VIVIX-S VW
Device Facts
| Record ID | K200418 |
|---|---|
| Device Name | VIVIX-S VW |
| Applicant | Vieworks Co., Ltd. |
| Product Code | MQB · Radiology |
| Decision Date | Mar 18, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
VIVIX-S VW series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S VW series is not intended for mammography applications.
Device Story
VIVIX-S VW series consists of digital flat panel X-ray detectors (a-SI array) with imaging areas of 25x30cm, 36x43cm, and 43x43cm. Device intercepts X-ray photons; scintillator emits visible light; a-SI detectors convert light to electrical signals; signals converted to digital values. Integrated with operating PC and X-ray generator; used in clinical settings by radiology staff. Software (VXvue) acquires and processes data for display on monitors. Enables digitalization of X-ray images for diagnostic radiography. Benefits include improved workflow and image management compared to film-based systems.
Clinical Evidence
Single-blinded clinical concurrence study conducted per FDA guidance for solid-state X-ray imaging devices. Study compared subject device images to predicate devices (VIVIX-S 1717V, 1417N, 1012N), confirming equivalent diagnostic capability.
Technological Characteristics
Digital flat panel X-ray detector using amorphous silicon (a-SI) photodiode array and scintillator. Models: FXRD-2530VW/PLUS, FXRD-3643VW/PLUS, FXRD-4343VW/PLUS. Complies with IEC 60601-1, IEC 60601-1-2, 21 CFR 1020.30, 21 CFR 1020.31, ANSI/AAMI ES60601-1, and CAN/CSA-C22.2 No. 60601-1.
Indications for Use
Indicated for general-purpose diagnostic radiographic procedures in 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
Submission Summary (Full Text)
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March 18, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Vieworks Co., Ltd. % Mrs. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 IRVINE CA 92620
# Re: K200418
Trade/Device Name: VIVIX-S VW Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: January 27, 2020 Received: February 20, 2020
Dear Mrs. 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. 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
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K200418
Device Name VIVIX-S VW
Indications for Use (Describe)
VIVIX-S VW series is used for the general-purpose diagnostic procedures, and as intended to replace radiographic film/ screen systems. The VIVIX-S VW series is not intended for mammography applications.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
(K200418)
This 510(k) summary information is prepared in accordance with 21 CFR807.92
# 1. Date Prepared [21 CFR 807.92(a) (1)]
3/9/2020
# 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 VW |
|----------------------------|---------------------------------------------------------------------------------------------------|
| Model Name: | FXRD-4343VAW, FXRD-4343VAW PLUS, FXRD-3643VAW, FXRD-3643VAW PLUS, FXRD-2530VAW, FXRD-2530VAW PLUS |
| Common Name: | Digital Flat Panel X-ray Detector |
| Classification Name: | Regulation Name: Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR 892.1680 |
| Product Code: | MQB |
| Device Class: | 2 |
#### 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
| 510(k) Number: | K181003 |
|----------------------------|------------------------------------------|
| Applicant: | Vieworks Co., Ltd. |
| Trade Name: | VIVIX-S 1717V |
| Model Name: | FXRD-1717VA<br>FXRD-1717VB |
| Common Name: | Digital Flat Panel X-ray Detector |
| Classification Name: | Regulation Name: Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR 892.1680 |
| Product Code: | MQB |
| Device Class: | 2 |
| Decision Date: | 03/15/2018 |
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Type: Traditional 510(k) Number: K163703 Vieworks Co., Ltd. Applicant: Trade Name: VIVIX-S 1417N Model Name: FXRD-1417NAW FXRD-1417NBW Digital Flat Panel X-ray Detector Common Name: Classification Name: Regulation Name: Stationary X-Ray System Classification Panel: Radiology Classification Regulation: 21 CFR 892.1680 Product Code: MQB Device Class: 2 01/05/2017 Decision Date: Type: Traditional 510(k) Number: K152885 Applicant: Vieworks Co., Ltd. Trade Name: VIVIX-S 1012N Model Name: FXRD-1012NA FXRD-1012NB FXRD-1012NAW FXRD-1012NBW Digital Flat Panel X-ray Detector Common Name: Regulation Name: Stationary X-Ray System Classification Name: Classification Panel: Radiology Classification Regulation: 21 CFR 892.1680 Product Code: MQB Device Class: 2 Decision Date: 01/28/2016 Type: Traditional
# 5. Description of the Device [21 CFR 807.92(a) (4)]
- General Description o
VIVIX-S VW, a series for of flat panel detectors models named; FXRD-2530VW, FXRD-2530VW PLUS, FXRD-3643VW, FXRD-3643VW PLUS, FXRD-4343VW, FXRD-4343VW PLUS, with imaging areas of 25cm x 30cm, 36cm x 43cm, 43cm, respectively. The device intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value, and the Software which acquires and processes the data values from the detector. The resulting digital images will be displayed on monitors. These devices should be integrated with an operating PC and an X-Ray generator. It can be utilized to digitalize x-ray images and transfer for radiography diagnostic.
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# 6. Indications for Use [21 CFR 807.92(a)(5)]
VIVIX-S VW series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S VW 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 1751S device to be substantially equivalent to the predicate devices. The proposed devices are functionally identical to the predicate devices.
# 8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
When compared to the predicate devices (K181003, K163703, K152885), the VIVIX-S VW 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)
There are no significant difference between the VIVIX-S 1751S 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 Device | Subject Device | Equivalence |
|---------------|-----------------------------------|-----------------------------------|-----------------|
| 510(k) Number | K181003 | - | - |
| Manufacturer | Vieworks Co., Ltd. | - | - |
| Device Name | VIVIX-S 1717V | VIVIX-S VW | - |
| Detector | FXRD-1717VA,<br>FXRD-1717VB | FXRD-4343VAW<br>FXRD-4343VAW PLUS | - |
| SCU | - | FXRS-04A<br>FXRP-02A | Power<br>Supply |
| Software | VXvue | VXvue | Software |
| Common Name | Digital Flat Panel X-ray Detector | - | Equivalent |
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| Classification Name | Solid State X-Ray Imager (Flat Panel/Digital Imager) | | Equivalent |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification Panel | | Radiology | Equivalent |
| Classification<br>Regulation | 21 CFR 892.1680 | | Equivalent |
| Product Code | | MQB | Equivalent |
| Device Class | | 2 | Equivalent |
| Indications for Use | VIVIX-S 1717V series is<br>indicated for digital<br>imaging solution designed<br>as a general radiographic<br>system for human<br>anatomy. It is intended to<br>replace film or screen<br>based radiographic<br>systems in all general<br>purposes of diagnostic<br>procedures. It is not to be<br>used for mammography. | The VIVIX-S VW detectors<br>are used for the general-<br>purpose diagnostic<br>procedures, and as well as<br>intended to replace<br>radiographic film / screen<br>systems.<br>The VIVIX-S VW detectors<br>are not intended for<br>mammography<br>applications. | Equivalent |
| MTF<br>(Measured Values,<br>at 1lp/mm) | FXRD-1717VA:<br>72 | FXRD-4343VAW:<br>76 | |
| (Measured Values,<br>at 1lp/mm) | FXRD-1717VB:<br>60 | FXRD-4343VAW PLUS:<br>60 | |
| DQE<br>(Measured Values,<br>at 1lp/mm) | FXRD-1717VA:<br>45 | FXRD-4343VAW:<br>45 | |
| | FXRD-1717VB:<br>28.5 | FXRD-4343VAW PLUS:<br>53 | |
| Spatial Resolution | 3.5 lp/mm | FXRD-4343VAW:<br>3.5 lp/mm | |
| | | FXRD-4343VAW PLUS:<br>3.5 lp/mm | |
| Parameter | Predicate Device | Subject Device | Equivalence |
|----------------------|------------------------------------------------------|-----------------------------------|-----------------|
| 510(k) Number | K163703 | - | - |
| Manufacturer | Vieworks Co., Ltd. | - | - |
| Device Name | FXRD-1417N | VIVIX-S 3643VW | - |
| Detector | FXRD-1417NAW,<br>FXRD-1417NBW | FXRD-3643VAW<br>FXRD-3643VAW PLUS | - |
| SCU | FXRS-03A<br>FXRS-04A<br>FXRP-02A | FXRS-04A<br>FXRP-02A | Power<br>Supply |
| Software | VXvue | VXvue | Software |
| Common Name | Digital Flat Panel X-ray Detector | | Equivalent |
| Classification Name | Solid State X-Ray Imager (Flat Panel/Digital Imager) | | Equivalent |
| Classification Panel | Radiology | | Equivalent |
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| Classification<br>Regulation | 21 CFR 892.1680 | | Equivalent |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | MQB | | Equivalent |
| Device Class | 2 | | Equivalent |
| Indications for Use | FXRD-1417NAW and<br>FXRD-1417NBW are<br>indicated for digital<br>imaging solution designed<br>as a general radiographic<br>system for human<br>anatomy. It is intended to<br>replace film or screen<br>based radiographic<br>systems in all general<br>purposes of diagnostic<br>procedures. It is not to be<br>used for mammography. | The VIVIX-S VW detectors<br>are used for the general-<br>purpose diagnostic<br>procedures, and as well as<br>intended to replace<br>radiographic film / screen<br>systems.<br>The VIVIX-S VW detectors<br>are not intended for<br>mammography<br>applications. | Equivalent |
| MTF<br>(Measured Values,<br>at 1lp/mm) | FXRD-1417NAW:<br>75 | FXRD-3643VAW:<br>74 | |
| | FXRD-1417NBW:<br>61.5 | FXRD-3643VAW PLUS:<br>59 | |
| DQE<br>(Measured Values,<br>at 1lp/mm) | FXRD-1417NAW:<br>46.5 | FXRD-3643VAW:<br>41.5 | |
| | FXRD-1417NBW:<br>27.5 | FXRD-3643VAW PLUS:<br>51 | |
| Spatial Resolution | 3.5lp/mm | FXRD-3643VAW:<br>3.5lp/mm | |
| | | FXRD-3643VAW PLUS:<br>3.5lp/mm | |
| Parameter | Predicate Device | Subject Device | Equivalence |
|---------------------|---------------------------------------------------------------|-----------------------------------|-----------------|
| 510(k) Number | K152855 | - | - |
| Manufacturer | Vieworks Co., Ltd. | - | - |
| Device Name | VIVIX-S 1012N | VIVIX-S 2530VW | - |
| Detector | FXRD-1012NA,<br>FXRD-1012NB,<br>FXRD-1012NAW,<br>FXRD-1012NBW | FXRD-2530VAW<br>FXRD-2530VAW PLUS | - |
| SCU | FXRS-02A<br>FXRS-03A<br>FXRS-04A<br>FXRP-02A | FXRS-04A<br>FXRP-02A | Power<br>Supply |
| Software | VXvue | VXvue | Software |
| Common Name | Digital Flat Panel X-ray Detector | - | Equivalent |
| Classification Name | Solid State X-Ray Imager (Flat Panel/Digital Imager) | - | Equivalent |
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| Classification Panel | Radiology | | Equivalent |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification | | | |
| Regulation | 21 CFR 892.1680 | | Equivalent |
| Product Code | MQB | | Equivalent |
| Device Class | 2 | | Equivalent |
| Indications for Use | FXRD-1012NA, FXRD-<br>1012NB, FXRD-1012NAW<br>and FXRD-1012NBW are<br>indicated for digital imaging<br>solution designed as a<br>general radiographic<br>system for human anatomy.<br>It is intended to replace film<br>or screen based<br>radiographic systems in all<br>general purposes of<br>diagnostic procedures. It is<br>not to be used for<br>mammography. | The VIVIX-S VW detectors<br>are used for the general-<br>purpose diagnostic<br>procedures, and as well as<br>intended to replace<br>radiographic film / screen<br>systems. The VIVIX-S VW<br>detectors are not intended<br>for mammography<br>applications. | Equivalent |
| MTF<br>(Measured Values,<br>at 1lp/mm) | FXRD-1012NA(W):<br>75 | FXRD-2530VAW:<br>76 | |
| | FXRD-1012NB(W):<br>58.5 | FXRD-2530VAW PLUS:<br>60 | |
| DQE<br>(Measured Values,<br>at 1lp/mm) | FXRD-1012NA(W):<br>49 | FXRD-2530VAW:<br>46 | |
| | FXRD-1012NB(W):<br>27 | FXRD-2530VAW PLUS:<br>52 | |
| Spatial Resolution | 4.0 lp/mm | FXRD-2530VAW:<br>4.0 lp/mm | |
| | | FXRD-2530VAW PLUS:<br>4.0 lp/mm | |
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### 9. Summary of Non-Clinical Data
A comparison test was conducted between the subject devices (VIVIX-S VW) and the predicate device (K181003, K163703, K152885) on the items such as DQE, MTF and spatial resolution.
These detectors comply with the following international and FDA-recognized consensus standards:
- · 21CFR1020.30, Diagnostic X-ray Systems and their major components
- · 21CFR1020.31, Radiographic equipment
- - IEC 60601-1 Medical Electrical Equipment -- Part 1: General Requirements for Basic Safety and Essential Performance.
- CAN/CSA-C22.2 No. 60601-1 (2008) (Medical Equipment –Part 1
: General Requirements for Basic Safety and Essential Performance) (includes National Differences for Canada)
- ANSI/AAMI ES60601-1 (2005+ C1:09+A2:10) (Medical Electrical Equipment Part 1
- · IEC 60601-1-2 Medical Electrical Equipment Part 1-2
- : General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
# 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 VW provide images of equivalent diagnostic capability to the predicate devices, the VIVIX-S 1717V, VIVIX-S 1417N, VIVIX-S 1012N and its results demonstrate substantial equivalence.
# 11. Conclusion [21 CFR 807.92(b) (3)]
The VIVIX-S VW Digital X-ray detectors are substantially equivalent to the currently marketed and predicate devices (K181003) 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, 3 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 VW 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.
