(29 days)
No
The document mentions "Advanced digital image processing" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe any training or testing of algorithms on data sets, which are characteristic of AI/ML technologies. The performance studies focus on standard imaging metrics and a concurrence study comparing diagnostic capability to a predicate device, not on AI/ML performance metrics.
No.
The device is used for diagnostic procedures, specifically capturing X-ray images for diagnosis, and does not provide therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "VIVIX-S 1717V series is used for the general-purpose diagnostic procedures." Additionally, the "Device Description" mentions that the device transfers "digitalized images for radiography diagnostic."
No
The device description clearly states that the VIVIX-S 1717V series are "digital X-ray flat panel detectors" that intercept X-ray photons and convert them into electrical signals. This involves physical hardware components (scintillator, photo-detectors) and is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "general-purpose diagnostic procedures" and "to replace radiographic film/ screen systems." This describes a device used for in vivo imaging (imaging within the living body) using X-rays.
- Device Description: The description details how the device intercepts X-ray photons and converts them into digital images for radiography diagnostic. This is consistent with an in vivo imaging device.
- Input Imaging Modality: The input modality is X-ray, which is used for imaging within the body.
- Anatomical Site: The anatomical site is "human anatomy," further indicating in vivo use.
IVD devices, on the other hand, are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening.
This device is a digital X-ray detector, which is a component of an X-ray imaging system used for in vivo diagnostic imaging.
N/A
Intended Use / Indications for Use
VIVIX-S 1717V series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S 1717V series is not intended for mammography applications.
Product codes
MOB, MQB
Device Description
VIVIX-S 1717V - Models FXRD-1717VA and FXRD-1717VB intercept X-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create an electrical signals. After the electrical signals are generated, these are converted to a digital value, and an image will be displayed on the monitor.
These devices should be integrated with an operating PC and an X-Ray generator to digitalize Xray images and transfer the digitalized images for radiography diagnostic.
Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and image information sharing on the network.
Differences between models
VIVIX-S 1717V - Models FXRD-1717VA and FXRD-1717VB are digital X-ray flat panel detectors, and each model has a 17 x 17 inch imaging area.
The scintillator used in FXRD-1717VA is Csl and Gadox was used for FXRD-1717VB.
Mentions image processing
Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and image information sharing on the 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
A comparison test was conducted between the subject devices and the predicate device (K152894) on the items such as DQE, MTF and spatial resolution.
A single-blinded concurrence study according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices was conducted, and the study confirmed that the new x-ray detectors VIVIX-S 1717V - FXRD-1717VA and FXRD-1717VB provide images of equivalent diagnostic capability to the predicate devices, the VIVIX-S 1717N, and its results demonstrate substantial equivalence.
Key Metrics
DQE (%) (1lp/mm):
FXRD-1717VA: 53.5
FXRD-1717VB: 29
MTF (%) (1lp/mm):
FXRD-1717VA: 66.5
FXRD-1717VB: 58
Resolution: 3.5 lp/mm
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.
0
May 15, 2018
Image /page/0/Picture/1 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.
Vieworks Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt IRVINE CA 92620
Re: K181003
Trade/Device Name: VIVIX-S 1717V Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: March 29, 2018 Received: April 16, 2018
Dear Ms. Chung:
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 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);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hsl 2 Nils
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
VIVIX-S 1717V
Indications for Use (Describe)
VIVIX-S 1717V series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S 1717V series is not intended for mammography applications.
| 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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3
510(k) Summary
[As required by 21 CFR 807.92] (K181003)
This 510(k) summary information is prepared in accordance with 21 CFR807.92.
1. Date Prepared [21 CFR 807.92(a) (1)]
05/11/2018
2. Submitter's Information [21 CFR 807.92(a) (1)]
Name of Sponsor: Vieworks Co., Ltd. Address: (Gwanyang-dong) 41-3, Burim-ro 170beon-gil,Dongan-gu, Anyang-si, Gyeonggi-do, 431-060 Republic of Korea Contact Name: Kim, Jordin / Regulatory Affairs Associate Registration Number: 3006013411 Name of Manufacturer: Same as Sponsor
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]
| Trade Name: | VIVIX-S 1717V |
|---|---|
| Model Name: | FXRD-1717VA |
| FXRD-1717VB | |
| Common Name: | Digital Flat Panel X-ray Detector |
| Classification Name: | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR 892.1680 |
| Regulation Name: | Stationary X-ray System |
| Product Code: | MQB |
| Device Class: | 2 |
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
| 510(k) Number: | K152894 |
|---|---|
| Product Code: | MQB |
| Applicant: | Vieworks Co., Ltd. |
| Trade Name: | VIVIX-S 1717N |
| Model Name: | FXRD-1717NA |
| FXRD-1717NB | |
| FXRD-1717NAW | |
| FXRD-1717NBW | |
| Decision Date: | 02/26/2016 |
| Type: | Traditional |
4
5. Description of the Device [21 CFR 807.92(a) (4)]
- General Description O
VIVIX-S 1717V - Models FXRD-1717VA and FXRD-1717VB intercept X-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create an electrical signals. After the electrical signals are generated, these are converted to a digital value, and an image will be displayed on the monitor.
These devices should be integrated with an operating PC and an X-Ray generator to digitalize Xray images and transfer the digitalized images for radiography diagnostic.
Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and image information sharing on the network.
- O Differences between models
VIVIX-S 1717V - Models FXRD-1717VA and FXRD-1717VB are digital X-ray flat panel detectors, and each model has a 17 x 17 inch imaging area.
The scintillator used in FXRD-1717VA is Csl and Gadox was used for FXRD-1717VB.
6. Indications for Use [21 CFR 807.92(a)(5)]
VIVIX-S 1717V series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S 1717V series is not intended for mammography applications.
7. Technological Characteristics [21 CFR 807.92(a) (6)]
Comparisons with the predicate, devices show the technological characteristics of the proposed VIVIX-S 1717V - FXRD-1717VA and FXRD-1717VB devices to be substantially equivalent to the predicate devices. The proposed devices are functionally similar to the predicate devices.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
When compared to the predicate devices (K152894), the FXRD-1717VA and FXRD-1717VB presented in this submission has the same:
- · Intended Use
- Technological characteristics
- · Operating principle
- · Design features
- Communication Method
- · Scintillator Materials
- Resolution
There is similar performance as follow.
- Performance (MTF)
- Performance (DQE)
5
There are no significant difference between the FXRD-1717NAW and FXRD-1717NBW 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.
| Parameter | Predicate Devices | Subject Device |
|---|---|---|
| 510(k) Number | K152894 | |
| Manufacturer | Vieworks Co., Ltd. | |
| Model Name | FXRD-1717NA, | |
| FXRD-1717NB, | ||
| FXRD-1717NAW, | ||
| FXRD-1717NBW | FXRD-1717VA, | |
| FXRD-1717VB | ||
| Common Name | Digital Flat Panel X-ray Detector | |
| Classification Name | Solid State X-Ray Imager (Flat Panel/Digital Imager) | |
| Classification Panel | Radiology | |
| Classification Regulation | 21 CFR 892.1680 | |
| Product Code | MQB | |
| Device Class | 2 | |
| Indications for Use | FXRD-1717NA, FXRD-1717NB, | |
| FXRD-1717NAW and FXRD- | ||
| 1717NBW are indicated for | ||
| digital imaging solution designed | ||
| as a general radiographic system | ||
| for human anatomy. It is | ||
| intended to replace film or | ||
| screen based radiographic | ||
| systems in all general purposes of | ||
| diagnostic procedures. It is not to | ||
| be used for mammography. | VIVIX-S 1717V series is used for | |
| the general-purpose diagnostic | ||
| procedures, and as well as | ||
| intended to replace radiographic | ||
| film/ screen systems. The VIVIX-S | ||
| 1717V series is not intended for | ||
| mammography applications. | ||
| Design | ||
| Panel Shape | Square Panel | Square Panel |
| Field of View | 17 x 17inch | 17 x 17inch |
| Dimensions | ||
| (H x W x D) | 460.0 x 460.0 x 15.5mm | 460.0 x 460.0 x 15.5mm |
| Pixel Pitch | 0.14mm | 0.14mm |
| Materials Scintillator | Csl: TI, | |
| Gd2O2S:Tb | Csl: TI, | |
| Gd2O2S:Tb | ||
| Performance | ||
| DQE (%) (1lp/mm) | FXRD-1717NAW: | |
| 54 | ||
| FXRD-1717NBW: | ||
| 31 | FXRD-1717VA: | |
| 53.5 | ||
| FXRD-1717VB: | ||
| 29 | ||
| MTF (%) (1lp/mm) | FXRD-1717NAW: | |
| 72 | ||
| FXRD-1717NBW: | ||
| 58 | FXRD-1717VA: | |
| 66.5 | ||
| FXRD-1717VB: | ||
| 58 | ||
| Resolution | 3.5 lp/mm | 3.5 lp/mm |
| Communication Method | Wired | |
| (FXRD-1717NA, | ||
| FXRD-1717NB), | ||
| Wireless | ||
| (FXRD-1717NAW, | ||
| FXRD-1717NBW) | Wired |
6
9. Summary of Non-Clinical Data
A comparison test was conducted between the subject devices and the predicate device (K152894) on the items such as DQE, MTF and spatial resolution.
These detectors comply with the following international and FDA-recognized consensus standards:
| [IEC 60601-1 2005, Edition 3.1]
[IEC 60601-1-2, Edition 3] | Medical Electrical Equipment -- Part 1: General
Requirements For Basic Safety And Essential Performance
Medical Electrical Equipment - Part 1-2: General
Requirements For Basic Safety And Essential Performance
- Collateral Standard: Electromagnetic Compatibility -
Requirements And Tests |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| [IEC 62220-1, Edition 1.0] | Medical electrical equipment - Characteristics of digital X-
ray imaging devices - Part 1: Determination of the
detective quantum efficiency |
| [NEMA PS 3.1 - 3.20 2011] | Digital Imaging and Communications in Medicine (DICOM)
Set |
| [IEC 62133, Edition 2.0] | IEC 62133 Edition 2.0 2012-12 Secondary Cells And
Batteries Containing Alkaline Or Other Non-Acid
Electrolytes• Safety Requirements For Portable Sealed
Secondary Cells, And For Batteries Made From Them, For
Use In Portable Applications [Including: Corrigendum 1
(2013) |
10. Summary of Clinical Data
A single-blinded concurrence study according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices was conducted, and the study confirmed that the new x-ray detectors VIVIX-S 1717V - FXRD-1717VA and FXRD-1717VB provide images of equivalent diagnostic capability to the predicate devices, the VIVIX-S 1717N, and its results demonstrate substantial equivalence.
Although clinical images were provided, they are not necessary to establish substantial equivalence based on the modifications to the device (note X-ray digital detector that is based on the predicate technology) but they provide further evidence in addition to the laboratory performance data to show that the subject device works as intended.
7
11. Conclusion [21 CFR 807.92(b) (3)]
The VIVIX-S 1717V - FXRD-1717VA and FXRD-1717VB Digital X-ray detectors are substantially equivalent to the currently marketed and predicate devices (K152894) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, Substantial equivalence was demonstrated through the non-clinical performance, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC60601-1, IEC 60601-1-2, IEC62220-1 and NEMA PS 3.1 - 3.20, IEC 62133 and the clinical test, which complied with the requirements specified in the CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.
The results of these tests demonstrate that VIVIX-S 1717V - FXRD-1717VA and FXRD-1717VB Digital X-ray detectors meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, non-clinical performance data, safety testing, and clinical image concurrence data demonstrates that the device is as safe, as effective, and performs as well the predicate devices.