ELIAN Digital Diagnostic X-ray System

K150506 · Osko, Inc. · KPR · Apr 8, 2015 · Radiology

Device Facts

• Record ID: K150506
• Device Name: ELIAN Digital Diagnostic X-ray System
• Applicant: Osko, Inc.
• Product Code: KPR · Radiology
• Decision Date: Apr 8, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

ELIAN is a digital radiographic image acquisition system; captures X-ray images using an indirect conversion detector panel (a-Si layer with CsI). System components include U-arm mechanical mount, X-ray generator, detector panel, power box, and Flugel software. Operated by qualified doctors or technicians in radiology environments. Flugel software manages signal transfer between detector and generator, captures image data, and performs defect correction. Output is high-resolution digital radiographic images viewed by clinicians to support diagnostic decision-making. Benefits include improved image quality and potential for reduced radiation exposure compared to predicate devices due to higher DQE performance.

Clinical Evidence

Clinical images of eight body parts (Chest, Shoulder, L-Spine, Hand, Forearm, Foot, Knee) were provided to demonstrate diagnostic equivalency to the predicate device. Clinical data was supplementary to bench testing, which included DQE and MTF measurements per IEC 62220-1:2003, confirming superior performance in resolution and efficiency.

Technological Characteristics

Stationary digital X-ray system; indirect conversion detector (a-Si with CsI). U-arm mount; high-frequency generator. Detector dimensions 17" x 17"; 127-micron pixel size; 14-bit dynamic range. Connectivity via DICOM (NEMA PS 3.1-3.20). Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Software: Flugel (image acquisition/correction).

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of all body parts. Contraindicated for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Sedecal X-Plus LP Plus Digital (K090238)
• CXDI-50G (K031447)

Reference Devices

• XmaruView1 (K102078)
• 1717SCC (K122173)
• Toshiba E7252X (K133782)

Submission Summary (Full Text)

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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 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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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) |

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# 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.<br>7260 NW 58th Street, Miami, Florida 33166, USA<br><a href="http://www.oskomedical.com">www.oskomedical.com</a> |
|--------------|------------------------------------------------------------------------------------------------------------------------------|
|--------------|------------------------------------------------------------------------------------------------------------------------------|

| 2. Contact Person | Name: Wang Choi |
|-------------------|----------------------------------------------------------------------------------|
| | Position: Vice President |
| | E-mail: <a href="mailto:[e-mail]">[e-mail]</a> |
| | 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<br>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<br>Sedecal, Inc<br>892.1680, Product Code: KPR<br>K090238 (Decision Date - Feb. 27. 2009)<br>CXDI-50G<br>CANON, Inc.<br>892.1680, Product Code: MQB<br>K031447 (Decision Date - May, 21, 2003) |

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## 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.

10. 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.

11. 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:<br>ELIAN<br>Product Code: KPR | Predicate: (K090238)<br>Sedecal X-Plus LP Plus<br>Digital<br>Product Code: KPR | Predicate: (K031447)<br>CXDI 50G<br>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<br>X-ray system is intended<br>for use on adult and<br>pediatric patients for<br>taking diagnostics<br>radiographic exposure<br>of all body parts and<br>operated by a<br>qualified/trained doctor<br>or technician. NOT<br>intended for<br>Mammography use | Intended for use by a<br>qualified/trained doctor or<br>technician on both adult and<br>pediatric subjects for taking<br>diagnostic radiographic<br>exposures of the skull,<br>spinal column, chest,<br>abdomen, extremities, and<br>other body parts.<br>Applications can be<br>performed with the patient<br>sitting, standing, or lying in<br>the prone or supine position. | The Canon digital<br>radiography CXDI-50G<br>is a portable X-ray<br>digital camera that can<br>take images of any part<br>of the body. It directly<br>converts the X-ray<br>images captured by<br>LANMIT (Large Area<br>New MIS Sensors and<br>TFT) sensor into a<br>high-resolution digital<br>images. |
| Configuration | U-Arm mount | U-Arm mount | - |
| Electrical<br>safety | Electrical Safety per<br>IEC-60601. UL listed. | Electrical Safety per IEC-<br>60601. UL listed. | Electrical Safety per IEC-<br>60601. UL listed. |
| Performance<br>Standard | 21 CFR 1020.30 | 21 CFR 1020.30 | 21 CFR 1020.30 |
| Generator | High frequency | High frequency | - |
| X-ray tube | Toshiba (E7252X) used<br>for the marketed device:<br>K133782 | - | - |
| Collimator | Manual(Daesung) | Manual(Ralco) or<br>Automatic (Huestis) | - |
| Image<br>acquisition | Digital 1717SCC ( K122173)<br>-Type: Wired.<br>Acquisition Software:<br>flugel (Private label pro<br>duct for XmaruView1,<br>K102078) | Digital<br>CANON CXDI Panels, mult<br>iple models: 50C, 50G, 40C<br>and 40G | CXDI-50G<br>(K031447) |
| Detector<br>Dimensions | 17" x 17" | | 19.3" x 18.8" |
| MTF | 0.49 (1lp/mm), 0.234<br>(2lp/mm), 0.11<br>(3lp/mm),<br>0.083(3.5lp/mm) | | 0.50 (1lp/mm), 0.22<br>(2lp/mm), 0.11<br>(3lp/mm) |
| DQE | DQE(0) - 0.22, DQE(1)<br>-0.35, DQE(2)-0.275,<br>DQE(3)-0.14 | | DQE(0) – 0.1, DQE(1)<br>-0.25, DQE(2)-0.17,<br>DQE(3)-0.09 |
| Pixel Size | 127 x 127 microns | | 160x160 microns |
| Dynamic<br>Range | 14 bits | | 12 bits |
| Spatial<br>Resolution | 3.5 lp/mm | | 3.1 lp/mm |

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### 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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

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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.

16. Conclusion

The ELIAN is substantially equivalent to the Predicate Device in design and performance.

17. Manufacturing Facility

# OSKO, INC.

7260 NW 58th Street, Miami, Florida, 33166 USA Establishment Registration Number: 301066640