(41 days)
Not Found
No
The description focuses on standard digital radiography components and image correction, with no mention of AI/ML terms or functionalities.
No.
This device is described as a diagnostic X-ray system, intended for image acquisition and diagnosis, not for treating any medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The ELIAN diagnostic X-ray system is intended for use..." thereby identifying it as a diagnostic device. Additionally, the clinical testing aimed to "investigate the diagnostic equivalency of detector panels."
No
The device description explicitly lists multiple hardware components including a Detector Panel, Case, Grid, Power Box, Switch Box, Interconnecting Cables, U-arm Mechanical, and Generator, in addition to software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- ELIAN's Function: The ELIAN diagnostic X-ray system is used for radiographic imaging of the human body. It captures images using X-rays that pass through the patient. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
- Intended Use: The intended use clearly states "radiographic exposure of all body parts," which is consistent with in vivo imaging.
- Device Description: The description details components like a Detector Panel, X-ray Generator, and U-arm Mechanical, all of which are part of an X-ray imaging system.
Therefore, based on the provided information, the ELIAN diagnostic X-ray system is a medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ELIAN diagnostic X-ray system is intended for use on adult and pediatric patients radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. NOT intended for Mammography use.
Product codes (comma separated list FDA assigned to the subject device)
KPR
Device Description
The ELIAN is a digital radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment.
The ELIAN system includes a Detector Panel, Soft Ware, Case, Grid, Power Box, Switch Box, Interconnecting Cables, U-arm Mechanical and Generator. The Detector Panel is an indirect conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Si layer with CSI. The Power Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Flugel SW transfers signals between the Detector and X-ray Generator and also indicates the status of the panel using console. Finally, the Flugel SW contains for image data capture and correction of defects on the image data.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
all body parts
skull, spinal column, chest, abdomen, extremities, and other body parts.
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
qualified/trained doctor or technician / typical radiology environment
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)
Non-Clinical Testing:
The performance of Detector can be evaluated by DQE and MTF according to IEC 62220-1:2003 Standard. DQE & MTF have been tested by acquiring the X-ray image with designated devices.
The overall test results conclude that ELIAN has outperformed the predicate device Sedecal X-Plus LP Plus Digital (K090238) in terms of modulation transfer function and detective quantum efficiency.
ELIAN has been tested in accordance with Safety (IEC 60601-1; 2005 + A1 (2012)), EMC (EN60601-1-2:2007 / AC : 2010 (IEC60601-1-2:2007)), IEC 60601-2-54 (First Edition) : 2009 and DICOM standards (NEMA PS 3.1-3.20:2011).
Clinical Testing:
Clinical study is to investigate the diagnostic equivalency of detector panels with the same a-Se technology and same pixel sizes. We've tested for eight body parts (Chest, Shoulder, L-Spine_L, L-Spine_AP, Hand, Forearm, Foot and Knee) compared to the predicate device. The result of tests demonstrated that ELIAN produces diagnostic images of equivalent quality as the predicate device Sedecal X-Plus LP Plus Digital of Sedecal, Inc. (K090238).
"Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended."
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.
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 7, 2016
OSKO, Inc. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K150506
Trade/Device Name: Elian digital diagnostic x-ray system Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: February 23, 2015 Received: February 26, 2015
Dear Mr. Kim:
This letter corrects our substantially equivalent letter of April 08, 2015.
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
1
forth in the quality systems (OS) 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 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
2
Indications for Use
510(k) Number (if known)
Device Name
ELIAN Digital Diagnostic X-ray System
Indications for Use (Describe)
The ELIAN diagnostic X-ray system is intended for use on adult and pediatric patients radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. NOT intended for Mammography use.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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: February 23, 2015
Submitter's Name, address, telephone number, a contact person:
| 1. Submitter | OSKO, Inc.
7260 NW 58th Street, Miami, Florida 33166, USA
www.oskomedical.com |
| -------------- | ------------------------------------------------------------------------------------------------------------------------------ |
|---|
| 2. Contact Person | Name: Wang Choi |
|---|---|
| Position: Vice President | |
| E-mail: bioking@medisoneconet.com | |
| Telephone: + 1 305-599-7161 |
Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:
| 3. Device Classification Name | Stationary X-ray System |
|---|---|
| 4. Device Name | ELIAN |
| Digital Diagnostic X-Ray System | |
| 5. Classification | 21 CFR 892.1680 |
| 6. Product Code | KPR |
| 7. Device Class | 2 |
| 8. Predicate Device | Sedecal X-Plus LP Plus Digital |
| Sedecal, Inc | |
| 892.1680, Product Code: KPR | |
| K090238 (Decision Date - Feb. 27. 2009) | |
| CXDI-50G | |
| CANON, Inc. | |
| 892.1680, Product Code: MQB | |
| K031447 (Decision Date - May, 21, 2003) |
4
9. Device Description
The ELIAN is a digital radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment.
The ELIAN system includes a Detector Panel, Soft Ware, Case, Grid, Power Box, Switch Box, Interconnecting Cables, U-arm Mechanical and Generator. The Detector Panel is an indirect conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Si layer with CSI. The Power Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Flugel SW transfers signals between the Detector and X-ray Generator and also indicates the status of the panel using console. Finally, the Flugel SW contains for image data capture and correction of defects on the image data.
- Intended Use
The ELIAN diagnostic X-ray system is intended for use on adult and pediatric patients for taking diagnostics radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. NOT intended for Mammography use.
- Summary of the Technological Characteristics of the device compared to the Predicate Device
The ELIAN digital diagnostic X-ray system described in this 501K has the similar indications for use and technical characteristics as the predicate device, Sedecal X-Plus LP Plus Digital of Sedecal, Inc. (K090238)
| Feature | New Device:
ELIAN
Product Code: KPR | Predicate: (K090238)
Sedecal X-Plus LP Plus
Digital
Product Code: KPR | Predicate: (K031447)
CXDI 50G
Product Code: MQB |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | OSKO, Inc | Sedecal, Inc. | Canon Inc. |
| Appearances | Image: OSKO, Inc. | Image: Sedecal, Inc. | Image: Canon Inc. |
| Intended Use | The ELIAN diagnostic
X-ray system is intended
for use on adult and
pediatric patients for
taking diagnostics
radiographic exposure
of all body parts and
operated by a
qualified/trained doctor
or technician. NOT
intended for
Mammography use | Intended for use by a
qualified/trained doctor or
technician on both adult and
pediatric subjects for taking
diagnostic radiographic
exposures of the skull,
spinal column, chest,
abdomen, extremities, and
other body parts.
Applications can be
performed with the patient
sitting, standing, or lying in
the prone or supine position. | The Canon digital
radiography CXDI-50G
is a portable X-ray
digital camera that can
take images of any part
of the body. It directly
converts the X-ray
images captured by
LANMIT (Large Area
New MIS Sensors and
TFT) sensor into a
high-resolution digital
images. |
| Configuration | U-Arm mount | U-Arm mount | - |
| Electrical
safety | Electrical Safety per
IEC-60601. UL listed. | Electrical Safety per IEC-
60601. UL listed. | Electrical Safety per IEC-
60601. UL listed. |
| Performance
Standard | 21 CFR 1020.30 | 21 CFR 1020.30 | 21 CFR 1020.30 |
| Generator | High frequency | High frequency | - |
| X-ray tube | Toshiba (E7252X) used
for the marketed device:
K133782 | - | - |
| Collimator | Manual(Daesung) | Manual(Ralco) or
Automatic (Huestis) | - |
| Image
acquisition | Digital 1717SCC ( K122173)
-Type: Wired.
Acquisition Software:
flugel (Private label pro
duct for XmaruView1,
K102078) | Digital
CANON CXDI Panels, mult
iple models: 50C, 50G, 40C
and 40G | CXDI-50G
(K031447) |
| Detector
Dimensions | 17" x 17" | | 19.3" x 18.8" |
| MTF | 0.49 (1lp/mm), 0.234
(2lp/mm), 0.11
(3lp/mm),
0.083(3.5lp/mm) | | 0.50 (1lp/mm), 0.22
(2lp/mm), 0.11
(3lp/mm) |
| DQE | DQE(0) - 0.22, DQE(1)
-0.35, DQE(2)-0.275,
DQE(3)-0.14 | | DQE(0) – 0.1, DQE(1)
-0.25, DQE(2)-0.17,
DQE(3)-0.09 |
| Pixel Size | 127 x 127 microns | | 160x160 microns |
| Dynamic
Range | 14 bits | | 12 bits |
| Spatial
Resolution | 3.5 lp/mm | | 3.1 lp/mm |
5
6
12. Comparison discussion:
The model Sedecal X-Plus LP Plus Digital and CANON CXDI 50G are the primary predicate device. The subject device and predicate device are substantially equivalent, having the same intended use, configuration, electrical safety, performance standard, collimator and image acquisition. The differences are pixel size, dynamic range and spatial resolution only. Both subject device and predicate device are categorized in product code KPR : equivalence between these models is evident.
There are similar characteristics between ELIAN and its predicate devices. The similarities ELIAN and the predicate device are listed below.
A few differences are as follows.
These differences do not raise any new questions of safety or effectiveness.
- Differences in Dimensions
Dimensions of 1717SCC is 17X17" and that of CXDI-5 0G is 19.3X18.8". But it has no effect on efficiency and safety.
- Differences in Pixel size
Pixel size of 1717SCC is 127 x 127 microns and that of CXDI-50G is 160 x 160 microns. But it has no effect on efficiency and safety.
- Differences in Spatial Resolution
Spatial Resolution of 1717SCC is 3.5 lp/mm and that of CXDI-50G is 3.1 lp/mm. But it has no effect on efficiency and safety.
- Differences in Non Clinical Performance
The MTF and DQE performance of the 1717 SCC digital flat panel for ELIAN are consistently higher than CDXI-50G equipped by Sedecal X-Plus LP Plus Digital.
In summary, both detectors are similar in terms of the capacity of transferring the modulation of the input signal at a given spatial frequency to its output, a useful measure of true or effective resolution.
Higher DQE values of 1717SCC. compared to CDXI-50G. indicate that less radiation is needed to achieve identical image quality; increasing the DQE and leaving radiation exposure constant will improve image quality.
- Different image viewing software
1717SCC digital flat panel is compatible with the imaging software used with the submitted device is 'flugel' and it is identical to the XmaruView V1., cleared under K102078.
In conclusion, the ELIAN is substantially equivalent to predicate devices.
13. Summary of Non-Clinical Testing
The performance of Detector can be evaluated by DQE and MTF according to IEC 62220-1:2003 Standard. DQE & MTF have been tested by acquiring the X-ray image with designated devices.
The overall test results conclude that ELIAN has outperformed the predicate device Sedecal X-Plus LP Plus Digital (K090238) in terms of modulation transfer function and detective quantum efficiency.
7
Moreover, ELIAN has been tested in accordance with Safety (IEC 60601-1; 2005 + A1 (2012)), EMC (EN60601-1-2:2007 / AC : 2010 (IEC60601-1-2:2007)), IEC 60601-2-54 (First Edition) : 2009 and DICOM standards (NEMA PS 3.1-3.20:2011).
14. Summary of Clinical Testing
Clinical study is to investigate the diagnostic equivalency of detector panels with the same a-Se technology and same pixel sizes. We've tested for eight body parts (Chest, Shoulder, L-Spine_L, L-Spine_AP, Hand, Forearm, Foot and Knee) compared to the predicate device. The result of tests demonstrated that ELIAN produces diagnostic images of equivalent quality as the predicate device Sedecal X-Plus LP Plus Digital of Sedecal, Inc. (K090238).
"Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended."
15. Functional and Safety Testing
The ELIAN has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and has shown good performance, substantially equivalent to the predicate device.
The ELIAN has also met applicable Electro Magnetic Compatibility (EMC) requirements.
- Conclusion
The ELIAN is substantially equivalent to the Predicate Device in design and performance.
- Manufacturing Facility
OSKO, INC.
7260 NW 58th Street, Miami, Florida, 33166 USA Establishment Registration Number: 301066640