EPX-Series Mobile X-ray System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 24, 2015 ECOTRON Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025 Re: K151038 Trade/Device Name: EPX-Series Mobile X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: June 19, 2015 Received: June 25, 2015 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. {1}------------------------------------------------ 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/Resourcesfor You/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 yours. Michael D'Hara For Robert Ochs, Ph.D. Acting 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) K151038 Device Name Epx-series Mobile X-ray System #### Indications for Use (Describe) This product, diagnostic X-ray system, is radiation medical equipment used by a qualified / trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays. This product is used on hand (wrist), foot (ankle), shoulder, elbow, knee, and other body parts. | 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 a company called "ecoTRON." The logo has a blue square with three vertical lines on the left side. To the right of the square is the text "eco & electronics" in a smaller font. Below the square and text is the word "ecoTRON" in a larger font, with "eco" in blue and "TRON" in gray. EPX Series Diagnostic X-ray System: F1600, F2400, F2800, F3200, F4000, F5000 ## SECTION 07 510(k) SUMMARY SECTION 07 Page 1 / 8 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for "eco & electronics eddTRON". The logo has a blue square design on the left side of the logo. The text "eco & electronics" is in black font and is located above the word "eddTRON". The word "eddTRON" is in a gray font. #### 1. Traditional 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR Part 807.92. Date 510K summary prepared : April 10, 2015 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, 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: | Trade/proprietary name: | EPX Series Mobile X-ray System<br>F1600, F2400, F2800, F3200, F4000, F5000 | |-----------------------------------|----------------------------------------------------------------------------| | Regulation Name: | Mobile X-ray System | | Regulation Number: | 21 CFR 892.1720 | | Regulatory Class: | II | | Product Code: | IZL | | Predicate Device<br>Manufacturer: | JOB Corporation | | Device: | PORTA 100HF | | 510(k) Number: | K122697 | | Decision Date: | Oct. 5, 2012 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for "eco & electronics eddTRON". The logo features a series of blue squares on the left, followed by the text "eco & electronics" in a smaller font. Below this, the word "eddTRON" is displayed in a larger, gray font. ## 2. Device Description This product, portable X-ray generator, is radiation medical equipment which can only be used by professional radiologists. It controls and marks Xray dose within the range of X-ray exposure limited by hardware. Also it uses algorithm of X-ray output for processing and control. This portable Xray generator requires equipment for X-ray images. Small in size, this product is convenient to carry with, and suitable for being moved around. The main body used with a stand. And when attached to a stand, it is easy to adjust positioning for medical imaging. #### 3. Indications for Use This rroduct, diagnostic X-ray system, is radiation ment used by a qualified / trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays. This product is used on hand (wrist), foot (ankle), shoulder, elbow, knee, and other body parts. #### 4. Summary of Design Control Risk management EPX mobile X-ray series have been developed to provide the mobility of X-ray users to patients while meeting the critical functional requirements and international safety standards The risks and 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 overal 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: EPX mobile X-ray series escribed in this 510(k) have the similar indications for use and technical characteristics as the predicate device, PORTA 100HF (K122697) manufactured by JOB Corporation. #### 6. Substantial Equivalence EPX Series mobile X-ray system conforms to the FDA recognized standards as like the predicate device. Based on the recognized standard conformity evidences related to electro-, mechanical-, clinical-, and risk management, it is confirmed that EPX Series is substantially equivalent to the predicate device. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for "eco & electronics eddTRON". The logo features a blue square design on the left, followed by the text "eco & electronics" in black. Below this, the word "eddTRON" is displayed in a larger, gray font, creating a visually distinct and modern brand identity. | Characteristics | EPX series Mobile X-ray System<br>(F1600, F2400, F2800, F3200, F4000, F5000) | | | | | | PORTA 100HF (K122697) , JOB<br>Corporation | SE-# | | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------------------------|-----------------------------|-----------------------------|-----------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------| | Intended Use | This product, diagnostic X-ray system, is radiation medical equipment used by<br>a qualified / trained physician or technician on both adult and pediatric subjects<br>for taking diagnostic X-rays.<br>This product is used on hand (wrist), foot (ankle), shoulder, elbow, knee, and<br>other body parts. | | | | | | Intended use by a<br>qualified/technician on both adult and pediatric subjects for taking<br>diagnostic X-rays | Simil<br>ar | | | Energy Source | 110V~120V / 220V~240V,<br>Single 50/60 Hz | | | | | | 100V-120V or 200V-240V<br>Single 50/60 Hz | Same | | | User Interface | Up and down Rotary switch for kV and mAs value with 7 segment LED | | | | | | Up and down Rotary switch for kV<br>and mAs value with 7 segment<br>LED | Same | | | Exposure switch | Dual stage, deadman type with curled cable. | | | | | | Dual stage, deadman type with<br>curled cable. | Same | | | Controls | Software based | | | | | | Software based | Same | | | Construction | Monobloc HF generator, Medical full bridge inverter system | | | | | | Monobloc HF generator, Medical<br>full bridge inverter system | Same | | | High Voltage<br>Adjustment | High frequency inverter | | | | | | High frequency inverter | Same | | | Line Voltage<br>Adjustment | Automatic, Dynamic | | | | | | Automatic, Dynamic | Same | | | Exposure times | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | 0.01 - 2.50 sec, 32 steps | | | | (sec) | 0.01~2.46<br>sec,<br>20steps | 0.01-4.0<br>sec,<br>25steps | 0.01-3.57<br>sec,<br>25steps | 0.01-3.2<br>sec,<br>25steps | 0.01-4.0<br>sec,<br>25steps | 0.01-5.0<br>sec,<br>25steps | | Simil<br>ar | | | Tube Potential | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | 40-100kV (2kV step) | Simil<br>ar | | | (kV) | 40-90kV<br>(1kV step) | 40-100kV<br>(1kV step) | 40-120kV<br>(1kV step) | 40-100kV<br>(1kV step) | 50~110kV<br>(1kV step) | 50~110kV<br>(1kV step) | | | | | Tube current | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | 30mA (40-66kV)<br>20mA (68kV – 100kV) | #1 | | | | 12~30mA | 20~40mA | 14~40mA | 25~60mA | 20~80mA | 20~<br>100mA | | | | | | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | | | | | mAs | 0.4~32mAs | 0.4~100mAs | 0.4~100mAs | 0.4~100mAs | 0.4~100mAs | 0.4~100mAs | 0.3 mAs – 50 mAs | #2 | | | X-ray tube | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | Toshiba D-124 | #3 | | | | D-125 | D-125 | D-125 | D-205B | OX/110-15 | OX/110-15 | | | | | Anode heat<br>storage | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | 20K HU | #4 | | | | 50K HU | 50K HU | 50K HU | 40k HU | 42k HU | 42k HU | | | | | Focal Spot | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | 1.2mm | #5 | | | | 1.2mm | 1.2mm | 1.2mm | 2.0mm | 1.8mm | 1.8mm | | | | | Total Filtration | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | | | | | | 3.3mm AL.Eq<br>@75kV | 3.3mm ALEq<br>@75kV | 3.3mm ALEq<br>@75kV | 3.3mm ALEq<br>@75kV | 3mm ALEq<br>@75kV | 3mm ALEq<br>@75kV | 2.5mm AL. eq. at 100kV | #6 | | | Collimator | Complete with 30 sec. timer and cross indication line | | | | | | | Complete with 30 sec. timer and<br>cross indication line | Same | | Performance<br>Standard | 21CFR 1020.30 | | | | | | | 21CFR 1020.30 | same | | Electrical Safety | IEC 60601-1:<br>IEC 60601-1-3<br>IEC 60601-2-28<br>IEC 60601-1-2<br>IEC 60601-2-54 | | | | | | | IEC 60601-1:<br>IEC 60601-1-3<br>IEC 60601-2-28<br>IEC 60601-1-2<br>IEC 60601-2-7<br>IEC 60601-2-54 | #7 | | X-ray Radiography | Conventional X-ray film or digital imaging detector | | | | | | | Conventional X-ray film or digital<br>imaging detector | same | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for eco & electronics edotron. The logo has a blue square design on the left side of the logo. The text "eco & electronics" is in black and is located on the top right side of the logo. The text "edoTRON" is in gray and is located on the bottom right side of the logo. # EPX Series Diagnostic X-ray System: F1600, F2400, F2800, F3200, F4000, F5000 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image is a logo for "eco & electronics edoTRON". The logo has a blue icon on the left, followed by the text "eco & electronics" in black. Below that is the word "edoTRON", with "edo" in blue and "TRON" in gray. The logo is simple and modern, with a focus on the company's name and its connection to electronics. ## 7. Difference Discussion | SE-# | SE discussion | |---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SE-#1, #2, | EPX Series mobile X-ray system performs similar or better compared to the predicate device in terms of performance<br>specifications. For EPX-F1600, the performance specification is almost identical to the predicate device In terms<br>of kV, tube current. EPX-F1600 provides more segmented kV step control compared to the predicate.<br>EPX-F2400<br>and EPX-F2800 have similar or higher capacity than the predicate device in terms of KV and tube current setting<br>which may require shorter patient exposure time.<br>EPX-F3200, EPX-4000 and EPX-F5000 are equipped with even higher performance specifications and higher tube<br>current control is possible. The high voltage controls X-ray penetration and thus the image. The<br>tube current and exposure time affect the dose and therefore the darkness of the image.<br>Such differences in performance do not raise additional risk concerns. | | SE-#3, #4, #5 | F1600, F2400, and F2800 show the same effective focal spot. The effective focal spot for F3200, F4000, and<br>F5000 is larger than the predicate device. The effective focal spot size is controlled by the size of the actual focal<br>spot and the anode target angle. Larger effective focal spot results wider useful beam. EPX series has larger<br>anode heat storage than the predicate device. It refers to the capacity of the thermal energy of which the X-ray<br>tube must be able to support and dissipate during and after an exam. | | SE-#6 | The minimum filtration reduces patient radiation dose by eliminating low energy that would otherwise be<br>absorbed by the patient's skin.<br>Positive means are determined through linear interpolation to provide that at least the minimum filtration needed<br>to achieve the above beam quality requirements is in the useful beam during each exposure, according to the HVL<br>provisions of 1020.30(m)(1). | | SE-# 7 | IEC 60601-2-7 is withdrawn and replaced with IEC 60601-1 3rd Ed. | #### 8. Summary of the technological characteristics of the device compared to the predicate device: The indications for use, mechanical components, performances and safety characteristics of EPX mobile X-ray series described in this 510(() are similar to those of the predicate device. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image is a logo for "eco & electronics eddoTRON". The logo features a series of blue squares on the left side, followed by the text "eco & electronics" in a smaller font size. Below this text is the word "eddoTRON" in a larger, bolder font. The color of "eddoTRON" is gray. EPX Series Diagnostic X-ray System: F1600, F2400, F2800, F3200, F4000, F5000 The primary differences are the specifications of X-ray generator of the subject device. The performance specifications of the subject device are similar or higher than that of the such as the X-ray generator and X-ray tube ande heat content (Heating Unit), These differences do not have an effect on safety and effectiveness compared to the predicate device. ## 9. Performance Testing/Data Testing for verfication and validation of the device was found acceptable to substantial equivalence. Safety compliance checking (including EMC, and so on) was evaluated according to the IEC Standards. ECOTRON Co., Ltd certifies conformance to Voluntary Standards covering electrical and Mechanical safety. In conclusion is of electrical hazards was mitiqated and is substantially equivalent of the predicate device in terms of safety and effectiveness. #### 10. Description of non-clinical tests. EPX series diagnostic X-ray system has been tested for electromagnetic compatibility (IEC 60601-1-2, IEC 60601-2-54, IEC 60601-1-3, IEC 60601-2-28, and IEC 60601-1:2005.) The device also complies with FDA EPRC Performance Standard: 21 CFR 1020.30 and 31. The software validation and verification was also performed. The results of nonclinical testing indicate that the EPX series mobile X-ray system is as safe and effective as the predicate device. Compliance evidences were submitted for the following standards: - IEC 60601-1: Test Report issued by 3rd party testing lab A - IEC 60601-1-2: Test Report issued by 3rd party testing lab A - IEC 60601-1-3: Test Report issued by 3rd party testing lab A - IEC 60601-2-54: Test Report issued by 3rd party testing lab A - EPRC Standard: 21 CFR 1020.30 and 31: In-house Test Report A - ISO 14971: Risk management file A #### 11. Description of clinical tests. No cinical data is necessary to effectiveness for purposes of determining substantial equivalence of the proposed modification. Bench testing was performed to assess the device safety and effectiveness. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for "eco & electronics eddoTRON". The logo features a blue square design on the left, followed by the text "eco & electronics" in a smaller font size. Below this text is the word "eddoTRON" in a larger, bold font, with the "eddo" part in blue and the "TRON" part in gray. The overall design is clean and modern. EPX Series Diagnostic X-ray System: F1600, F2400, F2800, F3200, F4000, F5000 #### 12. Conclusion as to Substantial Equivalence EPX SERIES are substantially equivalent to the predicate device PORTA 100 HF (K122697). These 2 devices are very similar in the intended use, the design principle, the perfornance and the applicable standards. Some characteristics, for exer interfaces and the capacity of X-ray generator and X-ray tube are different. However the compliance demonstrations and description of nonclinical review result in this submission that these differences do not raise any new questions of safety and effectiveness. Therefore, ECOTRON CO., LTD. concludes EPX series of mobile X-ray system are substantially equivalent with the predicate device PORTA 100 HF (K122697) of JOB Corporation.