(103 days)
The Varian 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 hardcopy images with a laser printer. I mage 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 Varian Nexus DR™ Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).
The Varian Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The Varian Nexus DR™ Digital X-ray Imaging System 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, Varian PaxScan 4336Wv4, computer, monitor, and the digital imaging software.
The provided document is a 510(k) premarket notification for the Nexus DR 100 Digital X-ray Imaging System (with PaxScan 4336Wv4). It focuses on establishing substantial equivalence to existing predicate devices.
Based on the provided text, the document primarily discusses non-clinical testing and general validation, rather than a specific study designed to meet predetermined acceptance criteria for a new AI or diagnostic algorithm's performance. The information requested in the prompt is highly relevant for studies proving the performance of AI/CADe/CADx devices. This submission, however, is for a digital X-ray imaging system, which is a hardware and software system for image acquisition and display, and not explicitly an AI-driven diagnostic tool in the sense of the prompt's questions.
Therefore, many of the questions regarding specific acceptance criteria for diagnostic performance, sample sizes for test sets, experts for ground truth, adjudication methods, MRMC studies, and training set details are not fully addressable from this document as it does not describe such a study for the device's diagnostic performance.
However, I can extract information related to the technological characteristics comparison which serves as a form of "acceptance criteria" for substantial equivalence.
1. A table of acceptance criteria and the reported device performance
For this 510(k) submission, "acceptance criteria" are not framed in terms of diagnostic performance metrics like sensitivity or specificity for a specific condition. Instead, the device's performance is compared against predicate devices based on technological characteristics and physical image quality parameters to demonstrate substantial equivalence. The "acceptance" is that these characteristics are equivalent or better than the predicates.
| Feature/Item | Predicate Device (Nexus DRFTM Digital X-ray Imaging System) | Predicate Device (Stingray DR Digital Radiographic System) | Subject Device (Nexus DRTM Digital X-ray Imaging System with PaxScan 4336Wv4) | Acceptance Criterion (Implicit for Substantial Equivalence) | Subject Device Performance (Reported) |
|---|---|---|---|---|---|
| Flat Panel Detector | Varian PaxScan 4343R | Trixell Pixium 4600 | Varian PaxScan 4336Wv4 | Comparable or improved detector technology | Varian PaxScan 4336Wv4 (Wireless with vTrigger) |
| Detector Material | a-Si sensor array with CsI or Gd2O2S:TB scintillator | a-Si sensor array with CsI scintillator | a-Si sensor array with CsI or Gd2O2S:TB scintillator | Comparable material used for X-ray detection | a-Si sensor array with CsI or Gd2O2S:TB scintillator |
| Detector Dimensions | 17" x 17" | 17" x 17" | 17" x 14" | Comparable or slightly different, maintaining intended use | 17" x 14" |
| Pixel Size | 139 x 139 microns | 143 x 143 microns | 139 x 139 microns | Comparable or smaller for higher resolution | 139 x 139 microns |
| Detector Element Matrix | 3072 x 3072 | 2981 x 3021 | 3072 x 2560 | Comparable or higher for better image detail | 3072 x 2560 |
| Dynamic Range | 14 bits | 14 bits | 16 bits | Comparable or higher for better contrast resolution | 16 bits |
| Uniform Density | 1.63 | N/A | 1.52 | Comparable or improved (lower variability implying better uniformity) | 1.52 |
| Spatial Resolution | 3.2 lp/mm | 3.51 lp/mm | 3.2 lp/mm | Comparable or better for detail visibility | 3.2 lp/mm |
| Sensitivity | 128 @ 1.1uGy/frame, ..., 3143 @ 30uGy/frame (14-bit) | N/A | 540 @ 1.1uGy/frame, ..., 12804 @ 30uGy/frame (16-bit) | Comparable or higher for better low-dose performance | Significantly higher (540 @ 1.1uGy/frame, 12804@ 30uGy/frame) (16-bit subject panel) |
| Signal to Noise Ratio | 67 @ 2.8uGy/frame, ..., 275 @ 50uGy/frame | N/A | 73 @ 2.8uGy/frame, ..., 285 @ 50uGy/frame | Comparable or higher for reduced noise | Higher (73 @ 2.8uGy/frame, 285 @ 50uGy/frame) |
| Modulation Transfer Function | 0.521 @ 1cycle/mm, ..., 0.08 @ 3cycles/mm | N/A | 0.551 @ 1cycle/mm, ..., 0.099 @ 3cycles/mm | Comparable or higher for better detail preservation | Higher (0.551 @ 1cycle/mm, 0.099 @ 3cycles/mm) |
| Detective Quantum Efficiency | 0.242 @ 1cycle/mm, ..., 0.04 @ 3cycles/mm | N/A | 0.232 @ 1cycle/mm, ..., 0.07 @ 3cycles/mm | Comparable or higher for overall image quality and dose efficiency | Comparable (0.232 @ 1cycle/mm, 0.07 @ 3cycles/mm) |
| Total Image Processing Time | 10 seconds per image | 30 seconds per image | 10 seconds per image | Comparable or faster | 10 seconds per image |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical tests and a technological characteristics comparison to establish substantial equivalence. It refers to "Validation Protocols" and "predetermined test methods and corresponding acceptance criteria" but does not detail a specific "test set" of clinical images or patients in the sense of a diagnostic performance study. The data presented is characteristic measurements of the detector and system, not image data from patients for a diagnostic evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a clinical study where experts established ground truth for diagnostic decisions.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is used in diagnostic performance studies, which are not detailed in this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for a digital X-ray imaging system, not an AI-assisted diagnostic device, and thus no MRMC study for AI assistance is described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this device is an imaging system and not primarily a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a diagnostic performance study. The "ground truth" for the non-clinical tests would be the measured physical properties of the system and detector according to standard testing methodologies (e.g., those detailed in the referenced FDA guidance for solid-state X-ray imaging devices).
8. The sample size for the training set
Not applicable. The document does not describe an AI/ML component with a "training set" for diagnostic performance. The device involves image processing algorithms, but these are typically deterministic or rule-based for image enhancement, not machine learning algorithms trained on large datasets for diagnostic classification.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for a diagnostic AI/ML algorithm.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2016
Varian Medical Systems, X-ray Products – InfiMed % Ms. Catherine Mulcahy Regulatory Affairs Manager 121 Metropolitan Drive LIVERPOOL NY 13088
Re: K161459
Trade/Device Name: Nexus DR 100 Digital X-ray Imaging System (with PaxScan 4336Wv4) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: August 5, 2016 Received: August 8, 2016
Dear Ms. Mulcahy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Ocks
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161459
Device Name
Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
Indications for Use (Describe)
The Varian 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 dedications 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 hardcopy images with a laser printer. I mage 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 Varian 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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Image /page/3/Picture/0 description: The image shows the Varian Medical Systems logo. The logo consists of the word "VARIAN" in black, with a blue accent mark above the "I". Below "VARIAN" is the text "medical systems" in black. To the right of the logo is the text "A partner for life", with "A partner for" in gray and "life" in blue.
Section 3: 510(k) Summary
| Date Prepared: | 5/25/2016 | ||
|---|---|---|---|
| Contact Person: | Catherine MulcahyRegulatory Affairs Manager | ||
| Telephone: | 315-234-6853 | ||
| Fax: | 315-234-6801 | ||
| Submitter Name: | Varian Medical Systems, X-Ray Products - InfiMed121 Metropolitan DriveLiverpool, NY 13088 | ||
| Device Trade Name: | Nexus DRTM Digital X-ray Imaging System(with PaxScan 4336Wv4) | ||
| Common Name: | Digital Radiographic System | ||
| Regulation: | 21 CFR 892.1680 | ||
| Classification Name: | Stationary X-ray System | ||
| Primary Product Code: | MQB | ||
| Primary Predicate Device: | Stingray DR Digital Radiographic System | 510(k) Number: | Product Code |
| K992794 | MQB | ||
| Reference Predicate Device: | Nexus DRFTM Digital X-ray Imaging System | 510(k) Number: | Product Code |
| K130318 | JAA, MQB |
Device Description:
The Varian Nexus DR™ Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The Varian Nexus DR™ Digital X-ray Imaging System 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, Varian PaxScan 4336Wv4, computer, monitor, and the digital imaging software.
Intended Use:
The Varian 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
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Image /page/4/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in black, with a blue accent mark over the "I". Below "VARIAN" is the text "medical systems" in a smaller font. To the right of the logo is the tagline "A partner for life", with "A partner for" in gray and "life" in blue.
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 Varian Nexus DR™ Digital X-ray Imaging System 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 PaxScan 4336Wv4) supports the same modality as the predicate devices with similar components or imaging concepts. and delivers equivalent or better image quality as the predicate devices. The comparison chart below reveals that functions performed by the predicate devices are performed by the modified device for the DR application. Therefore, the modified device is substantially equivalent to the predicate devices.
However, the modified device, Nexus DR™ Digital X-ray Imaging System (with PaxScan 4336Wv4), has the ability to interface with the Varian PaxScan 4336Wv4 wireless detector with vTrigger capability. The Nexus DR™ Digital X-ray Imaging System (with PaxScan 4336Wv4) is not integrated with the x-ray generator. With vTrigger, there is no intercepting of the Prep/Expose signals from the generator. The receptor is placed in a "ready" mode by the user and on the Nexus DR™ User Interface. The user operates the generator (technique and exposure switch) when the receptor indicates it is "ready." The receptor captures the exposure once it arrives and acquires the data.
| Feature/Item | Nexus DRFTMDigital X-ray ImagingSystemReference Predicate | Stingray DRDigital RadiographicSystemPrimary Predicate | Nexus DRTMDigital X-ray ImagingSystemSubject Device |
|---|---|---|---|
| Device Type | |||
| 510 (k) Number | K130318 | K992794 | K161459 |
| Flat PanelDetector | VarianPaxScan 4343R | TrixellPixium 4600 | VarianPaxScan 4336Wv4 |
| DetectorMaterial | a-Si sensor array withCsI or Gd2O2S:TBscintillator | a-Si sensor array withCsI scintillator | a-Si sensor array withCsI or Gd2O2S:TBscintillator |
| DetectorDimensions | 17" x 17" | 17" x 17" | 17" x 14" |
| PixelSize | 139 x 139 microns | 143 x 143 microns | 139 x 139 microns |
| Detector ElementMatrix | 3072 x 3072 | 2981 x 3021 | 3072 x 2560 |
| DynamicRange | 14 bits | 14 bits | 16 bits |
Comparison Chart:
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Image /page/5/Picture/0 description: The image shows the Varian Medical Systems logo. The logo consists of the word "VARIAN" in black, with a blue accent over the "I", and the words "medical systems" in black below it. To the right of the logo is the text "A partner for life", with "A partner for" in gray and "life" in blue.
| UniformDensity | 1.63 | N/A | 1.52 |
|---|---|---|---|
| SpatialResolution | 3.2 lp/mm | 3.51 lp/mm | 3.2 lp/mm |
| Sensitivity | 128 @ 1.1uGy/frame395 @ 3.9uGy/frame1060 @ 10uGy/frame3143 @ 30uGy/frame(14-bit reference panel) | N/A | 540 @ 1.1uGy/frame1206 @ 3.9uGy/frame4290 @ 10uGy/frame12804@ 30uGy/frame(16-bit subject panel) |
| Signal to NoiseRatio | 67 @ 2.8uGy/frame96 @ 7uGy/frame147 @ 17uGy/frame275 @ 50uGy/frame | N/A | 73 @ 2.8uGy/frame117 @ 7uGy/frame174 @ 17uGy/frame285 @ 50uGy/frame |
| ModulationTransferFunction | 0.521 @ 1cycle/mm0.206 @ 2cycles/mm0.08 @ 3cycles/mm | N/A | 0.551 @ 1cycle/mm0.234 @ 2cycles/mm0.099 @ 3cycles/mm |
| DetectiveOuantumEfficiency | 0.242 @ 1cycle/mm0.125 @ 2cycles/mm0.04 @ 3cycles/mm | N/A | 0.232 @ 1cycle/mm0.15 @ 2cycles/mm0.07 @ 3cycles/mm |
| ExternalConnectivity | DICOM3.0 Compatible | DICOM3.0 Compatible | DICOM3.0 Compatible |
| OperatorConsole | Graphical UserInterface | Graphical UserInterface | Graphical UserInterface |
| ImageProcessor | Intel Based PC,nvidia GPU | Pentium Based PC | Intel CPU Based PC |
| ImageStorage | Hard Drive | Hard Drive | Hard Drive |
| OperatingSystem | Windows 7 | Windows NT | Windows 10 |
| Total ImageProcessing Time | 10 secondsper image | 30 secondsper image | 10 secondsper image |
| PowerRequirements | 110/120V,230/240V,50/60 Hz | 110/120V,230/240V,50/60 Hz | 110/120V,230/240V,50/60 Hz |
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/Guidanc eDocuments/ucm073781.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 Xray Imaging System (with PaxScan 4336Wv4) is as safe and effective as the predicate devices and does not raise different questions of safety and effectiveness.
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Image /page/6/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in black, with the "i" in "VARIAN" being blue. Below "VARIAN" is the text "medical systems" in black. To the right of the logo is the text "A partner for life", with "A partner for" in gray and "life" in blue.
Clinical Tests Discussion:
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/Guidanc eDocuments/ucm073781.pdf.
Conclusion:
Based upon the results of Verification and Validation testing, the Nexus DR™ Digital Xray Imaging System (with PaxScan 4336Wv4) 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 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.