO GU60A (K140332), and GU60A-65 has a HVG (High Voltage Generator) which have no significant difference in materials, energy source or technological characteristics compared to the predicate device. Comparisons of the following technological characteristics were assessed and the results demonstrate the substantial equivalence to the predicate device. | Manufacturer Contents | XGEO GU60A<br>(K140332) | GU60A & GU60A-65 | Discussion | |---------------------------------------------|---------------------------------------------------------------|------------------------------------------------------|---------------| | (4) Detector | *NOTE: S4335-W and S3025-W were already cleared with K150165. | | | | Name | S4343-W | S4335-W<br>S3025-W | | | Detector type | CsI | CsI | Same | | | Indirect | Indirect | Same | | Detector area | 17"X17"<br>(425mmX425m) | 14"X17"<br>(345mmX425m)<br>10"X12"<br>(245mmX295 mm) | Difference(1) | | Number of pixels | 3,036 x 3,040 | 2,466 x 3,040<br>1,750 x 2,108 | Difference(2) | | Pixel pitch(um) | 140 | 140 | Same | | High contrast limiting<br>resolution(lp/mm) | 3.57 | 3.57 | Same | | Communication | Wired / Wireless | Wired / Wireless | Same | | Manufacturer<br>Contents | XGEO GU60A (K140332) | GU60A | GU60A-65 | Discussion | | |-------------------------------------------------|----------------------|----------------|--------------|------------|---------------| | (3) High Voltage Generator | | | | | | | Type | High Frequency | High Frequency | | Same | | | Output<br>RANGE | Max. Power | 50kW | 50kW | 65kW | Difference(3) | | | Tube Voltage | 40-150kV | 40-150kV | | Same | | | Tube Current | 10-630mA | 10-630mA | 10-800mA | Difference(4) | | | Exposure<br>Time | 1msec-6.3sec | 1msec-6.3sec | | Same | | AEC (Automatic<br>Exposure Control) | Yes | Yes | | Same | | | APR (Anatomically<br>Programmed<br>Radiography) | Yes | Yes | | Same | | | A. Differences Explanation | | | | | | Explanation {5}------------------------------------------------ # SAMSUNG ELECTRONICS Co., Ltd. Image /page/5/Picture/1 description: The image shows the Samsung logo. The logo is blue and white. The word "SAMSUNG" is written in white letters on a blue background. The background is an oval shape. 510(k) Premarket Notification - Traditional | (1) | Detector Area | Proposed medical device's S4335-W and S3025-W detectors<br>have smaller area than the predicate device's detectors while<br>technical specification is identical among them such as type &<br>pixel pitch, and the smaller area does not contribute any adverse<br>impacts to the device's safety and performance. | |-----|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | (2) | Number of pixels<br>Resolution and pixel<br>pitch of detector | Proposed medical device's S4335-W and S3025-W detector have<br>smaller detector area. Therefore, the proposed medical device's<br>numbers of pixels is smaller than the predicate device's detectors<br>while pixel pitch is identical among them, and the smaller number<br>of pixels does not contribute any adverse impacts to the device's<br>safety and performance. | | (3) | HVG Max Power | Proposed GU60A-65's HVG has higher max power than the<br>predicate device's max power, and the higher max power does not<br>contribute any adverse impacts to the device's safety and<br>performance. | | (4) | HVG Tube Current<br>Range | Proposed GU60A-65's HVG has higher max tube current than the<br>predicate device's max tube current, and the higher max tube<br>current does not contribute any adverse impacts to the device's<br>safety and performance. | The proposed GU60A & GU60A-65 devices have the same intended use, and the differences among the predicate device and the proposed devices do not introduce any new potential safety & performance risks, and the proposed devices are substantially equivalent to and performs as well as the predicate device. ## 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 devices show no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device. ## 12. Clinical data A Clinical images review report is prepared in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices, which shows the equivalent diagnostic capability to the predicate device. ## 13. Conclusions The results of non-clinical and clinical data demonstrate that the proposed devices are as safe, as effective, and perform as well as the legally marketed device. - 14. Samsung Electronics Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.