Yushan X-Ray Flat Panel Detector with DROC

{0}------------------------------------------------ October 11, 2020 Image /page/0/Picture/1 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. InnoCare Optoelectronics Corp. % Yumei Cheng Senior Engineer Rm. B, No. 2, Sec. 2, Huanxi Rd., Xinshi Dist., Tainan City, Taiwan 744 REPUBLIC OF CHINA Re: K201528 Trade/Device Name: Yushan X-Ray Flat Panel Detector with DROC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: June 2, 2020 Received: August 31, 2020 Dear Yumei Cheng: 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). 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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) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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). 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Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality 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) #### K201528 #### Device Name Yushan X-Ray Flat Panel Detector with DROC #### Indications for Use (Describe) The Wireless(V14C, V14G, V17C, V17G)/Wired(V14C, V14G, V17C, V17G, V17Ge) Yushan X-Ray Flat Panel Detector with DROC is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector with DROC is not intended for mammography, tomography, and angiography applications. | Type of Use (Select one or both, as applicable) | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <table style="border:none"><tr><td><span> <div style="display:inline-block; border: 1px solid black; width: 10px; height: 10px; text-align: center;">X</div> Prescription Use (Part 21 CFR 801 Subpart D) </span></td><td><span> <div style="display:inline-block; border: 1px solid black; width: 10px; height: 10px; text-align: center;"></div> Over-The-Counter Use (21 CFR 801 Subpart C) </span></td></tr></table> | <span> <div style="display:inline-block; border: 1px solid black; width: 10px; height: 10px; text-align: center;">X</div> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <div style="display:inline-block; border: 1px solid black; width: 10px; height: 10px; text-align: center;"></div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | <span> <div style="display:inline-block; border: 1px solid black; width: 10px; height: 10px; text-align: center;">X</div> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <div style="display:inline-block; border: 1px solid black; width: 10px; height: 10px; text-align: center;"></div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | **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}------------------------------------------------ # 510(k) Summary K201528 #### I. SUBMITTER InnoCare Optoelectronics Corp. Rm. B, No. 2, Sec. 2, Huanxi Rd., Xinshi Dist., Tainan City 744, Taiwan (R.O.C.) TEL: +886-6-700-7238 # 22598 Email: yumei.cheng@innocare-x.com Contact Person: Yumei Cheng / Senior Engineer Date Prepared: Jun 02, 2020 ### II. DEVICE Trade name: Yushan X-Ray Flat Panel Detector with DROC Model name: V14C, V14G, V17C, V17G, V17G, V17Ge Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680 Device class: Class II ## III. PREDICATE DEVICE Substantial equivalence to the following predicate device is as follows: Trade/Device Name: Yushan X-Ray Flat Panel Detector FDA 510(k) clearance number: K191939 Manufacturer: InnoCare Optoelectronics Corp. Decision Date: 08/29/2019 Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680 Device class: Class II > FDA-Summary-A1 10f8 {4}------------------------------------------------ ## IV. DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFI-CATION InnoCare's Yushan X-Ray Flat Panel Detector with DROC, model V14C, V14G, V17C, V17G are portable digital detector system, while V17Ge is a non-protable digital detector. The Yushan X-Ray Flat Panel Detector with DROC is designed to be used in any environment that would typically use a radiographic cassette for examinations. Model V14C, V14G, V17C, V17G support both wireless and wired/tethered data communication between the detector and the system, while model V17Ge is only applicable for wired use. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. Every model have memory exposure mode, and extended image readout feature. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water. The Yushan X-Ray Flat Panel Detector with DROC is currently indicated for general projection radiographic applications and offers two different detector types in terms of scintillator materials (gadolinium oxysulfide (GOS) and cesium iodide (Csl)). The Yushan X-Ray Flat Panel Detector with DROC sensor can automatically collects x-ray images from an x-ray source. It collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided and controlled by independent system manufacturers. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images. Yushan series is working due to the combination of SDK(software development kit) and DROC(Digital Radiography Operating Console). The SDK provides the interface for DROC to control the Yushan X-Ray Flat Panel Detector. SDK initiates the taking of X-ray images from the Yushan X-Ray Flat Panel Detector, through the Sensor Driver application. Once an X-ray is taken, Sensor Driver reads it from the flat panel and transfers it to SDK. Then the DROC will take > FDA-Summary-A1 2of8 {5}------------------------------------------------ the image data from SDK for further image process and display. The DROC is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function include: - 1. Detector status update - 2. Xray exposure workflow - 3. Image viewer and measurement. - 4. Post image process and DICOM file I/O - 5. Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network The software level of concern for the Yushan X-Ray Flat Panel Detector with DROC has been determined to be moderate based on the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The cybersecurity risks of the Yushan X-Ray Flat Panel Detector with DROC have been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation, and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g., requirements, verification). ## V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Yushan X-Ray Flat Panel Detector with DROC (V14C, V14G, V17C, V17G) and its predicate device, Yushan X-Ray Flat Panel Detector (V14C, V14G) are portable digital detector systems, while the model V17Ge is a non-portable type, that are used to acquire x-ray exposures. Yushan X-Ray Flat Panel Detector with DROC has the same Indications for Use, and very similar functional and technical requirements as the predicate device, K191939. The comparison of technological characteristics are listed in the following table. Yushan X-Ray Flat Panel Detector with DROC has been successfully tested and validated, there are 5 models in this submission, V14C, V14G, V17C, V17G, V17Ge, and V14C, V14G are exactly the same device in K191939 named V14C and V14G, except for the modification of the user interface which has > FDA-Summary-A1 3of8 {6}------------------------------------------------ been changed into DROC version, and V17C, V17G, V17Ge are the serial models using the same user interface, DROC. Please refer to the following table for more detailed information. | Product name | Yushan X-Ray Flat Panel Detector<br>with DROC | Yushan X-Ray Flat Panel Detector | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Model name | V14G<br>V14C<br>V17G<br>V17C<br>V17Ge | V14G<br>V14C | | Manufacturer | InnoCare Optoelectronics Corp. | InnoCare Optoelectronics Corp. | | Qualified<br>number | - | K191939 | | Clinical | | | | Indications for<br>use | The Wireless(V14C, V14G, V17C,<br>V17G)/Wired(V14C, V14G,<br>V17C, V17G, V17Ge) Yushan X-<br>Ray Flat Panel Detector with<br>DROC is intended to capture for<br>display radiographic images of<br>human anatomy. It is intended for<br>use in general projection radio-<br>graphic applications wherever<br>conventional film/screen or CR<br>systems may be used. The Yushan<br>X-Ray Flat Panel Detector with<br>DROC is not intended for mam-<br>mography, fluoroscopy, tomogra-<br>phy, and angiography applications. | The Wireless/Wired Yushan X-Ray<br>Flat Panel Detector is intended to<br>capture for display radiographic<br>images of human anatomy. It is<br>intended for use in general projec-<br>tion radiographic applications<br>wherever conventional film/screen<br>or CR systems may be used. The<br>Yushan X-Ray Flat Panel Detector<br>is not intended for mammography,<br>fluoroscopy, tomography, and an-<br>giography applications. | | | | | | | - FDA Standards 21 CFR<br>- 892.1680 for stationary x-ray<br>- system<br>- European Medical Devices<br>- Directive (93/42/EEC)<br>- EN ISO 13485<br>- ISO 14971<br>- ANSI/AAMI ES60601-1<br>- CAN/CSA C22.2 No. 60601-<br>- 1:14<br>- IEC 60601-1-2<br>- IEC 62304<br>- IEC 60601-1-6<br>- IEC 62366-1<br>- ISO 10993-1<br>- ISO 10993-5<br>- ISO 10993-10<br>- ISO 15223-1 | - FDA Standards 21 CFR<br>- 892.1680 for stationary x-ray<br>- system<br>- European Medical Devices<br>- Directive (93/42/EEC)<br>- EN ISO 13485<br>- ISO 14971<br>- ANSI/AAMI ES60601-1<br>- CAN/CSA C22.2 No. 60601-<br>- 1:14<br>- IEC 60601-1-2<br>- IEC 62304<br>- IEC 60601-1-6<br>- IEC 62366-1<br>- ISO 10993-1<br>- ISO 10993-5<br>- ISO 10993-10<br>- ISO 15223-1 | | Compliance<br>standard | Technical | | | | V14G:<br>460(W)×383(L)×15(H)<br>V14C:<br>460(W)×383(L)×15(H)<br>V17G:<br>460(W)×460(L)×15(H)<br>V17C:<br>460(W)×460(L)×15(H)<br>V17Ge:<br>460(W)×460(L)×15(H) | V14G:<br>460(W)×383(L)×15(H)<br>V14C:<br>460(W)×383(L)×15(H) | | Dimensions<br>(mm) | | | | Weight (Kg) | V14G: 2.7 | V14G: 2.7 | | | | | | | V14C: 2.7 | V14C: 2.7 | | | V17G: 3.2 | | | | V17C: 3.2 | | | | V17Ge: 3.5 | | | Scintillator | V14G: GOS | | | | V14C: CsI | | | | V17G: GOS | V14G: GOS | | | V17C: CsI | V14C: CsI | | | V17Ge: GOS | | | Pixel Pitch | 140 μm | 140 μm | | DQE | GOS: at 1 lp/mm, RQA5 is 0.27<br>CsI: at 1 lp/mm, RQA5 is 0.48 | GOS: at 1 lp/mm, RQA5 is 0.27<br>CsI: at 1 lp/mm, RQA5 is 0.48 | | MTF | GOS: at 1 lp/mm, RQA5 is 0.52<br>CsI: at 1 lp/mm, RQA5 is 0.69 | GOS: at 1 lp/mm, RQA5 is 0.52<br>CsI: at 1 lp/mm, RQA5 is 0.69 | | Max.<br>resolution | GOS: 3.57 lp/mm<br>CsI: 3.57 lp/mm | GOS: 3.57 lp/mm<br>CsI: 3.57 lp/mm | | A/D Conversion | 16 bit | 16 bit | | Pixels | V14G: 2500 x 3052 | | | | V14C: 2500 x 3052 | | | | V17G: 3072 x 3072 | V14G: 2500 x 3052 | | | V17C: 3072 x 3072 | V14C: 2500 x 3052 | | | V17Ge: 3072 x 3072 | | | Interface | Wired: Gigabit Ethernet<br>(100BASE-TX or 10BASE-T)<br>Wireless: IEEE802.11 ac /a/g/n<br>* V17Ge is not applicable for<br>wireless function. | | | | | Wired: Gigabit Ethernet<br>(100BASE-TX or 10BASE-T)<br>Wireless: IEEE802.11 ac /a/g/n | | Power Source | Rechargeable Lithium Battery<br>* V17Ge is not applicable | Rechargeable Lithium Battery | | Biological | | | | Biological<br>safety | All material contact with patients<br>are in accordance with ISO 10993. | All material contact with patients<br>are in accordance with ISO 10993. | | Others | | | | Accessories | - Battery (Optional)* V17Ge is<br>not applicable<br>- Power supply (Adapter)<br>- SE cable (Back-up cable)<br>- Power Cord | - Battery (Optional)<br>- Power supply (Adapter)<br>- SE cable (Back-up cable)<br>- Power Cord | FDA-Summary-A1 4of8 {7}------------------------------------------------ FDA-Summary-A1 50f8 {8}------------------------------------------------ FDA-Summary-A1 {9}------------------------------------------------ ## INCX #### VI. PERFORMANCE DATA Non-clinical Performance Data: Yushan X-Ray Flat Panel Detector with DROC (V14C, V14G, V17C, V17G, V17Ge) confirms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-1-6, ANSI AAMI IEC 62366-1 and ANSI/AAMI HE75. In addition, the FDA's Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (issued on September 1, 2016) was followed to describe the detector characteristics; Radio Frequency Wireless Technology in Medical Devices (issued on August 14, 2013), FCC 47 CFR PART 15 SUBPART C, FCC 47 CFR PART 15 SUBPART E and FCC SAR were followed to test the wireless features, which V17Ge is not applicable for this test; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued on May 11, 2005) was followed to evaluate the level of concern as moderate; Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued on October 2, 2014) was also followed to consider issues related to cybersecurity in the design and development process of this device. Additionaly, the risk analysis, necessary verification and validation activities were performed. Load-bearing characteristics and protection against ingress of water were tested and passed. The internal circuit design was demonstrated through EMC emission testing: IEC60601-1-2, FCC 47 CFR PART 15 SUBPART B, ETSI EN 301 489- > FDA-Summary-A1 7of8 {10}------------------------------------------------ 17 V3.1.1:2017 and ETSI EN 301 489-1 V2.1.1:2017, and the results were satisfactory. Biocompatibilities were demonstrated through ISO 10993 series to prove the using material safe and effective. Furthermore, the image quality evaluation confirmed that the image quality of the Yushan X-Ray Flat Panel Detector with DROC is substantially equivalent to that of the predicate device. Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies. #### VII. CONCLUSIONS Yushan X-Ray Flat Panel Detector with DROC is substantially equivalent to the predicate device in technical characteristics, design features, operating principles, functional and performance characteristics, and for the intended uses in the stated medical specialties. Yushan X-Ray Flat Panel Detector with DROC is designed to comply with applicable federal and international safety and performance standards. Based upon the supporting data summarized above, we concluded the Yushan X-Ray Flat Panel Detector with DROC (V14C, V14G, V17C, V17G, V17Ge) is as safe and effective as the legally marketed device Yushan X-Ray Flat Panel Detector (Yushan V14C, Yushan V14G) (K191939), and do not raise different questions of safety and effectiveness than K191939. > FDA-Summary-A1 8of8