DIAMOND-5A/6A/8A

{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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. DRGEM Corporation % Mr. Carl Alletto Consultant OTech Inc 8317 Belew Drive MCKINNEY TX 75071 October 1, 2019 ### Re: K192453 Trade/Device Name: Diamond-5A/6A/8A Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: September 2, 2019 Received: September 9, 2019 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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 (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 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, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K192453 Device Name DIAMOND-5A/6A/8A #### Indications for Use (Describe) DIAMOND-5A/6A/8A, is a stationary digital diagnostic x-ray system that is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------|-----------------------------------------------------------| | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 contains the logo for DRGEM. The logo has the letters "DR" in bold black font, followed by "GEM" in a teal font. Below the logo is the text "Your Best Healthcare" in a smaller font size. ### 510(k) Summary - K192453 This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. ### I. SUBMITTER DRGEM Corporation 7F E-B/D Gwangmyeong Techno-Park 60, Haan-ro, Gwangmyeong-si, Gyeonggi-do, 14322 Korea Email: radcheck@drgem.co.kr TEL: +82-2-869-8566, FAX: +82-2-869-8567 Contact Person: Mr. Ki-Nam YANG, Director | QM representative Date Prepared: September 22, 2019 ### II. DEVICE Product Name: DIAMOND-5A/6A/8A Common Name: Digital Diagnostic X-ray System Regulation Name: Stationary X-Ray System Product Code: KPR Regulation number: 892.1680 Requlatory Class: = ### III. PREDICATE DEVICES Primary Predicate Device DIGITAL DIAGNOSTIC X-RAY SYSTEM (K102408) (DIAMOND), by DRGEM, product code KPR. Regulation 892.1680 Reference Predicate Device RADMAX Digital Imaging Software, K182537, by DRGEM, product code: LLZ. Regulation 892.2050 ### IV. DEVICE DESCRIPTION DIAMOND-5A/6A/8A, system is a digital radiographic system. There are 3 power output configurations which are reflected in the model designation "5A/6A/8A". The models have 3 different output power ratings: | System Model | DIAMOND-5A | DIAMOND-6A | DIAMOND-8A | |-----------------|------------|------------|------------| | X-Ray Generator | GXR-52 | GXR-68 | GXR-82 | | Output Rating | 52kW | 68kW | 82kW | DIAMOND 5A/6A/8A. incorporates digital flat panel detector technology, along with an automatic motorized U-arm radiographic stand and mobile patient table that can fit into smaller rooms without the need of ceiling support structures for X-Ray tube suspensions. The digital flat panel digital detectors that are used in DIAMOND-5A/6A/8A, are the VAREX Model 4343Rv3 (Ethernet interface) and 4336Wv4 (wireless). The Model 4343Rv3 (Ethernet interface) was cleared with the primary predicate device and both the Model 4343Rv3 (Ethernet interface) and 4336Wv4 (wireless) were cleared with RADMAX the reference predicate device. The main components of the x-ray source are the tube assembly, motorized x-ray collimator, HV cable assembly and high frequency x-ray generator. A touch screen LCD {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains a logo for "DRGEM Your Best Healthcare". The word "DR" is in bold black font, while "GEM" is in a teal color. Below the company name is the slogan "Your Best Healthcare" in a smaller font size. based x-ray control console provides a user interface and technique selection. The automatic collimator supports high accuracy for selected x-ray field size over SID. Selection of an anatomical study on the imaging software automatically sets up the x-ray generator's pre-programmed exposure technique setting, motorized radiographic stand positioning, x-ray collimation and post image processing for selected study. Also, removable high-resolution grids which have 100 and 180cm (40 and 72 inch) focal distance supplies excellent image quality per each SID. The integrated touch screen console located in the tube side, operator can easily control the radiographic techniques and stand positioning. Furthermore, the operator can verify the digital x-ray image on this screen. The GUI, automatically rotates corresponds to rotation angle of U-arm. The Radiographic stand has four motorized joints, and automatic positioning can be accomplished by preprogrammed data which can be easily reprogrammed by operator. Total of seven safety sensors are located over U-arm, detector and tube side to protect. against collision with patient or obstacles to control the speed or stop the positioning. Also, a mobile patient table with heavy patient load is provided for radiographic study which needs table. A remote-control is provided for remote motorized control of the stand, and the movement will stop as soon as the key is no longer pressed. The predicate device contains image handling software that was designed at the same time the product was originally developed. The subject device will replace the original image handling module with the RADMAX Digital Image Software cleared under K182537. This will improve the software changeability when a change is needed and also will improve cyber security since there was no documented cyber security plan at the time of the original product development. RADMAX can also perform system control such as the collimation size, filter selection, etc. for the GXR series x-ray generators. #### V. INDICATIONS FOR USE DIAMOND-5A/6A/8A, is a stationary digital diagnostic x-ray system that is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications. ### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES The subject device and the predicate device are stationary digital x-ray systems devices. The predicate device, K102408, DIGITAL DIAGNOSTIC X-RAY SYSTEM (DIAMOND) from DRGEM and the reference predicate device K182537, RADMAX Digital Imaging Software are being merged. The reference predicate device is replacing the digital imaging handling software module that was originally developed for the predicate. The intended use of the modified device, as described in the labeling, has not changed as a result of the modification. Any difference between the subject device and the predicate device does not affect safety or efficacy. No other changes were made to the predicate, besides the stated differences. | Specification | Subject Device | Predicate Device<br>(K102408) | Reference Predicate<br>RADMAX (K182537) | Impact of Differences | |------------------------------------------------|--------------------------------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | DIAMOND<br>5A/6A/8A | DIGITAL<br>DIAGNOSTIC X-<br>RAY SYSTEM | RADMAX Digital<br>Imaging System<br>Software | Not applicable | | Manufacturer | DRGEM<br>Corporation | DRGEM<br>Corporation | DRGEM Corporation | Not applicable | | Model Number | DIAMOND<br>5A/6A/8A | DIAMOND<br>5A/6A/8A | RADMAX | Not applicable | | Specification | Subject Device | Predicate Device<br>(K102408) | Reference Predicate<br>RADMAX (K182537) | Impact of Differences | | High Frequency<br>X-ray Generator | | | | | | Output Power | 52KW, 68KW,<br>82KW | 52KW, 68KW,<br>82KW | Not applicable,<br>RADMAX is image<br>management software<br>and does not have<br>Output Power. | No differences | | Generator models<br>(manufactured by<br>DRGEM) | GXR-52, GXR-68,<br>GXR-82 | GXR-52, GXR-68,<br>GXR-82 | Not applicable | No differences | | Line voltage | 400/480VAC | 400/480VAC | Not applicable | No differences | | Image<br>Acquisition | | | | | | Detector | VAREX<br>Model 4343Rv3<br>(Ethernet)/ 4336W<br>v4 (wireless) | VAREX<br>Model 4343Rv3<br>(Ethernet) | VAREX<br>Model 4343Rv3<br>(Ethernet)/ 4336W v4<br>(wireless) | The predicate device uses an<br>Ethernet interface and the subject<br>device interfaces to either Ethernet<br>or wireless detectors. The detectors<br>were cleared with the primary<br>predicate and reference predicate.<br>The subject device system has<br>been tested and there is "No<br>negative impact on safety or<br>efficacy" and there are no new<br>potential or increased safety risks<br>concerning this difference. | | Image<br>Management<br>Software | | | | | | Horizontal Flip | Available | Available | Available | These features between the<br>Primary Predicate, Reference<br>Predicate and Subject device are<br>similar. There may be some<br>rearrangement of headers and or<br>button locations since RADMAX is<br>the latest Image Management<br>software. The subject device<br>system has been tested and there is<br>"No negative impact on safety or<br>efficacy" and there are no new<br>potential or increased safety risks<br>concerning this difference. | | Vertical Flip | Available | Available | Available | Same as above | | Rotate CW/CCW | Available | Available | Available | Same as above | | Text Annotation | Available | Available | Available | Same as above | | Ruler: Distance<br>tool | Available | Available | Available | Same as above | | Angle<br>measurement tool | Available | Available | Available | Same as above | | Zoom | Available | Available | Available | Same as above | | Magnify | Available | Available | Available | Same as above | | Image panning | Available | Available | Available | Same as above | | Auto fitting to<br>window size | Available | Available | Available | Same as above | | Image crop/cut<br>function | Available | Available | Available | Same as above | | Specification | Subject Device | Predicate Device<br>(K102408) | Reference Predicate<br>RADMAX (K182537) | Impact of Differences | | Image Copy | Available | Available | Available | Same as above | | Recover the<br>original image | Available | Available | Available | Same as above | | Window level<br>CD Burning | Available | Available | Available | Same as above | | DICOM Print | Available | Available | Available | Same as above | | Image Stitching | Available | Available | Available | Same as above | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains a logo for DRGEM. The letters "DR" are in black, and the letters "GEM" are in teal. Below the logo is the text "Your Best Healthcare" in a smaller font. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for DRGEM, a healthcare provider. The letters "DR" are in bold, black font, while "GEM" is in a teal color. Below the company name is the slogan "Your Best Healthcare" in a smaller, lighter font. The logo is simple and professional, conveying a sense of trust and reliability. ### VII. PERFORMANCE DATA #### Nonclinical Testing: The DIAMOND-5A/6A/8A system, has been assessed and tested and has passed predetermined testing criteria. The Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by the subject device 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. ### Summary: Based on the performance as documented in the V&V Testing, the subject device was found to have a safe and effectiveness profile that is similar to the predicate device. The following International Standards were used to develop and verify the system. DIAMOND-5A/6A/8A, device has met all the requirements listed in the Standards except for inapplicable requirements (which are listed in the various test reports): | Std # | Safety/EMC Standards Description | FDA Rec.<br>Standard # | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | IEC 60601-1-3 | Medical electrical equipment<br>Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray<br>Equipment | 12-269 | | IEC 62366 (IEC<br>60601-1-6) | IEC 62366:2007 + A1:2014 - Usability engineering process checklist | 5-114 | | IEC 60601-2-28 | IEC 60601-2-28<br>Medical electrical equipment Part 2: Particular requirements for the safety of X-ray<br>source assemblies and X-ray tube assemblies for medical diagnosis | 12-204 | | IEC 60601-2-54 | IEC 60601-2-54<br>Medical electrical equipment<br>Part 2: Particular requirements for the basic safety and essential<br>performance of X-ray equipment for radiography and radioscopy | 12-296 | | IEC 62304:2006 | ANSI AAMI IEC 62304:2006<br>Medical device software - Software life cycle processes | 13-32 | | IEC 60601-1 | Medical electrical equipment, Part 1: General requirements for basic safety and<br>essential performance | 19-4 | | NEMA PS 3.1 | NEMA PS 3.1 - 3.20 (2016). Digital Imaging and Communications in Medicine<br>(DICOM) Set DICOM Standard. | 12-300 | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for DRGEM. The letters "DR" are in bold black font, while the letters "GEM" are in a teal color. Below the letters is the text "Your Best Healthcare" in a smaller font. | Std # | Safety/EMC Standards Description | FDA Rec.<br>Standard # | |----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | IEC/ISO10918-1 | JPEG Standard IEC/ISO10918-1 First edition 1994-02-15, Information technology<br>- Digital compression and coding of continuous-tone still images: Requirements<br>and guidelines [Including: Technical Corrigendum 1 | 12-261 | | IEC 62494-1 | IEC 62494-1 Edition 1.0 (2008-08), Medical electrical equipment - Exposure index<br>of digital X-ray imaging systems - Part 1: Definitions and requirements for general<br>radiography. | 12-215 | | ISO 14971:2007 | ISO 14971:2007/(R)2010 (Corrected 4 October 2007), Medical devices -<br>Applications of risk management to medical devices. | 5-40 | | ISO 15223-1 | ISO 15223-1 Third Edition 2016-11-01, Medical devices - Symbols to be used<br>with medical device labels, labelling, and information to be supplied - Part 1:<br>General requirements. | 5-117 | ### VIII. CONCLUSIONS The 510(k) Pre-Market Notification for DIAMOND-5A/6A/8A, contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The new device and the primary predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and 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 comparably to the predicate devices.