ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR

{0}------------------------------------------------ Image /page/0/Picture/0 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. March 23, 2018 ECOTRON Co., Ltd. % Mr. Dave Kim President Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025 #### Re: K180473 Trade/Device Name: ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-Arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB. JAA, OXO Dated: February 15, 2018 Received: February 22, 2018 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 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); {1}------------------------------------------------ #### Page 2 - Mr. Dave Kim 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert 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) K180473 Device Name ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-Arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR Indications for Use (Describe) The ANY VIEW DR SERIES (Anyviw-500DR, Anyview-240DR) is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures. This system can be applied in emergency room, operation room, cast room or etc. of hospital | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> <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. 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}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for "eco & electronics eddotron". The logo has a blue square design on the left side of the logo. The text "eco & electronics" is in black and is above the word "eddotron", which is in a gray color. ## SECTION 07 # 510(k) SUMMARY {4}------------------------------------------------ ## 1. Traditional 510(k) SUMMARY This summary of 510(k) is being submitted in accordance with requirements of SMDA 1990 and 21 CFR Part 807.92. Date 510K summary prepared : February 15, 2018 Submitter's Name, address, telephone number, a contact person: | Submitter's Name : | ECOTRON Co, Ltd. | |-------------------------|----------------------------------------------------------------------------------| | Submitter's Address: | Rm 504, Hanshin IT Tower II, 47, Digital-ro 9-gil,<br>Geumcheon-gu, Seoul, Korea | | Submitter's Telephone: | Tel:+82-2-2025-3760 / Fax:+82-2-2025-3764 | | Contact person: | Mr. Sang Bong Lee / RA Assist Mgr | | Official Correspondent: | Dave Kim (davekim@mtech-inc.net) | | Address: | 8310 Buffalo Speedway, Houston, TX 77025 | | Telephone: | +713-467-2607 | | Fax: | +713-583-8988 | Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known: | 510K Number: | | |-------------------------|-------------------------------------------------| | Trade/proprietary name: | ANYVIEW DR SERIES | | | FPD Fluoroscopic Mobile C-Arm | | Model Number: | ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR | | Regulation Name: | Interventional Fluoroscopic Mobile X-ray System | | Regulation Number: | 21 CFR 892. 1650 | | Regulatory Class: | Class II | | Product Code: | OWB, JAA, OXO | | Predicate Device | | | Trade Name | ANYVIEW-500R Fluoroscopic Mobile X-ray System | | 510(k) Clearance # | K160279 | | Clearance date | 10/14/2016 | | Classification Name | Image Intensified Fluoroscopic X-ray System | | Classification Panel | Radiology | | CFR Section | 21CFR 892.1650 (Produce Code; OWB, JAA, OXO) | | Device Class | Class II | | | | {5}------------------------------------------------ #### Reference Device | Trade Name | |----------------------| | 510(k) Clearance # | | Clearance date | | Classification Name | | Classification Panel | | CFR Section | | Device Class | D2RS AT Digital Dynamic Remote System K150306 10/10/2015 Image Intensified Fluoroscopic X-ray System Radiology 21CFR 892.1650 (Produce Code; JAA) Class II #### 2. Device Description The ANYVIEW DR SERIES (Anyviw-500DR, Anyview-320DR, Anyview-240DR) are mobile x-ray fluoroscopic imaging systems used by radiation experts. ANYVIEW DR SERIES are a digital fluoroscopic imaging systems with Flat Panel Detector (FPD) used in diagnostic and interventional procedures. ANYVIEW DR SERIES are composed of C-arm, x-ray generating equipment (x-ray controller, high voltage generator, x-ray tube, motor-type collimator), FPD, and workstation (console computer and monitor). ANYVIEW imaging software is a Digital Imaging System (DIS) designed for C-arm, ANYVIEW FPD Fluoroscopic Mobile X-ray System. ANYVIEW imaging software provides useful functions to manage X-ray images obtained from ANYVIEW DR SERIES FPD Fluoroscopic Mobile X-ray System. ANYVIEW imaging software provides various image tools. One of the most noticeable features is that the C-arm imaqes taken during an exam are stored in the database for further review. I Image data is integrated with the patient information in DICOM(OPTION) compatible format which allows compatibility with existing DICOM and PACS system. #### 3. Indications for Use The ANYVIEW DR SERIES (Anyviw-500DR, Anyview-320DR, Anyview-240DR) is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures. This system can be applied in emergency room, operation room, cast room or etc. of hospital. #### 4. Summary of Design Control Risk management ANYVIEW DR SERIES FPD Fluoroscopic Mobile X-ray System has been developed to provide the mobility of X-ray users for convenient access to patients while meeting the {6}------------------------------------------------ critical functional requirements and international safety standards. The risks and the hazardous impact of the device design were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the device design and production phase 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 and production were successfully mitigated and accepted. #### 5. Summary of the technological characteristics of the device compared to the predicate device: The indications for use and technical characteristics of ANYVIEW DR SERIES FPD Fluoroscopic system described in the 510(k) summary are similar to those of the predicate device, Anyview-500R Fluoroscopic Mobile X-ray System (K160279). Other than the digital flat panel detector, the ANYVIEW DR SERIES, the subject device, uses the same hardware, and same Anyview imaging software used for the predicate device (K160279). The difference is that the subject device is equipped with VIVIX-D 1212G digital detector whereas the predicate device is using imaging intensifier for imaging acquisition. In addition, ANYVIEW DR SERIES Fluoroscopic system offers lower power output compared to the predicate device. #### 6. Substantial Equivalence ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-Arm conforms to the FDA recognized standards as like the predicate device. Based on the recognized standard conformity evidences related to electro-, mechanical-, software-, clinical-, and risk management, it's the sponsor's opinion that the subject device is a safe and effective device. | Characteristics | Anyview FPD Fluoroscopic Mobile X-ray System | Anyview-500R Fluoroscopic Mobile X-ray System (K160279) | SE-# | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | Intended Use | The ANYVIEW DR SERIES (Anyviw-500DR, Anyview-320DR, Anyview-240DR) is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during | Anyview-500R mobile C-arm, fluoroscopic x-ray system, is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic | Same | | | diagnostic<br>and<br>interventional procedures. | and<br>interventional procedures. | | | | This system can be<br>applied in emergency<br>room, operation room,<br>cast room or etc. of<br>hospital. | This system can be<br>applied in emergency<br>room, operation room,<br>cast room or etc. of<br>hospital. | | | Energy Source | 220V~230V,<br>Single 50/60 Hz | 220V~230V,<br>Single 50/60 Hz | Same | | X-ray<br>Generator<br>Type | HFG INVERTER TYPE | HFG INVERTER TYPE | Similar | | Output power | Anyview-240DR 2.4 kW<br>Anyview-320DR 3.2 kW<br>Anyview-500DR 5.0 kW | 5kW | #1 | | Fluoroscopy | | | | | -Continuous<br>mode | 0.5-10mA | 0.5-10mA | Same | | -Pulsed mode | 0.5-20mA | 0.5-20mA | Same | | -Boost mode | 30mA | 30mA | Same | | Radiography<br>mode | | | | | -kV range | Anyview-240DR 40-110<br>Anyview-320DR 40-110<br>Anyview-500DR 40-125 | 40-125 kV | Similar<br>#2 | | -mA range | Anyview-240DR 16-30<br>Anyview-320DR 15-40<br>Anyview-500DR 20-100 | 20-100 mA | Similar<br>#2 | | -mAs range | Anyview-240DR 0.8-100<br>Anyview-320DR 0.8-100<br>Anyview-500DR 0.8-200 | 0.8~200mAs | Similar<br>#2 | | X-ray tube<br>type | TOSHIBA XRR-2251 | TOSHIBA XR-2551 | Same | | Max kV | 125kV | 125kV | Same | | Focal spot (S/L) | 0.3 / 0.6 | 0.3 / 0.6 | Same | | Target angle | 10° | 10° | Same | | Anode heat<br>capacity | 210 KHU | 210 KHU | Same | | Collimator | Open/close motorized | Open/close motorized | Same | | | | | | | type | | | | | Rotation | 360° | 360 ° | Same | | Detector | Flat Panel: TFT: a-Si w/<br>CsI: TI scintillator | Imaging<br>Intensifier:<br>E5830SD-P4A (TOSHIBA) | #3 | | Input FOV | 12 x 12 in | 9inch | Similar | | Central<br>resolution | 3.4 lp/mm | *54/62/70 lp/cm | #4 | | Laser Pointer | Included | Included | | | (1) Laser Class | Class II | Class II | | | (2) Max Power | 5mW | 5mW | Same | | (3) Wavelength | 655nM | 655nM | Same | | Viewing SW | ANYVIEW imaging<br>software | ANYVIEW imaging<br>software (K160279) | Same | | Performance<br>Standard | 21CFR 1020.30/1020.32 | 21CFR 1020.30/1020.32 | Same | | Electrical Safety | IEC 60601-1:<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-2-28<br>IEC 60601-2-43<br>IEC 60601-2-54 | IEC 60601-1:<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-2-28<br>IEC 60601-2-43<br>IEC 60601-2-54 | Same | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for "ecoTRON eco & electronics". The logo features the word "ecoTRON" in a bold, sans-serif font, with "eco" in blue and "TRON" in gray. Above "ecoTRON" is the text "eco & electronics" in a smaller, sans-serif font. To the left of "ecoTRON" are three blue squares. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for "eco & electronics edOTRON". The logo has three blue squares on the left side, followed by the word "edOTRON" in grey. Above the word "edOTRON" is the text "eco & electronics" in black. The logo is simple and modern, and the colors are clean and professional. Note *: Anyview-500R imaging intensifier (K160279) has different entrance field sizes; 9/6/4.5 inch. Therefore, the central resolution for each entrance field size is different; 54/62/70 lp/cm, respectively #### SSXI Performance Comparison Data (#5) | | Subject Device | Predicate device (Anyview-500R) | |--------------------|-------------------------------|------------------------------------------------| | Model Name | VIVIX-D 1212G | E5830SD-P4A (previously cleared under K160065) | | Manufacturer | VIEWORKS | TOSHIBA | | Size | 12 x 12 in (2048x2048 pixels) | 9 in (230mm min) | | MTF | 54 % @ 1 lp/mm | | | DQE | 69 % @ 1 lp/mm | 65 % | | Spatial resolution | 3.4 lp/mm | 5.2 lp/mm | #### SSXI Performance Comparison Data (#6) | | Subject Device | Reference Device<br>(D2 RS_AT Digital Dynamic<br>Remote System) | |--|----------------|-----------------------------------------------------------------| |--|----------------|-----------------------------------------------------------------| {9}------------------------------------------------ | Model Name | VIVIX-D 1212G | Pixium RF 4343 (K150306) | |--------------------|-------------------------------|-----------------------------| | Manufacturer | VIEWORKS | Thalaes | | Size | 12 x 12 in (2048x2048 pixels) | 17x17 in (2874x2840 pixels) | | MTF | 60% @ 1 lp/mm,<br>28%@2lp/mm | 62% @ 1 lp/mm, 25%@2 lp/mm) | | DQE | 69%@ 1 lp/mm, 44%@ 2lp/mm | 52% @ 1 lp/mm, 42%@2 lp/mm) | | Spatial resolution | 3.4 lp/mm | 3.4 lp/mm | ## 7. Difference Discussion | SE-# | SE discussion | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SE-#1, #2,<br>#3,#4 | #1, #2:<br>Both the subject device and predicate device have the same generator.<br>Therefore, the output power ranges (kV, mA, mAs) are the same for the<br>subject and predicate device. The maximum output power for different<br>models of the subject device can be limited by software setting. | | | #3, #4, #5, #6<br>The predicate device (Anyview-500R) is equipped with Image Intensifier.<br>Anyview-500DR, the subject device, is equipped with a FPD which<br>converts charging level of receiving light element to AD for output on a<br>monitor. It reduces distortions during the data conversion. The<br>grayscale per pixel of Image Intensifier after digital data conversion is<br>12bit (4096 step) whereas the grayscale of FPD is 16bit (65536 step). A<br>higher grayscale can express X-ray image better and more details. In<br>addition, the output resolution of the subject device is 4 times higher than<br>the predicate device; 2K x 2K and 1K x 1K, respectively. | | | The VIVIX-D 1212G FPD for the subject device is compared to Pixium RF<br>4343, FPD equipped for the reference device. Each FPD for the subject<br>device and the reference device has the same spatial resolution of 3.4<br>lp/mm and demonstrates equivalent bench test performance in terms of<br>MTF and DQE. | #### 8. Summary of the technological characteristics of the device compared to the predicate device: The indications for use, operating principle, and technical characteristics of the subject device described in this 510k are similar to those of the predicate device. The specifications of X-ray tube, X-ray generator, and X-ray tube anode heat content (Heating Unit) of the subject device are identical to those of the predicate device. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for "eco & electronics edotron". The "eco" part is in a smaller font and is above the word "edotron". The "edo" part of "edotron" is in blue, while the "tron" part is in gray. To the left of the word "edo" are three blue squares. The primary difference is that the subject device is equipped with a flat panel detector whereas the predicate device uses image intensifier. MTF, DQE and spatial resolution for each detector type have been studied for comparison between the subject and predicate device. The bench testing demonstrated equivalent performance between the subject and predicate device. The pixel size (2k x 2k) of the subject device is better than the active pixel (1K x 1K) of the predicate device. These differences do not have significant effect on safety and effectiveness compared to the predicate device. ANYVIEW imaging software of the subject device and the predicate device is identical. #### 9. Description of non-clinical tests. The subject device has been tested for electrical safety and electromagnetic compatibility. The device also complies with FDA EPRC Performance Standard: 21 CFR 1020.30-32. The software validation and verification testing was also performed. The results of nonclinical testing indicate that the subject device is as safe and effective as Anyview-500R Fluoroscopic Mobile X-ray System, the predicate device. Compliance evidences were submitted for the following standards: - > IEC60601-1:2005 + A1 (2012) - > IEC60601-1-2:2014 - > IEC60601-1-3:2008 - > IEC60601-2-28:2010 - > IEC60601-2-43:2010 - > IEC60601-2-54:2009 - > NEMA PS 3.1-3.20 The subject device meets EPRC requlation requirements. - > 21CFR1020.30 - > 21CFR1020.32 {11}------------------------------------------------ #### 10. Description of clinical tests. No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification. Bench testing was performed to assess the device safety and effectiveness. #### 11. Conclusion as to Substantial Equivalence The ANYVIEW DR SERIES (Anyviw-500DR, Anyview-320DR, Anyview-240DR), the subject device are substantially equivalent to the predicate (K160279). The intended use, the design principle, and the applicable standards for the subject device are identical to those of the predicate device. Some characteristics, for example, their appearance, the user interfaces and the detector's performance are different. However, the performance test and non-clinical consideration result demonstrate that these differences do not raise any new questions of safety and effectiveness. Therefore, it is the sponsor's opinion that the subject device appears to be as safe and effective as the predicate device.