(86 days)
The 2430TCA 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 2430TCA detector.
2430TCA 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 TFT 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. 2430TCA detector is connected to the viewing station via a LAN cable.
The provided text is a 510(k) summary for the Rayence 2430TCA with Xmaru W, a digital mammography system. While it discusses the device's characteristics and compares it to a predicate device (2430MCA with Xmaru W), it does NOT contain detailed information about acceptance criteria for an AI/software component, nor a specific study proving it meets such criteria in terms of AI performance.
The document primarily focuses on demonstrating substantial equivalence of the detector (2430TCA) to its predicate (2430MCA) based on physical characteristics, imaging performance (MTF, DQE, NPS), and human expert review of images. It also mentions general software (Xmaru W) but doesn't detail any AI functionality or its validation.
Therefore,Based on the provided FDA 510(k) summary, I cannot provide the requested information about acceptance criteria and a study proving an AI component of the device meets those criteria.
The document discusses the substantial equivalence of a Full-Field Digital Mammography System (including a detector and image processing software). It focuses on the hardware (2430TCA detector) and its image quality parameters (MTF, DQE, NPS) compared to a predicate device. While it mentions "Xmaru W is an integrated software solution," it does not describe any specific AI or machine learning functionality within this software, nor does it discuss validation studies for such a component.
The "Summary of Performance Testing" section describes:
- Human expert review of plain radiographic images from the 2430TCA and 2430MCA, concluding "overall, better image quality of the same anatomical position in the separate patients" for 2430TCA.
- Non-clinical tests (MTF, DQE, NPS) performed on the detector, not an AI algorithm.
Therefore, many of the specific points you've asked for (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not present in this document because it is focused on the performance of a digital X-ray detector and its fundamental image quality, not an AI algorithm.
If this device were to have an AI component for advanced image analysis (e.g., CADe for lesion detection), that information would typically be in a separate section detailing the AI's performance validation, often with a different set of acceptance criteria and study designs that align with the specific AI function (e.g., sensitivity, specificity, FROC analysis, reader studies). This document does not suggest the presence or validation of such an AI component for diagnostic aid.
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March 12, 2025
Rayence Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group LLC 7505 Fannin St Suite 610 Houston, Texas 77054
Re: K243849
Trade/Device Name: 2430TCA 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: February 11, 2025 Received: February 11, 2025
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 (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,
YANNA S. KANG -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices 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
Submission Number (if known)
Device Name
2430TCA with Xmaru W
Indications for Use (Describe)
The 2430TCA 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 2430TCA detector.
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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510(k) Summary K243849
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
- Date 510k summary prepared: March 13, 2025
2. Submitter's Name, address, telephone number, a contact person:
| Submitter's Name : | Rayence Co., Ltd. |
|---|---|
| Submitter's Address: | 14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do,Republic of Korea |
| Submitter's Telephone: | +82-31-8015-6459 |
| Contact person: | Mr. Dong Hyeon Oh / Manager / +82-31-8015-6298 |
| Official Correspondent: | Dave Kim, MBA (davekim@mtechgroupllc.com)Mtech Group LLC |
| Address: | 7505 Fannin St. Ste 610, Houston, TX 77054 |
| Telephone: | +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:
| Detector(2430TCA) | Software (Xmaru W) | |
|---|---|---|
| Trade/proprietary name | 2430TCA with Xmaru W | |
| Common Name | Digital Flat Panel X-rayDetector | Radiological ImageProcessing System |
| Regulation Number | 21 CFR 892.1715 | 21 CFR 892.2050 |
| Regulation Name | Full-field digitalmammography system | Picture archiving andcommunications system |
| Regulation Class | Class II | Class II |
| Product Code | MUE | LLZ |
Proposed Device : K243849
Predicate Device : K202902
| Detector(2430MCA) | Software (Xmaru W) | |
|---|---|---|
| Trade/proprietary name | 2430MCA with Xmaru W | |
| Common Name | Digital Flat Panel X-rayDetector | Radiological Image ProcessingSystem |
| Regulation Number | 21 CFR 892.1715 | 21 CFR 892.2050 |
| Regulation Name | Full-field digitalmammography system | Picture archiving andcommunications system |
| Regulation Class | Class II | Class II |
| Product Code | MUE | LLZ |
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3. Device Description
2430TCA 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 TFT 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.
2430TCA detector is connected to the viewing station via a LAN cable.
4. Indication for use
The 2430TCA 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 2430TCA detector.
5. Summary of Design Control Risk management
2430TCA digital X-ray detector is a modification of 2430MCA (K202902). The risks and the hazardous impact of the device modification were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the modification 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.
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6. Summary of the technological characteristics of the device compared to the predicate device:
Detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate devices (K202902).
6.1 Scintillator layer
- scintillator layer. ( * scintillator : a phosphor that produces scintillations)
| Scintillator Type | Proposed | Predicate |
|---|---|---|
| CsI (Cesium Iodide) | 2430TCA | 2430MCA (K202902) |
6.2 Power source
| Proposed2430TCA | Predicate2430MCA | ||
|---|---|---|---|
| Power | Type | Power supply | Power supply |
| Model name | RP006A | RS1417 | |
| Dimension | 188 X 92 X 41.5 | 188 X 92 X 41.5 | |
| Weight | 0.5 | 0.5 | |
| Rating | Input: 100-240VAC (50/60Hz)Output: 24VDC (Max 1.7A) | Input: 100-240VAC (50/60Hz)Output: 24VDC (Max 1.7A) |
6.3 Recommended Generator specifications
| Genoray(K103425) | alphaST(K981641) | LoradM4(K030666) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Focal Spot (Large)(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 | 60-80mAkV Large 22-24 80 25-28 80 29-34 70 35 60 | ||||||||||
| mAs | 1-600mAs | 3-400mAs | |||||||||||
| Focal Spot (Small)(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 | 20-28mAkV Small 22-24 24 25-28 28 29-34 24 35 20 | ||||||||||
| mAs | 100mAs |
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6.4 Comparison table
| Subject device | Predicate device | ||
|---|---|---|---|
| Model | 2430TCA | 2430MCA | Similarity |
| Feature | Image: 2430TCA | Image: 2430MCA | - |
| IntendedUse | The 2430TCA Digital FlatPanel X-Ray Detector isindicated for digitalimaging solution designedfor a mammographicsystem. It is intended toreplace film or screen basedmammographic systems inscreening mammography.Xmaru W is an integratedsoftware solution indicatedfor use with the 2430TCAdetector. | The 2430MCA Digital FlatPanel X-Ray Detector isindicated for digitalimaging solution designedfor a mammographicsystem. It is intended toreplace film or screen basedmammographic systems inscreening mammography.Xmaru W is an integratedsoftware solution indicatedfor use with the 2430MCAdetector. | Same |
| DetectorType | TFT Photodiode Array | CMOS Photodiode Array | differentdetector typebut it is sameindirectconversionmethod ofRadiation imagedetection |
| Scintillator | CsI:Tl | CsI:Tl | Same |
| ImagingArea | 227.3 X 289.0 mm | 231.8 X 304.0 mm | Similar |
| Pixel pitch | 74 µm | 70 µm (Full resolution)140 µm (2x2 binning) | Similar |
| TotalPixelmatrix | 3072 X 3906 | 3312 X 4344 (Fullresolution)1656 X 2172 (2x2 binning) | Similar |
| DQE | 2.0lp/mm : 57.65.0 lp/mm : 18.8 | 2.0lp/mm : 57.85.0 lp/mm : 26.4 | Similar |
| MTF | 2.0lp/mm : 62.55.0lp/mm : 25.3 | 2.0lp/mm : 51.55.0lp/mm : 12.5 | Similar |
| A/D | 16 bits | 14 bits | Different A/Dconversion bit |
| but this meansthat the2430TCA canconvert moreanalog values todigital. | |||
| Dimensions | 327.5 X 253.7 X 15mm | 327.5 X 253.7 X 14.2mm | Similar |
| Weight | 1.9 kg | 2.2 kg | Similar |
| Viewer Software (option) | Xmaru W | Xmaru W | Same |
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7. Summary of Performance Testing
2430TCA X-ray detector has the same indications for use, scintillator material (CsI:T1), general specifications, and the same risk analysis characteristics compared to the predicate device, 2430MCA (K202902). The pixel matrix and pixel pitch sizes are different due to different imaging areas. However, the differences do not raise new concerns for the safety and effectiveness of the subject device.
The clinical and non-clinical test reports for the subject device were prepared and submitted to FDA to demonstrate the substantial equivalency of the subject device's performance compared to the predicate device.
Upon review by MQSA-certified radiologists of the plain radiographic images taken with 2430TCA and the 2430MCA, overall, better image quality of the same anatomical position in the separate patients.
The outline of the breasts is clearly visible with the delineation of linear structures featuring margins and microcalcification. Contrast resolution and brightness were better depicted on the subject device with better anatomical structures and artifacts detection. When enlarged on a mammography display, the subject device had less background noise interference than the predicate device. Reviewers found all studies acceptable overall clinical image quality for screening mammography.
In conclusion, both 2430TCA and 2430MCA have demonstrated sufficient image quality to aid for diagnostic purposes.
The non-clinical test report contains the MTF, DQE, and NPS performance test comparison between the subject device and the predicate device by using the identical test equipment and the same analysis method described by IEC 62220-1.
Based on the evaluation of non-clinical considerations, the sponsor can claim the substantial equivalence between the subject device and the predicate device regarding diagnostic image quality.
The manufacturing facility is in conformance with the design control procedure requirements specified in 21 CFR 820.30 and the relevant 21 CFR820 standards, as the records are available for review.
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8. Summary for any testing and reference guidance:
-
Electrical, mechanical, environmental safety and performance testing according to
standard IEC 60601-1:2005, AMD1:2012, AMD2:2020 (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+AMD1:2020
-
IEC 62220-1-2: Medical electrical equipment Characteristics of digital X-ray > imaging devices - Part 1-2: Determination of the detective quantum efficiency -Detectors used in mammography
-
Non-clinical consideration according to FDA Guidance "Guidance for Industry A 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"
-
A Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
9. Conclusions:
In accordance with the performance outcomes, 2430TCA X-ray detectors demonstrated equivalent or better performance compared to 2430MCA. Therefore, Rayence claims the substantial equivalency between the subject device and the predicate device in terms of diagnostic image quality about safety and effectiveness.
§ 892.1715 Full-field digital mammography system.
(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.