(25 days)
Not Found
No
The document mentions "image processing algorithms" and a "scatter correction algorithm (vSharp™)" but does not use terms like AI, ML, deep learning, or neural networks. The description focuses on standard digital imaging techniques and algorithms for image enhancement, not adaptive or learning-based systems.
No.
The device is an X-ray imaging system used for diagnosis, not for treating a disease or condition.
Yes
The device is described as enabling operators to "acquire, display, process, export images," and that its "Image processing algorithms enable the operator to bring out diagnostic details." It is also stated that the images are displayed "in high quality for clinical diagnosis." This all indicates that the device is used to generate information that aids in diagnosis.
No
The device description explicitly states that the system includes hardware components such as an image receptor, computer, and monitor, in addition to the software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The Varex Nexus DR Digital X-ray Imaging System is an imaging system that uses X-rays to create images of the internal structures of the body. It does not examine specimens derived from the human body in vitro.
- Intended Use: The intended use clearly states it's for "general radiographic examinations and applications," which are in vivo procedures (performed on a living organism).
- Device Description: The description focuses on the components and technology used for acquiring and processing X-ray images, not for analyzing biological specimens.
Therefore, the Varex Nexus DR Digital X-ray Imaging System falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Varex Nexus DR Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hard-copy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software.
The Varex Nexus DR Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).
Product codes
MQB
Device Description
The Nexus DR™ Digital X-ray Imaging System (with vSharp™) is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. Nexus DR™ Digital Xray Imaging System (with vSharp™) is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform.
The modified device consists of an X-ray imaging receptor, computer, monitor, and the digital imaging software and the optional vSharp software.
The Nexus DR™ Digital X-ray Imaging System (with vSharp™) is a configurable product platform designed to allow Varex to leverage the common components of digital X-ray imaging systems from which the following medical modalities can be served: General Radiography (excluding fluoroscopy, angiography, and mammography). Nexus DR™ Digital X-ray Imaging System (with vSharp™) is then configured to function on a computer with modality specific components, functionality and capabilities to complete the specific product package.
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)
Non-clinical Data submitted is consistent with FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" available at the website http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc m073781.pdf.
Validation was completed in accordance with the Validation Protocols included with this submission. Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria. In conclusion, all release criteria have been met and the Nexus DR. Digital X-ray Imaging System (with vSharp™) is as safe and effective as the predicate devices and does not raise different questions of safety and effectiveness.
No clinical testing was performed as a result of this modification. However, both Usability Testing and Image Comparisons were performed and the results can be found in VOL 018 Appendix R Clinical Data.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
Varex Imaging Corporation c/o Michael Ryn Regulatory Affairs Manager 121 Metropolitan Drive LIVERPOOL, NY 13088
December 20, 2019
Re: K193238
Trade/Device Name: Nexus DR Digital X-Ray Imaging System (with vSharp) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: November 22, 2019 Received: November 25, 2019
Dear Michael Ryn:
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
1
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,
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
2
Indications for Use
510(k) Number (if known) K193238
Device Name
Nexus DR Digital X-ray Imaging System (with vSharp)
Indications for Use (Describe)
The Varex Nexus DR Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hard-copy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software.
The Varex Nexus DR Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).
| 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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3
Image /page/3/Picture/1 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made up of four vertical lines in different colors: blue, dark blue, yellow, and green. To the right of the "V" is the word "VAREX" in dark blue, with the word "IMAGING" in smaller, lighter blue letters below it.
Varex Imaging Corporation 121 Metropolitan Drive Liverpool, NY 13088- USA www.vareximaqinq.com
510(k) Summary
Date Prepared: 11/22/2019
| Contact Person: | Michael Van Ryn |
|---|---|
| Regulatory Affairs Manager | |
| Telephone: | 315-234-6853 |
| Fax: | 315-234-6801 |
| Submitter Name: | Varex Imaging Corporation |
| 121 Metropolitan Drive | |
| Liverpool, NY 13088 | |
| Subject Device | |
| Trade Name: | Nexus DR Digital X-ray Imaging System |
| (with vSharp) | |
| Common Name: | Digital Radiographic System |
| Regulation: | 21 CFR 892.1680 |
| Classification Name: | Stationary X-ray System |
| Class: | II |
Primary Predicate Device
Primary Product Code: MQB
| Trade Name: | Nexus DR. Digital X-ray Imaging System
(with Integrated Generator) |
|----------------------|-----------------------------------------------------------------------|
| Common Name: | Digital Radiographic System |
| Regulation: | 21 CFR 892.1680 |
| Classification Name: | Stationary X-ray System |
| Class: | II |
| Primary | Product Code: MQB |
| 510(k) Number: | K190146 |
Device Description:
The Nexus DR™ Digital X-ray Imaging System (with vSharp™) is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. Nexus DR™ Digital Xray Imaging System (with vSharp™) is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform.
The modified device consists of an X-ray imaging receptor, computer, monitor, and the digital imaging software and the optional vSharp software.
The Nexus DR™ Digital X-ray Imaging System (with vSharp™) is a configurable product platform designed to allow Varex to leverage the common components of digital X-ray imaging systems from
4
Image /page/4/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made up of three vertical lines in different colors: blue, yellow, and green. To the right of the "V" is the word "VAREX" in blue, and below that is the word "IMAGING" in smaller, gray letters.
Varex Imaging Corporation 121 Metropolitan Drive Liverpool, NY 13088- USA www.vareximaqinq.com
which the following medical modalities can be served: General Radiography (excluding fluoroscopy, angiography, and mammography). Nexus DR™ Digital X-ray Imaging System (with vSharp™) is then configured to function on a computer with modality specific components, functionality and capabilities to complete the specific product package.
Like the predicate device, the modified Nexus DR™ Digital X-ray Imaging System (with vSharp™) is in a class of devices that all use similar technology to acquire digital radiographic images. These devices convert X-rays into visible light that shines onto a TFT array, which converts the visible light into a digital electronic signal. This process is ultimately used for the same purpose as Radiographic film, to create an X-ray image.
Identical to the predicate device, the modified device is capable of interfacing with flat panel detectors in v Trigger Mode or RAD Mode utilizing an external I/O box to interface with compatible X-ray generators, in non-integrated mode. The modified device also retains the ability to apply the grid suppression feature.
Similar to the already cleared Nexus DR™ Digital X-ray Imaging System with Integrated Generator the modified device, Nexus DR™ Digital X-ray Imaging System (with vSharp™), has the same intended use for the DR application. The modified device, however, adds vSharp™ scatter correction algorithm into the Nexus DR Software, the image contrast is enhanced and the images produced have similar detail contrast as images acquired with an anti-scatter grid. The Nexus DR Digital X-ray Imaging System can then store the images on the local computer, archive them to CD/DVD media, transfer them to Hard Copy format via DICOM printers, or transfer them to PACS reviewing stations in DICOM format.
Indications for Use:
The Nexus DR™ Digital X-ray Imaging System (with vSharp™) is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. Nexus DR™ Digital X-ray Imaging System (with vSharp™) enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software.
The Nexus DR™ Digital X-ray Imaging System (with ySharp™) is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).
Technological Characteristics Comparison:
The Nexus DR™ Digital X-ray Imaging System (with vSharp™) supports the same modality as the predicate device with similar components or imaging concepts, has the same Indications for Use as the predicate device, and delivers equivalent image quality as the predicate device. The comparison chart below reveals that functions performed by the predicate device are performed by the modified device for the DR application. Therefore, the modified device is substantially equivalent to the predicate device.
However, the modified device, Nexus DR™ Digital X-ray Imaging System (with vSharp™), adds the vSharp™ scatter correction algorithm into the Nexus DR Software, the image contrast is enhanced and
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Image /page/5/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made up of vertical lines in blue, yellow, and green. To the right of the "V" is the text "VAREX" in blue, and below that is the text "IMAGING" in a smaller font size.
the images produced have similar detail contrast as images acquired with an anti-scatter grid. All other features and functions remain unchanged.
Through the use of a digital flat panel detector, the Nexus DR™ Digital X-ray Imaging System (with vSharp™) is capable of acquiring digital radiographic images, processing and then displaying them in high quality for clinical diagnosis. The Nexus DR™ Digital X-ray Imaging System (with vSharp™) can then store the images on the local computer, archive them to CD/DVD media, transfer them to Hard Copy format via DICOM printers, or transfer them to PACS reviewing stations in DICOM format.
Nexus DR™ Digital X-ray Imaging System (with vSharp™) is an additional feature to the stationary X-Ray system which adds the vSharp™ scatter correction algorithm into the Nexus DR Software, the image contrast is enhanced and the images produced have similar detail contrast as images acquired with an antiscatter grid. Acquired imaging can be stored on the local computer, archived to CD/DVD, transferred to Hard Copy format via DICOM printers, or transferred to a PACS reviewing station in DICOM format.
| Feature/Item | Nexus DR™ Digital X-
ray Imaging System
(with Integrated
Generator) | Nexus DR™
Digital X-ray
Imaging System
with vSharp™ |
|---------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------|
| Device Type | Predicate Device | Subject Device |
| 510 (k) Number | K190146 | Pending |
| Integrated CPI
CMP200
Generator | Yes | Same |
| vSharp™ scatter
correction | No | Yes |
| External
Connectivity | DICOM 3.0 Compatible | Same |
| Operator
Console | Graphical User | Same |
| Image
Processor | Intel CPU Based PC | Same |
| Image
Storage | Hard Drive | Same |
| Operating
System | Windows 10 | Same |
| Digital
Imaging
Systems | Radiography modes
(remote control) – using
a large flat panel
detector | Same |
| Digital
Imaging | Radiography | Same |
Comparison Chart:
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Image /page/6/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made up of three vertical lines in different colors: blue, yellow, and green. To the right of the "V" is the text "VAREX" in a dark blue sans-serif font. Below "VAREX" is the word "IMAGING" in a smaller, lighter blue font.
| Supported
Flat panels | Varian PaxScan
4343R
Varian PaxScan
4336W | Same |
|--------------------------|----------------------------------------------------|------|
| Power
Requirements | 110/120V,
230/240V,
50/60 Hz | Same |
Non-clinical Tests Discussion:
Non-clinical Data submitted is consistent with FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k) 's for Solid State X-ray Imaging Devices" available at the website http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc m073781.pdf.
Validation was completed in accordance with the Validation Protocols included with this submission. Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria. In conclusion, all release criteria have been met and the Nexus DR. Digital X-ray Imaging System (with vSharp™) is as safe and effective as the predicate devices and does not raise different questions of safety and effectiveness.
Clinical Tests Discussion:
No clinical testing was performed as a result of this modification. However, both Usability Testing and Image Comparisons were performed and the results can be found in VOL 018 Appendix R Clinical Data.
Please refer to Appendix O for the completed form "FDA 3674 Certification of Compliance with Clinical Trials".
Standards and Guidance Documents:
Electrical Safety and EMC Standards
The modified device conforms to these consensus standards and has passed all relevant required testing:
- IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- IEC 60601-2-54 CONSOLIDATED VERSION Edition 1.1 2015-04, Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy [Including: Amendment 2 (2018)]
- AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012; ● Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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Image /page/7/Picture/0 description: The image shows the logo for Varex Imaging. The logo consists of a stylized "V" made up of vertical lines in different colors, followed by the text "VAREX" in a dark blue sans-serif font. Below "VAREX" is the word "IMAGING" in a smaller, lighter blue sans-serif font. The overall design is clean and modern.
- IEC 60601-1-2 Edition 3: 2007-03; Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests (2007)
- IEC 60601-1-6 Edition 3: 2013-10; Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Data Storage and Exchange Standards
The Nexus DR. Digital X-ray Imaging System is designed to meet American College of Radiology / American College of Cardiology / National Electrical Manufacturers Association DICOM, Version 3.0, Parts 1 through 8, Part 10 (Media Storage and File Formats), Part 11 (Media Storage Applications Profiles) and Part 12 (CD-R Annex):
- NEMA PS 3.1 - 3.20; Digital Imaging and Communications in Medicine (DICOM) Set (2016)
Radiation Control
The Nexus DR. Digital X-ray Imaging System meets the requirements of the Radiation Performance Standards of 21 CFR Subchapter J, applicable Sections 21 CFR 1020.30, 1020.31 and 1020.32.
Any video monitors chosen for this application meet the requirements of the Radiation Performance Standards of 21 CFR Subchapter J, applicable Section 21 CFR 1020.10.
Optical disk storage devices (reader and writer) comply with Radiation Performance Standards of 21 CFR Subchapter J, applicable Section 21 CFR 1040.10.
Guidance
The following guidance documents were considered and utilized in the development of the modified device. Applicable identified requirements derived from these guidance documents have been met.
- Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices ●
- How to Prepare a Special 510(k)
- Guidance for Content of Premarket Submissions for Software Contained in Medical Devices
- Deciding When to Submit a 510(k) for a Change to and Existing Device
- Pediatric Information for X-ray Imaging Device Premarket Notifications
- Applying Human Factors and Usability Engineering to Medical Devices
- Use of Symbols in Medical Device Labeling
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices ●
- Refuse to Accept Policy for 510(k)s ●
- eCopy Program for Medical Device Submissions
- Global Unique Device Identification Database (GUDID)
Conclusion:
Based upon the results of Verification and Validation testing, the Nexus DR. Digital X-Ray Imaging System (with ySharp™) has no new indications for use, has no significant technological differences, and is as safe and effective as, does not raise different questions of safety and effectiveness and is therefore substantially equivalent to the above listed current legally marketed predicate device.