(39 days)
1212FCA is indicated for digital imaging solution designed for human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
1212FCA is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an IGZO TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize Xray images for radiographic diagnosis. The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis. The subject detectors are not wireless, but they are connected to a viewing station by ethernet connection.
The provided text is a 510(k) Summary for a digital flat panel X-ray detector (1212FCA). It details the device's characteristics and demonstrates its substantial equivalence to a predicate device (1012WCC) through non-clinical performance testing. It focuses on the fundamental image quality parameters of the detector itself, rather than an AI-powered diagnostic algorithm.
Therefore, many of the requested elements regarding AI performance, human reader studies, and sophisticated ground truth establishment for a diagnostic AI are not applicable to this submission. The device is a hardware component that captures X-ray images, which are then used by physicians for diagnosis.
Here's the breakdown of the information available in the document, addressing the prompts where relevant and indicating N/A for those that are not pertinent to this type of device submission:
Device Name: 1212FCA (Digital Flat Panel X-ray Detector)
1. Table of Acceptance Criteria and Reported Device Performance:
The document demonstrates substantial equivalence to the predicate device (1012WCC) by showing comparable or better performance in key image quality metrics. The "acceptance criteria" here is implicitly "performance on par with or better than the predicate device as measured by established international standards."
| Metric / Characteristic | Predicate Device (1012WCC) Reported Performance | Proposed Device (1212FCA) Reported Performance | Acceptance Criterion (Implicit) | Outcome |
|---|---|---|---|---|
| MTF (Modulation Transfer Function) | Equivalent or Better | Passed | ||
| 0.1 lp/mm | 0.527 | 0.488 | Equivalent or Better | Passed |
| 1 lp/mm | 0.327 | 0.283 | Equivalent or Better | Passed |
| 2 lp/mm | 0.210 | 0.181 | Equivalent or Better | Passed |
| 2.5 lp/mm | 0.136 | 0.117 | Equivalent or Better | Passed |
| DQE (Detective Quantum Efficiency) | Equivalent or Better | Passed | ||
| DQE (0) | 0.756 | 0.778 | Equivalent or Better | Passed |
| NPS (Noise Power Spectrum) | (Not explicitly quantified, but mentioned as compared) | (Not explicitly quantified, but mentioned as compared) | Equivalent or Better | Passed |
Assessment: The document states: "1212FCA demonstrated equivalent or better performance in terms of MTF and DQE as well as NPS compared to 1012WCC, the predicate device, at all spatial frequencies." While the MTF values listed for the proposed device appear lower than the predicate, the narrative explicitly claims "equivalent or better performance." This might imply that specific application contexts or other factors (e.g., pixel pitch differences impacting spatial frequency ranges) were considered in the determination of "equivalent or better" performance, or it could be a slight discrepancy in the provided table vs. the summary statement. For a hardware device, "equivalent or better" based on these standard metrics, conducted under IEC standards, is the typical acceptance.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as "sample size" in the context of clinical images or patient data. The performance testing was conducted on the device itself using technical measurements according to IEC standards. This typically involves a controlled phantom or physical measurement setup.
- Data Provenance: N/A for clinical data. The tests were "non-clinical" and conducted on the physical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: N/A. Ground truth for hardware performance metrics like MTF, DQE, and NPS is established through standardized physical measurements and calculations (e.g., using phantoms and precise equipment), not by human experts interpreting images.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set:
- Adjudication Method: N/A. There is no human interpretation or diagnostic ground truth to adjudicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- MRMC Study: No. This is a hardware device; MRMC studies are for evaluating the impact of AI or new imaging techniques on human reader performance for diagnosis.
- Effect Size of Human Reader Improvement: N/A.
6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:
- Standalone Performance: N/A. This device is not an algorithm. Its "performance" is its ability to produce high-quality X-ray raw data, which then needs to be processed and interpreted by a human and/or console software.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Technical performance metrics (MTF, DQE, NPS) derived from standardized physical measurements following IEC 62220-1. This is not clinical ground truth (e.g., pathology, outcomes data).
8. The Sample Size for the Training Set:
- Sample Size: N/A. This device is a hardware component; it does not involve a training set as would a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth Establishment: N/A.
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October 26, 2020
Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Rayence Co., Ltd. % Mr. Dave Kim President Mtech Group 7707 Fannin St., Ste. 200 HOUSTON TX 77054
Re: K202722
Trade/Device Name: 1212FCA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: September 15, 2020 Received: September 17, 2020
Dear Mr. 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 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) K202722
Device Name
1212FCA
Indications for Use (Describe)
1212FCA is indicated for digital imaging solution designed for human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
| 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 K202722
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: October 15, 2020
| 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, Korea | ||
| Submitter's Telephone: | +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: | 7707 Fannin St. Ste 200-V111, 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:
| Trade/proprietary name | : 1212FCA |
|---|---|
| Common Name | : Digital Flat Panel X-ray Detector |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Regulatory Class | : Class II |
| Product Code | : MQB |
| Predicate Device : | |
|---|---|
| Trade/Device Name | :1012WCC |
| Common Name | : Digital Flat Panel X-ray Detector |
| 510(k) Number | : K162518 |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Regulatory Class | : Class II |
| Product Code | : MQB |
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2. Device Description
1212FCA is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an IGZO TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize Xray images for radiographic diagnosis.
The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis.
The subject detectors are not wireless, but they are connected to a viewing station by ethernet connection.
3. Indication for use
1212FCA is indicated for digital imaging solution designed for human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.).It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
4. Summary of Design Control Risk management
1212FCA digital X-ray detector is a modification of 1012WCC (K162518). 1212FCA was developed for the purpose of retrofitting the stationary X-ray system with a film detector. 1212FCA is slightly larger than 1012WCC (K162518).
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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5. Summary of the technological characteristics of the device compared to the predicate device:
1212FCA detector described in this 510(k) have the same indications for use and similar technical characteristics as its predicate devices, 1012WCC (K162518).
| Characteristic | Proposed Device | Predicate Device | |||
|---|---|---|---|---|---|
| Manufacturer | Rayence Co.,Ltd. | Rayence Co.,Ltd. | |||
| Product Name | 1212FCA | 1012WCC | |||
| Feature | Image: 1212FCA | Image: 1012WCC | |||
| 510(k) number | K202722 | K162518 | |||
| Intended Use | 1212FCA is indicated for digitalimaging solution designed forhuman anatomy including head,neck, cervical spine, arm, leg andperipheral (foot, hand, wrist,fingers, etc.). It is intended toreplace film based radiographicdiagnostic systems and provide acase diagnosis and treatmentplanning for physicians and otherhealth care professionals. Not tobe used for mammography. | 1012WCC and 1012 WGC DigitalFlat Panel X-Ray Detector isindicated for digital imagingsolution designed for humananatomy including head, neck,cervical spine, arm, leg andperipheral (foot, hand, wrist,fingers, etc.). It is intended toreplace film based radiographicdiagnostic systems and provide acase diagnosis and treatmentplanning for physicians and otherhealth care professionals. Not tobe used for mammography. | Similar | ||
| Detector Type | IGZO TFT + PIN type photodiode | Amorphous Silicon, TFT | Similar | ||
| Scintillator | CsI:Tl | CsI:Tl | Same | ||
| Imaging Area | 12 x 12 inches | 10 x 12 inches | Similar | ||
| Pixel matrix | 1536 X 1536 (Full resolution)768 X 768 (2x2 binning) | 2304 X 1792 | Similar | ||
| Pixel pitch | 194 µm (Full resolution) / 388 µm(2x2 binning) | 127 μm | Similar | ||
| A/D conversion | 14 / 16 bit | 14 / 16bit | Same | ||
| Frame rate | 18 (Full resolution) / 36 (2x2 binning) | - | Notknown | ||
| MTF | 0.1 lp/mm | 0.527 | 0.488 | ||
| 1 lp/mm | 0.327 | 0.283 | |||
| 2 lp/mm | 0.210 | 0.181 | |||
| 2.5 lp/mm | 0.136 | 0.117 | |||
| DQE (0) | 0.778 | 0.756 | |||
| Preview time | <2 seconds | <2 seconds | Same |
5.1 Comparison table
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| RAW | RAW | Same | |
|---|---|---|---|
| Data output | *The RAW files are convertible intoDICOM 3.0 by console S/W | *The RAW files are convertible intoDICOM 3.0 by console S/W | |
| Dimensions | 334.0 x 326.0 x 49.9 mm | 328 X 268 X 15 mm | Similar |
| Weight | 3.4 kg | 3.5 kg (incl. battery) | Similar |
5.2 Scintillator layer
*scintillator layer. ( * scintillator : a phosphor that produces scintillations)
| Proposed | Predicate | |
|---|---|---|
| CsI (Cesium Iodide) | 1212FCA | 1012WCC |
5.3 Power source
| Proposed1212FCA | Predicate1012WCC | ||
|---|---|---|---|
| Power | Type | Power adapter | Power supply |
| Model name | AHM85PS24 | RP003A | |
| Dimension | 150 X 64 X 37(cable length: 900 mm) | 188 X 92 X 41.5 | |
| Weight | 0.5 | 0.5 | |
| Rating | Input: 100-240 Vac, 1.0 A, 50/60 HzOutput: 24VDC (Max 3.54A) | Input: 100-240VAC (50/60Hz)Output: 24VDC (Max 1.7A) |
5.4 Generator specifications
| Model | Manufacture | Specification | |||
|---|---|---|---|---|---|
| CMP 200 | Communications & PowerIndustries | 32kW | 40kW | 50kW | |
| kVp | 40-125 | 40-150 | |||
| mA | 10-400 | 10-500 | 10-630 | ||
| EDITOR HFe 501 | Rontgenwerk Bochum | kVp | 40-150 | ||
| mA | 10-630 | ||||
| UD150L-40E/40F | Shimadzu | kVp | 40-150 | ||
| mA | @100 kVp- 500(320) | ||||
| @80 kVp- 630(400) | |||||
| PXR-321B | Poskom Co.,Ltd. | kVp | 125/150 | ||
| mA | 500 |
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6. Summary of Performance Testing
1212FCA Digital Flat Panel X-Ray Detector has the same indications for use, the same scintillator material (CsI:TI ), the same generator specifications and the same risk analysis characteristics compared to 1012WCC, the predicate devices (K162518). The pixel matrix and pixel pitch sizes are different due to different imaging areas but the differences do not raise new concerns for the safety and effectiveness of the subject device.
The non-clinical test report for the subject device was prepared and submitted to FDA to demonstrate the substantial equivalency of the subject device performance compared to the predicate device. The nonclinical test report contains the MTF, DQE and NPS performance test comparison between the subject device (1212FCA), and the predicate device (1012WCC), by using the identical test equipment and same analysis method described by IEC 62220-1.
The MTF and DQE testing represent the ability to visualize object details of a certain size and contrast. 1212FCA demonstrated equivalent or better performance in terms of MTF and DQE as well as NPS compared to 1012WCC, the predicate device, at all spatial frequencies.
Based on the non-clinical consideration evaluation, the sponsor can claim the substantial equivalency between the subject device and the predicate device in terms of diagnostic 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.
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7. Summary for any testing and reference guidance:
- A Electrical, mechanical, environmental safety and performance testing according to standard IEC 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.
- A IEC 62220-1 Ed 1.0 Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging
- Non-clinical consideration according to FDA Guidance "Guidance for the Submissions of A 510(k)'s for Solid State X-ray Imaging Devices"
- ♪ "Guidance for the Contents of Premarket Submission for Software Contained in Medical Device".
- ♪ Pediatric Information for X-ray Imaging Device Premarket Notifications
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices A
8. Conclusions:
Based on the non-clinical consideration performance outcomes, the sponsor, claims the substantial equivalency between the subject device and the predicate device in terms of diagnostic image quality with no new concern for safety and effectiveness.
§ 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.