1717SCC_127um and 1717SCC_140um

{0}------------------------------------------------ June 9, 2017 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Rayence Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025 Re: K171420 Trade/Device Name: 1717SCC 127um and 1717SCC 140um Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: May 1, 2017 Received: May 15, 2017 Dear Dave 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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. 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/ResourcesforYou/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. Michael D. O'Hara For Robert A. 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) Device Name 1717SCC_127um and 1717SCC_140um #### Indications for Use (Describe) 1717SCC 127um and 1717SCC 140um are 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. Type of Use (Select one or both, as applicable) | 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.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}------------------------------------------------ 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: June 7, 2017 # Submitter's Name, address, telephone number, a contact person: | Submitter's Name : | Rayence Co., Ltd. | |-------------------------|------------------------------------------------------| | Submitter's Address: | 14, Samsung 1ro 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) | | 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 | :1717SCC_127µm and 1717SCC_140µm | |------------------------|--------------------------------------------| | Common Name | : Digital Flat Panel X-ray Detector | | 510(k) Number | : K171420 | | Regulation Number | : 21 CFR 892.1680 | | Regulation Name | : Stationary X-ray System | | Product Code | : MQB | | Predicate Device : | | | Trade/Device Name | : 1717SGN / 1717SCN | | Common Name | : Digital Flat Panel X-ray Detector | | 510(k) Number | : K150150 (Decision Date – March 27. 2015) | | Regulation Number | : 21 CFR 892.1680 | | Regulation Name | : Stationary X-ray System | | Product Code | : MQB | {4}------------------------------------------------ #### Reference Device : | Device | : 1717SCC | |-------------------|-------------------------------------| | 510(k) Number | : K122173 | | Common Name | : Digital Flat Panel X-ray Detector | | Regulation Number | : 21 CFR 892.1680 | | Regulation Name | : Stationary X-ray System | | Product Code | : MQB | ## 2. Device Description : While 1717SCC 127um is identical to 1717SCC (K122173), both 1717SCC 127 um and 1717SCC 140um are digital solid state X-ray detectors based on flat-panel technology. These radiographic image detectors and processing unit consist of a scintillator coupled to an a-Si TFT sensor. Both devices are connected to the user PC via wired LAN (ethernet cable) and need to be integrated with a radiographic imaging system. Both devices do not operate as an X-ray generator controller but can be utilized to convert X-ray to light and light to electrical signals for image data digitization. The RAW files can be further processed as DICOM compatible image files by separate console SW (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis. ### 3. Indication for use : 1717SCC and 127um and 1717SCC 140um are 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. ### 4. Summary of the Design Control Risk management: 1717SCC_127µm is identical to 1717SCC (K122173). 1717SCC_140µm digital X-ray detector is a modification of 1717SCN (K150150). 1717SCC 140um was developed for the purpose of retrofitting the stationary X-ray system with a film detector. 1717SCC 127um and 1717SCC 140um are connected to a PC with an ethernet cable. The risks and the hazardous impact of the device modification were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design change were successfully mitigated and accepted. {5}------------------------------------------------ - 5. Summary of the technological characteristics of the device compared to the predicate device: 1717SCC_127μm is identical to 1717SCC (K122173). Both 1717SCC_127μm and 1717SCC_140μm detectors described in this 510(k) have the same indications for use and similar technical characteristics as its predicate device, 1717SCN(K150150) flat panel detector, of Rayence Co., Ltd # 5.1 Scintillator layer * scintillator layer. ( * scintillator : a phosphor that produces scintillations) | | Proposed | Predicate | |------------------------|--------------------------------|-----------| | CsI<br>(Cesium Iodide) | 1717SCC_127μm<br>1717SCC_140μm | 1717SCN | # 5.2 Dimensions and Weight | | | Proposed | Predicate | |--------------|------------|---------------------|-------------------| | | | 1717SCC | 1717SGN / 1717SCN | | Detector | Model name | 1717SCC_127 $\mu$ m | 1717SCN | | | | 1717SCC_140 $\mu$ m | | | | | W x L x H | 460 X 460 X 15.5 | | | | Weight | 4 kg | | Power supply | Model name | RS1717 | RS1717 | | | | W x L x H | 188 X 92 X 41.5 | | | | Weight | 0.5 kg | # 5.3 Power Requirements (Power supply) | | | Proposed<br>1717SCC | Predicate<br>1717SGN / 1717SCN | |-----------------|------------|-----------------------------|--------------------------------| | Power<br>supply | Model name | RS1717 | RS1717 | | | W x L x H | AC 100 - 240 V~,<br>50/60Hz | AC 100 - 240 V~,<br>50/60Hz | {6}------------------------------------------------ ## 5.4 Proposed Labeling Image /page/6/Figure/2 description: The image shows labels for two different devices, a detector and a power supply, under two categories: "Proposed 1717SCC" and "Predicate 1717SGN / 1717SCN". The detector labels show model numbers 1717SCC and 1717SCN, respectively, along with manufacturer information, ratings, and compliance details. The power supply labels show model number RS1717 for both categories, along with input/output specifications, safety certifications, and manufacturer information. ### 5.5 Recommended Generator Specification | Model | Manufacture | Specification | | | | |----------------|-----------------------------------|---------------|--------------------|--------|--------| | CMP 200 | Communications & Power Industries | 32kW | 40kW | 50kW | | | | | kVp | 40-125 | | 40-150 | | | | mA | 10-400 | 10-500 | 10-630 | | EDITOR HFe 501 | Rontgenwerk Bochum | kVp | 40-150 | | | | | | mA | 10-630 | | | | UD150L-40E/40F | Shimadzu | kVp | 40-150 | | | | | | mA | @100 kVp- 500(320) | | | | | | | @80 kVp- 630(400) | | | | PXR-321B | Poskom Co.,Ltd. | kVp | 125/150 | | | | | | mA | 500 | | | Image /page/6/Picture/5 description: The image shows a yellow caution sign. The sign is a yellow triangle with a black border. Inside the triangle is a black exclamation point. Below the triangle is the word "CAUTION" in black, bold letters. To our best knowledge, the detector is compatible with the X-ray generators with the specifications described above. If you have questions regarding the compatibility issue for other generators which are not listed above, please contact your Rayence representative. This information will be included in user/installation documents for the end user. {7}------------------------------------------------ # 5.6 Comparison table | Characteristi<br>C | Proposed<br>1717SCC | Predicate<br>1717SGN / 1717SCN | Remark | |--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | 510(k) number | | K150150 | | | Intended Use | 1717SCC 127um and<br>1717SCC_140um, are indicated for<br>digital imaging solution designed for<br>general radiographic system for human<br>anatomy. It is intended to replace film<br>or screen based radiographic systems<br>in all general purpose diagnostic<br>procedures. Not to be used for<br>mammography. | 1717SGN and 1717SCN Digital<br>Flat Panel X-Ray Detector is<br>indicated for digital imaging<br>solution designed for general<br>radiographic system for human<br>anatomy. It is intended to replace<br>film or screen based radiographic<br>systems in all general purpose<br>diagnostic procedures. Not to be<br>used for mammography. | Same | | Manufacturer | Rayence Co., Ltd. | Rayence Co., Ltd. | Same | | Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Same | | Scintillator | 1717SCC_127µm<br>1717SCC_140μm<br>CsI:Tl | 1717SCN<br>CsI:Tl | Same | | Imaging Area | 17 x 17 inches | 17 x 17 inches | Same | | Pixel matrix | 127 type : 3328 x 3328<br>140 type : 3072 x 3072 | 3072 x 3072 | Same | | Pixel pitch | 127 μm / 140 μm | 139 µm | Similar | | Resolution | 3.9 lp/mm | 3.9 lp/mm | Same | | A/D conversion | 14 bit for 127 µm / 16 bit for 140 µm | 14 / 16 bit | Same | | Preview time | ≤2 | ≤2 | Same | | Data output | RAW<br>*The RAW files are convertible into<br>DICOM 3.0 by console S/W | RAW<br>*The RAW files are convertible<br>into DICOM 3.0 by console S/W | Same | | Dimensions | 460 × 460 × 15.5 mm | 460 × 460 × 15.5 mm | Same | | Weight | 4 kg | 4 kg | Same | | Application | General Radiology system or Portable<br>system<br>Available with upright stand, table, | General Radiology system or<br>Portable system<br>Available with upright stand,<br>table, | Same | {8}------------------------------------------------ ## 6. Summary of Performance Testing: 1717SCC 127um is identical to 1717SCC (K122173). 1717SCC 127um and 1717SCC 140um Digital Flat Panel X-Ray Detectors have the same indications for use, material, form factor, performance, and safety characteristics compared to the predicate devices, 1717SCN. 1717SCC_140μm is almost identical to 1717SCN (K150150) including the scintillator type (both CsI:TI), imaging area (17x17inch), pixel matrix (3072 x 3072), and resolution (3.9lp/mm) The difference between two devices is the pixel pitch; 140 um vs 139um, respectively. It is minor and does not raise new concerns for the safety and effectiveness of the subject device. The non-clinical test report and clinical consideration report for each subject device were prepared and submitted to FDA separately to demonstrate the substantial equivalency of the subject devices compared to each respective predicate device. The non-clinical test report contains the MTF, DQE and NPS test results of 1717SCC_140µm by using the identical test equipment and same analysis method described by IEC 62220-1. The comparative result of the MTF and DQE test for 1717SCC 140um detector with respect to the predicate device demonstrated that the MTF and DQE of the 1717SCC 140 um performed better than the performance of 1717SCN. The MTF and DQE represents the ability to visualize object details of a certain size and contrast. 1717SCC 140um has higher MTF and DOE performance compared to 1717SCN at high spatial frequencies, especially from 2 1p/mm. The comparison of the MTF and DOE for 1717SCC 140um detector demonstrated that it performed almost same and slightly better than the performance of 1717SCN. To further demonstrate the substantial equivalency of two devices, clinical images are taken from both subject devices and reviewed by a licensed physician to render an expert opinion. Both the test subject, 1717SCC_140µm and the predicate device, 1717SCN, have been evaluated and compared by taking sample radiographs of similar age group and anatomical structures in accordance with the test protocol of diagnostic radiography evaluation procedure. After a broad review of plain radiographic images taken with the subject device and the predicate device, the images obtained with 1717SCC_140um, the subject device, are superior to the same view obtained from a similar patient with 1717SCN, the predicate devices. In general, both the spatial and soft tissue contrast resolution are superior using 1717SCC_140μm. Specifically, the soft tissues on extremity films were seen with better clarity. There is little difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion. {9}------------------------------------------------ Based on the non-clinical and clinical consideration test and the outcome of a comparative review by an expert for both devices, the sponsor can claim the substantial equivalency between the subject devices and their predicate device in terms of diagnostic image quality. The manufacturing facility is in conformance with the design control procedure requirements and the relevant EPRC standards as specified in 21 CFR 802.30 and the records are available for review. # 7. Summary for any testing in the submission: Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:2005 (3rd Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2: 2007. Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory. ## 8. 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 1717SCC 127um and 1717SCC 140um are safe and effective and substantially equivalent in comparison with their predicate devices.