(228 days)
No
The summary describes a standard digital X-ray detector and associated software for image acquisition and processing, with no mention of AI or ML capabilities.
No.
The device is for diagnostic imaging (replacing film or screen-based radiographic systems for diagnostic procedures) and does not provide therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is intended for "general purposes of diagnostic procedures" and the "Device Description" mentions that it "can be utilized to digitalize x-ray images and transfer for radiography diagnostic."
No
The device description clearly states it is a flat panel detector (FXRD-4386WB) which is a hardware component that intercepts x-ray photons and converts them to electrical signals. While it includes software for data acquisition and processing, it 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 "digital imaging solution designed as a general radiographic system for human anatomy." This describes an imaging device used to visualize internal structures of the body, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details how the device captures X-ray photons and converts them into digital images for display. This is consistent with a medical imaging device, not an IVD.
- Input Imaging Modality: The input is X-ray, which is a form of radiation used for imaging, not a method for analyzing biological samples.
- Anatomical Site: It's used for "human anatomy," meaning it images the body itself.
- No mention of analyzing biological samples: The description and intended use do not mention any process involving the analysis of samples taken from a patient.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to create images of the body.
N/A
Intended Use / Indications for Use
VIVIX-S 4386W 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. It is intended for both adult and pediatric populations.
Product codes
MQB
Device Description
VIVIX-S 4386W, a flat panel detector model named; FXRD-4386WB with imaging areas of 43cm x 86cm. 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
human anatomy
Indicated Patient Age Range
adult and pediatric populations
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 4386W) and the predicate device (K181003) on the items such as DQE, MTF and spatial resolution.
A single-blinded concurrence study was conducted, and the study confirmed that the new VIVIX-S 4386W provides 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)
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
September 13, 2022
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 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. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave., STE 160 IRVINE CA 92612
Re: K220239
Trade/Device Name: VIVIX-S 4386W Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: August 10, 2022 Received: August 12, 2022
Dear Priscilla 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220239
Device Name VIVIX-S 4386W
Indications for Use (Describe)
VIVIX-S 4386W 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. It is intended for both adult and pediatric populations.
| 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 («220239)
[As required by 21 CFR 807.92]
This 510(k)-summary information is prepared in accordance with 21 CFR807.92
1. Date Prepared [21 CFR 807.92(a) (1)]
09/06/2022
2. Submitter's Information [21 CFR 807.92(a) (1)]
Name of Sponsor: Vieworks Co., Ltd. Address: 41-3, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggido, 14055 Republic of Korea Contact Name: Oh, Kevin / 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 4386W |
|---|---|
| Model Name: | FXRD-4386WB |
| 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 |
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
510(k) Number: K181003 Product Code: MQB Applicant: Vieworks Co., Ltd. Trade Name: VIVIX-S 1717V Decision Date: 03/15/2018 Type: Traditional
5. Description of the Device [21 CFR 807.92(a) (4)]
General Description
VIVIX-S 4386W, a flat panel detector model named; FXRD-4386WB with imaging areas of 43cm x 86cm. 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
4
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.
6. Indications for Use [21 CFR 807.92(a)(5)]
VIVIX-S 4386W 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. It is intended for both adult and pediatric populations.
7. Technological Characteristics [21 CFR 807.92(a) (6)]
Comparisons with the predicate, the system shows the technological characteristics of the proposed 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 4386W presented in this submission has the subsequently equivalent:
- Intended Use
- Technological characteristics
- Operating principle
- · Design features
- Communication Method
The MTF value of the subject device is higher than the one of the predicate device models (FXRD-1717VB) but DQE value of is little lower than the predicate device. However, the difference is not significant (just one 1)p/mm value difference), and the test result of the concurrence clinical study shows that this difference does not raise an issue in substantial equivalence.
Based on the information and the test result we submitted, we conclude that the subject device 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 | K220239 | - | |
| Manufacturer | Vieworks Co., Ltd. | - | ||
| Device Name | VIVIX-S 1717V | VIVIX-S 4386W | - | |
| Compo- | ||||
| nent | Detector | FXRD-1717VA, | ||
| FXRD-1717VB | FXRD-4386WB | - | ||
| SCU | - | FXRS-04A | Power Supply | |
| Software | VXvue | VXvue | Equivalent | |
| 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 | ||
| Classification Regulation | 21 CFR 892.1680 | Equivalent | ||
| Product Code | MQB | Equivalent | ||
| Device Class | 2 | Equivalent | ||
| Indications for Use | VIVIX-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 4386W 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. It is | ||||
| intended for both adult | ||||
| and pediatric | ||||
| populations. | Equivalent | |||
| Panel Shape | Square Panel | Square Panel | Equivalent | |
| Field of View | 17 x 17inch | 17 x 34inch | Similar | |
| Design | Dimensions | |||
| (H x W x D) | 460.0 x 460.0 x | |||
| 15.5mm | 900 mm × 465 mm × | |||
| 17.0 mm | Equivalent | |||
| Pixel Pitch | 0.14mm | 0.14mm | Equivalent | |
| Weight | 4.5kg | 8kg (With two battery | ||
| packs) | Equivalent | |||
| Materials Scintillator | Csl: TI, | |||
| Gd2O2S:Tb | Gd2O2S:Tb | Substantially | ||
| Equivalent | ||||
| Image sensor | TFT: a-Si (Amorphous | |||
| Silicon) | TFT: a-Si (Amorphous | |||
| Silicon) | Equivalent | |||
| Data | ||||
| Transmis | ||||
| -sion | Wired | Max. 1Gbps | Max. 1Gbps | Equivalent |
| Communication Method | Wired | Wired / Wireless | Substantially | |
| Equivalent | ||||
| Perform- | ||||
| ance | MTF | |||
| (1lp/mm) | FXRD-1717VA: | |||
| Horizontal 66 | ||||
| Vertical 67 | ||||
| FXRD-1717VB: | ||||
| Horizontal 58 | ||||
| Vertical 58 | FXRD-4386W: | |||
| 62 | Substantially | |||
| Equivalent | ||||
| DQE | ||||
| (1lp/mm) | FXRD-1717VA: | |||
| Horizontal 53 | ||||
| Vertical 54 | FXRD-4386W: | |||
| 28 | Substantially | |||
| Equivalent | ||||
| FXRD-1717VB: | ||||
| Horizontal 29 | ||||
| Vertical 29 | ||||
| Resolution | 3.5 lp/mm | 3.5 lp/mm | Equivalent | |
| Active Area | 430.08 x 430.08 (mm) | 430.08 mm × 860.16 mm | ||
| 430.08 mm × 430.08 mm | Substantially | |||
| Equivalent | ||||
| Pixel Size | 140 μm | 140 μm | Equivalent | |
| Grayscale | 16 bit | 16 bit | Equivalent | |
| Image | ||||
| Acquisition | ||||
| Time | Wired | 1.5 sec | Max. 5 sec. | |
| (Exposure time is set to | ||||
| 500ms, Excluding | ||||
| exposure time) | Similar | |||
| Wireless | • Max. 5 sec. | |||
| (IEEE802.11ac, MiMO | ||||
| 3x3, 5GHz, 80MHz) | ||||
| (Exposure time is set to | ||||
| 500ms, Excluding | ||||
| exposure time) | ||||
| Active Array | 3072 x 3072 pixels | 3072 x 6144 pixels | ||
| 3072 x 3072 pixels | Substantially | |||
| Equivalent | ||||
| 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) | ||||
| • Software Trigger | Substantially | |||
| Equivalent | ||||
| Spatial Resolution | 3.5lp/mm | Min. 3.5lp/mm | Equivalent | |
| Technology | Structured 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 potential | ||||
| detective quantum | ||||
| efficiency and partial | ||||
| resolution. | Structured 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 potential | ||||
| detective quantum | ||||
| efficiency and partial | ||||
| resolution. | Equivalent | |||
| Principle of Operation | 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 | 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 | Equivalent | |||
| charge is then | ||||
| collected at each | ||||
| photodiode and turns | ||||
| into a digital value by | ||||
| using the underlying | ||||
| readout electronics. | charge is then collected | |||
| at each photodiode | ||||
| and turns into a digital | ||||
| value by using the | ||||
| underlying readout | ||||
| electronics. |
Table 1: Comparison of Subject Device VIVIVX-S 4386W to the Predicate
5
6
7
9. Summary of Non-Clinical Data
A comparison test was conducted between the subject devices (VIVIX-S 4386W) 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
10. Summary of Clinical Data
A single-blinded concurrence study was conducted, and the study confirmed that the new VIVIX-S 4386W provides images of equivalent diagnostic capability to the predicate devices, the VIVIX-S 1717V and its results demonstrate substantial equivalence.
11. Conclusion [21 CFR 807.92(b) (3)]
The VIVIX-S 4386W is 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.
The results of these tests demonstrate that VIVIX-S 4386W 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.