HF1202H PowerPlus Portable X-ray Equipment

{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 a human figure, represented by three overlapping profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 2, 2016 MinXray, Inc. % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114 Re: K153059 Trade/Device Name: HF1202H PowerPlus™ Portable X-ray Equipment Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: October 19, 2015 Received: October 21, 2015 Dear Daniel Kamm: 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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/ResourcesforYou/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, Robert Ochs 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) K153059 Device Name HF1202H PowerPlus(tm) Portable X-ray Equipment Indications for Use (Describe) This radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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: 510(k) Number K153059 MinXray, Inc. 3611 Commercial Avenue Northbrook, Illinois 60062, USA Toll Free 1-800-221-2245 (USA & Canada) Tel. 1-847-564-0323 Fax 1-847-564-9040 Date Prepared: January 25, 2016 Keith Kretchmer, President Contact: - 1. Identification of the Device: Proprietary-Trade Name: HF1202H PowerPlus™ Portable X-Ray Equipment - Classification Name: Mobile x-ray system, Product Code IZL Regulation Number 892.1720 2. Common/Usual Name: Mobile Diagnostic X-Ray System - 3. Equivalent legally marketed device: K040046, MinXray HF120/60 PowerPlus,™ made by Mikasa X-Ray Co. Ltd. (for MinXray). Mobile x-ray system, Product Code IZL Regulation Number 892.1720 - Indications for Use (intended use): This radiographic system is intended for use by a qualified/trained 4. physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. - 5. Description of the Device: The MinXray HF1202 consists of an X-ray generator (tubehead/control), continuously adjustable light beam collimator, mounting trunnion, exposure cord with 2-stage exposure switch, and AC power cord. If a stand is purchased with the HF1202, such as the MinXray XGS series of gas spring portable mobile stands, instructions for assembly of the stand and the attachment of the HF1202 are included with the stand. This is a high-frequency generator of updated design. The unit has a serial port and a Bluetooth port for communication of technique factors to a PC. The PC cannot initiate an exposure. When used, the PC must employ FDA cleared software and digital receptor panels. Known compatible with Toshiba FDX4343RP and FDX4343RPW digital x-ray panels. The FDX4343RP was cleared in K130883 (and K131211) and the FDX4343RPW was cleared in K143257. - 6. Safety and Effectiveness, comparison to predicate device. The results of bench testing indicates that the new device is as safe and effective as the predicate device. Proper system operation is fully verified upon installation. | | K040046, MinXray HF120/60<br>PowerPlus™, made by Mikasa X-Ray<br>Co. Ltd. (made for MinXray) | HF1202H PowerPlus™ Portable X-Ray<br>Equipment | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use: | This radiographic system is intended<br>for use by a qualified/trained physician<br>or technician on both adult and<br>pediatric subjects for taking diagnostic<br>x-rays. (Not for mammographic use.<br>Language later required by FDA) | (SAME) This radiographic system is intended for<br>use by a qualified/trained physician or<br>technician on both adult and pediatric subjects<br>for taking diagnostic x-rays. Not for<br>mammographic use. | | Size / weight: | 453 x 292 x 224 mm 17.94kgs | 460 x 305 x 225 mm 19.5kgs | | Energy Source: | 120V 50 - 60AC | SAME | | | K040046, MinXray HF120/60<br>PowerPlus,™ made by Mikasa X-Ray<br>Co. Ltd. (made for MinXray) | HF1202H PowerPlus™ Portable X-Ray<br>Equipment | | Use Interface: | Up-Down pushbuttons for kVp<br>selections and exposure time<br>selections and exposure time<br>selections with LED indicators mAs<br>indicator. | SAME | | Exposure times: | (0.01–0.2sec) in 0.01sec. Step<br>(0.2-0.4sec) in 0.02sec. Step<br>(0.4-1.0sec) in 0.05sec Step<br>(1.0-5.0sec) in 0.1sec Step | (0.02–0.2sec) in 0.01sec. Step<br>(0.2-0.4sec) in 0.02sec. Step<br>(0.4-1.0sec) in 0.05sec Step<br>(1.0-5.0sec) in 0.1sec Step | | mA: | 60 mA(0.01-0.1sec),<br>42 mA (0.11–5.0sec) @ 40 - 50 kVDC<br>50 mA(0.01-0.1sec),<br>35 mA (0.11–5.0sec) @ 52 - 60 kVDC<br>45 mA(0.01-0.1sec),<br>31.5 mA (0.11–5.0sec) @ 62 - 70 kVDC<br>38 mA(0.01-0.1sec),<br>26.6 mA (0.11–5.0sec) @ 72 - 80 kVDC<br>33 mA(0.01-0.1sec),<br>23.1 mA (0.11–5.0sec) @ 82 - 90 kVDC<br>30 mA(0.01-0.1sec),<br>21 mA (0.11–5.0sec) @ 92 - 100 kVDC<br>20 mA(0.01-0.1sec),<br>14 mA (0.11–5.0sec) @ 102 - 120 kVDC | 60 mA(0.02-0.05sec),<br>45mA (0.06 -0.2sec),<br>33 mA(0.22-5.0sec), @ 40 - 60 kVDC<br>55 mA(0.02-0.05sec),<br>41.3mA (0.06 -0.2sec),<br>30.3 mA(0.22-5.0sec), @ 62 - 70 kVDC<br>50 mA(0.02-0.05sec),<br>37.5mA (0.06 -0.2sec),<br>27.5 mA(0.22-5.0sec), @ 72 - 80 kVDC<br>45 mA(0.02-0.05sec),<br>33.8mA (0.06 - 0.2sec),<br>24.8 mA(0.22-5.0sec), @ 82 - 90 kVDC<br>40 mA(0.02-0.05sec),<br>30.0mA (0.06 - 0.2sec),<br>22.0 mA(0.22-5.0sec), @ 92 - 100 kVDC<br>30 mA(0.02-0.05sec),<br>22.5mA (0.06-0.2sec),<br>16.5 mA(0.22-5.0sec), @ 102 - 110 kVDC<br>25 mA(0.02-0.05sec),<br>18.8mA (0.06-0.2sec),<br>13.8 mA(0.22-5.0sec), @ 112 - 120 kVDC | | Memory settings<br>(technique) | 5 memories via pushbutton | 10 memories via pushbutton | | HF Generator | 85 kHz | SAME | | kW | 2.4 kW peak | 3.0 kW peak | | kVp: | 40 – 120kVp | SAME | | X-ray Tube | Superior X-ray Tube Company<br>SXR-130 1.2 mm, 65 kHU | SAME | | Collimator | Advantech | Collimare® | | Serial<br>Communication | Not available | RS-232 or Bluetooth for communication of<br>technique factors to a PC. | | | K040046, MinXray HF120/60<br>PowerPlus™, made by Mikasa X-Ray<br>Co. Ltd. (made for MinXray) | HF1202H PowerPlus™ Portable X-Ray<br>Equipment | | Photo | Image: K040046, MinXray HF120/60 PowerPlus | Image: HF1202H PowerPlus Portable X-Ray Equipment | ## 7. Substantial Equivalence Chart {4}------------------------------------------------ {5}------------------------------------------------ - 8. Summary of non-clinical testing: Software validation and risk analysis was performed. Laboratory testing was performed according to the following standards: IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) Medical Electrical Equipment, Part 1: General Requirements for Safety IEC 60601-1-2:2007 Medical Electrical Equipment-Part 1-2: General Requirements for Safety - 2. Collateral Standard-Electromagnetic compatibility - Requirements and tests IEC 60601-1-3:2008 (Second Edition) for use with IEC 60601-1: 2005 (Third Edition) Medical electrical equipment Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment IEC 60601-1-6:2010 (Third Edition) for use in conjunction with IEC 60601-1: 2005 (Third Edition)Medical electrical equipment Part 1-6: General requirements for safety - Collateral Standard: Usability including IEC 62366: Application of usability engineering to medical devices IEC 60601-2-28:2010 (Second Edition) for use in conjunction with IEC 60601-1: 2005 (Third edition) Medical electrical equipment Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis IEC 60601-2-54 (First Edition): 2009 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy IEC 62304:2006 (First Edition) Medical device software: Software life-cycle processes IEC 62366: 2007 (First Edition) + A1: 2014 Medical devices – Application of usability engineering to medical devices. The test results showed compliance with these standards. We also confirmed overall operation by taking and reviewing test images; however, sample clinical images were not required to determine substantial equivalence. The Bluetooth® module is FCC approved and was validated for use with the HF1202H. - 9. Summary of clinical testing: Not applicable. Clinical testing was not deemed to show substantial equivalence. We relied on non-clinical testing and compliance with standards. - 10. Conclusion: After analyzing bench tests, it is the conclusion of MinXray Inc. that the HF1202H PowerPlus™ Portable X-Ray Equipment 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.