1417WGC_127um and 1417WGC_140um

K171417 · Rayence Co., Ltd. · MQB · Jun 12, 2017 · Radiology

Device Facts

• Record ID: K171417
• Device Name: 1417WGC_127um and 1417WGC_140um
• Applicant: Rayence Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: Jun 12, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

1417WGC_127um and 1417WGC_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.

Device Story

The 1417WGC 127um and 140um are digital flat-panel X-ray detectors using amorphous silicon (a-Si) TFT sensors and a Gadolinium Oxysulfide (Gd2O2S:Tb) scintillator. The device captures X-ray radiation, converts it into digital signals, and transmits images via wireless LAN (IEEE 802.11a/g/n/ac) or wired connection to a separate console system. It is intended for use in general radiographic systems (upright stands, tables, or portable setups) by healthcare professionals. The device does not control the X-ray generator. Raw image data is processed by external console software (e.g., Xmaru View V1) into DICOM-compatible files for clinical diagnosis. By providing digital images, the device enables faster image acquisition and review compared to traditional film-screen systems, facilitating clinical decision-making in general radiology.

Clinical Evidence

Clinical evaluation involved a comparative review of radiographs taken with the 1417WGC 140um and the 1417WGA predicate. A licensed US radiologist evaluated images of similar age groups and anatomical structures. The review concluded that the 1417WGC 140um provided superior spatial and soft tissue contrast resolution compared to the predicate, with no difficulty in evaluating anatomic structures for diagnostic conclusions.

Technological Characteristics

Flat-panel detector using Amorphous Silicon (a-Si) TFT sensor and Gd2O2S:Tb scintillator. Pixel matrix: 3328x2816 (127um) or 3052x2500 (140um). Connectivity: Wireless LAN (IEEE 802.11a/g/n/ac) and wired. Power: Battery-operated. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 62220-1 (DQE/MTF).

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

• 1417WGA (K131114)

Reference Devices

• 1417WGC (K141563)
• Xmaru View V1 and Xmaru PACS (K160579)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 12, 2017

Rayence Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025

Re: K171417

Trade/Device Name: 1417WGC 127um and 1417WGC 140um Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: May 1, 2017 Received: May 15, 2017

Dear Dave 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

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Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical devicerelated 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.

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.

Michael D. O'Hara
For

Robert A. 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)

K171417

Device Name

1417WGC_127um and 1417WGC_140um

#### Indications for Use (Describe)

1417WGC 127um and 1417WGC 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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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: June 7, 2017

Submitter's Name, address, telephone number, a contact person:

| Submitter's Name : | Rayence Co., Ltd. |
|-------------------------|---------------------------------------------------------|
| Submitter's Address: | 14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea |
| Submitter's Telephone: | [phone] |
| Contact person: | Mr. Kee Dock Kim / RA Team Manager / [phone] |
| Official Correspondent: | Dave Kim ([e-mail]) |
| (U.S. Designated 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: | : 1417WGC_127µm and 1417WGC_140µm |
|-------------------------|-------------------------------------|
| Common Name | : Digital Flat Panel X-ray Detector |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Product Code | : MQB |
| Predicate Device : | |
| Device | :1417WGA |
| 510(k) Number | : K131114 |
| Common Name | : Digital Flat Panel X-ray Detector |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Product Code | : MQB |
| Reference Device: | |

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| Device | : 1417WGC (Manufactured by Rayence) |
|-------------------|-------------------------------------|
| 510(k) Number | : K141563 |
| Common Name | : Digital Flat Panel X-ray Detector |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Product Code | : MQB |

# 2. Device Description

While 1417WGC_127um digital X-ray detector is identical to 1417WGC (K141563), both 1417WGC 127um and 1417WGC 140um are wired/wireless digital solid state X-ray detectors which are 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. Both devices do not operate as an X-ray generator controller but both 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 / Xmaru View V1 and Xmaru PACS/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis.

#### 3. Indication for use

1417WGC_127um and 1417WGC_140µm 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.

# 4. Summary of Design Control Risk management

1417WGC_127um digital X-ray detector is identical to 1417WGC (K141563). 1417WGC_140um digital X-ray detector is a modification of 1417WGA (K131114) was developed for the purpose of ideal for inroom and portable imaging with a film detector. 1417WGC_140μm is slightly thinner and lighter than 1417WGA.

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.

### 5. Summary of the technological characteristics of the device compared to the

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## predicate device:

1417WGC_127μm digital X-ray detector is identical to 1417WGC (K141563). 1417WGC_140μm detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, 1417WGA.

#### 5.1 Comparison table

| Characteristic | Proposed<br>Rayence Co.,Ltd.<br>1417WGC | Predicate<br>Rayence Co.,Ltd.<br>1417WGA | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Feature | Image: Rayence Co.,Ltd. 1417WGC | Image: Rayence Co.,Ltd. 1417WGA | |
| 510(k) number | | K131114 | Same |
| Intended Use | 1417WGC_127µm and<br>1417WGC_140µm are indicated for<br>digital imaging solution designed for<br>general radiographic system for human<br>anatomy. It is intended to replace film or<br>screen based radiographic systems in all<br>general purpose diagnostic procedures.<br>Not to be used for mammography. | 1417WGA Digital Flat Panel X-Ray<br>Detector is indicated for digital<br>imaging solution designed for general<br>radiographic system for human<br>anatomy. It is intended to replace film<br>or screen based radiographic systems<br>in all general purpose diagnostic<br>procedures. Not to be used for<br>mammography. | Same |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Same |
| Scintillator | 1417WGC_127µm<br>1417WGC_140µm | 1417WGA | Same |
| Imaging Area | 14 x 17 inches | 14 x 17 inches | Same |
| Pixel matrix | 127 : 3328 X 2816<br>140 : 3052 X 2500 | 3328 x 2816 | Similar |
| Pixel pitch | 127 µm / 140 µm | 127 µm | Similar |
| Resolution | 3.9 lp/mm | 3.9 lp/mm | Same |
| A/D conversion | 14 bit for 127 µm /16 bit for 140 µm | 14 bit | Same |
| Preview time | ≤2(wied / wireless) | 2~3 seconds (wired) / 3~5 seconds<br>(wireless) | Similar |
| Data output | RAW<br>*The RAW files are convertible into<br>DICOM 3.0 by console S/W | RAW<br>*The RAW files are convertible into<br>DICOM 3.0 by console S/W | Same |
| Dimensions | 460 x 384 × 15 mm | 460 x 417 × 15.9 mm | Similar |
| Weight | 3.0 kg (incl. battery) | 3.9 kg (incl. battery) | Similar |
| Application | General Radiology system or<br>Wireless/Wired portable system | Wireless portable system | Same |
| | Available with upright stand, table,<br>universal stand. | universal stand | |
| Added<br>Optional<br>Components | Battery & Battery Charger<br>Interface Box<br>IrDA module | Battery & Battery Charger | Similar |

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### 5.2 Scintillator layer

*scintillator layer. ( * scintillator : a phosphor that produces scintillations)

| | Proposed | Predicate |
|--------------------------------------|--------------------------------|-----------|
| Gd₂O₂S:Tb<br>(Gadolinium Oxysulfide) | 1417WGC_127μm<br>1417WGC_140μm | 1417WGA |

## 5.3 Added Optional Components (Comparison with Predicate device)

| 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 generator.<br>2) Data transfer and charging battery while detector is in use<br>(Connect between detector and Interface Box), Up to three detector<br>can be connected.<br>3) Transmitting an image/command between the detector and PC.<br>4) Wireless AP. |
| IrDA module<br>Image: IrDA module | Sharing function for PC and detector. |

#### 5.4 Recommended Generator Specifications

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| Model | Manufacture | Specification | | |
|----------------|--------------------------------------|---------------|--------------------|--------|
| CMP 200 | Communications & Power<br>Industries | 32kW | 40kW | 50kW |
| | | kVp | 40-125 | 40-150 |
| | | mA | 10-400 | 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 | |

# 6. Summary of Performance Testing

1417WGC_127μm digital X-ray detector is identical to 1417WGC (K141563). 1417WGC_140μm Digital Flat Panel X-Ray Detectors have the same indications for use, the same imaging area (14 x 17), based on the same scintillator material (Gd2O2S:Tb), the same resolution (3.9 lp/mm), performance, and safety characteristics compared to the predicate devices. The pixel pitch sizes are different but the differences do not raise new concerns for the safety and effectiveness of the subject device.

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. DOE and NPS test results of 1417WGC 140um 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 1417WGC_140um detector with respect to the predicate device demonstrated that the MTF and DOE of the both 1417WGA performed similarly compared with the predicate devices. The MTF and DQE represents the ability to visualize object details of a certain size and contrast. 1417WGC_140um has similar MTF and DQE performance at all spartial frequencies, especially from 2 1p/mm to 3.5 lp/mm. The comparison of the MTF and DQE for 1417WGC_140um detector demonstrated that the performed almost same with 1417WGA.

To further demonstrate the substantial equivalency of two devices, clinical images are taken from both

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subject devices and reviewed by a licensed US radiologist to render an expert opinion. Both the test subject (1417WGC 140um) and the predicate devices (1417WGA) have been evaluated and compared by taking sample radiographs of similar age groups 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 1417WGC 140um and 1417WGA, the images obtained with the 1417WGC 140um are superior to the same view obtained from a similar patient with 1417WGA, the predicate devices. In general, both the spatial and soft tissue contrast resolution are superior using the 1417WGC_140μm. Specifically, the soft tissues on extremity were seen with better clarity. There is little difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion.

Based on the non-clinical and clinical consideration test and the outcome of a comparative 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.

## 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.

Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed.

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 Rayence Co., Ltd. concludes that 1417WGC_127um and 1417WGC_140um are safe and effective and substantially equivalent in comparison with the predicate device.