BSD3543W

K200787 · Bontech Co., Ltd. · MQB · Apr 23, 2020 · Radiology

Device Facts

• Record ID: K200787
• Device Name: BSD3543W
• Applicant: Bontech Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: Apr 23, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The BSD3543W (BT-DA22W/BT-DB22W) 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

Digital X-ray flat panel detector; intercepts X-ray photons via scintillator (Gdos or CsI); converts to visible light; illuminates amorphous silicon (a-Si) TFT array; generates electrical signals; converts to digital values. Used in general radiography; integrated with X-ray generator and operating PC. Wireless and wired operation. Healthcare providers use viewing software to display, manage, and share images for diagnostic purposes. Benefits include efficient diagnosis and digital image management.

Clinical Evidence

Clinical image comparison study conducted by an American board-certified radiologist. Images from subject and predicate devices were reviewed and rated. Results demonstrated similar overall image quality with no radiographic abnormalities or diagnostic issues.

Technological Characteristics

Amorphous Silicon (a-Si) TFT flat panel detector; Scintillator: Gdos or CsI; 14x17 inch imaging area; 2500 x 3052 pixel matrix; 140 μm pixel pitch; 16-bit A/D conversion; Wireless/Wired connectivity; Power: 100-240V AC input, 12V DC output. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for digital imaging in general radiographic procedures for human anatomy. Intended to replace film/screen systems. 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

• BSD3543 (K162487)

Reference Devices

• ClearVision Exam Vue Flat Panel Detector (K160143)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Bontech Co. Ltd. % Mr. Dave Kim President Mtech Group 7707 Fannin Street. Suite 200 HOUSTON TX 77054

Re: K200787

Trade/Device Name: BSD3543W Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: March 24, 2020 Received: March 26, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

April 23, 2020

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200787

Device Name BSD3543W

### Indications for Use (Describe)

The BSD3543W (BT-DA22W/BT-DB22W) 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 generalpurpose diagnostic procedures. It is 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> |

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## 510(k) Summary K200787

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

Date of Submission

April 17, 2020

#### I. SUBMITTER

| Submitter's Name | BONTECH Co., Ltd. |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Submitter's Address | Youngtong-gu Youngtong-dong 980-3,<br>Digital Empire D #1201,<br>Suwon city, Gyeonggi-do, South Korea 443-702 |
| Submitter's Telephone | [phone] |
| Contact person | Mr. Ki Chan Ahn / RA Manager |
| Official Correspondent | Dave Kim ([e-mail]) |
| Address | 7707 Fannin St. Ste 200, Houston, TX 77054 |
| Telephone | [phone] |

#### II. DEVICE

| Trade/proprietary Name | BSD3543W |
|------------------------|------------------------------------------------------|
| | Digital Flat Panel X-ray Detector |
| Model No. | BT-DA22W / BT-DB22W |
| Common or Usual Name | Solid State X-ray Imager (Flat Panel/Digital Imager) |
| Regulation Name | Stationary X-ray System |
| Regulation Number | 21 CFR 892.1680 |
| Product Code | MQB |
| Regulatory Class | Class II |
| Over the Counter Use | |

#### III. PREDICATE DEVICE

| Primary Manufacturer | BONTECH Inc. |
|----------------------|-------------------------------------|
| Device Name | BSD3543 |
| | Digital Flat Panel X-ray Detector |
| 510(k) Number | K162487 |
| Regulation Name | Stationary X-ray System |
| Regulation Number | 21 CFR 892.1680 (Product Code: MQB) |
| Regulatory Class | Class II |

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#### IV. REFERENCE DEVICE

Trade/Device Name: 510(K) Number Regulation Name: Regulation Number Regulatory Class

ClearVision Exam Vue Flat Panel Detector K160143 stationary X-ray System 21 CFR 892.1680 (Product Code: MQB) Class II

#### V. DEVICE DESCRIPTION

BSD3543W (BT-DA22W/BT-DB22W) is a digital X-ray flat panel detector which intercepts x-ray photons and the scintillator (BT-DB22W(Gdos) / BT-DA22W(CsI)) 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. The BSD3543W is a wireless version of the predicate device, the BSD3543.

#### VI. INDICATIONS FOR USE:

The BSD3543W (BT-DA22W/BT-DB22W) 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.

#### VII. PREDICATE COMPARISON

| | Proposed | Predicate | Remark |
|------------------|--------------------------------------------|-----------------------------------------------|--------|
| Characteristic | BONTECH<br>BSD3543W<br>(BT-DA22W/BT-DB22W) | BONTECH<br>BSD3543<br>(BT-DA22-IA/BT-DB22-IA) | |
| 510(k)<br>number | K200787 | K162487 | |

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| Indications<br>for Use | The BSD3543W (BT-<br>DA22W/BT-DB22W) detector<br>is 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. | The BSD3543(BT-DA22-IA/BT-<br>DB22-IA) detector is indicated for<br>digital imaging solution designed<br>for general radiographic system<br>for human anatomy. It is intended<br>to replace film or screen based<br>radiographic system in all<br>general-purpose diagnostic<br>procedures. It is not to be used for<br>mammography. | Same | | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------|---------|
| Detector<br>Type | Amorphous Silicon (a-Si), TFT | Amorphous Silicon (a-Si), TFT | Same | | |
| Scintillator | BT-DB22W(Gdos) / BT-<br>DA22W(CsI) | BT-DB22-IA(Gdos) / BT-DA22-<br>IA(CsI) | Same | | |
| Imaging Area | 14 x 17 inches | 14 x 17 inches | Same | | |
| Pixel matrix | 2500 x 3052 | 2500 x 3052 | Same | | |
| Pixel pitch | 140 μm | 140 μm | Same | | |
| Resolution | 3.5 lp/mm | 3.5 lp/mm | Same | | |
| A/D<br>conversion | 16 bit | 16 bit | Same | | |
| Grayscale | 65,536 (16bit) | 65,536 (16bit) | 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<br>into DICOM 3.0 by console S/W | Same | | |
| Viewing SW | Raw Image Viewer | Raw Image Viewer | Same | | |
| Dimensions | 384 x 460 x 15 mm | 350 x 428 x 15 mm | Similar | | |
| MTF (Spatial<br>Resolution) | GDOS<br>% @ 1<br>lp.mm | CsI<br>% @ 1<br>lp.mm | GDOS<br>% @ 1<br>lp.mm | CsI<br>% @ 1<br>lp.mm | Similar |
| | 60 | 60 | 59 | 58 | |

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| | % @2<br>lp.mm | 29 | % @2<br>lp.mm | 28.2 | % @2<br>lp.mm | 28 | % @2<br>lp.mm | 26 | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|-----------------|------|-------------------------------------------------------------------------------------|------|-----------------|-----|---------|
| | % @3.5<br>lp.mm | 12 | % @3.5<br>lp.mm | 10.6 | % @3.5<br>lp.mm | 10 | % @3.5<br>lp.mm | 10. | |
| | GDOS | | CsI | | GDOS | | CsI | | Similar |
| | % @0<br>lp.mm | 39.2 | % @0<br>.lp.mm | 70.1 | % @0<br>lp.mm | 39.2 | % @0<br>lp.mm | 68 | |
| DQE | % @ 1<br>lp.mm | 30.2 | %@1<br>lp.mm | 60.2 | % @ 1<br>lp.mm | 29 | % @ 1<br>lp.mm | 57 | |
| | % @2<br>lp.mm | 24.9 | %@2<br>lp.mm | 54.5 | %@2<br>lp.mm | 24 | %@2<br>lp.mm | 51 | |
| | % @3.5<br>lp.mm | 14.7 | % @3.5<br>lp.mm | 29.7 | % @3.5<br>lp.mm | 14 | % @3.5<br>lp.mm | 27 | |
| Power<br>Supply | Input: 100~240 V, 50/60 Hz,<br>Output: 12 V, 3.75 A | | | | Input: 100~240 V, 50/60 Hz,<br>Output: 12 V, 6 A | | | | Same |
| Application | General Radiology system<br>Available with upright stand,<br>table, universal stand | | | | General Radiology system<br>Available with upright stand,<br>table, universal stand | | | | Same |
| picture | Image: detector | | | | Image: detector with cable | | | | Similar |
| | Proposed Device (K200787):<br>Wireless, Wired | | | | Predicate Device (K162487): Wired | | | | |
| Wireless<br>capability /<br>functionality | The Clear Vision ExamVue Flat Panel Detector, the reference device (K160143),<br>uses the same detector type, aSi TFTD. Both, the subject and reference devices are<br>wired and wireless cassette sized panel with the same function and intended use.<br>They offer the same size: 14x17 (35x43cm), and similar pixel size: 2500 x 3052<br>vs 2466 x 3040. | | | | | | | | |

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When compared to the predicate device (K162487), the subject device, BSD3543W (BT-DA22W/BT-DB22W), presented in this submission has demonstrated equal or superior performances in terms of the following characteristics:

- . Intended Use
- Pixel pitch ●
- Resolution ●
- MTF, DQE performance
- Operating principle ●
- Basic design
- . Viewing software

The imaging area and pixel matrix of BSD3543W (BT-DA22W/BT-DB22W) and the predicate device are same. The subject device and the reference device are substantially equivalent in basic design, function, operational principles and intended use.

The Clear Vision ExamVue Flat Panel Detector, the reference device (K160143), uses the same detector type, aSi TFTD, for the collection of light generated by a CsI scintillator, for the purpose of creating a digital X-ray image.

The subject device and the reference device offer the same size, 14x17 (35x43cm), similar pixel size, 2500x 3052 vs 2466 x 3040, both wired and wireless cassette sized panel, function and intended use.

#### VIII. SUMMARY OF NON-CLINICAL TESTS

The following FDA guidance documents were used in the development of BSD3543W.

- . "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices"
- . "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- . "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"
- . "Radio Frequency Wireless Technology in Medical Devices"

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.

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

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Electrical Safety:

Testing was conducted in accordance with IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2012 reprint))

### Electromagnetic Compatibility:

Testing was conducted in accordance with IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements for basic safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests

### Software:

The viewing software for the subject device is identical to the predicate device. Software verification and validation testing as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005)

Performance testing was conducted to show that the subject device performs as intended and equally or superior than the performance of the predicate device.

The non-clinical performance testing constrains that the main physical values for performance of X-ray detectors such as DOE and MTF. The performance test results show that the subject device, BSD3543W (BT-DA22W/BT-DB22W), offers almost identical but superior imaging performance compared to BSD3543 at all spatial frequencies. The ability of BSD3543W (BT-DA22W/BT-DB22W) to utilize the input image signal are similar to BSD3543 at same patient exposure levels as shown in the detective quantum efficiency graph.

The detector is tested for the integration to a generator and viewing software as below. -Generator:

- > kV Range: 40~125kV, 1kV step (Optional 40~150kV)
- > mA Range: 10 to 500mA
- > Timer Range: 0.001 to 10 sec, 38 steps

-Viewing Software:

S/W name: Raw Image Viewer, Version: 1.1

- > > Data format: raw
The subject device's wireless transmission parameters were evaluated using E.U.T for radio frequency wireless coexistence test. These parameters are used to assess the quality of service (OoS) provided by the subject device wireless function.

To characterize the wireless medical telemetry system for this QoS study, the measured parameters consisted of 1) Image acquired, 2) Receiving signal level, 3) delay time, 4)Through, and 5) signal strength and the outcomes passed the pre-defined acceptance criteria of quality of service (OoS) by the subject device.

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#### IX. SUMMARY OF CLINICAL TESTS

Images taken from the predicate and subject devices were reviewed and rated in comparison by an American board-certified radiologist. Based on image comparison test and data analysis, images taken from BSD3543W, the subject device, have similar quality overall compared with BSD3543, the predicate device. There are no other radiographic abnormalities and any issue with diagnostic images.

#### X. CONCLUSIONS

Based on the information above, BSD3543W (BT-DA22W/BT-DB22W) digital flat panel detector is substantially equivalent to the predicate device.