Edge Air Digital Flat Panel X-ray Detector

K172681 · Osko, Inc. · MQB · Oct 6, 2017 · Radiology

Device Facts

• Record ID: K172681
• Device Name: Edge Air Digital Flat Panel X-ray Detector
• Applicant: Osko, Inc.
• Product Code: MQB · Radiology
• Decision Date: Oct 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

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.

Device Story

Edge Air is a wired/wireless digital solid-state flat-panel X-ray detector; utilizes amorphous silicon TFT sensor coupled to a CsI:Tl scintillator. Captures X-ray radiation; converts to digital image data. Wireless communication via IEEE 802.11a/g/n/ac. Integrated into radiographic systems (upright stands, tables). Operates with console software (Xmaru View V1/PACS) to process RAW files into DICOM images. Used by clinicians/technicians in clinical settings for diagnostic radiography. Output viewed by radiologists for clinical decision-making; replaces film/screen systems. Benefits include high-speed digital image acquisition and improved workflow.

Clinical Evidence

Clinical images reviewed by a licensed radiologist compared Edge Air to predicate 1717WCC. Evaluated sample radiographs across similar age groups and anatomical structures. Expert opinion concluded spatial and soft tissue contrast resolutions are equivalent, with soft tissue clarity on extremity films noted. Bench testing included MTF, DQE, and NPS per IEC 6220-1.

Technological Characteristics

Flat-panel detector; Amorphous Silicon TFT sensor; CsI:Tl scintillator. 17x17 inch imaging area; 3072x3072 pixel matrix; 140um pixel pitch. 14/16-bit A/D conversion. Wireless (802.11a/g/n/ac, 2.4/5GHz, 3x3 MIMO). Dimensions 460x460x15mm; weight 3.5kg. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), 21 CFR 1020.30/31 (radiation).

Indications for Use

Indicated for digital radiographic imaging of human anatomy in general-purpose diagnostic procedures. Not 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

• 1717WCC (K162519)

Reference Devices

• Xmaru View V1 and Xmaru PACS (K160579)

Submission Summary (Full Text)

{0}------------------------------------------------

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 [phone] or [phone] 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 [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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

K172681

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) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### 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 [e-mail]

"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}------------------------------------------------

## 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: | [phone] |
| Contact Person: | Ms. Vivian Garcia / RA Manager / [phone] |
| Official Correspondent: | Dave Kim ([e-mail]) (U.S. Agent) |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | [phone] |
| Fax: | [phone] |

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) | |

{4}------------------------------------------------

#### 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<br>Classification<br>Name | Device name | 510(k)<br>number | Applicant |
|---------------|----------------------------------------------|--------------------------------------------------------------------------|------------------|----------------------|
| FDA<br>510(k) | System, Image<br>Processing,<br>Radiological | Xmaru View V1 and<br>Xmaru PACS, Medical<br>image processing<br>software | K160579 | Rayence Co.,<br>Ltd. |

#### 5.1 Comparison Table

| Characteristic | Proposed<br>OSKO, INC.<br>Edge Air | Predicate<br>Rayence Co., Ltd.<br>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-<br>Ray Detector is indicated for<br>digital imaging solution<br>designed for general<br>radiographic system for human<br>anatomy. It is intended to<br>replace film or screen based<br>radiographic system in all<br>general-purpose diagnostic<br>procedures. Not to be used for<br>mammography. | 1717WCC Digital Flat Panel X-<br>Ray Detectors are indicated for<br>digital imaging solution<br>designed for general<br>radiographic system for human<br>anatomy. It is intended to<br>replace film or screen based<br>radiographic system in all<br>general-purpose diagnostic<br>procedures. Not to be used for<br>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 |

{6}------------------------------------------------

# 510(k) Submission - Edge Air

| Resolution | 3.9 lp/mm | 3.9 lp/mm | Same |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| A/D<br>Conversion | 14 / 16 bit | 14 / 16 bit | Same |
| Preview Time | <2 | <2 | Same |
| MTF<br>(@1lp/mm) | 58 (%)<br>*Result value from Non-<br>Clinical Report | 56 (%) | Similar |
| DQE<br>(@0.1lp/mm) | 77.5 (%)<br>* Result value from Non-<br>Clinical Report | 80 (%) | Similar |
| Data Output | RAW<br>*The RAW files are convertible<br>into DICOM 3.0 by console<br>S/W | RAW<br>*The RAW files are convertible<br>into DICOM 3.0 by console<br>S/W | Same |
| Imaging<br>Software | Xmaru View 1 / Xmaru PACS<br>(Version 2.0.0) | Xmaru View 1 / Xmaru PACS<br>(Version 2.0.0) | Same |
| Wireless<br>Specifications | -Standard: 802.11 a/g/n/ac compliance<br>Without DFS (5.25GH to 5.35GHzand<br>5.47 to 5.725) Band<br>-Peak Rate:1300Mbps<br>-Frequency: 2.4 GHz / 5 GHz<br>-Bandwith: 20MHz / 40MHz / 80MHz<br>-MIMO: 3 x 3 | -Standard: 802.11 a/g/n/ac compliance<br>Without DFS (5.25GH to 5.35GHzand<br>5.47 to 5.725) Band<br>-Peak Rate:1300Mbps<br>-Frequency: 2.4 GHz / 5 GHz<br>-Bandwith: 20MHz / 40MHz / 80MHz<br>-MIMO: 3 x 3 | Same |
| Dimensions | 460 × 460 × 15 mm | 460 × 460 × 15 mm | Same |
| Weight | 3.5 kg (incl. battery) | 3.5 kg (incl. battery) | Same |
| Application | General Radiology system or<br>Wireless/Wired portable system<br>Available with upright stand,<br>table, universal stand | General Radiology system or<br>Wireless/Wired portable system<br>Available with upright stand,<br>table, universal stand | Same |
| Added<br>Optional<br>Components | Battery & Battery Charger<br>Interface Cox IrDA module | Battery & Battery Charger<br>Interface Cox IrDA module | Same |

The Edge Air Digital Flat Panel Detector is identical to the wireless hardware and . functionality of the predicate device, 1717WCC.

Maximum wireless signal rate derived from IEEE standard specifications. Actual data throughput will vary. Network conditions and environmental factors, including volume of network traffic, building materials and construction, and network overhead, lower actual data throughput rate.

## 5.2 Scintillator Layer

The scintillator (a phosphor that produces scintillations) layer of the Edge Air detector is described as below.

{7}------------------------------------------------

# 510(k) Submission – Edge Air

| | Proposed | Predicate |
|------------------------|----------|-----------|
| CsI<br>(Cesium Iodide) | Edge Air | 1717WCC |

## 5.3 Added Optional Components

| Components | Description |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Battery & Battery Charger<br>Image: Battery and battery charger | Sources of electricity |
| Mobile Battery Charger<br>Image: Mobile battery charger | |
| Interface Box<br>Image: Interface box | 1) Connector to synchronize the detector and its generator.<br>2) Data transfer and battery charge while the detector is in use<br>(Connect between the detector and Interface Box), Up to<br>three detectors can be connected.<br>3) Transmitting an image/command between the detector and<br>PC.<br>4) Wireless AP. |
| IrDA module<br>Image: IrDA module | Sharing function for PC and the detector. |

## 5.4 Recommended Generator Specification

| Model | Manufacture | Specification | | |
|---------|--------------------------------------|---------------|--------|--------|
| CMP 200 | Communications & Power<br>Industries | 32kW | 40kW | 50kW |
| | | kVp | 40-125 | 40-150 |

{8}------------------------------------------------

# 510(k) Submission - Edge Air

| | | 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 | POSKO, m Co.,Ltd. | kVp | 125/150 | | |
| | | mA | 500 | | |

Image /page/8/Picture/2 description: The image shows a caution sign. The sign is a white square with a black dashed border. Inside the square, there is a black triangle with an exclamation point inside. Below the triangle, the word "CAUTION" is written in black, bold letters.

To our best knowledge, the detector is compatible with the X-rav 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 OSKO, Inc. representative.

## 6. Summary of Performance Testing compared with predicate device

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.

{9}------------------------------------------------

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.

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. Conclusion:

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 Air is substantially equivalent in comparison with 1717WCC, the predicate device as described herein.