(28 days)
No
The document describes a digital X-ray detector and image processing software, but there is no mention of AI or ML being used in the device or its associated software. The image processing is described as being handled by separate console software.
No
The device is described as an X-ray detector used for capturing and digitalizing X-ray images for diagnostic procedures, not for treatment.
Yes
The device is intended to be used in "general purpose diagnostic procedures" and for "radiographic diagnosis".
No
The device description explicitly states it is a "wired/wireless digital solid state X-ray detector" based on "flat-panel technology" and consists of a "scintillator coupled to an a-Si TFT sensor." This clearly describes hardware components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "digital imaging solution designed for general radiographic system for human anatomy." This describes an imaging device used on the body, not a device used to test samples from the body (which is the definition of an IVD).
- Device Description: The description details an X-ray detector that captures and digitalizes X-ray images. This is consistent with an in-vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
The device is a medical imaging device used for diagnostic purposes, but it operates by capturing images of the internal structure of the human body using X-rays, not by performing tests on biological specimens.
N/A
Intended Use / Indications for Use
1417WGC 127um and 1417WGC 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.
Product codes (comma separated list FDA assigned to the subject device)
MOB
Device Description
While 1417WGC_127um digital X-ray detector is identical to 1417WGC (K141563), both 1417WGC 127um and 1417WGC 140um are wired/wireless digital solid state X-ray detectors which 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. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. Both devices do not operate as an X-ray generator controller but both 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical images are taken from both subject devices and reviewed by a licensed US radiologist to render an expert opinion. Both the test subject (1417WGC 140um) and the predicate devices (1417WGA) 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. DOE and NPS test results of 1417WGC 140um by using the identical test equipment and same analysis method described by IEC 62220-1.
The comparative result of the MTF and DQE test for 1417WGC_140um detector with respect to the predicate device demonstrated that the MTF and DOE of the both 1417WGA performed similarly compared with the predicate devices. The MTF and DQE represents the ability to visualize object details of a certain size and contrast. 1417WGC_140um has similar MTF and DQE performance at all spartial frequencies, especially from 2 1p/mm to 3.5 lp/mm. The comparison of the MTF and DQE for 1417WGC_140um detector demonstrated that the performed almost same with 1417WGA.
To further demonstrate the substantial equivalency of two devices, clinical images are taken from both subject devices and reviewed by a licensed US radiologist to render an expert opinion. Both the test subject (1417WGC 140um) and the predicate devices (1417WGA) 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 1417WGC 140um and 1417WGA, the images obtained with the 1417WGC 140um are superior to the same view obtained from a similar patient with 1417WGA, the predicate devices. In general, both the spatial and soft tissue contrast resolution are superior using the 1417WGC_140μm. Specifically, the soft tissues on extremity were seen with better clarity. There is little difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, overlaid with a human profile. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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: K171417
Trade/Device Name: 1417WGC 127um and 1417WGC 140um 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
1
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
2
Indications for Use
510(k) Number (if known)
Device Name
1417WGC_127um and 1417WGC_140um
Indications for Use (Describe)
1417WGC 127um and 1417WGC 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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3
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) |
| (U.S. Designated agent) | |
| 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: | : 1417WGC_127µm and 1417WGC_140µm |
|---|---|
| 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 : | |
| Device | :1417WGA |
| 510(k) Number | : K131114 |
| Common Name | : Digital Flat Panel X-ray Detector |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Product Code | : MQB |
| Reference Device: |
4
| Device | : 1417WGC (Manufactured by Rayence) |
|---|---|
| 510(k) Number | : K141563 |
| 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 1417WGC_127um digital X-ray detector is identical to 1417WGC (K141563), both 1417WGC 127um and 1417WGC 140um are wired/wireless digital solid state X-ray detectors which 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. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. Both devices do not operate as an X-ray generator controller but both 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
1417WGC_127um and 1417WGC_140µm 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
1417WGC_127um digital X-ray detector is identical to 1417WGC (K141563). 1417WGC_140um digital X-ray detector is a modification of 1417WGA (K131114) was developed for the purpose of ideal for inroom and portable imaging with a film detector. 1417WGC_140μm is slightly thinner and lighter than 1417WGA.
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.
5. Summary of the technological characteristics of the device compared to the
5
predicate device:
1417WGC_127μm digital X-ray detector is identical to 1417WGC (K141563). 1417WGC_140μm detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, 1417WGA.
5.1 Comparison table
| Characteristic | Proposed
Rayence Co.,Ltd.
1417WGC | Predicate
Rayence Co.,Ltd.
1417WGA | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Feature | Image: Rayence Co.,Ltd. 1417WGC | Image: Rayence Co.,Ltd. 1417WGA | |
| 510(k) number | | K131114 | Same |
| Intended Use | 1417WGC_127µm and
1417WGC_140µm 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. | 1417WGA Digital Flat Panel X-Ray
Detector is 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. | Same |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Same |
| Scintillator | 1417WGC_127µm
1417WGC_140µm | 1417WGA | Same |
| Imaging Area | 14 x 17 inches | 14 x 17 inches | Same |
| Pixel matrix | 127 : 3328 X 2816
140 : 3052 X 2500 | 3328 x 2816 | Similar |
| Pixel pitch | 127 µm / 140 µm | 127 µm | Similar |
| Resolution | 3.9 lp/mm | 3.9 lp/mm | Same |
| A/D conversion | 14 bit for 127 µm /16 bit for 140 µm | 14 bit | Same |
| Preview time | ≤2(wied / wireless) | 23 seconds (wired) / 35 seconds
(wireless) | Similar |
| Data output | RAW
*The RAW files are convertible into
DICOM 3.0 by console S/W | RAW
*The RAW files are convertible into
DICOM 3.0 by console S/W | Same |
| Dimensions | 460 x 384 × 15 mm | 460 x 417 × 15.9 mm | Similar |
| Weight | 3.0 kg (incl. battery) | 3.9 kg (incl. battery) | Similar |
| Application | General Radiology system or
Wireless/Wired portable system | Wireless portable system | Same |
| | Available with upright stand, table,
universal stand. | universal stand | |
| Added
Optional
Components | Battery & Battery Charger
Interface Box
IrDA module | Battery & Battery Charger | Similar |
6
5.2 Scintillator layer
*scintillator layer. ( * scintillator : a phosphor that produces scintillations)
| Proposed | Predicate | |
|---|---|---|
| Gd₂O₂S:Tb | ||
| (Gadolinium Oxysulfide) | 1417WGC_127μm | |
| 1417WGC_140μm | 1417WGA |
5.3 Added Optional Components (Comparison with Predicate device)
| Components | Description |
|---|---|
| Battery & Battery Charger | |
| Image: Battery and Battery Charger | Sources of electricity. |
| Mobile Battery Charger | |
| Image: Mobile Battery Charger | |
| Interface Box | |
| Image: Interface Box | 1) Connector to synchronize the detector and generator. |
- Data transfer and charging battery while detector is in use
(Connect between detector and Interface Box), Up to three detector
can be connected. - Transmitting an image/command between the detector and PC.
- Wireless AP. |
| IrDA module
Image: IrDA module | Sharing function for PC and detector. |
5.4 Recommended Generator Specifications
7
| Model | Manufacture | Specification | ||
|---|---|---|---|---|
| CMP 200 | Communications & Power | |||
| Industries | 32kW | 40kW | 50kW | |
| kVp | 40-125 | 40-150 | ||
| mA | 10-400 | 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) | |||
| mA | @80 kVp- 630(400) | |||
| PXR-321B | Poskom Co.,Ltd. | kVp | 125/150 |
6. Summary of Performance Testing
1417WGC_127μm digital X-ray detector is identical to 1417WGC (K141563). 1417WGC_140μm 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 (Gd2O2S:Tb), the same resolution (3.9 lp/mm), performance, and safety characteristics compared to the predicate devices. The 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. DOE and NPS test results of 1417WGC 140um by using the identical test equipment and same analysis method described by IEC 62220-1.
The comparative result of the MTF and DQE test for 1417WGC_140um detector with respect to the predicate device demonstrated that the MTF and DOE of the both 1417WGA performed similarly compared with the predicate devices. The MTF and DQE represents the ability to visualize object details of a certain size and contrast. 1417WGC_140um has similar MTF and DQE performance at all spartial frequencies, especially from 2 1p/mm to 3.5 lp/mm. The comparison of the MTF and DQE for 1417WGC_140um detector demonstrated that the performed almost same with 1417WGA.
To further demonstrate the substantial equivalency of two devices, clinical images are taken from both
8
subject devices and reviewed by a licensed US radiologist to render an expert opinion. Both the test subject (1417WGC 140um) and the predicate devices (1417WGA) 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 1417WGC 140um and 1417WGA, the images obtained with the 1417WGC 140um are superior to the same view obtained from a similar patient with 1417WGA, the predicate devices. In general, both the spatial and soft tissue contrast resolution are superior using the 1417WGC_140μm. Specifically, the soft tissues on extremity were seen with better clarity. There is little difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion.
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 and the relevant EPRC standards as specified in 21 CFR 802.30 and 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 1417WGC_127um and 1417WGC_140um are safe and effective and substantially equivalent in comparison with the predicate device.