(159 days)
The 'TOPAZ Mobile X-ray System' is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.
"TOPAZ" system is a system providing state-of-the-art image quality, user interface. "TOPAZ" system may be moved quietly and smoothly with motor drive mechanism "TOPAZ" system has a basic type column, and a collapsible type column option with a trendy design that allows driving without disturbing the front view. The core part of x-ray source adopts high quality tube assembly, motorized x-ray collimator. HV cable assembly and High Voltage X-Ray Generator. Touch screen LCD based x-ray control console provides user-friendly interface and easy technique selection. Collimator supports high accuracy for selected x-ray field size over any SID. Direct radiography via flat panel detector improves-exam speed and comfort with efficiency. Digital flat panel detector with Csl screen provides spatial resolution, MTF, DQE and stability based on fine pixel pitch. Selection of an anatomical study on the Digital Imaging Software automatically sets up the x-ray generator's preprogrammed exposure technique. The types of "TOPAZ" system are divided into TOPAZ-32D, and TOPAZ-40D according to maximum power and mA. The higher the maximum output, the wider the mA range to choose from, giving the user more technical options to choose from. The "TOPAZ Mobile X-ray System" consists of a tube assembly. x-ray collimator. High Voltage X-Rav Generator, detector and mechanical parts for mobility.
The provided text is a 510(k) Summary for the TOPAZ Mobile X-ray System, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the format typically used for AI/CADe devices. This document describes the device, its intended use, technological characteristics, and differences from the predicate, along with non-clinical testing for safety and EMC standards.
Therefore, the specific information about "acceptance criteria and the study that proves the device meets the acceptance criteria" as requested for AI/CADe devices (including details like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set details) is not present in this 510(k) Summary.
This document primarily asserts that the "TOPAZ Mobile X-ray System" is substantially equivalent to the predicate device "TOPAZ Mobile DR System (K201124)" based on:
- Identical intended use.
- Similar technological characteristics, with modifications thoroughly tested for safety and effectiveness against international standards.
- Nonclinical testing results provided in the 510(k) demonstrating that predetermined acceptance criteria were met for safety (electrical safety, EMC, radiation protection) and software validation.
The "study that proves the device meets the acceptance criteria" in this context refers to the nonclinical testing against various recognized international and FDA standards, not a clinical performance study with human readers or pathology, as would be expected for AI/CADe systems.
Here's a summary of the available information regarding acceptance criteria and testing, tailored to what is provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria and reported device performance in the typical format for clinical accuracy for AI/CADe. Instead, it states that the device was assessed, tested, and passed predetermined testing criteria during validation testing, aligning with the risk analysis. It also confirms that the device meets "all the requirements listed in the Standards" (see the Standards table below). The "device performance" reported is its conformance to these standards and its substantial equivalence to the predicate.
Nonclinical Standards Met (acting as acceptance criteria for safety and effectiveness):
| Standard | Description | FDA Rec. Standard | Reported Device Performance |
|---|---|---|---|
| IEC 60601-1 | Medical electrical equipment, Part 1: General requirements for basic safety and essential performance | 19-46 | Met all requirements |
| IEC 60601-1-2 (EMC) | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances Requirements and tests. | 19-36 | Met all requirements |
| IEC 60601-1-3 | Medical electrical equipment Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment | 12-336 | Met all requirements |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | 5-132 | Met all requirements |
| IEC 60601-2-28 | Medical electrical equipment Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis | 12-309 | Met all requirements |
| IEC 60601-2-54 | Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | 12-348 | Met all requirements |
| IEC 62304:2006 | Medical device software - Software life cycle processes | 13-79 | Met all requirements |
| ISO 14971:2019 | Medical devices - Applications of risk management to medical devices. | 5-125 | Met all requirements |
| ISO 15223-1 | Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements. | 5-134 | Met all requirements |
| NEMA PS 3.1 - 3.20 (2016). | Digital Imaging and Communications in Medicine (DICOM) Set DICOM Standard. | 12-349 | Met all requirements |
| IEC/ISO10918-1 | Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines | 12-261 | Met all requirements |
| IEC 62494-1 | Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography. | 12-215 | Met all requirements |
| TR 60601-4-2 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems | 19-19 | Met all requirements |
| FDA Guidance (various) | Pediatric Information for X-ray Imaging Device, Format for Traditional and Abbreviated 510(k)s, Submission of 510(k)s for Solid State X-ray Imaging Devices, Content of Premarket Submissions for Device Software Functions, Content of Premarket Submissions for Software contained in Medical Devices, Cybersecurity in Medical Devices. | N/A | Complies/Addressed |
| 21 CFR 1020.30-31 | Applicable requirements for X-ray equipment | N/A | Conforms |
2. Sample size used for the test set and the data provenance:
- Not Applicable/Not Provided. The document describes non-clinical engineering and software validation testing against standards, not a clinical study involving a "test set" of patient data for diagnostic performance. The focus is on the device's hardware, software (RADMAX), and new flat panel detectors meeting safety and electrical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable/Not Provided. Ground truth establishment by experts is relevant for clinical performance studies, which this document does not describe.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable/Not Provided. This is relevant for clinical performance studies.
5. 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:
- No. This document describes a 510(k) for an X-ray system, not an AI/CADe system. No MRMC study was performed or is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable/No. The device itself is an X-ray system, not an algorithm, and its performance is assessed in terms of meeting engineering and regulatory standards, not standalone diagnostic performance. The imaging software (RADMAX) is mentioned as identical to the predicate and has a "Basic Documentation Level" of concern, implying human interpretation of images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable/Not Provided. For the non-clinical testing described, "ground truth" would relate to the correct functioning of the hardware and software according to specifications and standards, not clinical diagnostic accuracy.
8. The sample size for the training set:
- Not Applicable/Not Provided. This is relevant for AI/ML models. While the device contains software, it is not described as an AI/ML diagnostic algorithm needing a training set. The software changes are primarily GUI and image processing module updates, verified for impact on safety and effectiveness (not AI training).
9. How the ground truth for the training set was established:
- Not Applicable/Not Provided. As above, this is not an AI/ML submission requiring a training set.
In summary, the provided 510(k) document is for a mobile X-ray system and demonstrates substantial equivalence through nonclinical testing against recognized performance, safety, and EMC standards, rather than a clinical performance study with acceptance criteria related to diagnostic accuracy, which would be typical for AI-powered diagnostic devices.
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December 16, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
DRGEM Corporation % Arim Kim Regulatory Affairs | Engineer 7F, E-B/D Gwangmyeong Techno-Park 60, Haan-ro GwangMyeong-si, Gyeonggi 14322 SOUTH KOREA
Re: K242015
Trade/Device Name: TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: July 10, 2024 Received: December 3, 2024
Dear Arim Kim:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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 Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K242015
Device Name
TOPAZ Mobile X-ray System (Models: TOPAZ-32D, TOPAZ-40D)
Indications for Use (Describe)
The 'TOPAZ Mobile X-ray System' is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.
| 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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Image /page/4/Picture/0 description: The image contains the logo for DRGEM. The letters "DR" are in bold black font, while "GEM" is in a teal color. Below the logo is the text "Your Best Healthcare" in a smaller, lighter font.
510(k) Summary
K242015
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
I. SUBMITTER [21 CFR 807.92(a) (1)]
DRGEM Corporation 7F. E-B/D Gwangmyeong Techno-Park, 60 Haan-Ro Gwangmyeong-Si Gyeonggi, KR 14322 Email: arkim@drgem.co.kr TEL: +82-70-4901-2743, FAX: +82-2-869-8567 Contact Person: Ms. Arim KIM, Engineer | Regulatory Affairs Date Prepared: June 15, 2024
II. PROPOSED DEVICE INFORMATION [21 CFR 807.92(a) (2)]
| Product Name: | TOPAZ Mobile X-ray System (Models: TOPAZ-32D, TOPAZ-40D) |
|---|---|
| Common Name: | Mobile x-ray system |
| Classification Name: | Mobile x-ray system |
| Product Code: | IZL |
| Regulation Number: | 892.1720 |
| Associated Product Code: | MQB |
| Regulatory Class: | II |
III. PREDICATE DEVICES INFORMATION [21 CFR 807.92(a) (3)]
Product Name: TOPAZ Mobile DR System (Models: TOPAZ-32D, TOPAZ-40D) Common Name: Mobile x-ray system Classification Name: Mobile x-ray system
510(k) Number: K201124 Product Code: IZL Requlation Number: 892.1720
Regulatory Class: ==============================================================================================================================================================================
IV. DEVICE DESCRIPTION [21 CFR 807.92(a) (4)]
● Device Features:
· TOPAZ Mobile X-ray System
"TOPAZ" system is a system providing state-of-the-art image quality, user interface.
"TOPAZ" system may be moved quietly and smoothly with motor drive mechanism
"TOPAZ" system has a basic type column, and a collapsible type column option with a trendy design that allows driving without disturbing the front view.
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Image /page/5/Picture/0 description: The image contains the logo for DRGEM. The logo has the text "DRGEM" in bold, with "DR" in black and "GEM" in teal. Below the logo is the text "Your Best Healthcare" in a smaller, lighter font.
The core part of x-ray source adopts high quality tube assembly, motorized x-ray collimator. HV cable assembly and High Voltage X-Ray Generator. Touch screen LCD based x-ray control console provides user-friendly interface and easy technique selection. Collimator supports high accuracy for selected x-ray field size over any SID.
Direct radiography via flat panel detector improves-exam speed and comfort with efficiency. Digital flat panel detector with Csl screen provides spatial resolution, MTF, DQE and stability based on fine pixel pitch.
Selection of an anatomical study on the Digital Imaging Software automatically sets up the x-ray generator's preprogrammed exposure technique.
The types of "TOPAZ" system are divided into TOPAZ-32D, and TOPAZ-40D according to maximum power and mA. The higher the maximum output, the wider the mA range to choose from, giving the user more technical options to choose from.
● Device Identification:
The "TOPAZ Mobile X-ray System" consists of a tube assembly. x-ray collimator. High Voltage X-Rav Generator, detector and mechanical parts for mobility.
● Device Characteristics:
·Software
The subject device 'TOPAZ Mobile X-ray System' use software (including firmware).
Its S/W (RADMAX) can perform processing the radiological image acquired from Solid State X-ray Imaging Device.
Software being used is identical to the predicate device 'TOPAZ Mobile X-ray System', and its LOC (Level of Concern) is ' Basic Documentation Level'.
Accordingly, this software (RADMAX) is based on predicate device 'TOPAZ Mobile X-ray System'.
·Software Level Determination
Basic Documentation Level
The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention, interprets all images and information being displayed and printed.
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Image /page/6/Picture/0 description: The image shows the logo for DRGEM, a healthcare company. The letters "DR" are in bold black font, while "GEM" is in a teal color. Below the company name is the tagline "Your Best Healthcare" in a smaller, lighter font.
·Cybersecurity
This device complies with cybersecurity requirements by ensuring the confidentiality, integrity, and availability of data and systems.
Potential vulnerabilities were identified through cybersecurity risk analysis, which included threat modeling, risk assessment, and the development of a software bill of materials. The design integrates security controls, such as authentication, encryption, integrity verification, event detection and logging, retention, recovery and secure software updates. Verification and tests were conducted to ensure the effectiveness of the implemented cybersecurity controls. The product labeling includes cybersecurity-related information, and users are provided with quidance and training on instruction for use.
● Environment of Use:
This 'TOPAZ Mobile X-ray System' is for use by medical professional Facility. To prevent excess radiation exposure to patient and operator from either primary or secondary radiation, this 'TOPAZ Mobile X-ray System' must be operated and serviced by trained personnel who are familiar with the safety precautions required.
● Brief Written Description of the Device:
The operating principles are as follows.
The irradiation conditions are 40 to 125 (150) kVp at the photographing site, and the tube current is 10 to 400 (500) mA. When X-rays generated under X-ray irradiation conditions enter the X-ray Film or Flat Panel detector, the film or flat panel detects X-rays incident through the incident surface during X-ray irradiation, and finally generates a radiographic image when X-ray irradiation is completed.
V. INDICATION FOR USE [21 CFR 807.92(a) (5)]
The 'TOPAZ Mobile X-ray System' is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.
VI. TECHNOLOGICAL CHARACTERISTICS [21 CFR 807.92(a) (6)]
The Subject device 'TOPAZ Mobile X-ray System' (Model: TOPAZ-32D, TOPAZ-40D) is based on the Predicate Device (TOPAZ Mobile DR System, K201124) including the system control, Indication for use and mechanical design.
The differences between the subject device and the predicate device have been thoroughly tested and verified for safety and effectiveness by an accredited Safety and EMC testing laboratory.
This 510(k) submission describes some modifications to the previously cleared predicate devices the 'TOPAZ Mobile DR System' (K201124). The changes to the predicate 'TOPAZ Mobile DR System' (K201124) include:
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Image /page/7/Picture/0 description: The image contains the logo for DRGEM. The letters "DRG" are in black, and the letters "EM" are in teal. Below the logo is the text "Your Best Healthcare" in a smaller font.
Software update from TPZ IWS 1.00.01 to RADMAX 1.02.09
-
- Imaging Software Model Name Change: We have changed the model name of our imaging software from 'TPZ IWS (XGRADMAX)' to 'RADMAX'.
- Graphical user interface (GUI): GUI of system software updated in order to improve 2) the look and feel of user interface for better visibility & faster workflow.
- Image Processing Module added (Module 3, 4): We conducted performance 3) verification of Flat Panel detectors compared to existing image processing modules. Verification and Validation testing concluded no impact on safety and effectiveness.
Component Change
-
- 21.5" capacitive touch monitor is applied : 21.5" monitor is applied for improved viewing angle and wide screen.
-
- New Collapsible Column Stand Option have been Added (Basic type, Collapsible type - Optional)
: We have added a new Collapsible column type stand option to our product. This collapsible type column stand features a trendy design that allows driving without disturbing the front view.
-
- Addition of detector : 4343W, Mars1417X, Mars1717X, Luna1012X, A1417MCW, A1717MCW, F1417MCW
·10x12 inch Wireless Flat Panel detectors have been added
·Luna1012X manufactured by IRAY Technology, FDA Cleared K221345
·14x17 inch Wireless Flat Panel detectors have been added
·Mars1417X manufactured by IRAY Technology, FDA Cleared K210316
·A1417MCW manufactured by H&abyz Co., Ltd., FDA Cleared K223930
·F1417MCW manufactured by H&abyz Co., Ltd., FDA Cleared K223930
·17x17 inch Wireless Flat Panel detectors have been added
·4343W manufactured by Varex Imaging Corp, FDA Cleared K202572
·Mars1717X manufactured by IRAY Technology, FDA Cleared K210314
·A1717MCW manufactured by H&abyz Co., Ltd., FDA Cleared K223930
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Image /page/8/Picture/0 description: The image shows the logo for DRGEM. The letters "DR" are in bold black font, while "GEM" is in a teal color. Below the company name is the text "Your Best Healthcare" in a smaller font size.
VII.SUBSTANTIAL EQUIVALENCE [21 CFR 807.92(b)]
Substantial Equivalence Comparison Table
| Item | Subject Device | Predicate Device | Impact of Differences |
|---|---|---|---|
| Device Name | TOPAZ Mobile X-ray System | TOPAZ Mobile DR System | The TOPAZ Mobile DR Systemhas been renamed to theTOPAZ Mobile X-ray System.This is a simple model namechange, and the differencesbetween the subject device andthe predicate device do notaffect the safety or efficacy ofthe modified device. |
| 510(k) number | K242015 | K202572 | - |
| Manufacturer | DRGEM Corporation | DRGEM Corporation | - |
| Model Name | TOPAZ-32DTOPAZ-40D | TOPAZ-32DTOPAZ-40D | Same as predicate |
| Appearance | Image: Basic type | Image | Yes, there is a differenceCollapsible type Column StandOption have been AddedModels have been testedagainst International Safety andEMC Standards. Any differencesbetween the subject device andpredicate device do not changeor add new potential safety risksIt is our determination that thereis "No negative impact on safetyor effectiveness" and there areno new potentialor increased safety risksconcerning this differenceSame as predicate |
| Image: Collapsible type | |||
| Indicationsfor Use | The 'TOPAZ Mobile X-ray System' isintended for use in obtaining humananatomical images of patients whocannot be moved to the radiologydepartment for medical diagnosis. | The TOPAZ Mobile DR System, is amobile X-ray imaging system, for thepurpose of acquiring X-ray images of thedesired parts of a patient's anatomy.This device is not intended formammography, bone density,fluoroscopy and angiographyapplications. | Same as predicateThe indications for use of theprevious TOPAZ Mobile DRSystem and the current TOPAZMobile X-ray System isessentially the same.The previous device describedthe general intended use ofacquiring X-ray images of thedesired body part of the patient.The current device emphasizesthe more specific situation ofacquiring images of immobilepatients.Therefore, the intended use ofthe two devices is essentially thesame, with only differences inwording.This device is not intended formammography, bone density,fluoroscopy and angiographyapplications.These contraindications apply toboth the previous TOPAZ Mobile |
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Image /page/9/Picture/0 description: The image contains a logo for "DRGEM Your Best Healthcare". The word "DR" is in black, and the word "GEM" is in teal. The words "Your Best Healthcare" are in a smaller font and are in black.
| DR System and the currentTOPAZ Mobile X-ray System.This matters are specified in thewarning and contraindicationsections on pages 13 and 18 ofthe Operation Manual(RMD1311-009) | |||||
|---|---|---|---|---|---|
| 1. High Frequency X- ray Generator | |||||
| Output PowerRating (kW) | 32kW | 40kW | 32kW | 40kW | |
| mA Range | Max. 400mA | Max. 500mA | Max. 400mA | Max. 500mA | Same as predicate |
| KV Range | 40 ~125 kV(option: 150kV) | 40 ~ 125 kV(option: 150kV) | 40 ~125 kV(option: 150kV) | 40 ~ 125 kV(option: 150kV) | |
| mAs Range | 0.1 ~500mAs | 0.1 ~500mAs | 0.1 ~500mAs | 0.1 ~500mAs | |
| 2. X-ray tube housing Assembly | |||||
| Configurationmodel | E7239X / CANON | E7239X / CANON | |||
| E7242X / CANON | E7242X / CANON | ||||
| E7299X / CANON | E7299X / CANON | ||||
| E7876X / CANON | E7876X / CANON | ||||
| E7884X / CANON | E7884X / CANON | ||||
| DXT-8M / DRGEM | DXT-8M / DRGEM | ||||
| DXT-11M / DRGEM | DXT-11M / DRGEM | ||||
| DXT-10M / DRGEM | DXT-10M / DRGEM | Same as predicate | |||
| DXT-12M / DRGEM | DXT-12M / DRGEM | ||||
| Focal spot | 1.0/2.0mm, | 1.0/2.0mm, | |||
| 0.3/1.0mm, | 0.3/1.0mm, | ||||
| 0.6/1.2mm, | 0.6/1.2mm, | ||||
| 0.6/1.5mm | 0.6/1.5mm | ||||
| Target angle | 12° to 16 | 12° to 16 | Yes, there is a difference.The addition of the Collapsibletype Column Stand Optionadds a 330 degree columnrotation range. Models havebeen tested againstInternational Safety and EMCStandards. Any differencesbetween the subject deviceand predicate device do notchange or add new potentialsafety risks. It is ourdetermination that there is "Nonegative impact on safety oreffectiveness" and there areno new potential or increasedsafety risks concerning thisdifference | ||
| depending upon the Tube | depending upon the Tube | ||||
| Columrotationrange | ± 325 degrees | ± 325 degrees, | |||
| ± 330 degrees | |||||
| Tube(Arm axis) | ± 180 degrees | ± 180 degrees | |||
| Tube axisrotationrange | -30~+90 degrees | -30~+90 degrees | Same as predicate | ||
| Max TubeVoltage | 125kV, 150kV | 125kV, 150kV | |||
| 3. Collimator (Beam Limiting Device) | |||||
| Configurationmodel | R108/R108F | R108/R108F | Yes, there is a difference.Collimator ConfigurationModels have been partiallydeleted based on predicatedevice. | ||
| DXC-RML | DXC-RML/DXC-RMH | It is our determination thatthere is "No negative impact onsafety or effectiveness" andthere are no new potentialor increased safety risksconcerning this difference | |||
| Lamp Type | LED lamp | LED and Halogen lamp | |||
| 4. Solid State X-ray Imaging Device | |||||
| - | PaxScan4336W / VAREX | There are differences betweenthe added detectors and theoriginal detector used in thepredicate device. All detectorshave been tested forcompatibility with TOPAZ viainternal testing and the addeddetectors have been cleared byFDA 510(k)s. It is ourdetermination that the addeddetectors do not have anegative impact on safety orefficacy and there are no newpotential or increased safetyrisks concerning thesedifferences. | |||
| Flat panelDetector | PaxScan4336W v4/ VAREX | PaxScan4336W v4/ VAREX | |||
| XRpad2 3025 HWC-M / VAREX | XRpad2 3025 HWC-M / VAREX | ||||
| XRpad2 4336 HWC-M / VAREX | XRpad2 4336 HWC-M / VAREX | ||||
| XRpad2 4343 HWC-M / VAREX | XRpad2 4343 HWC-M / VAREX | ||||
| Mano4336W / IRAY | Mano4336W / IRAY | ||||
| Mano4343W / IRAY | Mano4343W / IRAY | ||||
| 4343W / VAREX | - | ||||
| Mars1417X / IRAY | - | ||||
| Mars1717X / IRAY | - | ||||
| Luna1012X / IRAY | - | ||||
| F1417MCW / H&abyz | - | ||||
| A1417MCW / H&abyz | - | ||||
| A1717MCW / H&abyz | - | ||||
| 5. Imaging Processing Software | |||||
| Configurationmodel | RADMAX | TPZ_IWS (XGRADMAX) | Yes, there is a difference. Themodel name has beenchanged. | ||
| SoftwareVersion | 1.02 V | 1.00 V | see below difference | ||
| Horizontal Flip | Yes | Yes | Yes | ||
| Vertical Flip | Yes | Yes | Yes | ||
| RotateCW/CCW | Yes | Yes | Yes | ||
| Text Annotation | Yes | Yes | Yes | ||
| Ruler: Distancetoo | Yes | Yes | Yes | ||
| Anglemeasurementtool | Yes | Yes | Yes | ||
| Zoom | Yes | Yes | Yes | ||
| Magnify | Yes | Yes | Yes | ||
| Image panning | Yes | Yes | Yes | ||
| Auto fitting towindow size | Yes | Yes | Yes | ||
| Image crop/cut | Yes | Yes | Yes | ||
| Image Copy | Yes | Yes | Yes | ||
| Recover theoriginal image | Yes | Yes | Yes | ||
| Window levelCD Burning | Yes | Yes | Yes | ||
| DICOM Print | Yes | Yes | Yes | ||
| Image Stitching | Yes | Yes | Yes | ||
| ImageProcessingModule | ·Module 1·Module 2·Module 3 | ·Module1 : IMFOU·Module 2 : COV | Yes, there is a difference.Models have been conductedVerification activity. Any |
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| ·Module 4 | differences between the | ||
|---|---|---|---|
| · MODULE 1 | · Module1: IMFOU | subject device and predicate | |
| Edge Enhancement: 0 ~ 50 | Edge Enhancement: 0 ~ 50 | device do not change or add | |
| Contrast Factor: 1 ~ 200 | Contrast Factor: 1 ~ 200 | new potential safety risks. It is | |
| Image Frequency: 0 ~ 20 | Image Frequency: 0 ~ 20 | our determination that there is | |
| Image Latitude: -10 ~ 10 | Image Latitude: -10 ~ 10 | "No negative impact on safetyor effectiveness" and there | |
| Sharpness: 0 ~ 100 | Sharpness: 0 ~ 100 | are no new potential | |
| or increased safety risks | |||
| · MODULE 2 | · Module 2 : COV | concerning this difference | |
| Histogram Optimization: -100 ~ 100 | Histogram Optimization: -1 ~ 1(0.01Step) | ||
| Skin line Weight: -100 ~ 100 | Skinline Weight: -1 ~ 1(0.01 Step) | ||
| Latitude Compression: -100 ~ 100 | Latitude Compression: -1 ~ 1(0.01 Step) | ||
| Contrast Enhancement: -100 ~ 100 | Contrast Enhancement: -1 ~ 1(0.01Step) | ||
| Edge Enhancement: -100 ~ 100 | Edge Enhancement: -1 ~ 1(0.01 Step) | ||
| Noise Suppression: -100 ~ 100 | Noise Suppression: -1 ~ 1(0.01 Step) | ||
| Gamma: -20 ~ 20 | Gamma: -20 ~ 20 | ||
| Specification | |||
| · MODULE 3 | |||
| Global Brightness: -100 ~ 100 | |||
| Global Contrast: -100 ~ 100 | |||
| Latitude Compression: -100 ~ 100 | |||
| S-Structure Enhancement: -100 ~ 100Noise Suppression: -100 ~ 100 | |||
| Gamma: -20 ~ 20 | |||
| · MODULE 4 | |||
| Global Brightness: -20 ~ 20 | |||
| Global Contrast: -30 ~ 30 | |||
| Local Contrast: 0 ~ 20 | |||
| Small Enhancement: 0 ~ 20 | |||
| Latitude Reduction: -20 ~ 20 | |||
| Noise Suppression: 0 ~ 20 | |||
| Gamma: -20 ~ 20 |
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VIII. SUMMARY OF NON-CLINICAL Data [21 CFR 807.92(b) (1)]
Nonclinical Testing:
The 'TOPAZ Mobile X-ray 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.
| Std | Safety/EMC Standards Description | FDA Rec.Standard |
|---|---|---|
| IEC 60601-1 | Medical electrical equipment, Part 1: General requirements for basic safety and essentialperformance | 19-46 |
| IEC 60601-1-2(EMC) | IEC 60601-1-2 Edition 4.0 2014-02. Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance - Collateral Standard:Electromagnetic disturbances Requirements and tests. | 19-36 |
| IEC 60601-1-3 | Medical electrical equipmentPart 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment | 12-336 |
| IEC 60601-1-6 | IEC 60601-1-6 Edition 3.1 2013-10Medical electrical equipment - Part 1-6: General requirements for basic safety and essentialperformance - Collateral standard: Usability | 5-132 |
| IEC 60601-2-28 | IEC 60601-2-28Medical electrical equipment Part 2: Particular requirements for the safety of X-ray sourceassemblies and X-ray tube assemblies for medical diagnosis | 12-309 |
| IEC 60601-2-54 | IEC 60601-2-54Medical electrical equipmentPart 2: Particular requirements for the basic safety and essential performance of X-rayequipment for radiography and radioscopy | 12-348 |
| IEC 62304:2006 | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSIONMedical device software - Software life cycle processes | 13-79 |
| ISO 14971:2019 | ISO 14971:2019 Third Edition, Medical devices - Applications of risk management to medicaldevices. | 5-125 |
| ISO 15223-1 | ISO 15223-1 Fourth Edition 2021-07, Medical devices - Symbols to be used with medicaldevice labels, labelling, and information to be supplied - Part 1: General requirements. | 5-134 |
| NEMA PS 3.1 -3.20 (2016). | NEMA PS 3.1 - 3.20 (2022). Digital Imaging and Communications in Medicine (DICOM) SetDICOM Standard. | 12-349 |
| IEC/ISO10918-1 | JPEG Standard IEC/ISO10918-1 First edition 1994-02-15, Information technology - Digitalcompression and coding of continuous-tone still images: Requirements and guidelines[Including: Technical Corrigendum 1 (2005) | 12-261 |
| IEC 62494-1 | IEC 62494-1 Edition 1.0 (2008-08), Medical electrical equipment - Exposure index of digitalX-ray imaging systems - Part 1: Definitions and requirements for general radiography. | 12-215 |
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Image /page/13/Picture/0 description: The image contains the logo for DRGEM. The letters "DR" are in bold black font, while "GEM" is in a teal color. Below the logo is the text "Your Best Healthcare" in a smaller, lighter font.
| TR 60601-4-2 | TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance andinterpretation - Electromagnetic immunity: performance of medical electrical equipment andmedical electrical systems | 19-19 |
|---|---|---|
| FDA Guidance | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device Premarket Notificationsdated November 28, 2017 | |
| FDA Guidance | Format for Traditional and Abbreviated 510(k)s, Guidance for Industry and Food and Drug AdministrationStaff, Document issued on September 13, 2019. | |
| FDA Guidance | Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices dated September 1, 2016 | |
| FDA Guidance | Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and DrugAdministration Staff Document issued on June 14, 2023. | |
| FDA Guidance | Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Softwarecontained in Medical Devices, Document issued on: May 11, 2005 | |
| FDA Guidance | Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket SubmissionsGuidance for Industry and Food and Drug Administration Staff Document issued on September 27, 2023. |
Summary:
Based on the performance as documented in the V&V Testinq, 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 electrical safety, and EMC. 'TOPAZ Mobile X-ray System' has met all the requirements listed in the Standards except for inapplicable requirements (which are listed in the various test reports).
The subject device conforms to all applicable requirements of 21 CFR 1020.30-31
IX. CONCLUSIONS [21 CFR 807.92(b) (3)]
The 510(k) Pre-Market Notification for 'TOPAZ Mobile X-ray System', contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device and the 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.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.