(28 days)
1417WCC 127um and 1417WCC 140um are indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography
While 1417WCC 127um digital X-ray detector is identical to 1417WCC (K141566), both 1417WCC 127 um and 1417WCC 140 um are wired/wireless digital solid state X-ray detectors that are based on flat-panel technology. The wireless LAN(IEEE 802.11a/g/n/ac) communication signals images captured to the system and improves the user operability through high-speed processing. These radiographic image detectors and processing unit consist of a scintillator coupled to an a-Si TFT sensor. These devices need to be integrated with a radiographic imaging system. Both devices do not operate as an X-ray generator controller but can be utilized to capture and digitalize X-ray images for radiographic diagnosis. The RAW files can be further processed as DICOM compatible image files by separate console SW (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis.
The provided text describes Rayence Co., Ltd.'s 510(k) summary for their 1417WCC_127µm and 1417WCC_140µm digital flat panel X-ray detectors. The primary goal of the submission is to demonstrate substantial equivalence to predicate devices, namely 1417WCA (K130935) and 1417WCC (K141566).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific thresholds for performance metrics. Instead, it relies on demonstrating "similar" or "superior" performance compared to predicate devices, especially regarding MTF and DQE.
However, based on the provided text, we can infer the performance comparisons made:
| Characteristic | Acceptance Criteria (Implied: Similar to/Better than Predicate) | Reported Device Performance (1417WCC_127µm & 1417WCC_140µm) |
|---|---|---|
| Intended Use | Same as predicate (General radiography, not mammography) | Same as predicate |
| Detector Type | Same as predicate (Amorphous Silicon, TFT) | Amorphous Silicon, TFT |
| Scintillator | Same as predicate (CsI:Tl) | CsI:Tl |
| Imaging Area | Same as predicate (14 x 17 inches) | 14 x 17 inches |
| Pixel Matrix | Similar to predicate | 127: 3328 X 2816; 140: 3052 X 2500 (Different from predicate 127µm but deemed similar) |
| Pixel Pitch | Similar to/Same as predicate | 127 µm, 140 µm (Predicate was 127 µm, so 127 µm is same, 140 µm is different but considered acceptable) |
| Resolution | Same as predicate (3.9 lp/mm) | 3.9 lp/mm |
| A/D Conversion | Similar to predicate | 14 bit for 127 µm / 16 bit for 140 µm (Predicate was 14 bit) |
| Preview Time | Similar to predicate | ≤2 seconds (wired / wireless) (Predicate was 2 |
| Data Output | Same as predicate (RAW, convertible to DICOM 3.0) | RAW, convertible to DICOM 3.0 |
| Dimensions | Similar to predicate | 460 × 384 × 15 mm (Predicate was 460 × 417 × 15.9 mm, so similar/slight improvement for 140µm) |
| Weight | Similar to predicate | 3.0 kg (incl. battery) (Predicate was 3.9 kg, so lighter/superior for 140µm) |
| MTF Performance (from 2 lp/mm to 3.5 lp/mm) | Similar to predicate (1417WCA) | "similar MTF performance" |
| DQE Performance (from 2 lp/mm to 3.5 lp/mm) | Similar to predicate (1417WCA) | "similar DQE performance" |
| Diagnostic Image Quality (Clinical Evaluation) | Diagnostically acceptable and comparable to predicate, ideally superior. | "superior to the same view obtained from a similar patient with the predicate devices, 1417WCA." and "little difficulty in evaluating a wide range of anatomic structures necessary to provide a diagnostic review." |
| Safety and Effectiveness Concerns | No new concerns compared to predicate | "differences do not raise new concerns for the safety and effectiveness" |
| Electrical, Mechanical, Environmental Safety | Compliance with IEC 60601-1:2005 and IEC 60601-1-2: 2007 | Satisfactory results |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: Not explicitly stated. The text mentions "sample radiographs of similar age groups and anatomical structures" but does not quantify the number of images or patients.
- Data Provenance: Not explicitly stated. The origin (e.g., country) of the clinical images is not provided. It is not stated whether the study was retrospective or prospective, though the description of taking "sample radiographs" suggests it was likely a prospective acquisition for the purpose of the comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: "a licensed US doctor" is mentioned, implying a single expert.
- Qualifications of Experts: "a licensed US doctor" is the only qualification provided. No specialty (e.g., radiologist) or years of experience are specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The evaluation was performed by a single licensed US doctor, so there was no need for adjudication for consensus among multiple readers.
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
- MRMC Study: No. The study described is a comparison of two devices by a single expert, not an MRMC study comparing human readers with and without AI assistance. The device itself is a digital X-ray detector, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of an AI algorithm. The device is a hardware detector. However, non-clinical performance (MTF, DQE, NPS) was evaluated for the device itself. This can be considered a "standalone" evaluation of the detector's physical performance characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the clinical evaluation, the "ground truth" was established by the expert opinion of a licensed US doctor based on the visual assessment of diagnostic image quality from sample radiographs. There is no mention of pathology or outcomes data as ground truth. For the technical performance, physical measurements (MTF, DQE) against established standards (IEC 62220-1) served as the ground truth.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. The devices are digital X-ray detectors, not AI algorithms that require training sets.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for these hardware devices.
Summary of Studies and Evidence:
The submission relies on a combination of technical performance testing and a clinical evaluation to demonstrate substantial equivalence:
-
Technical Performance Testing:
- Standards: IEC 62220-1 for MTF, DQE, and NPS tests.
- Measurements: MTF and DQE were measured for the 1417WCC_140µm detector and compared to the predicate 1417WCA. The results indicated "similar MTF and DQE performance."
- Other Tests: Electrical, mechanical, and environmental safety and performance testing according to IEC 60601-1:2005 and IEC 60601-1-2: 2007, which yielded "satisfactory results."
- Risk Management: FMEA method was used to analyze risks, and identified hazards were reportedly mitigated.
-
Clinical Evaluation:
- Methodology: Sample radiographs of "similar age groups and anatomical structures" were taken using both the 1417WCC_140µm and the predicate 1417WCA device.
- Assessment: A "licensed US doctor" reviewed the images and rendered an "expert opinion."
- Findings: The expert found images from the 1417WCC_140µm to be "superior to the same view obtained from a similar patient with the predicate devices," specifically noting better clarity in soft tissues and "little difficulty in evaluating a wide range of anatomic structures necessary to provide a diagnostic review."
The overall conclusion is that based on these non-clinical and clinical considerations, the subject devices are substantially equivalent to the predicate devices in terms of diagnostic image quality, safety, and effectiveness.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2017
Rayence Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025
Re: K171418
Trade/Device Name: 1417WCC 127 μm and1417WCC 140 μm Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: May 1, 2017 Received: May 15, 2017
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. 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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael D. O'Hara
For
Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
1417WCC_127um and 1417WCC_140um
Indications for Use (Describe)
1417WCC 127um and 1417WCC 140um are indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. 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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1. 510(k) Summary
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: June 7, 2017
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: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | +713-467-2607 |
| Fax: | +713-583-8988 |
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: | 1417WCC_127 µm and1417WCC_140 µm |
|---|---|
| Common Name | : Digital Flat Panel X-ray Detector |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Product Code | : MQB |
| Predicate Device : | |
| Trade/Device Name | :1417WCA |
| Common Name | : Digital Flat Panel X-ray Detector |
| 510(k) Number | : K130935 |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Product Code | : MQB |
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Reference Device:
| Device | : 1417WCC (Manufactured by Rayence |
|---|---|
| 510(k) Number | : K141566 |
| Common Name | : Digital Flat Panel X-ray Detector |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Product Code | : MQB |
2. Device Description
While 1417WCC 127um digital X-ray detector is identical to 1417WCC (K141566), both 1417WCC 127 um and 1417WCC 140 um are wired/wireless digital solid state X-ray detectors that are based on flat-panel technology. The wireless LAN(IEEE 802.11a/g/n/ac) communication signals images captured to the system and improves the user operability through high-speed processing. These radiographic image detectors and processing unit consist of a scintillator coupled to an a-Si TFT sensor. These devices need to be integrated with a radiographic imaging system. Both devices do not operate as an X-ray generator controller but can be utilized to capture and digitalize X-ray images for radiographic diagnosis. The RAW files can be further processed as DICOM compatible image files by separate console SW (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis.
3. Indication for use
1417WCC 127 um and 1417WCC 140 um are indicated for digital imaging solution designed for general radiographic system for human anatomy. 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
1417WCC_127um digital X-ray detector is identical to 1417WCC (K141566). The 1417WCC_140μm digital X-ray detector is a modification of 1417WCA (K130935) developed for replacing a film detector for existing portable X-ray imaging systems. 1417WCC_140um adds portability with slightly thinner and lighter frame design compared to 1417WCA.
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:
1417WCC_127µm digital X-ray detector is identical to 1417WCC (K141566). Both 1417WCC_127 µm and 1417WCC_140 µm detectors described in this 510(k) have the same indications for use and similar technical characteristics as its predicate devices.
| Characteristic | ProposedRavence Co.,Ltd.1417WCC 127 um and1417WCC 140 um | PredicateRayence Co.,Ltd.1417WCA | |||
|---|---|---|---|---|---|
| Feature | |||||
| 510(k) number | K130935 | ||||
| Intended Use | 1417WCC_127 um and 1417WCC_140um are indicated for digital imagingsolution designed for generalradiographic system for humananatomy. It is intended to replace filmor screen based radiographic systems inall general purpose diagnosticprocedures. Not to be used formammography. | 1417WCA Digital Flat Panel X-RayDetector is indicated for digitalimaging solution designed forgeneral radiographic system forhuman anatomy. It is intended toreplace film or screen basedradiographic systems in all generalpurpose diagnostic procedures. Notto be used for mammography. | Same | ||
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Same | ||
| Scintillator | 1417WCC 127μm1417WCC_140um | CsI:Tl | 1417WCA | CsI:Tl | Same |
| Imaging Area | 14 x 17 inches | 14 x 17 inches | Same | ||
| Pixel matrix | 127 : 3328 X 28163328 x 2816140 : 3052 X 2500 | Similar | |||
| Pixel pitch | 127 um, 140 um | 127 μm | Same/different | ||
| Resolution | 3.9 lp/mm | 3.9 lp/mm | Same | ||
| A/D conversion | 14 bit for 127 um / 16 bit for 140 um | 14 bit | Similar | ||
| Preview time | ≤2 seconds(wired / wireless) | 2 | Similar | ||
| Data output | RAW*The RAW files are convertible intoDICOM 3.0 by console S/W | RAW*The RAW files are convertible intoDICOM 3.0 by console S/W | Same | ||
| Dimensions | 460 × 384 × 15 mm | 460 × 417 × 15.9 mm | Similar | ||
| Weight | 3.0 kg (incl. battery) | 3.9 kg (incl. battery) | Similar | ||
| Application | General Radiology system or | Wireless portable system | Same |
Comparison table 5.1
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| Wireless/Wired portable systemAvailable with upright stand, table,universal stand. | Available with upright stand,table, universal stand | ||
|---|---|---|---|
| AddedOptionalComponents | Battery & Battery Charger | Battery & Battery Charger | Similar |
| Interface Box | |||
| IrDA module |
5.2 Scintillator layer
*scintillator layer. ( * scintillator : a phosphor that produces scintillations)
| Proposed | Predicate | |
|---|---|---|
| CsI (Cesium Iodide) | 1417WCC_127μm1417WCC_140μm | 1417WCA |
5.3 Added Optional Components (Comparison with Predicate device)
| Components | Description |
|---|---|
| Battery & Battery ChargerImage: Battery and Battery Charger | Sources of electricity. |
| Mobile Battery ChargerImage: Mobile Battery Charger | |
| Interface BoxImage: Interface Box | 1) Connector to synchronize the detector and generator.2) Data transfer and charging battery while the detector is in use(Connect between the detector and Interface Box), Up to three3) Transmitting an image/command between the detector and PC.4) Wireless AP. |
| IrDA moduleImage: IrDA module | Sharing function for PC and detector. |
5.4 Recommended Generator Specifications
| Model | Manufacture | Specification |
|---|---|---|
| ------- | ------------- | --------------- |
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| 32kW | 40kW | 50kW | |||
|---|---|---|---|---|---|
| CMP 200 | Communications & PowerIndustries | 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 |
6. Summary of Performance Testing
1417WCC 127um digital X-ray detector is identical to 1417WCC (K141566). 1417WCC 127um and 1417WCC 140um Digital Flat Panel X-Ray Detectors have the same indications for use, the same imaging area (14 x 17), based on the same scintillator material (CsI:Tl ), the same resolution (3.9 lp/mm), performance, and safety characteristics compared to the predicate devices. The pixel matrix and pixel pitch sizes are different but 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 devices compared to each respective predicate device. The non-clinical test report contains the MTF, DQE and NPS test results of 1417WCC 140um by using the identical test equipment and same analysis method described by IEC 62220-1.
The MTF and DQE performance for 1417WCC_140μm detector and 1417WCA detector have been tested and compared. The MTF and DQE represent the ability to visualize object details of a certain size and contrast. 1417WCC 140um has similar MTF and DOE performance at all spatial frequencies, especially from 2 1p/mm to 3.5 lp/mm. The comparison of the MTF and DOE for both 1417WCC 140um detector an 1417WCA detector demonstrated that the 1417WCC_140μm performed almost same with 1417WCA.
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To further demonstrate the substantial equivalency of two devices, clinical images are taken from both subject devices and reviewed by a licensed US doctor to render an expert opinion. Both the test subject (1417WCC_140μm) and the predicate devices (1417WCA) have been evaluated and compared by taking sample radiographs of similar age groups and anatomical structures in accordance with the test protocol of diagnostic radiography evaluation procedure.
After a broad review of plain radiographic images taken with the 1417WCC 140um the images obtained with the 1417WCC 140um are superior to the same view obtained from a similar patient with the predicate devices, 1417WCA. In general, both the spatial and soft tissue contrast resolution are superior using the 1417WCC 140um. Specifically, the soft tissues on extremity films were seen with better clarity. There is little difficulty in evaluating a wide range of anatomic structures necessary to provide a diagnostic review.
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 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.
7. Summary for any testing in the submission:
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:2005 (3rd Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (Medical electrical equipment Part 1:General requirements for basic safety and essential performance) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2: 2007.
Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed.
All test results were satisfactory.
8. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Rayence Co., Ltd. concludes that 1417WCC_127µm and 1417WCC_140um are substantially equivalent in comparison with the predicate devices.
§ 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.