BSD4343 Digital Flat Panel X-ray Detector

K160204 · Bontech, Inc. · MQB · Jun 9, 2016 · Radiology

Device Facts

• Record ID: K160204
• Device Name: BSD4343 Digital Flat Panel X-ray Detector
• Applicant: Bontech, Inc.
• Product Code: MQB · Radiology
• Decision Date: Jun 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The BSD4343 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. It is not to be used for mammography.

Device Story

BSD4343 is a digital X-ray flat panel detector; intercepts X-ray photons using a Gadox:Tb scintillator; converts photons to visible light; illuminates an amorphous silicon (a-Si) TFT array to generate electrical signals; signals converted to digital values; images displayed on a monitor. Device integrates with an operating PC and X-ray generator; used in clinical settings for general radiography. Enables efficient diagnosis, information management, and network sharing of images. Benefits include digital conversion of X-ray images, replacing traditional film-based systems, and facilitating diagnostic workflows for healthcare professionals.

Clinical Evidence

Bench testing only. No clinical data was required. Performance was validated through non-clinical laboratory testing, including DQE, MTF, and NPS measurements, demonstrating resolution performance equivalent or superior to the predicate. Electrical safety and EMC testing conducted per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Detector: Amorphous Silicon (a-Si) TFT; Scintillator: Gadolinium Oxysulfide (Gadox:Tb); Imaging Area: 17x17 inches; Pixel Matrix: 3072x3072; Pixel Pitch: 140 μm; A/D Conversion: 16-bit; Resolution: 3.5 lp/mm; Connectivity: Networked (DICOM 3.0 compatible via console software); Standards: IEC 60601-1, IEC 60601-1-2, ISO 14971.

Indications for Use

Indicated for digital imaging in general radiographic systems for human anatomy; intended to replace film/screen-based systems for 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

• LLX240AB01 (K102587)

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 9, 2016

Bontech Inc. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K160204

Trade/Device Name: BSD4343 Digital Flat Panel X-ray Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: April 26, 2016 Received: April 26, 2016

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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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

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## Indications for Use

510(k) Number (if known) K160204

Device Name BSD4343 Digital Flat Panel X-ray Detector

#### Indications for Use (Describe)

The BSD4343 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. It is not to be used for mammography.

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

| <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## SECTION 07

# 510(k) SUMMARY

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## 1. Traditional 510(k) SUMMARY

This 510(k) summary is being submitted in accordance with requirements of SMDA 1990 and 21 CFR Part 807.92.

Date 510K summary prepared : January 18, 2016

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

| Submitter's Name : | BONTECH Inc. | |
|-------------------------|------------------------------------------------------------------------------------------------------------|--|
| Submitter's Address: | Youngtong-gu Youngtong-dong 980-3, Digital Empire D #1201,<br>Suwon city, Gyeonggi-do, South Korea 443-702 | |
| | Tel:+ 82-31-303-5254 / Fax: [phone] | |
| Contact person: | Mr. Kwang S Choi / RA Manager ([e-mail]) | |
| Official Correspondent: | Dave Kim, MBA | |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 | |
| Telephone: | [phone] | |
| Fax: | [phone] | |
| Email: | [e-mail] | |

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: | BSD4343 Digital Flat Panel X-ray Detector |
|-------------------------|-----------------------------------------------------|
| Device: | Solid State X-ay Imager (Flat Panel/Digital Imager) |
| Classification Name: | Stationary X-ray System |
| Regulation Number: | 21 CFR 892.1680 |
| Regulatory Class: | II |
| Product Code: | MQB |
| Predicate Device | |
| Manufacturer | Samsung Mobile Display Co., Ltd |
| Device | LLX240AB01 |
| 510(k) Number | K102587 |
| Decision Date | DEC 1, 2010 |

#### 2. Device Description

BSD4343 is a digital X-ray flat panel detector which intercepts x-ray photons and the scintillator (Gadox:Tb type) emits visible spectrum photons that illuminate an array of photo (a-SI)-detector that creates electrical signals. After the electrical signals are generated, it is converted to digital values, and the images will be displayed on the monitor. This device should be integrated with an operating PC and an X-Ray generator. It can digitalize x-ray images and transfer them for radiography diagnostics. Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and sharing of image information on network.

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## 3. Indications for Use

The BSD4343 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. It is not to be used for mammography.

#### 4. Summary of Design Control Risk management

The BSD4343 detector has been developed to meet the critical functional requirements and international safety standards. The risks and the hazardous impact of the device design were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the device design and production phase 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 and production were successfully mitigated and accepted.

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

The BSD4343 detector described in this 510(k) has similar indications for use and technical characteristics as the predicate device, LLX240AB01 digital flat panel X-ray detector manufactured by Samsung Mobile Display Co., Ltd.

## 6. Substantial Equivalence

The BSD4343 detector and components conform to the FDA recognized standards as like the predicate device. Based on the recognized standard conformity evidences related to electro- mechanical-, software-, clinical-, and risk management, it is confirmed that BSD4343 is substantially equivalent to the predicate device.

| Characteristic | Proposed<br>BONTECH<br>BSD4343 | Proposed<br>Samsung Mobile Display<br>LLX240AB01 | Remark |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| 510(k) number | - | K102587 | |
| Intended Use | The BSD4343 detector is<br>indicated for digital imaging<br>solution designed for general<br>radiographic system for human<br>anatomy. It is intended to replace<br>film or screen based radiographic<br>system in all general-purpose<br>diagnostic procedures. It is not to<br>be used for mammography. | LLX240AB01 Digital Flat Panel X-Ray<br>Detector is indicated for digital<br>imaging solution designed for<br>providing general radiographic<br>diagnosis of human anatomy<br>targeting both adult and children. It<br>is intended to replace film based<br>radiographic diagnostic systems and<br>provide a case diagnosis and<br>treatment planning for physicians<br>and other health care professionals.<br>Not to be used for mammography. | Same |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Same |

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| Scintillator | Gadolinium Oxysulfide | Gadolinium Oxysulfide | Same |
|----------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------|
| Imaging Area | 17 x 17 inches | 17 x 17 inches | Same |
| Pixel matrix | 3072 x 3072 (9.4 million) | 3072 x 3072 (9.4 million) | Same |
| Pixel pitch | 140 μm | 143 μm | Similarity |
| Resolution | 3.5 lp/mm | 3.5 lp/mm | Same |
| A/D conversion | 16 bit | 14 bit | Similarity |
| Grayscale | 16384 (14bit) | 16384 (14bit) | Same |
| Data output | RAW<br>*The RAW files are convertible<br>into 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 460 x 15 mm | 500 x 496.6 x 45 mm | Similarity |
| Application | General Radiology system<br>Available with upright stand,<br>table, universal stand | General Radiology system<br>Available with upright stand, table,<br>universal stand | Same |
| picture | Image: BONTECH | Image: detector | Similarity |

When compared to the predicate device (K102587), the BSD4343 presented in this submission has the same:

- Intended Use
- Technological characteristics
- · Operating principle
- · Design features
- Performance
- Communication Method

There are no significant difference between BSD4343 and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.

## 7. Performance Testing/Data

To minimize electrical and mechanical hazards, BONTECH adheres to recognized and established industry practice, and all equipment complies with the relevant FDA and international standards. For example, electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) was performed and EMC testing was conducted in accordance with standard IEC 60601-1-2: 2007, EN 60601-1-2:2007

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Through verification and validation activities, engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or identify new risks.

The instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.

#### 8. Description of non-clinical tests.

#### - Non-clinical study

The non-clinical performance testing constrains that the main physical values for comparison of X-rav devices like DQE. MTF NPS are basically equivalent to the predicate device LLX240AB01 (K102587). The results show that BSD4343 offer similar or better resolution performance than LLX240AB01 at 0 ~ 3.5lp/mm spatial frequencies. Moreover, the ability of BSD4343 to utilize the input image signal are more efficient than LLX240AB01 at same patient exposure as shown in the detective quantum efficiency graph.

#### -Electrical safety and EMC

BSD4343 has been tested for electrical safety standard IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 *2007) + AM1 (2012) and electromagnetic compatibility IEC 60601-1-2: 2007

The software validation and verification testing was also performed. The results of nonclinical testing indicate that the BSD4343 detector is as safe and effective as the predicate device.

Compliance evidences were submitted for the following standards:

- IEC 60601-1: Test Report issued by 3rd party testing lab A
- A IEC 60601-1-2: Test Report issued by 3rd party testing lab
- A ISO 14971: Risk management file

#### 9. Description of clinical tests.

Images reviewed were not necessary to establish substantial equivalence based on the modifications to the device as evidenced in the laboratory performance data to show that the subject device operates as the indicated.

#### 10. Conclusion as to Substantial Equivalence

The BSD4343 detector is substantially equivalent to the predicate device LLX240AB01 (K102587). Both subject and predicate devices are same or very similar in the intended use, the design principle, the performance and the applicable standards. Some characteristics, for example, their appearance, pixel pitch and weight are different. However the compliance reports, performance demonstrations that these differences do not raise any new questions of safety and effectiveness. Therefore, BONTECH Inc. concludes the BSD4343 digital flat panel detector is substantially equivalent with the predicate device LLX240AB01 (K102587) of Samsung Mobile Display Co., Ltd.