TOPA12 Portable X-ray Unit

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, and on the right is the FDA logo. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. August 16, 2023 NEUF Inc. % Yeonwoo Lee Senior Staff CTI co., Ltd A-1712. 43. Iliik-ro Gwangmyeong-si, Gyeonggi-do 14353 SOUTH KOREA Re: K230581 Trade/Device Name: TOPA12 Portable X-ray Unit Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: July 3, 2023 Received: July 19, 2023 Dear Yeonwoo Lee: 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. 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 {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, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230581 Device Name TOPA12 Portable X-ray Unit Indications for Use (Describe) The TOPA 12 Portable X-Ray Unit is intended for use by a qualified/trained doctor or technician on adult subjects for taking diagnostic radiographic exposures for acquiring X-ray images of the desired parts of patient anatomy of extremities. Type of Use (Select one or both, as applicable) | <span></span> <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | |--------------------------------------------------------------------------| | <span></span> <span></span> 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. 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SUBMITTER NEUF Inc. #103 Production Bldg. 13, Yulchonsandan 4-ro, Haeryong-myeon, Suncheon-si, Jeollanam-do, Republic of Korea Woo Sang Lee CEO of NEUF Inc. Email: ceo@@neufgen.com TEL: +82-61-740-2847 FAX: +82-61-743-5331 Date Prepared: May 12, 2023 #### II. DEVICE | Trade or Proprietary Name: | TOPA12 Portable X-ray Unit | |----------------------------|----------------------------| | Common or Usual Name: | Mobile X-ray System | | Classification Name: | System, X-Ray, Mobile | | Regulation Number: | 892.1720 | | Regulatory Class: | II | | Product Code: | IZI | #### III. PREDICATE DEVICE | 510(k) Number: | K222896 | |--------------------|-----------------------| | Trade/Device Name: | AirRay | | Product Name: | Diagnostic X-ray Unit | | Model Name: | AirRay | | Manufacturer: | POSKOM CO., LTD | | Regulation Number: | 892.1720 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for NEUF. The logo consists of a stylized, abstract symbol to the left of the word "NEUF" in bold, sans-serif, black font. The symbol is composed of four curved shapes, each in a different color: gray, pink, blue, and light green. The word "NEUF" is positioned to the right of the symbol, with each letter clearly defined and evenly spaced. | Regulatory Class: | II | |-------------------|-----| | Product Code: | IZL | #### DEVICE DESCRIPTION IV. This portable radiographic unit (Model: TOPA12) consists of a LED display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, a collimator. A cart or a stand can be used with the TOPA12. In addition, this unit has preset memory keys to store and select kV, The TOPA12 is used with a film-cassette or flatpanel detector. This device is a mains-powered portable X-ray unit, designed and manufactured by NEUF. Compared with traditional X-ray products, this device has exquisite structure, compact design, light weight and easy operation. The major components of the X-ray main unit include: handle, enclosure, control panel, system control (SYS) board, high-voltage tank, collimator (beam limiter), and system control software running on the SYS board. The system control software is for real-time interaction and control with various circuit modules inside the portable X-ray unit. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, and control the display of the status indicators. The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites. Since the kV range of this device is 40~90kVp, which is not suitable for breast exams, the device is not intended for mammography. The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. This portable X-ray unit is designed for handheld or stand-mounted imaging. This portable X-ray unit can be configured to an optional portable stand/rack or use a stand that complies with IEC 60601- 1 safety standard. The recommended maximum load that the stand can safely carry is 30kgs to ensure the mechanical stability and effectiveness of the device. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for NEUF. The logo consists of a stylized, four-pointed star-like shape to the left of the word "NEUF" in bold, sans-serif font. The star shape is divided into four sections, each with a different color: gray, pink, purple, and white. The word "NEUF" is in black. #### INDICATIONS FOR USE V. The TOPA 12 Portable X-Ray Unit is intended for use by a qualified/trained doctor or technician on adult subjects for taking diagnostic radiographic exposures for acquiring X-ray images of the desired parts of patient anatomy of extremities. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for "NEUF". The logo consists of a stylized, abstract symbol on the left and the word "NEUF" in bold, black letters on the right. The symbol is a geometric shape with three distinct sections colored gray, pink, and blue. The word "NEUF" is written in a sans-serif font. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI. | Item | Subject Device | Predicate Device | | | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | | TOPA12 Portable X-ray Unit | AirRay | | | | | 510(k) number : K230581 | 510(k) number : K222896 | | | | Indications for use | The TOPA 12 Portable X-Ray Unit is intended<br>for use by a qualified/trained doctor or<br>technician on adult subjects for taking<br>diagnostic radiographic exposures for acquiring<br>X-ray images of the desired parts of patient<br>anatomy of extremities. | The POSKOM Portable X-ray unit is a device<br>that can conveniently generate X-rays for<br>diagnosis when the patient<br>condition is difficult to move. Mainly used by<br>trained specialists, doctors or radiologists.<br><br>Indication:<br>The POSKOM Battery Type Portable X-ray<br>Unit is intended for use by a qualified/trained<br>doctor or technician on both<br>adult and pediatric subjects for taking<br>diagnostic radiographic exposures of the body<br>parts.<br>The device must be used for stand mounted<br>diagnostic imaging of head, abdomen, or<br>extremities.<br>The device must be used for stand mounted<br>imaging of the chest.<br>Applications can be performed with the patient<br>sitting, standing, or lying in the prone or<br>supine position.<br>Contraindication:<br>The use of X-radiation for diagnostic purposes<br>in the following subjects is contraindicated.<br>- Pregnancy, especially first trimester | Similar | | | | Dimension | 293×138×144mm | 325 X 268 X 250 mm | Similar | | | Item | Subject Device<br>TOPA12 Portable X-ray Unit<br>510(k) number : K230581 | Predicate Device<br>AirRay<br>510(k) number : K222896 | | | | Weight | 5.5kg | 5.0kg | Similar | | | Output Power | 1.2 kW | 1.6kW | Similar | | | Energy source | 25.2VDC 5000mAh | Lithium Polymer Battery 3.7V<br>5000mAh | Similar | | | Exposure times | 0.04 sec – 2 sec | 0.02 sec – 2 sec | Similar | | | Tube current | 40kV ~ 50kV / 20mA / 0.4 ~ 20mAs<br>51kV ~ 60kV / 15mA / 0.4 ~ 16mAs<br>61kV ~ 70kV / 15mA / 0.4 ~ 16mAs<br>71kV ~ 80kV / 15mA / 0.4 ~ 3.2mAs<br>71kV ~ 80kV / 10mA / 4.0 ~ 20mAs<br>81kV ~ 90kV / 10mA / 0.4 ~ 20mAs | 20mA (50 ~ 80kV / 0.4 ~ 3.2mAs)<br>10mA (50 ~ 70kV / 3.6 ~ 20mAs)<br>10mA (71 ~ 80kV / 3.6 ~ 16mAs)<br>15mA (81 ~ 90kV / 0.4 ~ 3.2mAs)<br>8mA (81 ~ 90kV / 3.6 ~ 16mAs) | Similar | | | Tube Voltage Range | 40 – 90 kV | 50 – 90 kVp | Similar | | Memory settings | 4 Memories | 10 Memories | Different | | | HF Generator | High frequency | High frequency | Same | | | X-ray Tube | OX/80-0.8(CEI) | OX/70-1.0 (C.E.I.) | Different | | | Collimator | ≥ 160 lx, max size 47 * 47 cm @ 1m | Double slit type and manually operation with<br>LED Light indicator | Different | | | Product image | Image: TOPA12 Portable X-ray Unit | Image: AirRay | - | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the word "NEUF" in bold, black, sans-serif font. To the left of the word is a stylized logo. The logo is composed of four triangular shapes, each in a different color: gray, pink, dark blue, and light blue. The logo is arranged in a way that creates a star-like or abstract geometric design. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for NEUF. The logo consists of a stylized, abstract symbol on the left and the word "NEUF" in bold, sans-serif font on the right. The abstract symbol is composed of four curved shapes in different colors: gray, pink, and blue. The word "NEUF" is in black. #### PERFORMANCE DATA VII. ### Non-clinical testing Sample clinical images of extremities (Elbow, Hand, Knee, Ankle, Foot) were reviewed by a qualified clinician, who found them to be of good quality and clinical utility. Software validation and risk analysis was performed. Laboratory testing was performed according to the following standards: | EN 60601-1:2006<br>/A1:2013/A12:2014/A2:2021<br>AAMI ES60601-1:2005,<br>ES60601-1:2005/AMD1:2012,<br>ES60601-1:2005/AMD2:2021<br>IEC 60601-1-3:2008 | Medical electrical equipment -- Part 1: General<br>requirements<br>for basic safety and essential performance | |-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1-<br>3:2008/AMD1:2013<br>IEC 60601-1-<br>3:2008/AMD2:2021 | Medical electrical equipment - Part 1-3: General<br>requirements for basic safety and essential performance<br>- Collateral Standard: Radiation protection in diagnostic<br>X-ray equipment | | IEC 60601-1-6:2010,<br>AMD1:2013, AMD2:2020 | Medical electrical equipment - Part 1-6: General<br>requirements for basic safety and essential performance<br>- Collateral standard: Usability | | IEC 60601-2-54:2009<br>+A1:2015+A2:2018 | Medical electrical equipment -- Part 2-54: Particular<br>requirements for the basic safety and essential<br>performance of X ray equipment for radiography and<br>radioscopy | | IEC 60601-1-2:2014+A1:2020<br>IEC 60601-1-2:2015/A1:2021 | Medical electrical equipment – Part 1-2: General<br>requirements for basic safety and essential performance<br>- Collateral standard: Electromagnetic disturbances –<br>Requirements and tests | | IEC 62133-2:2017 | Secondary cells and batteries containing alkaline or<br>other non-acid electrolytes - Safety requirements for<br>portable sealed secondary cells, and for batteries made<br>from them, for use in portable applications - Part 2:<br>Lithium systems | | IEC 62304:2006/AMD1:2016 | Medical device software - Software life-cycle processes | | IEC 62366-1:2015 | Medical devices - Application of usability engineering<br>to medical devices | ## Clinical studies Clinical studies were not performed. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for NEUF. The logo consists of a stylized, four-pointed star-like shape on the left, with each point a different color: gray, pink, purple, and blue. To the right of the shape is the word "NEUF" in bold, black, sans-serif font. The letters are closely spaced, giving the word a solid, impactful appearance. ### VIII. CONCLUSIONS After analyzing bench tests, it is the conclusion of NEUF Inc. that the TOPA 12 Portable X-ray Unit is as safe and effective as the predicate device, has the same indications for use, has few technological differences, which are addressed through performance testing and compliance with the standards listed above, thus rendering it substantially equivalent to the predicate device.