JADE Mobile X-Ray

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. DRGEM Corporation % Mr. Carl Alletto Consultant OTech. Inc. 8317 Belew Drive MCKINNEY TEXAS 75071 February 5, 2019 ### Re: K183388 Trade/Device Name: JADE Mobile X-Ray Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: December 1, 2018 Received: December 14, 2018 ### Dear Mr. Alletto: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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) K183388 Device Name JADE Mobile X-Ray Indications for Use (Describe) The JADE Mobile X-Ray, is a mobile X-ray device, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography, bone density, or dedicated pediations. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | 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. 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}------------------------------------------------ This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. 510(k) number: K183388 Date Prepared: December 1, 2018 Submitter's Information: 21 CFR 807.92(a)(1) Mr. Ki-Nam YANG Director | QM representative DRGEM Corporation 7F E-B/D Gwangmyeong Techno-Park 60, Haan-ro, Gwangmyeong-si, Gyeonggi-do, 14322 Korea Email: radcheck@drgem.co.kr Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) | Product Name: | JADE Mobile X-Ray | |------------------------|-----------------------| | Common Name: | Mobile X-Ray System | | Classification: | System, X-Ray, Mobile | | Regulation Number: | 892.1720 | | Product Code: | IZL | | Device Classification: | Class II | ### Predicate Device: 21 CFR 807. 92(a)(3) The JADE Mobile X-Ray, device is substantially equivalent to K182317: | Device Classification Name | System, X-Ray, Mobile | |------------------------------|------------------------------------| | 510(K) Number | K182317 | | Device Name | AMADEO M-DR Mini, AMADEO M-AX Mini | | Applicant | OEHM UND REHBEIN GMBH | | Regulation Number | 892.1720 | | Device Classification | Class II | | Classification Product Code | IZL | | Subsequent Product Code | MQB | | Decision | Substantially Equivalent (SESE) | | Regulation Medical Specialty | Radiology | | 510k Review Panel | Radiology | | Summary | Summary | | Type | Traditional | ### Device Description: 21 CFR 807 92(a)(4) The JADE Mobile X-Ray, is a mobile x-ray device that comes in two models: JADE-32 (3.2kw max. output and JADE-40 (4kw max. output). JADE is a non-motorized mobile diagnostic xray device that can facilitate X-ray examinations, in situations where it is not possible or {4}------------------------------------------------ feasible to transport the patient to a ward with fixed equipment. The unit is stable and precise when using the optional Mobile or Portable Stand. The electric tube unit and wheel locks. column rotation, and a simple user interface to provide for added operator convenience and rapid patient positioning. X-Ray technique presets can be saved. The JADE Mobile X-Ray device can be used with a film screen cassette or a flat panel detector which are supplied by the user and are not part of the JADE Mobile X-Ray, device. The software used with the JADE Mobile system is new and is not based on the predicate device. "Caution" The JADE Mobile X-ray should not be used as a handheld device. The JADE device consists of: - . High-Frequency X-ray Generator - Collimator with 30 seconds LED lamp timer - User Programmable APR - . Exposure Hand Switch - . Software(SDK, HT Frame and Membrane Console Firmware) | No. | PESS | Processor | Description | |-----|------|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | JADE | JADE_HTC | JADE_HTC at HT control board in x-ray generator controls whole x-ray generation<br>process by the control of System Control Module in CPC_SDK. This module<br>controls x-ray parameters such as kV, mA and exposure time, and controls the<br>filament and detector interfacing. | | | | JADE_MCC | JADE_MCC at console board in control console consist of generator control<br>module. JADE_MCC display the state of X-ray parameter and generator. | | 2 | CPC | CPC_SDK | CPC_SDK is the software provides user interface on generator control. CPC_SDK<br>consists of generator control Module and Display Module, System Diagnosis<br>Module | - . Optional equipment: - o Remote Controller (to control the Collimator Lamp, X-ray Exposure) - Portable Stand o - Mobile Stand O Indications for Use: 21 CFR 807 92(a)(5) The JADE Mobile X-Ray, is a mobile X-ray device, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography, bone density, or dedicated pediatric applications. Technological Characteristics: 21 CFR 807 92(a)(6) - . JADE Mobile X-ray specifications are in TABLE 1. - TABLE 2 is the collimator specifications and - TABLE 3, compares the predicate device and the new device. Any differences . between the predicate and the new device has no impact on safety or efficacy of the new device and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices. TABLE 1 Mobile X-Ray Unit Specs {5}------------------------------------------------ | Model | JADE-32 | JADE-40 | |----------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------| | Input Power | 100 - 240V~ (Free voltage input),<br>50/60Hz | 110 - 240V~ (Free voltage input),<br>50/60Hz | | Output Rating | Max. 3.2 kW (40mA@80kV,<br>32mA@100kV, 25mA@120kV) | Max. 4 kW (50mA@80kV,<br>40mA@100kV, 32mA@120kV) | | Type | Microprocessor controlled High Frequency inverter | | | KV Range | 40 ~ 120 KV, 81Step (1KV Step) | | | mA Range | 10 ~ 80 mA, 10Step (10, 12.5, 16,<br>20, 25, 32, 40, 50, 64, 80mA) | 10 ~ 100 mA, 11Step (10, 12.5, 16,<br>20, 25, 32, 40, 50, 64, 80, 100mA) | | Exposure Time | 0.01 ~ 10 seconds, 21Step (in 25% Steps) | | | mAs Range | 0.1 ~ 250 mAs, 35Step (in 25% Steps) | | | X-ray Tube Type | Stationary Anode | | | Focal Spot Size (Small / Large) | 0.5 / 1.5 mm | | | Anode Heat Storage Capacity | 56,000HU (40,000 J) | | | Power Cord Length | 5 m | | | Exposure Hand-switch Cord Length | 5 m (Max. Length) | | | X-ray switching frequency | 100 kHz | | | Control | 2 Point Control (kV, mAs) | | | Control Display | LED (7-seg display & indicators) | | | Anatomical Programs | Preprogrammed 9 APR data - User Programmable | | | External Interface | USB, Bluetooth (Option), DR Interface (Option) | | | Max. Input Power<br>Rating | 25 A @ 240 V~, 35 A @ 100 V~ | 24 A @ 240 V~, 34 A @ 110 V~ | | Weight | 16.8kg (37lb) (Including Collimator) | | ### TABLE 2 - Collimator Specs | Model | KM1 | |---------------------|-------------------------------------------| | Manufacturer | DRGEM | | Control | Manual with 15, 30, 45, 60sec. Lamp timer | | Field Shape | Rectangular | | Max. Field Size | 44x44cm (at 100cm SID) | | Leakage Radiation | < 40mR/hr. (at SID 1m) | | Max. kVp shield | 150kV | | Inherent Filtration | 2.0mmAl eq. | | Luminosity | Over 160LUX at 100cm SID | | Light source | 19W LED | | Standard | Rotating flange | | Option | Tape measure (Max. 200cm) | | Electrical Rating | 12 - 45VDC, 20W | {6}------------------------------------------------ | Dimension / Weight | 172(W) x 172(D) x 97(H) mm / 2.5kg(5.5lb) | |--------------------|-------------------------------------------| |--------------------|-------------------------------------------| TABLE 3 – Predicate and Subject Device Comparison The following information compares the subject device to the predicate. Any differences are due between the subject device and the predicated device has no impact on safety or efficacy of the modified device and does not raise any new potential safety risks and is equivalent in performance to existing legally marketed device. | Characteristic | Subject Device | Predicate K182317, AMADEO M-<br>DR Mini, AMADEO M-AX Mini | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The JADE Mobile X-Ray, is a<br>mobile X-ray device, for the<br>purpose of acquiring X-ray images<br>of the desired parts of a patient's<br>anatomy. This device is not<br>intended for mammography, bone<br>density, or dedicated pediatric<br>applications. | They Portable Diagnostic<br>Radiographic System are intended<br>for use by a qualified/trained doctor<br>or technician on both adult and<br>pediatric subjects for taking<br>diagnostic radiographic exposures<br>of the skull, spinal column, chest,<br>abdomen, extremities, and other<br>body parts. Applications can be<br>performed with the patient sitting,<br>standing, or lying in the prone or<br>supine position. (Not for<br>mammography). | | Configuration | Same as predicate | Line operated portable | | Generator | High frequency made by DRGEM | High frequency made by POSKOM | | Generator<br>power | Two power levels: JADE-32<br>(3.2kw max. output and JADE-40<br>(4kw max. output). | One power level: 5 KW | | Peak Voltage | 120kv | 110kv | | Collimator | DRGEM Corporation (Model KM1) | POSKOM PCMAX-100CAH | {7}------------------------------------------------ | Characteristic | Subject Device | Predicate K182317, AMADEO M-DR Mini, AMADEO M-AX Mini | |----------------------|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Image<br>acquisition | None | None or Either the PerkinElmer<br>XRpad2 4336 detector as cleared in<br>K161966 or the XenOR 35CW<br>(CareRay CareView1500CW)<br>cleared in K150929 (our model<br>XenOR 35CW) | | Software | DRGEM SDK | DICOMPACS DX-R | | Connections | USB, RS232 or Wi-Fi | Ethernet or Wi-Fi | | DICOM | None | Yes | | Electrical<br>Safety | Same | Electrical Safety per IEC-60601.<br>EMC per IEC-60601-1-2; IEC<br>60601-1-3 Radiation protection in<br>diagnostic X-ray equipment IEC<br>60601-2-54 Particular<br>Requirements for The Basic Safety<br>And Essential Performance of X-<br>Ray<br>Equipment for Radiography and<br>Radioscopy | | Image: X-Ray machine | Image: X-Ray machine | Image: X-Ray machine | ### Clinical Testing: Clinical testing is not necessary for the JADE Mobile system in order to demonstrate substantial equivalence to the predicate device. Nonclinical Testing: The complete system has been assessed and tested at the factory and by Standards testing facilities. The JADE Mobile X-Ray, device has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by JADE, and followed the process documented in the System Validation Test Plan. Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met. The main components of JADE Mobile X-ray, comply with the applicable regulatory requirements and design standards as follows: #### 1) SAFETY - IEC/EN 60601-1 3.1 Edition . {8}------------------------------------------------ - . EN 60601-1:2006/A1:2013 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance - EN 60601-1-3:2008/A1:2013. Medical electrical equipment -- Part 1-3: General . requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment - . EN 60601-1-6:2010/A1:2015. Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability - EN 60601-2-54:2009, Medical electrical equipment -- Part 2-54: Particular . requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy - EN 60601-2-28:2010, Medical electrical equipment -- Part 2-28: Particular . requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis 2) EMC - EN60601-1-2:2015, Medical electrical equipment Part 1-2: General requirements for . safety - Collateral standard: Electromagnetic compatibility - Requirements and tests - EN55011:2009/A1:2010, CISPR 11 :2009/A1:2010 ● - EN 61000-3-2:2014, Electromagnetic compatibility (EMC) -- Part 3-2: Limits Limits Limits -● for harmonic current emissions (equipment input current <= 16 A per phase) - . EN61000-4-2:2009, Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test - . EN61000-4-3:2006/A1:2007/A2:2010. Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test - . EN61000-4-4:2012, Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test - . EN61000-4-5:201, Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test - . EN61000-4-6:2014. Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radiofrequency fields - EN61000-4-8:2010, Electromagnetic compatibility (EMC) Part 4-8: Testing and . measurement techniques - Power frequency magnetic field immunity test - . EN61000-4-11:2004, Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests 4) OTHERS - EN ISO 15223-1:2016, Medical devices Symbols to be used with medical device ● labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016) - IEC TR60878:2003, Graphical Symbols for electrical equipment in medical practice ● - IEC60417-1:2000, Graphical Symbols for use on equipment-part1 : overview and application - . ISO 14971: 2012, Medical devices - Application of risk management to medical devices (ISO 14971:2012) The 510(k) Pre-Market Notification for the JADE Mobile X-Ray, contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device will be manufactured in accordance with the voluntary standards listed in the voluntary standard survey. The subject device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and {9}------------------------------------------------ intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices. Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device. Therefore, the JADE Mobile X-Ray, device, is substantially equivalent to the predicate device.