(30 days)
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 processing, analysis, or any other function. The performance studies focus on traditional imaging metrics like MTF and DQE, and clinical review by a radiologist.
No.
The device is indicated for digital imaging by replacing film or screen-based radiographic systems and capturing/digitalizing X-ray images for diagnosis, not for treating a disease or condition.
Yes
The device is described as being for "general purpose diagnostic procedures" and is utilized to "capture and digitalize X-ray images for radiographic diagnosis."
No
The device description explicitly states it is a "digital flat panel 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 involves capturing images of the human body using X-rays.
- Device Description: The description details a "digital flat panel X-ray detector" that captures and digitalizes X-ray images for "radiographic diagnosis."
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
This device is a component of a medical imaging system used for in vivo (within the living body) diagnosis through radiographic imaging, not in vitro (outside the living body) testing of samples.
N/A
Intended Use / Indications for Use
Edge is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general purpose diagnostic procedures. Not to be used for mammography.
Product codes
MQB
Device Description
Edge digital flat panel X-ray detector is based on flat-panel technology. 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 separate console SW (K160579 / XmaruView V1 and XmaruPACS/ 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 (Edge) and the predicate device (1717SCC 140 um (K171420)) 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 contains the MTF, DQE and NPS test results of Edge 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 Edge detector with respect to each respective predicate demonstrated that the MTF and DQE of the subject device performed similarly compared with the predicate device. The MTF and DQE represents the ability to visualize object details of a certain size and contrast. Edge has similar MTF and DQE performance at all spatial frequencies. The comparison of the MTF and DOE for Edge detector demonstrated that it performed almost same 1717SCC 140 um (K171420).
Clinical Consideration Report: "clinical images are taken from both subject devices and reviewed by a licensed US radiologist to render an expert opinion. Both the test subject (Edge) and the predicate device (1717SCC 140 um (K171420)) 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 Edge, the images obtained with Edge are superior to the same view obtained from a similar patient with the predicate devices, 1717SCC 140 µm (K171420). In general, both the spatial and soft tissue contrast resolution are superior using Edge. Specifically, the soft tissues on extremity films were seen with better clarity."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MTF (@11 p/mm): 59.1 (%)
DQE: 76 (%)
Predicate Device(s)
Reference Device(s)
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2017
OSKO, INC. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K172682
Trade/Device Name: Edge Digital Flat Panel X-ray Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 29, 2017 Received: September 6, 2017
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.
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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.
Michael D. O'Hara For
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 Edge Digital Flat Panel X-ray Detector
Indications for Use (Describe)
Edge is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system 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. Traditional 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: September 29, 2017 Submitter's Name, address, telephone number, a contact person:
| Submitter's Name : | OSKO, INC. |
|---|---|
| Submitter's Address: | 8085 NW 90th Street, Miami, Florida 33166, USA |
| Submitter's Telephone: | +1-305-599-7161 |
| Contact person: | Vivian Garcia / RA Manager / +1-305-599-7161 |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) (U.S. Agent) |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| 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 | :Edge |
|---|---|
| Common Name | : Digital Flat Panel X-ray Detector |
| Classification Name | : 21CFR892.1680 / Stationary x-ray system |
| Product Code | : MQB |
| Classification | : Class II |
| Predicate Device : | |
| Manufacturer | : Rayence Co., Ltd |
| Device | : 1717SCC_140µm |
| 510(k) Number | : K171420 |
| Classification Name | : 21CFR892.1680 / Stationary x-ray system |
| Product Code | : MQB |
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2. Device Description :
Edge digital flat panel X-ray detector is based on flat-panel technology. 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 separate console SW (K160579 / XmaruView V1 and XmaruPACS/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis.
3. Indication for use :
Edge is indicated for digital imaging solution designed for general radiographic system for human It is intended to replace film or screen based radiographic systems in all general anatomy. purpose diagnostic procedures. Not to be used for mammography.
4. Summary of the Design Control Risk Management:
The Edge digital X-ray detector is a modification of 1717SCC 140 um (K171420) which was developed for the purpose of retrofitting the stationary a film X-ray system. Edge is 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.
The Edge digital solid state X-ray detector uses the same panel and components that the predicate device, 1717SCC_140 µm (K171420) and that no changes were necessary to eiter the hardware or firmware of the device.
5. Summary of the technological characteristics of the device compared to the predicate device:
The Edge digital solid state X-ray detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, 1717SCC_140 um (K171420) flat panel detector, of Rayence Co., Ltd
The Edge digital solid state X-ray detector described in this 510(k) uses the same hardware, firmware and imaging software Xmaru View 1 and Xmaru PACS (K160579), without any change, that are used by the predicate device, 1717SCC_140 um.
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| Xmaru View 1 FDA 510(k) information is as follows: | |
|---|---|
| ---------------------------------------------------- | -- |
| Item | Device
Classification
Name | Device name | 510(k)
number | Applicant |
|---------------|----------------------------------------------|--------------------------------------------------------------------------|------------------|----------------------|
| FDA
510(k) | System, Image
Processing,
Radiological | Xmaru View V1 and
Xmaru PACS, Medical
image processing
software | K160579 | Rayence Co.,
Ltd. |
5.1 Scintillator layer
*scintillator layer. ( * scintillator : a phosphor that produces scintillations)
| Proposed | Predicate | |
|---|---|---|
| CsI | ||
| (Cesium Iodide) | Edge | 1717SCC_140 \u03bcm |
5.2 Dimensions and Weight
| | | Proposed
Edge | Predicate
1717SCC_140 $ \mu $ m |
|-----------------|------------|------------------|----------------------------------------------|
| Detector | Model name | Edge | 1717SCC_140 $\mu$ m |
| | 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 | 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
Edge | Predicate
1717SCC_140 μm |
|-----------------|------------|-----------------------------|-----------------------------|
| Power
supply | Model name | RS1717 | RS1717 |
| | W x L x H | AC 100 - 240 V~,
50/60Hz | AC 100 - 240 V~,
50/60Hz |
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| 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) | ||||
| mA | @80 kVp- 630(400) | ||||
| PXR-321B | Poskom Co.,Ltd. | kVp | 125/150 | ||
| mA | 500 |
5.4 Recommended Generator Specification
Image /page/6/Picture/3 description: The image shows a yellow caution sign. The sign is triangular in shape and has a black border. Inside the triangle is a black exclamation point. Below the triangle is the word "CAUTION" in black, block 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.
5.5 Comparison table
| Characteris
tic | Proposed
Edge | Predicate
1717SCC_140 $\mu$ m | Remarks |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 510(k)
number | K172682 | K171420 | |
| Intended
Use | Edge X-ray detectors, 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. | 1717SCC_127um and
1717SCC_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. | Same |
| Manufactur
er | OSKO, INC. | Rayence Co., Ltd. | |
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| Detector
| Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Same |
|---|---|---|---|
| Scintillator | CsI:Tl | CsI:Tl | Same |
| Imaging | |||
| Area | 17 x 17 inches | 140 type : 3072 x 3072 | Same |
| Pixel matrix | 3072 x 3072 | 3072 x 3072 | Same |
| Pixel pitch | 140 μm | 140 μm | Same |
| Resolution | 3.9 lp/mm | 3.9 lp/mm | Same |
| A/D | |||
| conversion | 14 / 16 bit | 14 / 16 bit | Same |
| Preview | |||
| time | ≤2 | ≤2 | Same |
| MTF (@11 | |||
| p/mm) | 59.1 (%) | 58.2 (%) | Similar |
| DQE | 76 (%) | ||
| *Result value from Non-Clinical | |||
| Report | 74 (%) | ||
| *Result value from Non- | |||
| Clinical Report | 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 | ||
| Imaging | |||
| Software | Xmaru View 1 / Xmaru PACS | ||
| (Version 2.0.0) | Xmaru View 1 / Xmaru | ||
| PACS (Version 2.0.0) | Same | ||
| Dimensions | 460 × 460 × 15.5 mm | 460 × 460 × 15.5 mm | Same |
| Weight | 4 kg | 4 kg | Same |
| Application | General Radiology system or | ||
| Portable system | |||
| Available with upright stand, | |||
| table, universal stand. | General Radiology system or | ||
| Portable system | |||
| Available with upright stand, | |||
| table, universal stand. | Same |
The Edge Digital Flat Panel Detector is identical to the wireless hardware and functionality ● of the predicate device, 1717SCC 140 µm.
Maximum wireless signal rate derived from IEEE standard specifications. Actual data throughput will vary. Network conditions and environmental factors, including volume of
8
network traffic, building materials and construction, and network overhead, lower actual data throughput rate.
6. Summary of Performance Testing:
The Edge Digital Flat Panel X-Ray Detector has the same indications for use, material, form factor, performance, and safety characteristics compared to the predicate devices, 1717SCC 140 um (K171420) respectively.
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 Edge 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 Edge detector with respect to each respective predicate demonstrated that the MTF and DQE of the subject device performed similarly compared with the predicate device. The MTF and DQE represents the ability to visualize object details of a certain size and contrast. Edge has similar MTF and DQE performance at all spatial frequencies. The comparison of the MTF and DOE for Edge detector demonstrated that it performed almost same 1717SCC 140 um (K171420).
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 (Edge) and the predicate device (1717SCC 140 um (K171420)) 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 Edge, the images obtained with Edge are superior to the same view obtained from a similar patient with the predicate devices, 1717SCC 140 µm (K171420). In general, both the spatial and soft tissue contrast resolution are superior using Edge. Specifically, the soft tissues on extremity films were seen with better clarity.
Based on the non-clinical and clinical consideration test and the outcome of a comparative
9
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.
Note: Clinical images were provided; even though these images are not necessary to establish substantial equivalence based on the modifications to the device, they provide additional evidence in addition to bench testing data to show that the complete system works as intended.
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.
The Non-clinical consideration & performance test have been conducted according to the following FDA Guidance.
-
Performance Standards for Ionizing Radiation Emitting Products, 21 CFR 1020
-
Diagnostic x-ray systems and their major components, 21 CFR 1020.30
-
Radiographic Equipment, 21 CFR 1020.31
-
FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices
-
FDA Guidance titled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"
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 OSKO, INC. concludes that Edge is substantially equivalent in comparison with 1717SCC_140μm (K171420) the predicate device as described herein.