Yushan X-Ray Flat Panel Detector with DROC

{0}------------------------------------------------ April 14, 2022 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". InnoCare Optoelectronics Corp. % Yumei Cheng Principal Engineer Rm. B. No. 2. Sec. 2. Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist. Tainan City, 741 TAIWAN Re: K220510 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: February 15, 2022 Received: February 22, 2022 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). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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You must comply with all the Act's {1}------------------------------------------------ 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 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 (OS) 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). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K220510 Device Name Yushan X-Ray Flat Panel Detector with DROC ### Indications for Use (Describe) The Wired Yushan X-Ray Flat Panel Detector 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 is not intended for mammography, fluoroscopy, tomography, and angiography applications. The use of this product is not recommended for pregnant women and the risk of radioactivity must be evaluated by a physician. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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SUBMITTER InnoCare Optoelectronics Corp. Rm. B. No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist., Tainan City 741, Taiwan, R.O.C. TEL: +886-6-700-7238 # 22598 Email: yumei.cheng@innocare-x.com Contact Person: Yumei Cheng / Principal Engineer Date Prepared: Feb 10, 2022 ## II. DEVICE Trade name: Yushan X-Ray Flat Panel Detector with DROC Model name: V17Ce 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 with DROC FDA 510(k) clearance number: K201528 Manufacturer: InnoCare Optoelectronics Corp. Decision Date: 10/11/2020 Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo "INCX" in a bold, sans-serif font. The "X" in the logo has a stylized design, with the right side of the "X" appearing as a gradient, transitioning from dark to light gray. Below the logo, the text "Device class: Class II" is displayed in a smaller, serif font. Trade/Device Name: FDR D-EVO FLAT PANEL DETECTOR SYSTEM FDA 510(k) clearance number: K132509 Manufacturer: FUJIFILM MEDICAL SYSTEMS USA, INC. Decision Date: 11/25/2013 Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680 ## IV. DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFI-CATION InnoCare's Yushan X-Ray Flat Panel Detector with DROC, model V17Ce is a nonprotable(wired) 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. 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. V17Ce 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 the scintillator material is 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 x-ray generator (an integral part of a complete x-ray system), is not part of the submission. 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, The personal computer is not part {5}------------------------------------------------ of this submission. Yushan series is working by using DROC(Digital Radiography Operating Console). 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). The device software is being used unchanged from the predicate system. ## V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Yushan X-Ray Flat Panel Detector with DROC(model: V17Ce) has the same Indications for Use, and very similar functional and technical requirements as the model V17Ge in K201528. 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 is one models in this submission, V17Ce, which is the exact same model of V17Ge in K201528, except for the Scintillator, C stands for CsI, and G stands for GOS. {6}------------------------------------------------ | Product name | Yushan X-Ray Flat Panel Detector<br>with DROC | Yushan X-Ray Flat Panel Detector<br>with DROC | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Model name | V17Ce | V17Ge | | Manufacturer | InnoCare Optoelectronics Corp. | InnoCare Optoelectronics Corp. | | Qualified<br>number | - | K201528 | | Clinical | | | | Intended use | The Wired Yushan X-Ray Flat<br>Panel Detector is intended to cap-<br>ture for display radiographic im-<br>ages of human anatomy. It is in-<br>tended 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. The use of<br>this product is not recommended<br>for pregnant women and the risk of<br>radioactivity must be evaluated by<br>a physician. | 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 in-<br>tended 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. | | Compliance<br>standard | - FDA Standards 21 CFR<br>892.1680 for stationary x-ray<br>system<br>- European Medical Devices<br>Directive (93/42/EEC) | - FDA Standards 21 CFR<br>892.1680 for stationary x-ray<br>system<br>- European Medical Devices<br>Directive (93/42/EEC) | | | | | | | - EN ISO 13485 | - EN ISO 13485 | | | - ISO 14971 | - ISO 14971 | | | - ANSI/AAMI ES60601-1 | - ANSI/AAMI ES60601-1 | | | - CAN/CSA C22.2 No. 60601-1:14 | - CAN/CSA C22.2 No. 60601-1:14 | | | - IEC 60601-1-2 | - IEC 60601-1-2 | | | - IEC 62304 | - IEC 62304 | | | - IEC 60601-1-6 | - IEC 60601-1-6 | | | - IEC 62366-1 | - IEC 62366-1 | | | - ISO 10993-1 | - ISO 10993-1 | | | - ISO 10993-5 | - ISO 10993-5 | | | - ISO 10993-10 | - ISO 10993-10 | | | - ISO 15223-1 | - ISO 15223-1 | | | Technical | | | Dimensions<br>(mm) | V17Ce:<br>460(W)×460(L)×15(H) | V17Ge:<br>460(W)×460(L)×15(H) | | Weight (Kg) | V17Ce: 3.6 | V17Ge: 3.5 | | Scintillator | V17Ce: CsI | V17Ge: GOS | | Pixel Pitch | 140 μm | 140 μm | | DQE | CsI: at 1 lp/mm, RQA5 is 0.48 | GOS: at 1 lp/mm, RQA5 is 0.27 | | MTF | CsI: at 1 lp/mm, RQA5 is 0.69 | GOS: at 1 lp/mm, RQA5 is 0.52 | | Max.<br>resolution | CsI: 3.57 lp/mm | GOS: 3.57 lp/mm | | A/D Conversion | 16 bit | 16 bit | | Pixels | V17Ce: 3072 x 3072 | V17Ge: 3072 x 3072 | | Interface | Wired: Gigabit Ethernet | Wired: Gigabit Ethernet | | | (100BASE-TX or 10BASE-T) | (100BASE-TX or 10BASE-T) | | Power Source | Not applicable | Rechargeable Lithium Battery<br>*not applicable on model V17Ge | | 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 | - Power supply (Adapter)<br>- SE cable (Back-up cable)<br>- Power Cord | - Battery (Optional)* V17Ge is<br>not applicable<br>- Power supply (Adapter)<br>- SE cable (Back-up cable)<br>- Power Cord | {7}------------------------------------------------ {8}------------------------------------------------ ## VI. PERFORMANCE DATA Non-clinical Performance Data: Yushan X-Ray Flat Panel Detector with DROC (V17Ce) 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; 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 18, 2018) 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 and the results were {9}------------------------------------------------ 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 (V17Ce) is as safe and effective as the legally marketed device Yushan X-Ray Flat Panel Detector (Yushan V17Ge) (K201528), and do not raise different questions of safety and effectiveness than K201528.