2430MCA with Xmaru W

{0}------------------------------------------------ June 21, 2021 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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. Rayence Co., Ltd % Dave Kim President Mtech Group 7707 Fannin St. Ste. 200 HOUSTON TX 77054 Re: K202902 Trade/Device Name: 2430MCA with Xmaru W Regulation Number: 21 CFR 892.1715 Regulation Name: Full-Field Digital Mammography System Regulatory Class: Class II Product Code: MUE, LLZ Dated: May 14, 2021 Received: May 18, 2021 Dear Dave 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 (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/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) k202902 Device Name 2430MCA with Xmaru W ### Indications for Use (Describe) The 2430MCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for a mammographic system. It is intended to replace film or screen based mammographic systems in screening mammography. Xmaru W is an integrated software solution indicated for use with the 2430MCA detector. Type of Use (Select one or both, as applicable) | <span style="font-size:10pt;"> <div><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> </span> | |----------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size:10pt;"> <div><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> </span> | ### 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}------------------------------------------------ # 510(k) Summary K202902 This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR Part 807.92. #### 1. Date 510k summary prepared: May 18, 2021 ## 2. Submitter's Information: | Name of sponsor | Rayence Co., Ltd. | |------------------------|---------------------------------------------------------| | Address | 14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea | | Telephone no. | +82-31-8015-6459 | | Contact Person | Mr. Kee Dock Kim / RA Team Manager / +82-31-8015-6459 | | Official Correspondent | Dave Kim (davekim@mtech-inc.net) | | Address | 7505 Fannin St. Ste 610, Houston, TX 77054 | | Telephone no. | +713-467-2607 | Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known: # Proposed Device : | | Detector (2430MCA) | Software (Xmaru W) | |---------------------------|------------------------------------------|------------------------------------------------| | Trade/proprietary<br>name | 2430MCA with Xmaru W | | | Common Name | Digital Flat Panel X-ray Detector | Radiological Image Processing<br>System | | Regulation Number | 21 CFR 892.1715 | 21 CFR 892.2050 | | Regulation Name | Full-field digital mammography<br>system | Picture archiving and communications<br>system | | Product Code | MUE | LLZ | ## Predicate Device : | | Detector (RSM 1824C) | Software (Rconsole1) | |---------------------------|------------------------------------------|------------------------------------------------| | 510(k) Number | K162670 | | | Applicant | DRTECH Corporation | | | Trade/proprietary<br>name | RSM 1824C with RConsloel | | | Common Name | Digital Flat Panel X-ray Detector | Radiological Image Processing<br>System | | Regulation Number | 21 CFR 892.1715 | 21 CFR 892.2050 | | Regulation Name | Full-field digital mammography<br>system | Picture archiving and communications<br>system | | Product Code | MUE | LLZ | {4}------------------------------------------------ ### 3. Device Description 2430MCA is a digital mammography X-ray detector that is based on flat-panel technology. This mammographic image detector and processing unit consists of a CsI scintillator coupled to a CMOS sensor. This device needs to be integrated with a mammographic imaging system. It can be utilized to capture and digitalize X-ray images for mammographic screening. The RAW files can be further processed as DICOM compatible image files by separate console SW, Xmaru W for a mammographic screening. 2430MCA detector is connected by wire to a viewing station via ethernet connection. ### 4. Indication for use The 2430MCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for a mammographic system. It is intended to replace film or screen based mammographic systems in screeming mammography. Xmaru W is an integrated software solution indicated for use with the 2430MCA detector. ### 5. Summary of Design Control Risk management The 2430MCA digital X-ray detector with Xmaru W is similar to the predicate device, RSM 1824C with Rconsole1 (K162670). 2430MCA is slightly larger than RSM 1824C with Rconsole1 (K162670). Biocompatibility test is not applicable because this device is mounted on the cassette or bucky stand of the mammography system and has no contact part with patients. The risks and the hazardous impact of the device were analyzed with FMEA method. The specific risk control and protective measures to mitigate the device risks were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design change were successfully mitigated and accepted. {5}------------------------------------------------ # 6. Summary of the technological characteristics of the device compared to the predicate device: The 2430MCA digital flat panel X-ray detector in this 510(k) has the similar indications for use and similar technical characteristics as its predicate device, RSM 1824C with Rconsole1 (K162670). | | Characteristic | Proposed Device | Predicate Device #1 | | |------------------------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | | Manufacturer | Rayence Co.,Ltd. | DRTECH Corporation | | | | Product Name | 2430MCA with Xmaru W | RSM 1824C with Rconsole1 | | | | 510(k) number | K202902 | K162670 | | | Intended Use | | The 2430MCA Digital Flat<br>Panel X-Ray Detector is<br>indicated for digital imaging<br>solution designed for a<br>mammographic system. It is<br>intended to replace film or<br>screen based mammographic<br>systems in screening<br>mammography.<br>Xmaru W is an integrated<br>software solution indicated<br>for use with the 2430MCA<br>detector. | The RSM 1824C is a<br>detector indicated for use in<br>screening and diagnostic<br>mammography.<br>The RConsole1 is an<br>integrated software solution<br>indicated for use with the<br>RSM Series detectors. | Similar | | | Detector Type | CMOS Photodiode Array | TFT a-Si | different detector<br>type but it is same<br>indirect<br>conversion<br>method of<br>Radiation image<br>detection | | Scintillator | | CsI | CsI | Same | | Image Area | | 231.8 X 304.0 mm | 233.4 x 175.1mm | Similar | | Pixel matrix | | 3312 X 4344 (Full<br>resolution)<br>1656 X 2172 (2x2 binning) | 3,072 x 2,304 | Similar | | Pixel pitch | | 70 um (Full resolution)<br>140 um (2x2 binning) | 76 um | Similar | | DOE | 2.0 lp/mm | 57.8 | 55.0 | Similar | | (%) | 5.0 lp/mm | 26.4 | 25.1 | | | MTF | 2.0 lp/mm | રી રે | 42.5 | Similar | | | 5.0 lp/mm | 12.5 | d 9.9 | | | Data output | | RAW<br>*The RAW files are<br>convertible into DICOM 3.0<br>by console S/W | DICOM 3.0 | Same | | Acquisition<br>devices | | Digital X-ray Detector | Digital X-ray Detector | Same | | Software<br>Function | | | | | | | Image viewing | Image viewing | Same | | | | Image search | Image search | | | | | Image storage | Image storage | | | | | Image annotation | Image annotation | | | | | Image measurement | Image measurement | | | | | Image processing | Image processing | | | | | Image stitch | Image stitch | | | #### Comparison table 6.1 {6}------------------------------------------------ #### 6.2 Scintillator layer * scintillator layer. ( * scintillator : a phosphor that produces scintillations) | | Proposed | Predicate | |---------------------|----------|-----------| | CsI (Cesium Iodide) | 2430MCA | RSM 1824C | ## 6.3 Power source | | specification | |------------|---------------------------------------------------------------| | Model name | RS1417 | | Dimension | 188 X 92 X 41.5 | | Weight | 0.5 | | Rating | Input: 100-240 Vac, 50/60 Hz<br>Output: Typ. 24VDC (Max 1.7A) | # 6.4 Integrated system recommended specifications ### 1) X-ray Unit - Source to image receptor distance (SID) focal-image distance of more than 600 mm - | Manufacturer | K<br>number | SID(mm) | |------------------|-------------|---------| | Genoray | K103425 | 650 | | Instrumentarium | K981641 | 600 | | AlphaST | | | | Hologic Lorad M4 | K030666 | 660 | - A detector large enough to take an image without having to take multiple images of the compressed breast. (24 cm x 26 cm or larger) - Optimizes the contrast of the entire breast image and makes the most of the limited Dynamic range of the display system. ## 2) X-ray Tube Genoray = Beryllium Window, Lorad M4 = Beryllium, 0.8mm thickness (maximum) {7}------------------------------------------------ - focal spot sizes. - Typical target-filter combination (filter material and thickness, focal spot sizes) - - Bucky size: The actual size is not listed anywhere on the equipment. Its size must be enough to cover 24 cm x 30cm (10 in x 12 in ) for a film cassette. | | Target<br>material | Filter | | Focal Spot | | |----------------------|--------------------|----------|-------------------|-------------------------------------|---------------------------------------| | | | Material | Thickness<br>(mm) | Small (mm)<br>(General<br>shooting) | Large (mm)<br>(Zoom<br>selected area) | | Genoray (K103425) | Mo | Mo/Al | 0.03/0.5 | 0.1 | 0.3 | | GE (K981641) | Mo/Rh | Mo/Rh | 0.03/0.025 | 0.1 | 0.3 | | Hologic M4 (K030666) | Mo | Mo/Rh | 0.03/0.025 | 0.1 | 0.3 | | Fujifilm (K133972) | Mo | Mo/Rh | 0.03/0.025 | | | | Simens (P140011) | Mo | Mo/Rh | | | | # 3) X-ray Generator - The trade name and model: Generay MX-series, Hologic Lorad M4 - - Anode material -> molybdenum - - Technique factors of x-ray generator - | | Genoray (k103425) | alphaST(K981641) | Lorad M4(K030666) | | | | | | | | | | | |--------------------------------------------|-------------------|------------------|---------------------------------------------------|--|--|--|--|--|--|--|--|--|--| | Focal Spot (Large)<br>(General shooting) | 0.3 mm | 0.3 mm | 0.3 mm | | | | | | | | | | | | Tube voltage | 22-39 kVp | kVp | 22-39 kVp | | | | | | | | | | | | Max. tube current | 85mA | 70-100mA | 60-80mA | | | | | | | | | | | | | | | kV Large 22-24 80 25-28 80 29-34 70 35 60 | | | | | | | | | | | | mAs | 1-600mAs | | 3-400mAs | | | | | | | | | | | | Focal Spot (Small)<br>(Zoom selected area) | 0.1 mm | 0.1 mm | 0.1 mm | | | | | | | | | | | | Tube voltage | 22-35 kVp | | 20-28kVp | | | | | | | | | | | | Max. tube current | 15mA | 20-30mA | 20-28mA | | | | | | | | | | | | | | | kV Small 22-24 24 25-28 28 29-34 24 35 20 | | | | | | | | | | | | mAs | 100mAs | | | | | | | | | | | | | {8}------------------------------------------------ · describe the method of implementing automatic exposure control (AEC) if provided as part of the system (for example, low level pre-exposure using the image receptor as the AEC detector). - Most systems measure the compressed breast thickness and use it. kV and target filter are changed to adjust to a lower or higher dose depending on the breast compression thickness. - To verify AEC operation, tested ACR Phantom to check the value of kVp and mAs. - - ## 4) X-ray Anti-scatter grid - Genoray = 4:1 91 lines/cm - - Instrumentarium AlphaST = 5:1, 31 lines/cm - primary transmission: N/A - - Anti-scatter grid provides the benefit of dose reduction. If the grid is not used and the dose is high, the exposure time is increased and the tube generates more heat. # 5) Breast compression system - 18 X 24cm /24x29 Compression Paddle, Polycarbonate material must match the size of the image receptor to prevent pushing the structure out of FOV - Electric / manual combination method, press the foot switch to proceed (all) - - Fine adjustment by turning the breast compression knob (all) - - Emergency compression release by pressing the compression release switch - # 7. Summary of Performance Testing The 2430MCA Digital Flat Panel X-Ray Detector has the similar indications for use, same scintillator material (CsI), and same risk management characteristics compared to the predicate devices. The pixel matrix and pixel pitch size of the subject device are similar but different in comparison with the predicate device due to different detector size. However, the differences do not raise new concerns for the safety and effectiveness of the subject device. The non-clinical test report and clinical consideration report for each subject device were prepared and submitted to FDA separately to demonstrate the substantial equivalency of the subject device compared to the predicate device. The non-clinical test report contains the sensitometric response, spatial resolution, noise analysis, dynamic range, erasure, fading, repeat exposures, AEC performance for the 2430MCA detector consistent with IEC 62220-1-2. The MTF and DQE performance for the subject device has been compared with the predicate device. The MTF and DQE represent the ability to visualize object details of a certain size and contrast. 2430MCA has {9}------------------------------------------------ demonstrated superior MTF and DQE performance in comparison with RSM 1824C , the predicate device, at all spatial frequencies. To further demonstrate the substantial equivalency of the subject and predicate device, clinical images obtained from the subject device and the predicate device are reviewed by three MQSA qualified US radiologists to render an expert opinion. Both the subject (2430MCA) and the predicate devices (RSM 1824C ) have been evaluated and compared by taking sample radiographs of similar age groups and anatomical structures in accordance with the test protocol of screening radiography. In compliance with CDRH's Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Full Field Digital Mammography System, the concurrent review of radiographic images taken from 2430MCA and RSM 1824C confirmed that 2340MCA, the subject device, provide images of equivalent or superior diagnostic capability to the predicate device. Based on the non-clinical and clinical consideration test and the outcome of a comparative review by an expert for both devices, the sponsor can claim the substantial equivalency between the subject devices and their predicate devices in terms of screening image quality. The manufacturing facility is in conformance with the design control procedure requirements specified in 21 CFR 820.30 and the relevant 21CFR820 standards as the records are available for review. # 7. Summary for any testing in the submission: - Electrical, mechanical, environmental safety and performance testing according to standard IEC A 60601-1: 2005, COR1:2006, COR2:2007, AMD1:2012 (Medical electrical equipment Part 1:General requirements for basic safety and essential performance) - > EMC testing were conducted in accordance with standard IEC 60601-1-2: 2014. - > IEC 6220-1-2: Medical electrical equipment - Characteristics of digital X-ray imaging devices -Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography - A Non-clinical consideration according to FDA Guidance "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Full Field Digital Mammography System" - A "Guidance for the Contents of Premarket Submission for Software Contained in Medical Device". # 8. Conclusions: After a review of plain radiographic images taken with 2430MCA and RSM 1824C, the images reviewed were found to be of acceptable overall clinical image quality for screening mammography. Based on the {10}------------------------------------------------ clinical and non-clinical consideration for the subject device, the sponsor, claims the substantial equivalency between the subject device and the predicate device in terms of screening image quality without new concern for safety and effectiveness.