DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA

K133409 · Rayence Co., Ltd. · MQB · Feb 21, 2014 · Radiology

Device Facts

• Record ID: K133409
• Device Name: DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA
• Applicant: Rayence Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: Feb 21, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

910SGA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck, spinal column, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health professionals. Not to be used for mammography.

Device Story

910SGA is a digital solid-state X-ray detector using flat-panel technology; consists of a Gadolinium Oxysulfide scintillator coupled to an amorphous silicon (a-Si) TFT sensor. Device captures X-ray radiation and converts it into digital signals; raw data is transmitted to a separate console software (not part of this submission) for processing into DICOM-compatible images. Used in clinical settings by physicians and health professionals for radiographic diagnosis and treatment planning. Replaces film-based systems; provides digital images for clinical decision-making. Benefits include improved workflow and diagnostic capability compared to traditional film radiography.

Clinical Evidence

No clinical trials; clinical evidence based on comparative review of sample radiographs. A licensed US radiologist reviewed clinical images from both the 910SGA and the predicate 1210SGA to render an expert opinion on diagnostic equivalence. Non-clinical bench testing included MTF, DQE, and NPS analysis per IEC 62220-1, confirming performance equivalence.

Technological Characteristics

Digital flat-panel detector; Amorphous Silicon (a-Si) TFT sensor; Gadolinium Oxysulfide scintillator. Dimensions: 9x10 inch imaging area; 2048x1792 pixel matrix; 127 μm pixel pitch. Weight: 2.0 kg. Connectivity: Integrates with external console software. Safety/EMC: IEC 60601-1:2005, IEC 60601-1-2:2007.

Indications for Use

Indicated for digital radiographic imaging of human anatomy including head, neck, spinal column, extremities, and peripheral regions in adults and pediatric patients. 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

• I210SGA (K113630)

Submission Summary (Full Text)

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K133409
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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: November 5th, 2013

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

| Submitter's Name : | Rayence Co., Ltd. |
|-------------------------|------------------------------------------------------------------------------|
| Submitter's Address: | 1F, 2F, 3F, #402, 14, Samsung 1-ro 1-gil, Hwaseong-si,<br>Gyeonggi-do, Korea |
| Submitter's Telephone: | [phone] |
| Contact person: | Mr. Kee Dock Kim / 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:

1

| Trade/proprietary name: | 910SGA |
|-------------------------|-----------------------------------------|
| Common Name: | Digital Flat Panel X-ray Detector |
| Classification Name : | 21CFR892.1680 / Stationary x-ray system |
| Product Code: | MQB |

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#### Predicate Device :

| Manufacturer | : Rayence Co., Ltd. |
|---------------|-------------------------------------------|
| Device | : I210SGA |
| 510(k) Number | : K113630 (Decision Date - DEC. 29. 2011) |

### Device Description :

910SGA is a digital solid state X-ray detector that is based on flat-panel technology. 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 X-ray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by separate console SW (not part of this 510K submission) for a radiographic diagnosis and analysis.

### Indication for use :

910SGA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck, spinal column, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health professionals. Not to be used for mammography.

### Summary of the technological characteristics of the device compared to the predicate device:

The 910SGA SSX1 detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device. 1210SGA flat panel detector, of Rayence Co., Ltd. Table I summarizes the technological characteristics of the 910SGA and 1210SGA, the predicate device.

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| | Proposed | Predicate |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Rayence Co.,Ltd.<br>910SGA | Rayence Co.,Ltd.<br>1210SGA |
| 510(k) number | - | K113630 |
| Intended Use | 910SGA Digital Flat Panel X-Ray<br>Detector is indicated for digital<br>imaging solution designed for<br>human anatomy including head,<br>neck, spinal column, arm, leg and<br>peripheral (foot, hand, wrist,<br>fingers, etc.). It is intended to<br>replace film based radiographic<br>diagnostic systems and provide a<br>case diagnosis and treatment<br>planning for physicians and other<br>health professionals. Not to be<br>used for mammography. | 1210SGA Digital Flat Panel X-Ray<br>Detector is indicated for digital<br>imaging solution designed for<br>human anatomy including head,<br>neck, spinal column, arm. leg and<br>peripheral (foot, hand, wrist.<br>fingers, etc.). It is intended to<br>replace film based radiographic<br>diagnostic systems and provide a<br>case diagnosis and treatment<br>planning for physicians and other<br>health professionals. Not to be used<br>for mammography. |
| Detector Type | Amorphous Silicon with TFT | Amorphous Silicon with TFT |
| Scintillator | Gadolinium Oxysulfide | Gadolinium Oxysulfide |
| Imaging Area | 9x 10 inches | 11 x 13 inches |
| Total Pixel<br>Matrix | 2048 x 1792 pixels | 2560 x 2080 pixels |
| Pixel pitch | 127 \n- the | |

Table 1: Comparison of 910SGA and 1210SGA

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| Weight | 2.0 kg | 3.0 kg |
|-------------|-----------------------------|-----------------------------------|
| Application | adults and pediatric care | adults and pediatric care |
| Feature | Image: flat square detector | Image: detector with raised edges |

Table 2: Size Comparison of 910SGA and 1210SGA

| Item | Unit | 910SGA | 1210SGA |
|------------------------|--------|---------------|-------------|
| Pixel Pitch | μm | 127 x 127 | 127 x 127 |
| Total Pixel Matrix | pixels | 2048 x 1792 | 2560 x 2080 |
| Total Pixel Area | mm | 260.1 x 227.6 | 264 x 325 |
| Effective Pixel Matrix | pixels | 2008 x 1752 | 2520 x 2040 |
| Fill factor | % | 61.03 | 65.14 |
| Weight | Kg | 2.0 Kg | 3.0 Kg |

### Summary of Performance Testing:

The 910SGA flat panel detector is a modified version of 1210SGA (K113630), FDA cleared predicate device from Rayence. Indications for use, material, form factor, performance, and safety characteristics between 910SGA and 1210SGA are identical. The non-clinical test report and clinical consideration report were prepared and submitted to FDA separately to demonstrate the substantial equivalency between two similar detectors. The non-clinical test report contains the MTF, DQE and NPS test results of 910SGA and 1210SGA by using the identical test equipment and same analysis method described by IEC 6220-1 The comparison of the MTF for 910SGA and 1210SGA detector demonstrated that the MTF of the 910SGA detector performed almost same with 1210SGA. Therefore the overall resolution performance and sharpness of 910SGA is almost same with 1210SGA. The DQE represents the ability to visualize object details of a certain size and contrast. 910GA demonstrated higher DQE performance than 1210GA at various spatial frequencies and provides almost same Signal-to Noise Ratio (SNR) transfer from the input to the output of a detector as a function of frequency. At the lowest spatial frequency, 910SGA has a DQE

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of 46% and that of 1210SGA is 45%. 910SGA also exhibited NPS which has almost same performance with 1210SGA. Therefore, the image quality of 910SGA is found to be substantially equivalent to 1210SGA at the same patient exposure.

To further demonstrate the substantial equivalency of two devices, clinical images are taken from both devices and reviewed by a licensed US radiologist to render an expert opinion. Both the test subject (910SGA) and control group (1210SGA) are 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.

Based on the non-clinical and clinical consideration test and the outcome of a comparative review by an expert for both devices, we can claim the substantial equivalency between 910SA and its predicate device, 1210SGA in terms of image quality.

### Summary for any testing in the submission

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1: 2005 + CORR.I(2006) + CORR(2007) (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, Class A.

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

The manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 802.30 and the records are available for review.

All test results were satisfactory.

#### 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 910SGA is safe and effective and substantially equivalent in comparison with 1210SGA, the predicate device as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

February 21, 2014

Rayence Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K133409

Trade/Device Name: Digital Flat Panel X-ray Detector/ 910sga Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: January 17, 2014 Received: January 23, 2014

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.

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Page 2-Mr. Kim

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

hun://www.lda.gov/MedicalDevices/Resourcesfor You/Industry/detault.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) 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/Safetv/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K133409

#### Device Name 910SGA Digital Flat Panel X-Ray Detector

#### Indications for Use (Describe)

910SGA Digital Flat Panel X-Ray Detector is indical imaging solution designed for human anatomy including head, neck, spinal column, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health professionals. Not to be used for mammography.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

O Over-The-Counter Use (21 CFR 807 Subpart C)

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FORM FDA 3881 (6/13)

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