VIVIX-S 1717V

K181003 · Vieworks Co., Ltd. · MQB · May 15, 2018 · Radiology

Device Facts

• Record ID: K181003
• Device Name: VIVIX-S 1717V
• Applicant: Vieworks Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: May 15, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended 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.

Device Story

VIVIX-S 1717V (models FXRD-1717VA/VB) is a digital flat panel X-ray detector; 17x17 inch imaging area. Intercepts X-ray photons; scintillator (CsI or Gadox) emits visible light; amorphous silicon (a-Si) photodetector array converts light to electrical signals; signals digitized for display on monitor. Integrated with operating PC and X-ray generator. Used in clinical settings for general radiography. Enables efficient diagnosis, information management, and network image sharing. Benefits patient through high-quality digital imaging replacing traditional film systems.

Clinical Evidence

Single-blinded clinical concurrence study conducted per CDRH guidance. Confirmed subject detectors provide images of equivalent diagnostic capability to predicate device. Clinical images provided as supplemental evidence to laboratory performance data (MTF, DQE, spatial resolution).

Technological Characteristics

Digital flat panel X-ray detector; 17x17 inch FOV; 0.14mm pixel pitch. Scintillator: CsI (FXRD-1717VA) or Gadox (FXRD-1717VB). Sensing: a-Si photodetector array. Connectivity: Wired. Standards: IEC 60601-1 (Ed 3.1), IEC 60601-1-2 (Ed 3), IEC 62220-1 (Ed 1.0), NEMA PS 3.1-3.20 (DICOM), IEC 62133 (Ed 2.0).

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

• VIVIX-S 1717N (K152894)

Submission Summary (Full Text)

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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);

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known)

K181003

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) | |
|----------------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <span style="font-size: larger;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |
| <div> <span> <span style="font-size: larger;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |

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# 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<br>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<br>FXRD-1717NB<br>FXRD-1717NAW<br>FXRD-1717NBW |
| Decision Date: | 02/26/2016 |
| Type: | Traditional |

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#### 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)

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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,<br>FXRD-1717NB,<br>FXRD-1717NAW,<br>FXRD-1717NBW | FXRD-1717VA,<br>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,<br>FXRD-1717NAW and FXRD-<br>1717NBW are indicated for<br>digital imaging solution designed<br>as a general radiographic system<br>for human anatomy. It is<br>intended to replace film or<br>screen based radiographic<br>systems in all general purposes of<br>diagnostic procedures. It is not to<br>be used for mammography. | VIVIX-S 1717V series is used for<br>the general-purpose diagnostic<br>procedures, and as well as<br>intended to replace radiographic<br>film/ screen systems. The VIVIX-S<br>1717V series is not intended for<br>mammography applications. |
| Design | | |
| Panel Shape | Square Panel | Square Panel |
| Field of View | 17 x 17inch | 17 x 17inch |
| Dimensions<br>(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,<br>Gd2O2S:Tb | Csl: TI,<br>Gd2O2S:Tb |
| Performance | | |
| DQE (%) (1lp/mm) | FXRD-1717NAW:<br>54<br>FXRD-1717NBW:<br>31 | FXRD-1717VA:<br>53.5<br>FXRD-1717VB:<br>29 |
| MTF (%) (1lp/mm) | FXRD-1717NAW:<br>72<br>FXRD-1717NBW:<br>58 | FXRD-1717VA:<br>66.5<br>FXRD-1717VB:<br>58 |
| Resolution | 3.5 lp/mm | 3.5 lp/mm |
| Communication Method | Wired<br>(FXRD-1717NA,<br>FXRD-1717NB),<br>Wireless<br>(FXRD-1717NAW,<br>FXRD-1717NBW) | Wired |

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#### 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]<br>[IEC 60601-1-2, Edition 3] | Medical Electrical Equipment -- Part 1: General<br>Requirements For Basic Safety And Essential Performance<br>Medical Electrical Equipment - Part 1-2: General<br>Requirements For Basic Safety And Essential Performance<br>- Collateral Standard: Electromagnetic Compatibility -<br>Requirements And Tests |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| [IEC 62220-1, Edition 1.0] | Medical electrical equipment - Characteristics of digital X-<br>ray imaging devices - Part 1: Determination of the<br>detective quantum efficiency |
| [NEMA PS 3.1 - 3.20 2011] | Digital Imaging and Communications in Medicine (DICOM)<br>Set |
| [IEC 62133, Edition 2.0] | IEC 62133 Edition 2.0 2012-12 Secondary Cells And<br>Batteries Containing Alkaline Or Other Non-Acid<br>Electrolytes• Safety Requirements For Portable Sealed<br>Secondary Cells, And For Batteries Made From Them, For<br>Use In Portable Applications [Including: Corrigendum 1<br>(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.

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#### 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.