(25 days)
No
The summary describes a digital X-ray detector and associated image processing software, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The focus is on the hardware's image acquisition capabilities and standard image processing.
No
The device is described as an X-ray detector for digital imaging, intended for diagnostic procedures, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "designed for general radiographic system for human anatomy" and "intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures." The "Device Description" also mentions that the RAW files can be processed into "DICOM compatible image files... for a radiographic diagnosis and analysis." Additionally, the "Summary of Performance Studies" describes clinical images being "reviewed by a licensed US radiologist" and "diagnostic radiography evaluation procedure."
No
The device description clearly states it is a digital solid state X-ray detector based on flat-panel technology, consisting of a scintillator coupled to an a-Si TFT sensor. This describes hardware components, not software only.
Based on the provided text, 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 in-vivo imaging device, not a device used to examine specimens from the human body (in vitro).
- Device Description: The description details an X-ray detector that converts X-rays to electrical signals for image data digitization. This is consistent with an in-vivo imaging system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
The device is a component of a radiographic imaging system used for diagnostic procedures on the human body, which is the definition of an in-vivo diagnostic device.
N/A
Intended Use / Indications for Use
1717SGC 127um and 1717SGC 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, MQB
Device Description
1717SGC 127um X-ray detector is identical to 1717SGC (K122182). Both 1717SGC 127um and 1717SGC 140um are digital solid state X-ray detectors based on flat-panel technology. These radiographic image detectors and processing unit consist of a scintillator coupled to an a-Si TFT sensor. Both devices are connected to the user PC via wired LAN (ethernet cable) and 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 convert X-ray to light and light to electrical signals for image data digitization.
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
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, 1717SGC 140μm and the predicate device,1717SGN, have been evaluated and compared by taking sample radiographs of similar age group 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, DQE and NPS test results of 1717SGC 140μm 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 1717SGC 140um 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. 1717SGC 140um has higher MTF and DOE performance at high spatial frequencies, especially from 2 lp/mm. The comparison of the MTF and DQE for 1717SGC 140um detector demonstrated that the performed almost same with 1717SGN.
After a broad review of plain radiographic images taken with the 1717SGC 140um, the images obtained with the 1717SGC 140µm are superior to the same view obtained from a similar patient with the predicate devices, 1717SGN and 1717SCN. In general, both the spatial and soft tissue contrast resolution are superior using the 1717SGC 140μm. 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.
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.
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.
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 9, 2017
Rayence Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025
Re: K171419
Trade/Device Name: 1717SGC 127um and 1717SGC 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
1717SGC_127um and 1717SGC_140um
Indications for Use (Describe)
1717SGC 127um and 1717SGC 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
1. Special 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 1ro gil, Hwaseong-Si, Gyeonggi-do, Korea |
| Submitter's Telephone: | +82-31-8015-6459 |
| Contact person: | Mr. Kee Dock Kim / Manager |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) |
| Address: | 12946 Kimberley Ln, Houston, TX 77079 |
| Telephone: | +713-467-2607 |
| Fax: | +713-464-8880 |
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: | 1717SGC_127µm and 1717SGC_140µm |
|---|---|
| Common Name | : Digital Flat Panel X-ray Detector |
| 510(k) Number | : K171419 |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Product Code | : MQB |
| Trade/Device Name | : 1717SGN / 1717SCN |
| Common Name | : Digital Flat Panel X-ray Detector |
| 510(k) Number | : K150150 (Decision Date – March 27. 2015) |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Product Code | : MQB |
Rayence Co., Ltd.
4
Reference Device :
| Device | : 1717SGC |
|---|---|
| 510(k) Number | : K122182 |
| 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 :
1717SGC 127um X-ray detector is identical to 1717SGC (K122182). Both 1717SGC 127um and 1717SGC 140um are digital solid state X-ray detectors based on flat-panel technology. These radiographic image detectors and processing unit consist of a scintillator coupled to an a-Si TFT sensor. Both devices are connected to the user PC via wired LAN (ethernet cable) and 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 convert X-ray to light and light to electrical signals for image data digitization.
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
1717SGC 127um and 1717SGC 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.
4. Summary of the Design Control Risk management:
1717SGC 127um X-ray detector is identical to 1717SGC (K122182). 1717SGC 140um digital X-ray detector is a modification of 1717SGN (K150150). 1717SGC 140um was developed for the purpose of retrofitting the stationary X-ray system with a film detector. 1717SGC 127um and 1717SGC 140um are connected to a PC with an ethernet cable.
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.
Rayence Co., Ltd.
5
5. Summary of the technological characteristics of the device compared to the predicate device:
Both 1717SGC_127um and 1717SGC_140um detectors described in this 510(k) have the same indications for use and similar technical characteristics as its predicate device, 1717SGN / (K150150) flat panel detector, of Rayence Co., Ltd
5.1 Scintillator layer
- scintillator layer. ( * scintillator : a phosphor that produces scintillations)
| Proposed | Predicate | |
|---|---|---|
| Gd₂O₂S:Tb | ||
| (Gadolinium Oxysulfide) | 1717SGC_127µm | |
| 1717SGC_140 µm | 1717SGN |
5.2 Dimensions and Weight
| | | Proposed
1717SGC | Predicate
1717SGN / 1717SCN |
|-----------|--------------|---------------------------------|--------------------------------|
| Detector | Model name | 1717SGC_127μm
1717SGC_140 μm | 1717SGN / 1717SCN |
| | W x L x H | 460 X 460 X 15.5 | 460 X 460 X 15.5 |
| | Weight | 4 kg | 4 kg |
| | Power supply | Model name | RS1717 |
| W x L x H | | 188 X 92 X 41.5 | 188 X 92 X 41.5 |
| Weight | | 0.5 kg | 0.5 kg |
5.3 Power Requirements (Power supply)
| | | Proposed
1717SGC | Predicate
1717SGN / 1717SCN |
|-----------------|------------|-----------------------------|--------------------------------|
| Power
supply | Model name | RS1717 | RS1717 |
| | W x L x H | AC 100 - 240 V~,
50/60Hz | AC 100 - 240 V~,
50/60Hz |
6
5.4 Proposed Labeling
Image /page/6/Figure/2 description: The image shows two tables comparing labels for 'Proposed 1717SGC' and 'Predicate 1717SGN / 1717SCN' devices. The first row of the table shows labels for a detector, with details like the manufacturer, model number (1717SGC or 1717SGN), ratings (24V or 24Vm, 1.90A), compliance certifications (CE0120, IEC 60601-1), and manufacturing information. The second row shows labels for a power supply, with details like the model number (RS1717), input/output specifications (100-240V, 24Vm, 1.90A), and fuse information (X2 T3. 15 AL 250 V).
5.5 Recommended Generator Specification
| Model | Manufacture | Specification | |||
|---|---|---|---|---|---|
| 32kW | 40kW | 50kW | |||
| CMP 200 | Communications & Power | ||||
| Industries | 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 |
Image /page/6/Picture/5 description: The image shows a caution sign. The sign is a yellow triangle with a black border. Inside the triangle is a black exclamation point. Below the triangle is the word "CAUTION" in black, bold letters.
To our best knowledge, the detector is compatible with the X-ray generators with the specifications described above. If you have questions regarding the compatibility issue for other generators which are not listed above, please contact your Rayence representative.
This information will be included in user/installation documents for the end user.
7
5.6 Comparison table
| Characteristic | Proposed
1717SGC | Predicate
1717SGN / 1717SCN |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | | K150150 |
| Intended Use | 1717SGC_127µm and
1717SGC_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. | 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. |
| Manufacturer | Rayence Co., Ltd. | Rayence Co., Ltd. |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT |
| Scintillator | 1717SGC_127µm
1717SGC_140 µm
Gd2O2S:Tb | 1717SGN Gd2O2S:Tb
1717SCN CSI:T1 |
| Imaging Area | 17 x 17 inches | 17 x 17 inches |
| Pixel matrix | 127 type : 3328 x 3328
140 type : 3072 x 3072 | 3072 x 3072 |
| Pixel pitch | 127 μm / 140 μm | 139 μm |
| Resolution | 3.9 lp/mm | 3.9 lp/mm |
| A/D conversion | 14 bit for 127 type / 16 bit for 140 type | 14 / 16 bit |
| Preview time | ≤2 | ≤2 |
| 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 |
| Dimensions | 460 × 460 × 15.5 mm | 460 × 460 × 15.5 mm |
| Weight | 4 kg | 4 kg |
| Application | General Radiology system or Portable
system
Available with upright stand, table, | General Radiology system or Portable system
Available with upright stand, table, universal
stand. |
8
6. Summary of Performance Testing:
1717SGC 127um X-ray detector is identical to 1717SGC (K122182). 1717SGC 127um and 1717SGC 140um Digital Flat Panel X-Ray Detectors have the same indications for use, material, form factor, performance, and safety characteristics compared to the predicate devices, 1717SGN.
1717SGC 140um is almost identical to 1717SGN (K150150) including the scintillator type (both Gd2O2S:Tb), maging area (17x17), pixel matrix (3072 x 3072), and resolution (3.9lp/mm).
The difference between two devices is the pixel pitch; 140 um vs 139um, respectively. It is minor and does 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 1717SGC 140μm 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 1717SGC 140um 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. 1717SGC 140um has higher MTF and DOE performance at high spatial frequencies, especially from 2 lp/mm. The comparison of the MTF and DQE for 1717SGC 140um detector demonstrated that the performed almost same with 1717SGN.
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, 1717SGC 140μm and the predicate device,1717SGN, have been evaluated and compared by taking sample radiographs of similar age group 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 1717SGC 140um, the images obtained with the 1717SGC 140µm are superior to the same view obtained from a similar patient with the predicate devices, 1717SGN and 1717SCN. In general, both the spatial and soft tissue contrast resolution are superior using the 1717SGC 140μm. 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.
Rayence Co., Ltd.
9
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 1717SGC 127um and 1717SGC 140um are safe and effective and substantially equivalent in comparison with the predicate devices.