DIGITAL FLAT PANEL X-RAY DETECTOR

{0}------------------------------------------------ K131114 Page 1 of 5 Rev.0 ## 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date 510K summary prepared: April 19, 2013 7 2013 Submitter's Name, address, telephone number, a contact person: | Submitter's Name : | Rayence Co., Ltd. | |-------------------------|-------------------------------------------| | Submitter's Address: | 1F, 2F, 3F, #402, 14, Samsung 1-ro 1-gil, | | | Hwaseong-si, Gyeonggi-do, Korea | | Submitter's Telephone: | +82-31-8015-6459 | | Contact person: | Mr. Kee Dock Kim / Manager | | Official Correspondent: | Dave Kim (davekim@mtech-inc.net) | | (U.S. Designated agent) | | | Address: | 12946 Kimberley Ln, Houston, TX 77079 | | Telephone: | +713-467-2607 | | Fax: | +713-464-8880 | Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known: | Trade/proprietary name: | 1417WGA | |-------------------------|-----------------------------------------| | Common Name: | Digital Flat Panel X-ray Detector | | Classification Name : | 21CFR892.1680 / Stationary x-ray system | | Product Code: | MQB | 1 {1}------------------------------------------------ #### Predicate Device : | Manufacturer | : Rayence Co., Ltd. | |---------------|-------------------------------------------| | Device | : 1417PGA | | 510(k) Number | : K122928 (Decision Date - JAN. 30. 2013) | #### Device Description : 1417WGA is a wired/wireless digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems. The wireless LAN(IEEE 802.11a/g/n) communication signals images captured to the system and improves the user operability through high-speed processing. This X-ray imaging detector consists of a scintillator directly coupled to an a-Si TFT sensor. 1417WGA is designed specifically to be integrated with a console PC system and X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files which can be viewed by console SW for a radiographic image diagnosis and analysis. #### Indication for use : 1417WGA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography. ### Summary of the technological characteristics of the device compared to the predicate device: The 1417WGA SSXI detector described in this 510(k) has the same indications for use and same technical characteristics as its predicate device. 1417GA flat panel detector, of Rayence Co., Ltd. Table 1 summarizes the technological characteristics of the 1417WGA and 1417GA. the predicate device. {2}------------------------------------------------ · | Characteristic | Proposed<br>Rayence Co.,Ltd.<br>1417WGA | Predicate<br>Rayence Co.,Ltd.<br>1417PGA | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | - | -K122928 | | Intended Use | 1417WGA Digital Flat Panel X-<br>Ray Detector is indicated for<br>digital imaging solution designed<br>for general radiographic system<br>for human anatomy. It is intended<br>to replace film or screen based<br>radiographic systems in all<br>general purpose diagnostic<br>procedures. Not to be used for<br>mammography. | 1417PGA Digital Flat Panel X-<br>Ray Detector is indicated for<br>digital imaging solution designed<br>for general radiographic system<br>for human anatomy. It is intended<br>to replace film or screen based<br>radiographic systems in all<br>general purpose diagnostic<br>procedures. Not to be used for<br>mammography. | | Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | | Scintillator | Gadolinium Oxysulfide | Gadolinium Oxysulfide | | Imaging Area | 14 x 17 inches | 14 x 17 inches | | Total Pixel<br>Number | 3328 x 2816 pixels | 3328 x 2816 pixels | | Pixel pitch | 127 um | 127 um | | Resolution | 3.9 lp/mm | 3.9 lp/mm | | A/D conversion | 14 bit | 14 bit | | Preview Image | 2~3 seconds (wired)<br>/ 3~5 seconds (wireless) | 2~3 seconds | | Data output | RAW<br>*The RAW files are<br>convertible into DICOM 3.0<br>by console S/W | RAW<br>*The RAW files are<br>convertible into DICOM 3.0<br>by console S/W | | Dimensions | 460 x 417 x 15.9 mm | 460 x 417 x 15.9 mm | | Weight | 3.6 kg (incl. battery pack) | 3.4 kg | | Application | Wireless portable system<br>Available with upright stand,<br>table, universal stand | Portable system<br>Available with upright stand,<br>table, universal stand | | Feature | Image: portable system | Image: portable system | Table I: Comparison of 1417WGA and 1417PGA 3 . {3}------------------------------------------------ #### 510(k) Submission - 1417WGA #### Table 2: Size Comparison of 1417WGA and 1417PGA | Item | Unit | 1417WGA | 1417PGA | |--------------------------------------------|--------|-------------|-------------| | Pixel Pitch | μm | 127 x 127 | 127 x 127 | | Total Pixel Number | pixels | 3328 x 2816 | 3328 x 2816 | | Effective Pixel Area | mm | 415 x 350 | 415 x 350 | | Effective Pixel Number(light<br>sensitive) | pixels | 3268x 2756 | 3268x 2756 | | Fill factor | % | 61.03 | 61.03 | | Weight | Kg | 3.6 Kg | 3.4 Kg | #### Summary of Performance Testing: The wireless/wired 1417WGA flat panel detector is a modified version of 1417PGA (K122928), FDA cleared predicate device from Rayence. Indications for use, material, form factor, performance, and safety characteristics between 1417WGA and 1417PGA are the same. The non-clinical test report and clinical consideration report were prepared and submitted to FDA separately to demonstrate the substantial equivalency between two different detectors. The non-clinical test report contains the MTF, DQE and NPS test results of 1417WGA and 1417PGA by using the identical test equipment and same analysis method described by IEC 6220-1 The comparison of the MTF for 1417WGA and 1417PGA detector demonstrated that the MTF of the 1417WGA detector performed almost same with 1417PGA. Therefore the overall resolution performance and sharpness of 1417WGA is almost same with 1417PGA. The DQE represents the ability to visualize object details of a certain size and contrast. 1417WGA demonstrated almost same DQE 4 Rev.0 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows handwritten text on a white background. The text at the top reads "K131114" and below that is "Page 5 of 5". In the bottom left corner, the text "Rev.0" is visible. The handwriting appears to be cursive and the overall image has a simple, document-like quality. performance with 1417PGA at various spatial frequencies and provides almost same Signal-to Noise Ratio (SNR) transfer from the input to the output of a detector as a function of frequency. At the lowest spatial frequency, the 1417WGA has a DQE: of 41% and that of 1417PGA is 42%. 1417WGA exhibited NPS which has almost same performance with 1417PGA. Therefore, the image quality of 1417WGA is almost same with 1417PGA at the same patient exposure. To further demonstrate the substantial equivalency of two devices, clinical images are taken from both devices and reviewed by a licensed US radiologist to render an expert opinion. Both test (1417WGA) and control group (1417PGA) are evaluated according to similar age group and anatomical structures were compared in accordance with the test protocol of diagnostic radiography evaluation procedure. Based on the non-clinical and clinical consideration test and the outcome of a comparative review by an expert for both devices, we can claim the substantial equivalency between 1417WGA and its predicate device, 1417PGA in terms of image quality. #### Safety, EMC and Performance Data : Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:1988 + A1:1991 + A2:1995 (Medical electrical equipment Part 1: General Requirements for Safety) was performed, and EMC testing were conducted in accordance with standard IEC60601-1-2:2007 (CISPR 11:2009/A1: 2010), EN60601-1-2:2007 +A1:2010 (Medical electrical equipment - Part 1-2: General Requirements for safety -- Collateral Standard : Electromagnetic Compatibility Requirements and tests). The equipment also complies with the standard FCC Rule part(s) 47CFR PART 15.107(B) / 47CFR PART 15.109(G) CLASSB. All test results were satisfactory. #### Conclusions: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Rayence Co., Ltd. concludes that 1417WGA is safe and effective and substantially equivalent in comparison with 1417PGA, , the predicate device as described herein. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a modern, abstract design. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September, 17, 2013 Ravence Co. Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 12946 Kimberley Lane HOUSTON TX 77079 Re: K131114 Trade/Device Name: Digital Flat Panel X-ray Detector/1417WGA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 30, 2013 Received: September 4, 2013 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. {6}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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, Smh) for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use 510(k) Number (if known): K131114 Digital Flat Panel X-Ray Detector /1417WGA Device Name: Indications for Use: 1417WGA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Flealth K131114 510(k) > Page 1 of 1