(27 days)
Not Found
No
The summary describes a digital X-ray detector and associated image processing software, but there is no mention of AI or ML being used for image analysis, interpretation, or any other function. The performance studies focus on standard imaging metrics (MTF, DQE, NPS) and radiologist review, not AI/ML performance metrics.
No
This device is an X-ray detector used for diagnostic imaging, not for treating conditions.
Yes
This device is an X-ray detector used to capture and digitalize X-ray images, which are then processed for "diagnostic analysis." Its intended use states "It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures."
No
The device description explicitly states it is a "wired/wireless digital solid state X-ray detector that is based on flat-panel technology" and includes hardware components like a scintillator and a-Si TFT sensor. While it interacts with software for image processing, the core device is hardware.
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 a device used to capture images of the human body using X-rays, which is an in vivo (within a living organism) diagnostic procedure, not in vitro (outside of a living organism, typically involving samples like blood or tissue).
- Device Description: The description details an X-ray detector that captures images of the human body. It doesn't mention any interaction with biological samples or reagents, which are characteristic of IVD devices.
- Input Imaging Modality: The input modality is X-Ray, which is an in vivo imaging technique.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to capture images of the internal structure of the human body directly.
N/A
Intended Use / Indications for Use
1717WCC and 1717WGC Digital Flat Panel X-Ray Detectors 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
MOB, MQB
Device Description
1717WCC / 1717WGC is a wired/wireless digital solid state X-ray detector that is 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. It 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 a separate console SW program (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co.,Ltd.) for a diagnostic 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
Non-clinical test: "The nonclinical test report contains the MTF, DQE and NPS test results of 1717WCC and 1717WGC by using the identical test equipment and same analysis method described by IEC 62220-1."
Clinical consideration test: "clinical images are taken from both subject devices and reviewed by a licensed US radiologist to render an expert opinion. Both the test subject (1717WCC and 1717WGC) and the predicate devices (1717WGC and 1717SGN) 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)
Study Type: Non-clinical test and clinical consideration test
Sample Size: Not specified for clinical images.
Key Results:
- Non-clinical test: "The comparative result of the MTF and DQE test for 1717WCC detector with respect to each respective predicate demonstrated that the MTF and DQE of the both subject devices performed better compared with each respective predicate device. The MTF and DQE represents the ability to visualize object details of a certain size and contrast. 1717WCC has higher MTF and DQE performance at high spartial frequencies, especially from 2 lp/mm. The comparison of the MTF and DQE for 1717WGC detector demonstrated that the performed almost same with 1717SGN."
- Clinical consideration test: "After a broad review of plain radiographic images taken with the 1717WCC and the 1717WGC, the images obtained with the 1717WCC and 1717WGC are superior to the same view obtained from a similar patient with the predicate devices, 1717WGC and 1717SGN. In general, both the spatial and soft tissue contrast resolution are superior using the 1717WGC. 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 correct conclusion."
- 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.)
- MTF Value:
- 1717WCC_127 vs 1717SCN: At 1.0 lp/mm (0.539 vs 0.566), 2.0 lp/mm (0.262 vs 0.251), 3.0 lp/mm (0.147 vs 0.123), 3.5 lp/mm (0.105 vs 0.086), 3.93 lp/mm (0.086 vs 0.080)
- 1717WGC_127 vs 1717SGN: At 1.0 lp/mm (0.557 vs 0.574), 2.0 lp/mm (0.247 vs 0.269), 3.0 lp/mm (0.106 vs 0.123), 3.5 lp/mm (0.067 vs 0.082), 3.93 lp/mm (0.046 vs 0.076)
- 1717WCC_139 vs 1717SCN: At 1.0 lp/mm (0.537 vs 0.566), 2.0 lp/mm (0.269 vs 0.251), 3.0 lp/mm (0.145 vs 0.123), 3.5 lp/mm (0.110 vs 0.086), 3.59 lp/mm (0.104 vs 0.080)
- 1717WGC_139 vs 1717SGN: At 1.0 lp/mm (0.556 vs 0.574), 2.0 lp/mm (0.260 vs 0.269), 3.0 lp/mm (0.123 vs 0.123), 3.5 lp/mm (0.084 vs 0.082), 3.59 lp/mm (0.078 vs 0.076)
- 1717WCC_140 vs 1717SCN: At 1.0 lp/mm (0.580 vs 0.566), 2.0 lp/mm (0.269 vs 0.251), 3.0 lp/mm (0.139 vs 0.123), 3.5 lp/mm (0.098 vs 0.086), 3.57 lp/mm (0.093 vs 0.081)
- 1717WGC_140 vs 1717SGN: At 1.0 lp/mm (0.556 vs 0.574), 2.0 lp/mm (0.260 vs 0.269), 3.0 lp/mm (0.123 vs 0.123), 3.5 lp/mm (0.084 vs 0.082), 3.57 lp/mm (0.078 vs 0.076)
- DQE(0):
- 1717WCC_127 vs 1717SCN: 0.71 vs 0.700
- 1717WGC_127 vs 1717SGN: 0.444 vs 0.420
- 1717WCC_139 vs 1717SCN: 0.705 vs 0.700
- 1717WGC_139 vs 1717SGN: 0.446 vs 0.420
- 1717WCC_140 vs 1717SCN: 0.775 vs 0.700
- 1717WGC_140 vs 1717SGN: 0.440 vs 0.420
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right, connected by a flowing ribbon-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2016
Rayence Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K162519
Trade/Device Name: 1717WCC / 1717WGC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 1, 2016 Received: September 9, 2016
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. 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 (reporting of medical device-related 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.
1
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/Resourcesfor You/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 yours,
Robert Oals
Robert 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
1717WCC 1717WGC
Indications for Use (Describe)
1717WCC and 1717WGC Digital Flat Panel X-Ray Detectors 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: October 3, 2016
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: | 1717WCC / 1717WGC |
|---|---|
| Common Name: | Digital Flat Panel X-ray Detector |
| Classification Name : | 21CFR892.1680 / Stationary x-ray system |
| Product Code: | 90 MQB |
Predicate Device :
| Manufacturer : | Rayence Co., Ltd. |
|---|---|
| Device : | 1717SCN / 1717SGN |
| 510(k) Number : | K150150 |
| Classification Name : | 21CFR892.1680 / Stationary x-ray system |
| Product Code: | MQB |
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2. Device Description
1717WCC / 1717WGC is a wired/wireless digital solid state X-ray detector that is 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. It 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 a separate console SW program (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co.,Ltd.) for a diagnostic analysis.
3. Indication for use
1717WCC and 1717WGC Digital Flat Panel X-Ray Detectors 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. Summarv of Design Control Risk management
The 1717WCC / 1717WGC digital X-ray detector is a modification of 1717SCN / 1717SGN (K150150). It was developed for the purpose of portable imaging. 1717WCC / 1717WGC is slightly thinner and lighter than 1717SCN / 1717SGN.
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 predicate device:
1717WCC and 1717WGC detector described in this 510(k) have the same indications for use and similar technical characteristics as the predicate devices, 1717SGN and 1717SCN.
Comparison table 5.1
5
| Characteristic | Proposed
Rayence Co.,Ltd.
1717WCC / 1717WGC | Predicate
Rayence Co.,Ltd.
1717SCN / 1717SGN |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Image: Proposed Rayence Co.,Ltd. 1717WCC / 1717WGC | Image: Predicate Rayence Co.,Ltd. 1717SCN / 1717SGN |
| 510(k) number | - | K150150 |
| Intended Use | 1717WCC and 1717WGC Digital Flat
Panel X-Ray Detector 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. | 1717SGN and 1717SCN 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. |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT |
| Scintillator | 1717WCC
1717WGC | CSI:T1
Gd2O2S:Tb |
| | CSI:T1
Gd2O2S:Tb | 1717SCN
1717SGN |
| Imaging Area | 17 x 17 inches | 17 x 17 inches |
| Pixel matrix | 127 : 3328 X 3328
139, 140 : 3072 X 3072 | 3072 x 3072 |
| Pixel pitch | 127, 139, 140 μm | 127 μm |
| Resolution | 3.9 lp/mm | 3.9 lp/mm |
| A/D conversion | 14 / 16 bit | 14 / 16 bit |
| Preview time | ≤2 |