(30 days)
No
The summary describes a digital X-ray detector and associated software for image processing and viewing, but there is no mention of AI or ML being used for image analysis, interpretation, or any other function. The image processing mentioned appears to be standard radiographic image processing.
No.
The device is described as an X-ray detector used for diagnostic imaging, not for treating diseases or conditions.
Yes
The device is explicitly stated to be "indicated for digital imaging solution designed for general radiographic system for human anatomy" and "It can be utilized to capture and digitalize Xray images for radiographic diagnosis". The images can then be processed for "diagnostic analysis".
No
The device description clearly 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. It is a physical device that captures X-ray images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Edge Air Digital Flat Panel X-Ray Detector is a device that captures and digitalizes X-ray images of the human anatomy. It is used in conjunction with a radiographic system for diagnostic imaging.
- Intended Use: The intended use clearly states it's for "digital imaging solution designed for general radiographic system for human anatomy" and "intended to replace film or screen based radiographic system in all general purpose diagnostic procedures." This describes an imaging device, not a device that analyzes biological samples.
The device's function and intended use fall under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Edge Air 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 system in all general purpose diagnostic procedures. Not to be used for mammography.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
Edge Air 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 Xray 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Edge Air Digital Flat Panel X-Ray Detector has the same indications for use, material, form factor, performance, and safety characteristics compared to the predicate device, 1717WCC. The non-clinical test and clinical consideration test for the Edge 41 have been performed to demonstrate the substantial equivalency of the subject devices compared to the predicate device, 1717WCC. The non-clinical test report contains the MTF, DOE and NPS test results of Edge Air by using the identical test equipment and same analysis method described by IEC 6220-1.
The comparative result of the MTF and DOE test for Edge 4" detector with respect to the predicate demonstrated that the MTF and DQE of the subject devices performed same with the predicate device, 1717WCC. The MTF and DQE represent the ability to visualize object details of a certain size and contrast. The comparable performance of the MTF and DQE for the Edge An detector demonstrated that the performed almost same with 1717WCC.
To further demonstrate the substantial equivalency of the Edge Art, clinical images have been reviewed by a licensed radiologist to render an expert opinion. The test subject (Edge Air) and the predicate device (1717WCC) have been evaluated and compared by talking 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 Edge Air, the image obtained with the Edge Air is similar to the same view obtained from a similar patient with the predicate device, 1717WCC. In general, the spatial and soft tissue contrast resolutions for both devices are equivalent. Specially, 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 review by an expert for the Edge Air, the sponsor can claim the substantial equivalency between the subject device and the predicate device 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.
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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 a staff with a serpent entwined around it, overlaid on three human profiles facing to the right. 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, 2017
OSKO, INC. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K172681
Trade/Device Name: Edge Air 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.
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.
Michael D.'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 Air Digital Flat Panel X-ray Detector
Indications for Use (Describe)
Edge Air 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 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: | Ms. 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: | +713-583-8988 |
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: | EdgeAir | |
|---|---|---|
| Common Name: | Digital Flat Panel X-ray Detector | |
| Classification Name: | 21CFR892.1680 / Stationary x-ray system | |
| Product Code: | MQB | |
| Product Classification: | Class II | |
| Predicate Device: | ||
| Manufacturer: | Rayence Co., Ltd. | |
| Device: | 1717WCC | |
| 510(k) Number: | K162519 | |
| Classification Name: | 21CFR892.1680 / Stationary x-ray system | |
| Product Code: | MQB (Class II) |
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2. Device Description
Edge Air 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 Xray 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. Intended Use
Edge Air 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 system in all general-purpose diagnostic procedures. Not to be used for mammography.
4. Summary of Design Control Risk Management
The Edge Air Digital Flat Panel X-Ray Detector is developed for the purpose of portable imaging. The risk 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 Air Digital Flat Panel Detector uses the same flat panel x-ray detector as that used in the predicate device, K162519, and that no changes were necessary to either the hardware or firmware of the device.
5. Summary of the technological characteristics of the device compared to the predicated device:
The Edge Air detector described in this 510(k) has the same indications for use and similar technical characteristics as the predicate devices, 1717WCC of Rayence Co., Ltd
5
510(k) Submission - Edge Air
The Edge Air detector described in this 510(k) uses the same hardware, firmware and the same version of imaging software Xmaru View 1 / Xmaru PACS (K160579), without any change, that are used by the predicate device, 1717WCC.
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 Comparison Table
| Characteristic | Proposed
OSKO, INC.
Edge Air | Predicate
Rayence Co., Ltd.
1717WCC | |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Feature | Image: OSKO, INC. Edge Air | Image: Rayence Co., Ltd. 1717WCC | |
| 510(k) number | K176281 | K162519 | |
| Intended Use | Edge Air 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 system in all
general-purpose diagnostic
procedures. Not to be used for
mammography. | 1717WCC 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 system in all
general-purpose diagnostic
procedures. Not to be used for
mammography. | Same |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Same |
| Scintillator | CsI:T1 | CsI:T1 | Same |
| Imaging Area | 17 x 17 inches | 17 x 17 inches | Same |
| Pixel Matrix | 3072 X 3072 | 3072 X 3072 | Same |
| Pixel Pitch | 140 um | 140 um | Same |
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510(k) Submission - Edge Air
| Resolution | 3.9 lp/mm | 3.9 lp/mm | Same |
|---|---|---|---|
| A/D | |||
| Conversion | 14 / 16 bit | 14 / 16 bit | Same |
| Preview Time |