(57 days)
VIVIX-S FW series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S FW series is not intended for mammography applications.
VIVIX-S -FW, a series for of flat panel detectors models named; FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW, with imaging areas of 25cm x 30cm, 36cm x 43cm, 43cm x 43cm, respectively. The detectors can acquire static images as well as fluoroscopic images up to 6fps.
The device intercepts x-ray photons and the scintillator (Cesium lodide) 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 is transmitted either by wire via cable or wirelessly through a system control unit (SCU), and the software called Vxvue acquires and processes the data values from the detector. The SW is of moderate level of concern. On the Vxvue, the use can view as well as perform basic manipulations such as (rotation, enlargement, etc.) on the acquired images. 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.
The provided text describes a 510(k) summary for a digital flat panel X-ray detector, VIVIX-S FW, and its substantial equivalence to a predicate device, VIVIX-S VW. The study focuses on demonstrating that the new device provides images of equivalent diagnostic capability to the predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are primarily based on demonstrating non-inferiority or equivalence to the predicate device in terms of "Performance (MTF)" and "Performance (DQE)," and meeting current spatial resolution standards. While the document states "similar performance," the exact acceptance thresholds (e.g., within a certain percentage point) for MTF and DQE are not explicitly quantified as absolute acceptance criteria values in the provided text. Instead, observed values are compared to the predicate.
| Parameter | Acceptance Criteria (Implicit: Similar/Equivalent to Predicate) | Predicate Device (Reported Performance) | Subject Device (Reported Performance) | Equivalence |
|---|---|---|---|---|
| VIVIX-S FW (FXRD-4343FAW) | ||||
| MTF (at 1lp/mm) | Similar to Predicate | 60 (FXRD-4343VAW PLUS) | 76 | - |
| DQE (at 1lp/mm) | Similar to Predicate | 53 (FXRD-4343VAW PLUS) | 45 | - |
| Spatial Resolution | 3.5 lp/mm (Predicate) | 3.5 lp/mm | 5 lp/mm | - |
| VIVIX-S FW (FXRD-3643FAW) | ||||
| MTF (at 1lp/mm) | Similar to Predicate | 59 (FXRD-3643VAW PLUS) | 74 | - |
| DQE (at 1lp/mm) | Similar to Predicate | 51 (FXRD-3643VAW PLUS) | 41.5 | - |
| Spatial Resolution | 3.5 lp/mm (Predicate) | 3.5 lp/mm | 5 lp/mm | - |
| VIVIX-S FW (FXRD-2530FAW) | ||||
| MTF (at 1lp/mm) | Similar to Predicate | 60 (FXRD-2530VAW PLUS) | 76 | - |
| DQE (at 1lp/mm) | Similar to Predicate | 52 (FXRD-2530VAW PLUS) | 46 | - |
| Spatial Resolution | 4.0 lp/mm (Predicate) | 4.0 lp/mm | 4.0 lp/mm | - |
Note on "Equivalence" Column in the provided table: The provided document's table includes an "Equivalence" column which states "Equivalent" for characteristics like Common Name, Classification Name, etc. For MTF, DQE, and Spatial Resolution, this column is blank in the source document, indicating a direct comparison rather than a simple "Equivalent" stamp. The text states "There is similar performance as follow" for MTF and DQE, and the table then lists the values.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "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 FW provide images of equivalent diagnostic capability to the predicate devices..."
- Sample Size: The specific sample size (number of images or cases) used for the clinical test set is not explicitly stated in the provided text.
- Data Provenance: The provenance (country of origin, retrospective/prospective) of the data used for the clinical study is not explicitly stated in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document mentions "a single-blinded concurrence study," which implies expert review. However:
- Number of Experts: The specific number of experts involved in establishing ground truth or evaluating images for the test set is not explicitly stated.
- Qualifications of Experts: The qualifications of these experts are not explicitly stated.
4. Adjudication Method for the Test Set
The document refers to a "single-blinded concurrence study." While this implies a comparison of images by readers, the specific adjudication method (e.g., 2+1, 3+1, none) for the test set is not explicitly stated. "Concurrence" suggests agreement among readers, but the process for resolving disagreements or establishing a definitive ground truth from the expert readings is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Improvement with AI vs. Without AI Assistance
- MRMC Study: The document describes a "single-blinded concurrence study" comparing the VIVIX-S FW device to predicate devices. This sounds like it could be an MRMC-like study in its nature of comparing image quality or diagnostic capability, but it's focused on device equivalence rather than AI assistance.
- AI Assistance Effect Size: The device described (VIVIX-S FW) is a digital X-ray detector, not an AI-powered diagnostic tool. Therefore, the study is not assessing the improvement of human readers with AI assistance. The concept of "AI vs. without AI assistance" is not applicable to this device and study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is an X-ray detector, which captures images. Its performance is evaluated through objective metrics like MTF and DQE, and through a clinical "concurrence study" involving human interpretation of the images produced by the device, comparing them to images from a predicate device. This is not an "algorithm-only" performance evaluation in the context of an AI algorithm, but rather a standalone evaluation of the image acquisition hardware. The non-clinical data (MTF, DQE, spatial resolution) are objective measures of the device's technical image quality, which can be seen as a form of standalone performance evaluation in the engineering sense.
7. The Type of Ground Truth Used
The clinical study is described as a "concurrence study" to confirm "equivalent diagnostic capability." This strongly suggests that the ground truth for diagnostic capability was established by expert consensus or through a process where experts evaluated the images for diagnostic equivalence. It does not mention pathology, outcomes data, or other definitive methods as the primary ground truth.
8. The Sample Size for the Training Set
The provided text describes a 510(k) for a hardware device (digital X-ray detector) and its associated software for image processing and viewing (Vxvue). It does not mention machine learning or AI models requiring a "training set." Therefore, a training set sample size is not applicable and not provided in this document.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of an AI model or training set, this question is not applicable based on the provided information.
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Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 20, 2022
Vieworks Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA. Inc. 18881 Von Karman Avenue, Suite 160 IRVINE CA 92612
Re: K221512
Trade/Device Name: VIVIX-S FW (Model: FXRD-4343FAW, FXRD-3643FAW, FXRD-2530FAW) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: Mav 24, 2022 Received: May 27, 2022
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
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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 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 (OS) 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
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Indications for Use
510(k) Number (if known) K221512
Device Name
VIVIX-S FW (Model: FXRD-4343FAW, FXRD-3643FAW, FXRD-2530FAW)
Indications for Use (Describe)
VIVIX-S FW series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S FW 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
(K221512)
This 510(k) summary information is prepared in accordance with 21 CFR807.92
1. Date Prepared [21 CFR 807.92(a) (1)]
6/30/2022
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-guAnyang-si, Gyeonggi-do, 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 FW |
|---|---|
| Model Name: | FXRD-4343FAW, FXRD-3643FAW, FXRD-2530FAW |
| 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: | K200418 |
|---|---|
| Applicant: | Vieworks Co., Ltd. |
| Trade Name: | VIVIX-S 4343VW PLUS |
| Model Name: | FXRD-4343VAW 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 |
| Decision Date: | 03/18/2020 |
| Type: | Traditional |
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510(k) Number: K200418 Vieworks Co., Ltd. Applicant: Trade Name: VIVIX-S 3643VW PLUS Model Name: FXRD-3643VAW PLUS 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 Decision Date: 03/18/2020 Type: Traditional 510(k) Number: K200418 Applicant: Vieworks Co., Ltd. Trade Name: VIVIX-S 2530VW PLUS Model Name: 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 03/18/2020 Decision Date: Type: Traditional
5. Description of the Device [21 CFR 807.92(a) (4)]
General Description O
VIVIX-S -FW, a series for of flat panel detectors models named; FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW, with imaging areas of 25cm x 30cm, 36cm x 43cm, 43cm x 43cm, respectively. The detectors can acquire static images as well as fluoroscopic images up to 6fps.
The device intercepts x-ray photons and the scintillator (Cesium lodide) 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 is transmitted either by wire via cable or wirelessly through a system control unit (SCU), and the software called Vxvue acquires and processes the data values from the detector. The SW is of moderate level of concern. On the Vxvue, the use can view as well as perform basic manipulations such as (rotation, enlargement, etc.) on the acquired images. 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 FW series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S FW 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 FW device 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 (K200418), the VIVIX-S FW 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 FW 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 | K200418 | - | - |
| Manufacturer | Vieworks Co., Ltd. | - | - |
| Device Name | VIVIX-S 4343VW | VIVIX-S 4343FW | - |
| Detector | VIVIX-S 4343VAW PLUS | FXRD-4343FAW | - |
| SCU | FXRS-04AFXRP-02A | FXRS-04AFXRP-03A | PowerSupply |
| 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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| ClassificationRegulation | 21 CFR 892.1680 | Equivalent | |
|---|---|---|---|
| Product Code | MQB | Equivalent | |
| Device Class | 2 | Equivalent | |
| Indications for Use | The VIVIX-S VW detectorsare used for the general-purpose diagnosticprocedures, and as well asintended to replaceradiographic film / screensystems.The VIVIX-S VW detectorsare not intended formammographyapplications. | The VIVIX-S FW detectorsare used for the general-purpose diagnosticprocedures, and as well asintended to replaceradiographic film / screensystems.The VIVIX-S VW detectorsare not intended formammographyapplications. | Equivalent |
| MTF | FXRD-4343VAW PLUS: | FXRD-4343FAW: | |
| (Measured Values,at 1lp/mm) | 60 | 76 | |
| DQE | FXRD-4343VAW PLUS: | FXRD-4343FAW: | |
| (Measured Values,at 1lp/mm) | 53 | 45 | |
| Spatial Resolution | 3.5 lp/mm | 5 lp/mm |
| Parameter | Predicate Device | Subject Device | Equivalence |
|---|---|---|---|
| 510(k) Number | K200418 | - | - |
| Manufacturer | Vieworks Co., Ltd. | - | - |
| Device Name | VIVIX-S 3643VW PLUS | VIVIX-S 3643FW | - |
| Detector | FXRD-3643VAW PLUS | FXRD-3643FAW | - |
| SCU | FXRS-04AFXRP-02A | FXRS-04AFXRP-03A | PowerSupply |
| 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 | |
| ClassificationRegulation | 21 CFR 892.1680 | Equivalent | |
| Product Code | MQB | Equivalent | |
| Device Class | 2 | Equivalent | |
| Indications for Use | The VIVIX-S VW detectors are used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film / screen systems.The VIVIX-S VW detectors are not intended for | The VIVIX-S FW detectors are used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film / screen systems.The VIVIX-S VW detectors are not intended for | Equivalent |
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| mammographyapplications. | mammographyapplications. | ||
|---|---|---|---|
| MTF(Measured Values,at 1lp/mm) | FXRD-3643VAW PLUS:59 | FXRD-3643FAW:74 | |
| DQE(Measured Values,at 1lp/mm) | FXRD-3643VAW PLUS:51 | FXRD-3643FAW:41.5 | |
| Spatial Resolution | 3.5lp/mm | 5lp/mm |
| Parameter | Predicate Device | Subject Device | Equivalence |
|---|---|---|---|
| 510(k) Number | K200418 | - | - |
| Manufacturer | Vieworks Co., Ltd. | - | - |
| Device Name | VIVIX-S 2530VW PLUS | VIVIX-S 2530FW | - |
| Detector | FXRD-2530VAW PLUS | FXRD-2530FAW | - |
| SCU | FXRS-04AFXRP-02A | FXRS-04AFXRP-03A | PowerSupply |
| 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 | |
| ClassificationRegulation | 21 CFR 892.1680 | Equivalent | |
| Product Code | MQB | Equivalent | |
| Device Class | 2 | Equivalent | |
| Indications for Use | The VIVIX-S VW detectorsare used for the general-purpose diagnosticprocedures, and as well asintended to replaceradiographic film / screensystems. The VIVIX-S VWdetectors are not intendedfor mammographyapplications. | The VIVIX-S FW detectorsare used for the general-purpose diagnosticprocedures, and as well asintended to replaceradiographic film / screensystems. The VIVIX-S VWdetectors are not intendedfor mammographyapplications. | Equivalent |
| MTF(Measured Values,at 1lp/mm) | FXRD-2530VAW PLUS:60 | FXRD-2530FAW:76 | |
| DQE(Measured Values,at 1lp/mm) | FXRD-2530VAW PLUS:52 | FXRD-2530FAW:46 | |
| Spatial Resolution | 4.0 lp/mm | 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 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
Test results are all a pass, and they indicate device safety and effectiveness.
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 FW provide images of equivalent diagnostic capability to the predicate devices, the VIVIX-S 4343VW, VIVIX-S 3643VW, VIVIX-S 2530VW and its results demonstrate substantial equivalence.
11. Conclusion [21 CFR 807.92(b) (3)]
The VIVIX-S FW Digital X-ray detectors are substantially equivalent to the currently marketed and predicate devices (K200418) 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 FW 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.
§ 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.