(37 days)
Not Found
No
The document mentions "advanced digital image processing" but does not provide any details or keywords (like AI, ML, deep learning, neural networks) that would indicate the use of AI/ML technology. The performance studies focus on standard radiographic metrics (DQE, MTF) and safety standards, not AI/ML performance metrics.
No.
The device is a digital an X-ray detector used for diagnostic imaging, not for treating diseases or conditions.
Yes
The device is marketed for "radiography diagnostics" and states that "it can digitalize x-ray images and transfer them for radiography diagnostics."
No
The device description explicitly states it is a digital X-ray flat panel detector which is a hardware component that intercepts x-ray photons and converts them into electrical signals. While it includes image processing software, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "digital imaging solution designed for general radiographic system for human anatomy." This involves imaging the human body directly, not testing samples taken from the body (which is what "in vitro" means - "in glass").
- Device Description: The description details how it captures X-ray photons and converts them into digital images for "radiography diagnostics." This is a form of medical imaging, not laboratory testing of biological samples.
- Input Imaging Modality: The input is X-ray, which is used for imaging the body, not for analyzing biological samples.
IVD devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device is used to create images of the human body itself.
N/A
Intended Use / Indications for Use
The BSD3543(BT-DA22-IA) 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.
Product codes
MQB
Device Description
BSD3543(BT-DA22-IA/BT-DB22-IA) is a digital X-ray flat panel detector which intercepts x-ray photons and the scintillator (BT-DB22-IA(Gdos) / BT-DA22-IA(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.
Mentions image processing
Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and sharing of image information on network.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The bench testing performed to compare the subject devices to the predicate followed FDA's guidance document: "Guidance for the Submission of 510(k)s for Solid State Xray Imaging 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. For example, electrical, mechanical, environmental safety and performance testing according to standard EN60601-1:2006+A1:2013 or IEC60601-1:2005 3.0 was performed and EMC testing was conducted in accordance with standard IEC 60601-1-2: 2007, EN 60601-1-2:2007. 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.
Electrical Safety: Testing was conducted in accordance with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
Electromagnetic Compatibility: Testing was conducted in accordance with IEC 60601-1-2:2007 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 better than the performance of the predicate device. The non-clinical performance testing constrains that the main physical values for comparison of X-ray devices like DQE and MTF are basically equivalent to the predicate device BSD4343 (K160204). The results show that BSD3543(BT-DA22-IA/BT-DB22-IA) offer similar or better resolution performance than BSD4343 at 0 ~ 3.5lp/mm spatial frequencies. Moreover, the ability of BSD3543(BT-DA22-IA/BT-DB22-IA) to utilize the input image signal are more efficient than BSD4343 at same patient exposure as shown in the detective quantum efficiency graph. These tests were conducted under conditions of single and double pumping mode and for the varying power sources (e.g., AC/DC power vs. battery power). The Detector is tested for the integration to a generator and viewing software.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Resolution: 3.5 lp/mm.
MTF (Spatial Resolution) for GDOS: @1 lp.mm 58.7%, @2 lp.mm 27.2%, @3.5 lp.mm 11.2%.
MTF (Spatial Resolution) for CsI: @1 lp.mm 60%, @2 lp.mm 28.1%, @3.5 lp.mm 12.4%.
DQE for GDOS: @0 lp.mm 37.9%, @ 1 lp.mm 29.7%, @2 lp.mm 22.4%, @3.5 lp.mm 10.8%.
DQE for CsI: @0 .lp.mm 70%, @ 1 lp.mm 59.4%, @2 lp.mm 51.4%, @3.5 lp.mm 28%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile, composed of three overlapping shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2016
Bontech Inc. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K162487
Trade/Device Name: BSD3543 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: September 2, 2016 Received: September 7, 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.
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) K162487
Device Name BSD3543 Digital Flat Panel X-ray Detector
Indications for Use (Describe)
The BSD3543(BT-DA22-IA) 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date of Submission
September 2, 2016
SUBMITTER I.
| Submitter's Name | BONTECH Inc. |
|---|---|
| Submitter's Address | Youngtong-gu Youngtong-dong 980-3, |
| Digital Empire D #1201, | |
| Suwon city, Gyeonggi-do, South Korea 443-702 | |
| Submitter's Telephone | +82 (31) 303-5254 |
| Contact person | Mr. Kwang S. Choi / RA Manager |
| Official Correspondent | Dave Kim (davekim@mtech-inc.net) |
| Address | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone | +713-467-2607 |
| Fax: | +713-583-8988 |
II. DEVICE
| Trade/proprietary Name | BSD3543
Digital Flat Panel X-ray Detector |
|------------------------|------------------------------------------------------|
| Model No. | BT-DA22-IA / BT-DB22-IA |
| 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 | K160204 |
| Regulation Name | Stationary X-ray System |
| Regulation Number | 21 CFR 892.1680 (Product Code: MQB) |
| Regulatory Class | Class II |
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IV. DEVICE DESCRIPTION
BSD3543(BT-DA22-IA/BT-DB22-IA) is a digital X-ray flat panel detector which intercepts x-ray photons and the scintillator (BT-DB22-IA(Gdos) / BT-DA22-IA(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.
INDICATIONS FOR USE: V.
The BSD3543(BT-DA22-IA/BT-DB22-IA) 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.
| Characteristic
510(k) number | Proposed
BONTECH
BSD3543
(BT-DA22-IA/BT-DB22-IA)
-K162487 | Predicate
BONTECH
BSD4343
K160204 | Remark |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Indications
for Use | The BSD3543(BT-DA22-IA/BT-DB22-IA) 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. | 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. | Same |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Same |
VI. PREDICATE COMPARISON
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| Scintillator | BT-DB22-IA(Gdos) / BT-DA22-IA(CsI) | Gadolinium Oxysulfide (Gdos) | Similar | |
|---|---|---|---|---|
| Imaging Area | 14 x 17 inches | 17 x 17 inches | Similar | |
| Pixel matrix | 2500 x 3052 | 3072 x 3072 | Similar | |
| Pixel pitch | 140 μm | 140 μm | Same | |
| Resolution | 3.5 lp/mm | 3.5 lp/mm | Same | |
| A/D conversion | 16 bit | 16 bit | Same | |
| Grayscale | 65,536 (16bit) | 16384 (14bit) | Similar | |
| Data output | RAW | |||
| *The RAW files are convertible into DICOM 3.0 by console S/W | RAW | |||
| *The RAW files are convertible 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 | 460 x 460 x 15 mm | Similar | |
| MTF (Spatial Resolution) | GDOS | CsI | GDOS | |
| % @1 lp.mm | ||||
| 58.7 | % @1 lp.mm | |||
| 60 | % @1 lp.mm | |||
| 52.3 | ||||
| % @2 lp.mm | ||||
| 27.2 | % @2 lp.mm | |||
| 28.1 | % @2 lp.mm | |||
| 23 | ||||
| % @3.5 lp.mm | ||||
| 11.2 | % @3.5 lp.mm | |||
| 12.4 | % @3.5 lp.mm | |||
| 10 | ||||
| DQE | GDOS | CsI | GDOS | Similar |
| % @0 lp.mm | ||||
| 37.9 | % @0 .lp.mm | |||
| 70 | % @0 lp.mm | |||
| 39.1 | ||||
| % @ 1 lp.mm | ||||
| 29.7 | % @ 1 lp.mm | |||
| 59.4 | % @1 lp.mm | |||
| 24.7 |
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| % @2 lp.mm | 22.4 | % @2 lp.mm | 51.4 | % @2 lp.mm | 16.3 | ||
|---|---|---|---|---|---|---|---|
| % @3.5 lp.mm | 10.8 | % @3.5 lp.mm | 28 | % @3.5 lp.mm | 10 | ||
| Power Supply | Input: 100~240 V, 50/60 Hz, Output: | ||||||
| 12 V, 6 A | Input: 100~240 V, 50/60 Hz, | ||||||
| Output: 12 V, 6 A | Same | ||||||
| Application | General Radiology system | ||||||
| Available with upright stand, table, | |||||||
| universal stand | General Radiology system | ||||||
| Available with upright stand, | |||||||
| table, universal stand | Same | ||||||
| picture | Image: detector with cable | Image: detector | Similar |
When compared to the predicate device (K160204), the BSD3543(BT-DA22-IA/BT-DB22-IA) presented in this submission has the same characteristics in the following:
- Intended Use
- Pixel pitch
- · Resolution
- · Operating principle
- · Basic design
- · Viewing software
The imaging area and pixel matrix of BSD3543(BT-DA22-IA/BT-DB22-IA) and the predicate device are different but they would not adversely affect the use of the product. Both devices are substantially equivalent in basic design, function, operational principles and intended use.
SUMMARY OF NON-CLINICAL TESTS VII.
The bench testing performed to compare the subject devices to the predicate followed FDA's guidance document: "Guidance for the Submission of 510(k)s for Solid State Xray Imaging 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. For example, electrical, mechanical, environmental safety and
7
performance testing according to standard EN60601-1:2006+A1:2013 or IEC60601-1:2005 3.0 was performed and EMC testing was conducted in accordance with standard IEC 60601-1-2: 2007, EN 60601-1-2:2007
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 :
Electrical Safety:
Testing was conducted in accordance with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
Electromagnetic Compatibility:
Testing was conducted in accordance with IEC 60601-1-2:2007 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 better than the performance of the predicate device.
The non-clinical performance testing constrains that the main physical values for comparison of X-ray devices like DQE and MTF are basically equivalent to the predicate device BSD4343 (K160204). The results show that BSD3543(BT-DA22-IA/BT-DB22-IA) offer similar or better resolution performance than BSD4343 at 0 ~ 3.5lp/mm spatial frequencies. Moreover, the ability of BSD3543(BT-DA22-IA/BT-DB22-IA) to utilize the input image signal are more efficient than BSD4343 at same patient exposure as shown in the detective quantum efficiency graph.
These tests were conducted under conditions of single and double pumping mode and for the varying power sources (e.g., AC/DC power vs. battery power).
The Detector is tested for the integration to a generator and viewing software as below. -Generator:
-
kV Range: 40
125kV, 1kV step (Optional 40150kV) -
mA Range: 10 to 500mA
-
Timer Range: 0.001 to 10 sec, 38 steps
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-Viewing Software: S/W name: Raw Image Viewer, Version: 1.1 ▷ Data format: raw
VIII. SUMMARY 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.
IX. CONCLUSIONS
Based on the information above, BSD3543(BT-DA22-IA/BT-DB22-IA) digital flat panel detector is substantially equivalent to the predicate device.