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 mammography, bone density, fluoroscopy and angiography applications.

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: 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 subject device comes in 2 hardware configurations; a Radiographic Stand configuration for a wired detector and a Radiographic Stand for removable detectors. The main components of the subject device are the same as the predicate. 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 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. The integrated touch screen console located on 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.

AI/ML Overview

The provided text is a 510(k) summary for the DRGEM Corporation's DIAMOND-5A/6A/8A stationary digital diagnostic x-ray system. This summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's diagnostic performance for measuring accuracy against a ground truth.

Therefore, much of the requested information (e.g., acceptance criteria for diagnostic capability, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and ground truth types for diagnostic accuracy) is not available in this document. The document primarily addresses the safety and performance of the hardware components and software in comparison to a previously cleared device.

Here's the information that can be extracted from the provided text:

Acceptance Criteria and Reported Device Performance (as pertains to safety and technical function):

Acceptance Criteria (General Safety and Performance)	Reported Device Performance
Follows international standards for medical electrical equipment, radiation protection, usability, X-ray source assemblies, X-ray equipment for radiography, software lifecycle, and risk management (e.g., IEC 60601 series, IEC 62366, ISO 14971).	The DIAMOND-5A/6A/8A device has met all the requirements listed in the cited International Standards (except for inapplicable requirements). Validation testing demonstrated that predetermined acceptance criteria were met.
The system's complete functionality (hardware and software, including new detectors) must have no negative impact on safety or efficacy.	The system has been tested, and there is no negative impact on safety or efficacy. No new potential or increased safety risks concerning the differences (e.g., added detectors, updated RADMAX software).
Performance profile similar to the predicate device.	The subject device was found to have a safe and effectiveness profile similar to the predicate device.
Compliant with DICOM standards for digital imaging.	NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set DICOM Standard.
Compliant with JPEG standards for image compression.	JPEG Standard IEC/ISO10918-1 First edition 1994-02-15.
Compliant with standards for exposure index of digital X-ray systems.	IEC 62494-1 Edition 1.0 (2008-08), Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography.

Detailed Study Information (as requested, with notes on unavailability):

Sample size used for the test set and the data provenance: Not applicable/available. The document describes non-clinical testing for safety and functionality, not a clinical study on diagnostic accuracy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/available. No clinical test set requiring expert ground truth for diagnostic accuracy is described.
Adjudication method for the test set: Not applicable/available.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable/available. This device is a digital X-ray system, not an AI-powered diagnostic aide for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/available. This refers to the performance of the X-ray system itself. The document states "The complete system has been assessed and tested at the factory and by Standards testing facilities. DIAMOND-5A/6A/8A, has passed all predetermined testing criteria." This indicates standalone testing for the system's technical function and safety.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/available for diagnostic accuracy. For safety and performance testing, the "ground truth" would be adherence to the cited international standards and predetermined testing criteria.
The sample size for the training set: Not applicable/available. The device is not an AI algorithm that requires a training set in the conventional sense for diagnostic tasks. Its software (RADMAX) is for image management and system control.
How the ground truth for the training set was established: Not applicable/available.

Summary of the Study (as described in the document):

The "study" described in the 510(k) summary is a non-clinical performance and safety assessment comparing the DIAMOND-5A/6A/8A system to its predicate device (also DIAMOND-5A/6A/8A, K192453). The primary purpose was to demonstrate that adding new digital flat panel detectors (Fujifilm, Varex, i-Ray models) and an updated version of the RADMAX image management software (version 1.01) did not negatively impact safety or efficacy and did not raise new safety risks.

The testing involved assessing the complete system's adherence to various international standards for medical electrical equipment, radiation protection, usability, software lifecycle processes, and risk management. The conclusion was that the device met all predetermined testing criteria and demonstrated a safe and effective profile similar to the predicate device. No clinical (diagnostic accuracy) studies are reported in this summary.

Summary

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September 10, 2020

Image /page/0/Picture/1 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 Regulatory Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071

Re: K202156

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: August 15, 2020 Received: August 19, 2020

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

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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

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Indications for Use

510(k) Number (if known) K202156

Device Name DIAMOND-5A/6A/8A

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Submission number: K202156

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: August 11, 2020

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

Contact Person: Mr. Ki-Nam YANG, Director | QM representative

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 Regulatory Class: II

III. PREDICATE DEVICE

The DIAMOND-5A/6A/8A subject device is substantially equivalent to: DIAMOND-5A/6A/8A (K192453), by DRGEM, product code KPR. Requlation 21 CFR 892.1680

IV. DEVICE DESCRIPTION

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 subject device comes in 2 hardware configurations; a Radiographic Stand configuration for a wired detector and a Radiographic Stand for removable detectors. The main components of the subject device are the same as the predicate. 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 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 imaqing 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. The integrated touch screen console located on 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.

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Submission number: K202156

. Selection of an anatomical study on the imaging software, (RADMAX), automatically sets up the x-ray qenerator'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 subject device contains the same image handling software as the predicate . device called RADMAX. RADMAX Digital Imaging Software, was cleared under K182537 and used in the predicate. RADMAX can perform image management and system control such as the collimation size, filter selection, etc. for the GXR series xray generators.

The digital flat panel digital detectors that are used in the subject device are:

Fujifilm, DR-ID 1272SE/ DR-ID 1274SE cleared under K142003 .
. Varex, PaxScan4343W cleared under K161459, and
. i-Ray, Mano4343W cleared under K201043.
. In addition to VAREX Model 4343Rv3 (Ethernet interface) and 4336Wv4 (wireless), used in the predicate.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

Summary of differences:

The subject device can use three previously cleared digital flat panel detectors in addition to the detectors used in the predicate device. The added detectors are:

Fujifilm, DR-ID 1272SE/ DR-ID 1274SE cleared under K142003
. Varex, PaxScan4343W cleared under K161459
i-Ray, Mano4343W cleared under K201043 .

The following information compares the subject device to the predicate and subject device.

Any differences between the subject device and the predicated device has no negative impact on safety or efficacy of the subject device and does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.

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Submission number: K202156

Specification	Predicate Device -K192453	Subject Device	Impact of Differences
Device Name	DIAMOND 5A/6A/8A	DIAMOND 5A/6A/8A	No difference
Manufacturer	DRGEM Corporation	DRGEM Corporation	No difference
Model Number	DIAMOND 5A/6A/8A	DIAMOND 5A/6A/8A	No difference
High Frequency X-ray Generator
Output Power	52KW, 68KW, 82KW	52KW, 68KW, 82KW	No difference
Generator models(manufactured byDRGEM)	GXR-52, GXR-68,GXR-82	GXR-52, GXR-C52,GXR-68, GXR-82	GXR-C52 X-Ray Generator isadded and uses single phase220/230V whereas the othergenerator models use 3 phase380/400/480V
Image Acquisition
Detectors	VAREX, Model4343Rv3	VAREX, Model 4343Rv3Fujifilm, Models DR-ID 1272SE/DR-ID 1274SEVarex, Model PaxScan4343Wi-Ray, Model Mano4343W	Differences: 3 additional flatpanel detectors:Fujifilm; K142003Varex; K161459iRAY; K201043The system has been testedand there is no negative impacton safety or efficacy and thereare no new potential orincreased safety risksconcerning these differences.
Image ManagementSoftware & Systemcontrol	RADMAX DigitalImaging Software -K182537	RADMAX DigitalImaging Software -K182537	No significant differences.RADMAX in the subject deviceis the latest ImageManagement software, version1.01. The system has beentested and there is no negativeimpact on safety or efficacy andthere are no new potential orincreased safety risksconcerning this difference.

VII. PERFORMANCE DATA

Nonclinical Testing:

Summary:

Based on the performance as documented in the testing, the subject device was found to have a safe and effectiveness profile that is similar to the predicate device.

The complete system has been assessed and tested at the factory and by Standards testing facilities. DIAMOND-5A/6A/8A, has passed all predetermined testing criteria.

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

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Submission number: K202156

activities and that the results demonstrated that the predetermined acceptance criteria were met.

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):

The main components of DIAMOND-5A/6A/8A comply with the regulatory requirements and design standards in this section as follows:

Std #	Safety/EMC Standards Description	FDA Rec.Standard #
IEC 60601-1-3	Medical electrical equipmentPart 1-3: General Requirements for Radiation Protection inDiagnostic X-Ray Equipment	12-269
IEC 62366 (IEC60601-1-6)	IEC 62366:2007 + A1:2014 – Usability engineering processchecklist	5-114
IEC 60601-2-28	IEC 60601-2-28Medical electrical equipment Part 2: Particular requirementsfor the safety of X-ray source assemblies and X-ray tubeassemblies for medical diagnosis	12-204
IEC 60601-2-54	IEC 60601-2-54Medical electrical equipmentPart 2: Particular requirements for the basic safety andessentialperformance of X-ray equipment for radiography andradioscopy	12-296
IEC 62304:2006	ANSI AAMI IEC 62304:2006Medical device software - Software life cycle processes	13-79
IEC 60601-1	Medical electrical equipment, Part 1: General requirementsfor basic safety and essential performance	19-4
NEMA PS 3.1	NEMA PS 3.1 - 3.20 (2016). Digital Imaging andCommunications in Medicine (DICOM) Set DICOM Standard.	12-300
IEC/ISO10918-1	JPEG Standard IEC/ISO10918-1 First edition 1994-02-15,Information technology - Digital compression and coding ofcontinuous-tone still images: Requirements and guidelines[Including: Technical Corrigendum 1	12-261
IEC 62494-1	IEC 62494-1 Edition 1.0 (2008-08), Medical electricalequipment - Exposure index of digital X-ray imaging systems- Part 1: Definitions and requirements for generalradiography.	12-215
ISO 14971:2007	ISO 14971:2007/(R)2010 (Corrected 4 October 2007),Medical devices - Applications of risk management tomedical devices.	5-40
ISO 15223-1	ISO 15223-1 Third Edition 2016-11-01, Medical devices -Symbols to be used with medical device labels, labelling, andinformation to be supplied - Part 1: General requirements.	5-117
Std #	Safety/EMC Standards Description	FDA Rec.Standard #
IEC 62366-1:2015	This part of IEC 6 2366 specifies a process for amanufacturer to analyze, specify, develop and evaluate theusability of a medical device as it relates to safety.	5-129

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Submission number: K202156

Conclusion:

The 510(k) Pre-Market Notification for the 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 subject device will be manufactured in accordance with the voluntary standards listed in the voluntary standard survey. The new device and predicate devices 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 device.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.