K Number
K190611
Device Name
VIVIX-S 1751S
Manufacturer
Date Cleared
2019-04-08

(28 days)

Product Code
Regulation Number
892.1680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VIVIX-S 1751S series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S 1751S series is not intended for mammography applications.
Device Description
VIVIX-S 1751S, whose model name is VIVIX-S 1751S with 17X51 inches of imaging area. The device intercepts x-ray photons, and its Gadox (Gadolinium Oxysulfide) 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 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. The detector can communicate with the generator by cable. It is utilized for capturing and transfer of digital x-ray images for radiography diagnosis. The X-ray generator and the imaging software are not part of the VIVIX-S 1751S.
More Information

K181003, VIVIX-S 1717V

No
The description focuses on the hardware and basic image processing (acquisition and processing of data values) without mentioning any advanced algorithms, learning, or AI/ML specific terms. The performance studies are based on standard imaging metrics and a concurrence study, not AI/ML performance metrics.

No
The device is used for diagnostic procedures by capturing and transferring digital X-ray images, not for therapy.

Yes

The "Intended Use / Indications for Use" section explicitly states that the device "is used for the general-purpose diagnostic procedures."

No

The device description clearly states it is a hardware device (detector) that intercepts x-ray photons and converts them to electrical signals, which are then processed by software. The software is a component of the system, but the core device is hardware.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
  • Device Function: The VIVIX-S 1751S series is an X-ray detector used to capture digital radiographic images of the human body. It works by intercepting X-ray photons and converting them into digital signals for display.
  • Intended Use: The intended use is for "general-purpose diagnostic procedures" and to "replace radiographic film/ screen systems." This clearly indicates its use in imaging the body directly, not analyzing samples taken from the body.
  • Device Description: The description details the process of capturing X-ray images and converting them to digital format. There is no mention of analyzing biological specimens.
  • Input Modality: The input modality is X-ray, which is an imaging technique applied to the body, not a method for analyzing biological samples.

Therefore, the VIVIX-S 1751S series falls under the category of a radiographic imaging device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

VIVIX-S 1751S series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S 1751S series is not intended for mammography applications.

Product codes

MQB

Device Description

VIVIX-S 1751S, whose model name is VIVIX-S 1751S with 17X51 inches of imaging area. The device intercepts x-ray photons, and its Gadox (Gadolinium Oxysulfide) 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 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. The detector can communicate with the generator by cable. It is utilized for capturing and transfer of digital x-ray images for radiography diagnosis. The X-ray generator and the imaging software are not part of the VIVIX-S 1751S.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

A comparison test was conducted between the subject devices (VIVIX-S 1751S) and the predicate device (K181003) 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 1751S provide images of equivalent diagnostic capability to the predicate devices, the VIVIX-S 1717V, and its results demonstrate substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K181003

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

510(k) Summary

[As required by 21 CFR 807.92]

K190611

This 510(k) summary information is prepared in accordance with 21 CFR807.92

1. Date Prepared [21 CFR 807.92(a) (1)]

03/28/2019

2. Submitter's Information [21 CFR 807.92(a) (1)]

Name of Sponsor: Vieworks Co., Ltd. (Gwanyang-dong) 41-3, Burim-ro 170beon-gil,Dongan-gu, Address: 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 1751S
Model Name:VIVIX-S 1751S
Common Name:Digital Flat Panel X-ray Detector
Regulation Name:Stationary X-Ray System
Classification Panel:Radiology
Regulation Number: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.
Decision Date:03/15/2018
Type:Traditional
Trade Name:VIVIX-S 1717V
Model Name:FXRD-1717VA
FXRD-1717VB
Common Name:Digital Flat Panel X-ray Detector
Regulation Name:Stationary X-Ray System
Classification Panel:Radiology
Regulation Number:21 CFR 892.1680
Product Code:MQB
Device Class:2

1

5. Description of the Device [21 CFR 807.92(a) (4)]

o General Description

VIVIX-S 1751S, whose model name is VIVIX-S 1751S with 17X51 inches of imaging area. The device intercepts x-ray photons, and its Gadox (Gadolinium Oxysulfide) 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 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. The detector can communicate with the generator by cable. It is utilized for capturing and transfer of digital x-ray images for radiography diagnosis. The X-ray generator and the imaging software are not part of the VIVIX-S 1751S.

6. Indications for Use [21 CFR 807.92(a)(5)]

VIVIX-S 1751S series is used for the general-purpose diagnostic procedures, and as intended to replace radiographic film/ screen systems. The VIVIX-S 1751S 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), the VIVIX-S 1751S presented in this submission has the same:

  • Intended Use
  • Operating principle
  • · Design features
  • Communication Method
  • Scintillator Materials
  • Resolution

There is similar performance as follow.

  • Performance (MTF)
  • Performance (DQE)

For the predicate device, VIVIX-S 1717V, only one panel (for 17x17 inch imaging) is used. For this type of detector to capture images for longer body parts such as whole spine or legs, an imaging process (stitching) on the 3 separately taken images from 3 exposures are required to create one long image.

2

On the other hand, the VIVIX-S 1751S detector features 3 of the panels to create longer images (17 x 34 inches and 17x51 inches) for single exposure and without the stitching process. 17 x 17 size image can be also captured with this type of detector as well.

ParameterPredicate DeviceSubject DeviceEquivalence
510(k) NumberK181003--
ManufacturerVieworks Co., Ltd.--
Device NameVIVIX-S 1717VVIVIX-S 1751S-
DetectorFXRD-1717VA,
FXRD-1717VBFXRD-1751SB-
Power Supply
Unit-FXRP-01APower Supply
IO BoxFXRI-01A-Power Supply
SoftwareVXvue-Software
Common NameDigital Flat Panel X-ray DetectorEquivalent
Classification
NameSolid State X-Ray Imager (Flat Panel/Digital Imager)Equivalent
Classification
PanelRadiologyEquivalent
Classification
Regulation21 CFR 892.1680Equivalent
Product CodeMQBEquivalent
Device Class2Equivalent
Intended UseVIVIX-S 1717V series is 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 1751S series is used
for the general-purpose
diagnostic procedures, and
as well as intended to
replace radiographic film/
screen systems. The VIVIX-S
1751S series is not intended
for mammography
applications.Equivalent
ParameterPredicate DeviceSubject DeviceEquivalence
Device NameVIVIX-S 1717VVIVIX-S 1751S-
Panel ShapeSquare PanelSquare PanelEquivalent
DesignField of View17 x 17inch17 x 51inch3 times
longer*
Dimensions
(H x W x D)460.0 x 460.0 x 15.5mm1357.0 x 532.0 x
30.0mmEquivalent
Pixel Pitch0.14mm0.14mmEquivalent
Weight4.5kgAbout 4.5kgEquivalent
Materials
ScintillatorCsl: TI,
Gd2O2S:TbGd2O2S:Tb

3

Image sensorTFT: a-Si (Amorphous Silicon)TFT: a-Si (Amorphous Silicon)Equivalent
Data
Transmis
-sionWiredMax. 1GbpsMax. 1GbpsEquivalent
Communication
MethodWiredWiredWiredEquivalent
Performa
-nceDQE
(1lp/mm)FXRD-1717VA:
40~60 (typ. 48%)
FXRD-1717VB:
20~40 (typ. 27%)Csl Type Not Available
FXRD-1751SB:
20%Equivalent
MTF
(1lp/mm)FXRD-1717VA:
50~70 (typ. 70%)
FXRD-1717VB:
40~60 (typ. 58%)Csl Type Not Available
FXRD-1751SB:
40%Equivalent
Resolution3.5 lp/mm3.5 lp/mmEquivalent
Active Area430.08 x 430.08 (mm)430.08(mm) x 430.08(mm)
430.08(mm) x 860.16(mm)
430.08(mm) x 1290.24(mm)The candidate device features 3 of the panels used for the predicate device.
Pixel Size140 μm140 μmEquivalent
Grayscale16 bit16 bitEquivalent
Image Acquisition
Time1.5 sec. (wired)10 sec.Longer
Active Array3072 x 3072 pixels3072 x 3072 pixels
3072 x 6144 pixels
3072 x 9216 pixelsEquivalent
Method of
Generator Interface• DR Trigger (External Line Trigger)
• AED (Auto Exposure Detection)
• Passive Trigger (External Line Trigger)• DR Trigger (External Line Trigger)
• AED (Auto Exposure Detection)Equivalent
Spatial Resolution3.5lp/mm3.5lp/mmEquivalent
TechnologyStructured scintillator is attached in the detector to increase the X-ray photon interaction, X-ray absorption, and the amount of available visible light. This enhances potentialStructured scintillator is attached in the detector to increase the X-ray photon interaction, X-ray absorption, and the amount of available visible light. This enhances potentialEquivalent
efficiency and partial
resolution.efficiency and partial
resolution.
Principle of
OperationGenerated X-ray
photons strike the
scintillator causing the
visible light emission
that is to be converted
into an electric charge
by the photodiode
array. The electric
charge is then collected
at each photodiode and
turns into a digital
value by using the
underlying readout
electronics.Generated X-ray
photons strike the
scintillator causing the
visible light emission
that is to be converted
into an electric charge
by the photodiode
array. The electric
charge is then collected
at each photodiode and
turns into a digital
value by using the
underlying readout
electronics.Equivalent

4

9. Summary of Non-Clinical Data

A comparison test was conducted between the subject devices (VIVIX-S 1751S) and the predicate device (K181003) 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
  • FDA guidance titled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"

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 1751S provide images of equivalent diagnostic capability to the predicate devices, the VIVIX-S 1717V, and its results demonstrate substantial equivalence.

5

11. Conclusion [21 CFR 807.92(b) (3)]

The VIVIX-S 1751S 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 Xray Imaging Devices.

The results of these tests demonstrate that VIVIX-S 1751S 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.

6

April 8, 2019

Image /page/6/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", and on the right, there is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.

Vieworks Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 IRVINE CA 92620

Re: K190611

Trade/Device Name: VIVIX-S 1751S Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: March 5, 2019 Received: March 11, 2019

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. 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

7

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

8

Indications for Use

510(k) Number (if known) K190611

Device Name VIVIX-S 1751S

Indications for Use (Describe)

VIVIX-S 1751S series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S 1751S 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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