(133 days)
Not Found
No
The description mentions "advanced digital image processing" but does not explicitly state or imply the use of AI or ML algorithms. The performance studies focus on traditional imaging metrics (DQE, MTF, NPS) and electrical/software validation, not AI/ML performance metrics.
No.
This device is an X-ray detector used for diagnostic imaging, not for treating diseases or conditions.
No
The device is a digital X-ray flat panel detector that captures X-ray images, which are then used for diagnostic procedures. It produces images for diagnosis, but it does not perform the diagnosis itself.
No
The device description clearly 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 software for image processing and display, the core device is a physical detector.
Based on the provided text, the BSD4343 detector is not an IVD (In Vitro Diagnostic) device.
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 describes an in vivo imaging device, meaning it's used to image the inside of a living organism (in this case, humans).
- Device Description: The description details how it captures X-ray photons and converts them into digital images for "radiography diagnostics." This is consistent with medical imaging, not in vitro testing.
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. The BSD4343 does not interact with such specimens.
Therefore, the BSD4343 is a medical imaging device used for diagnostic purposes on the human body, not an IVD device used for testing samples from the human body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MQB
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.
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
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical study: The non-clinical performance testing constrains that the main physical values for comparison of X-ray 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with flowing lines.
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.
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) 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ 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, | |
| Suwon city, Gyeonggi-do, South Korea 443-702 | ||
| Tel:+ 82-31-303-5254 / Fax: +82-31-303-5255 | ||
| Contact person: | Mr. Kwang S Choi / RA Manager (cks@inhwagroup.com) | |
| Official Correspondent: | Dave Kim, MBA | |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 | |
| Telephone: | +713-467-2607 | |
| Fax: | +713-583-8988 | |
| Email: | davekim@mtech-inc.net |
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
BONTECH
BSD4343 | Proposed
Samsung Mobile Display
LLX240AB01 | Remark |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| 510(k) number | - | K102587 | |
| 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. | LLX240AB01 Digital Flat Panel X-Ray
Detector is indicated for digital
imaging solution designed for
providing general radiographic
diagnosis of human anatomy
targeting both adult and children. It
is intended to replace film based
radiographic diagnostic systems and
provide a case diagnosis and
treatment planning for physicians
and other health care professionals.
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 | ||
| *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 | ||
| Dimensions | 460 x 460 x 15 mm | 500 x 496.6 x 45 mm | Similarity |
| Application | General Radiology system | ||
| Available with upright stand, | |||
| table, universal stand | General Radiology system | ||
| Available with upright stand, table, | |||
| 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.