(29 days)
The FDX Console is a workstation intended to associate digital (CR and/or DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. The FDX Console is not for use in Mammography.
The FDX Console is used by a radiographer for viewing Digital Radiography (DR) and Computed Radiography (CR) images for final quality assurance (QA) checking and image processing and optimization prior to transferring the images to external devices such as a PACS or a printer. Furthermore, when connected to Fuji Image Readers via a network, the FDX Console is used to enter patient ID information, exposure information, and in the case of CR register Image Plate (IP) barcode numbers. The FDX Console is compatible with the ACR/NEMA DICOM Version 3.0 standard. The four primary features of the FDX Console are patient identification, exam selection, image processing, and image transmission.
The provided text describes a 510(k) premarket notification for the FDX Console (DR-ID300CL) Software. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, not primarily to prove performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, specific device performance metrics, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance studies is explicitly stated as "not required" or not detailed in the document in the context of device performance evaluation.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or detection by the FDX Console software. This is because the device is a medical image processing workstation, not a diagnostic AI algorithm that directly interprets images for disease. The "acceptance criteria" discussed are related to conformance to voluntary standards and demonstrability of substantial equivalence.
| Acceptance Criteria (Not in terms of performance metrics) | Reported Device Performance and Compliance |
|---|---|
| Conformance to DICOM, V3.0 2007 | Conforms |
| Conformance to IEC 62304: 2006 (Medical Device Software – Software Life Cycle Processes) | Conforms |
| Conformance to IEC 62366: 2014 (Medical devices – Application of usability engineering to medical devices) | Conforms |
| All verification and validation activities performed as required by risk analysis | Results were satisfactory |
| Software modifications do not alter technological characteristics of predicates | Demonstrated (by comparison table) |
2. Sample Size for the Test Set and Data Provenance
Not Applicable (N/A) for a medical image processing workstation. The submission indicates that "Clinical studies were not required as there is no change in image processing." The focus was on non-clinical performance data (software V&V and conformance to standards) to demonstrate substantial equivalence to existing devices. There is no mention of a "test set" of medical images for evaluating diagnostic performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. As no clinical studies or test sets for diagnostic performance were conducted, no experts were used to establish ground truth for such a purpose.
4. Adjudication Method for the Test Set
N/A. No test set for diagnostic performance was utilized.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Clinical studies were not required as there is no change in image processing." Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. The FDX Console is described as a workstation that "applies image processing to facilitate diagnosis, display the image, and output the resulting image and exam data," meaning it is an assistive tool within a human workflow, not a standalone diagnostic algorithm. No standalone performance study was conducted or reported.
7. Type of Ground Truth Used
N/A. Since no clinical studies were performed to evaluate diagnostic performance against a ground truth, this is not applicable. The device's function is image processing and management, not direct diagnostic interpretation.
8. Sample Size for the Training Set
N/A. The FDX Console is an image processing software with fixed algorithms. It is not an AI/ML device that requires "training data" in the typical sense of machine learning for diagnostic tasks. Its function is to apply established image processing techniques.
9. How the Ground Truth for the Training Set Was Established
N/A. As the device does not involve machine learning requiring a training set with established ground truth, this information is not applicable. The software's algorithms are based on predefined image processing techniques.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16, 2017
FUJIFILM Medical Systems USA, Inc. % Mr. Peter Altman Regulatory and Quality Consultant 419 West Avenue STAMFORD CT 06902
Re: K170451
Trade/Device Name: FDX Console (DR-ID300CL) Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 8, 2017 Received: February 15, 2017
Dear Mr. Altman:
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,
Michael O'Hara
For
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)
K170451
Device Name FDX Console (DR-ID300CL) Software
Indications for Use (Describe)
The FDX Console is a workstation intended to associate digital (CR and/or DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. The FDX Console is not for use in Mammography.
| 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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Image /page/3/Picture/0 description: The image shows the Fujifilm logo. The logo consists of the word "FUJIFILM" in a bold, sans-serif font, with a red square above the "I" in "FUJIFILM". Below the logo is the tagline "Value from Innovation" in a smaller, sans-serif font. The logo is simple and modern, and the tagline conveys the company's commitment to providing value through innovation.
510(k) Summary
FDX Console (DR-ID300CL) Software
Date: February 8, 2017
Submitter's Information:
FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT, 06902, USA
Contact Person:
| Name: | Peter Altman |
|---|---|
| Title: | Regulatory and Quality Consultant |
| Telephone: | (203) 602-3576 |
| Facsimile: | (203) 602-3785 |
Identification of the Device:
| Proprietary/Trade Name: | FDX Console (DR-ID300CL) Software | |||
|---|---|---|---|---|
| Classification Name: | Picture Archiving and Communications System | |||
| Regulations Number: | 21 CFR 892.2050 | |||
| Product Codes: | LLZ | |||
| Device Class: | Class II | |||
| Review Panel: | Radiology | |||
| Common Name: | Medical | Image | Processing | Workstation or Acquisition Workstation |
Identification of the Legally Marketed Predicate Devices:
-
- FDR D-EVO Flat Panel Detector System (DR-ID600) with Improved Virtual Grid Software, K153464 cleared 4/8/2016
-
- Fuji Medical CR Console, K041990, cleared 8/6/2004
DEVICE DESCRIPTION l.
The FDX Console is used by a radiographer for viewing Digital Radiography (DR) and Computed Radiography (CR) images for final quality assurance (QA) checking and image processing and optimization prior to transferring the images to external devices such as a PACS or a printer. Furthermore, when connected to Fuji Image Readers via a network, the FDX Console is used to enter patient ID information, exposure information, and in the case of CR register Image Plate (IP) barcode numbers. The FDX Console is compatible with the ACR/NEMA DICOM Version 3.0 standard.
The four primary features of the FDX Console are patient identification, exam selection, image processing, and image transmission.
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Image /page/4/Picture/0 description: The image shows the Fujifilm logo. The logo consists of the word "FUJIFILM" in a bold, sans-serif font, with a red square above the "I" in "FUJIFILM". Below the logo is the tagline "Value from Innovation" in a smaller, sans-serif font. The logo is simple and modern, and the tagline conveys the company's commitment to innovation.
- Patient Identification feature: Patient demographics can be manually . entered using a keyboard or captured from a RIS/HIS using DICOM Worklist Management. Also, a Touch screen monitor and barcode reader streamlines this data entry.
- Exam Selection feature: Select the patient, select the applicable exam, for CR barcode the Imaging Plate (IP), and touch Start to select the exam or use the DICOM Worklist Management feature with Auto Exam Select.
- . Image Processing feature: DR and CR Images are processed, displayed and reviewed prior to image transfer.
- Image Transmission feature: Images are transferred to other medical imaging devices for softcopy viewing or storage devices for archiving or to a printer for hardcopy film output.
INDICATIONS FOR USE ..............................................................................................................................................................................
The FDX Console is a workstation intended to associate digital (CR and/or DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. The FDX Console is not for use in Mammography.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS .
The FDX Console is a software device based upon the predicate devices. The modifications implemented in Version 10.0 do not alter the technological characteristics of the predicates, i.e., software is installed on off-the-shelf computer hardware running Microsoft Windows operating systems.
SUBSTANTIAL EQUIVALENCE IV.
The FDX Console Version 10.0 Software is substantially equivalent to the following legally marketed device:
| Legally Marketed Device | 510(k) # | Clearance Date |
|---|---|---|
| Fuji Medical CR Console Model Flash IIP | K041990 | 8/6/2004 |
| FDR D-EVO FPD System (DR-ID600) (includes theFDX Console Version 9.0 software) | K153464 | 4/8/2016 |
The CR Console has been chosen as the predicate device because it is the FDX Console's predecessor and therefore the general design including software, GUI, features, and capabilities are extremely similar. One of the major differences is that the FDX Console has the capability to acquire and process images from all Fujifilm digital radiography system whereas the CR Console was limited to Computed Radiography only.
The FDX Console version 9.0 software was cleared with the FDR D-EVO FPD System (DR-ID600) in K153464. It has exactly the same image processing software as the subject Version 10.0 device. The only differences are that FDX Console V10.0 will be able to use the Microsoft Windows 10 operating
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Image /page/5/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a small red square above the "I" in Fujifilm. Below the logo, the words "Value from Innovation" are written in a smaller font.
system and that this submission introduces the SmartController and RemoteDesktop software capabilities allowing remote operation of the FDX Console. The following comparison applies:
| Subject Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| FDX Console (DR-ID300CL) Software | FDX Console (DR-ID300CL) With Virtual GridSoftware Optionfor the FDR D-EVO FPDsystem (DR-ID600)(K153464 cleared4/8/2016) | Fuji CR Console (FlashIIP)(K041990 cleared8/6/2004) | |
| Indicationsfor UseIndicationsfor use foroptions | The FDX Console is aworkstation intended toassociate digital (CRand/or DR) images withpatient and examinformation, apply imageprocessing to facilitatediagnosis, display theimage, and output theresulting image andexam data for furtherdisplay, distribution, orarchiving. The FDXConsole is not for use inMammography. | The Wireless/Wired FDR D-EVO flat panel detectorsystem is intended to capturefor display radiographicimages of human anatomy. Itis intended for use in generalprojection radiographicapplications includingpediatric and neonatal examswherever conventional film/screen or CR systems maybe used. The FDR D-EVO isnot intended formammography, fluoroscopy,tomography, and angiographyapplications.The FDR D-EVO can be usedwith Virtual Grid Software,which is optional imageprocessing software installedon Fujifilm's FDX Console.Virtual Grid Software can beused in lieu of an anti-scattergrid to improve imagecontrast in generalradiographic images byreducing the effects of scatterradiation. | The Fuji CR Console is aCR modality workstationintended to associate digitalFCR images (exceptmammography images)with patient and examinformation, apply imageprocessing to facilitatediagnosis, display theimage, and output theresulting image and examdata for further display,distribution, or archiving.None. |
| None. | |||
| Image Processing Characteristics | |||
| SpatialFrequencyProcessing | Yes | Yes | Yes |
| TonalConversion | Yes | Yes | Yes |
| Dynamic RangeControlProcessing(DRC) | Yes | Yes | Yes |
| TomographicArtifactSuppressionProcessing(TAS) | Yes | Yes | Yes |
| GradationProcessing | Yes | Yes | Yes |
| Multi-ObjectiveFrequencyProcessing | Yes | Yes | Yes |
| Subject Device | Predicate Device | Predicate Device | |
| FDX Console (DR-ID300CL) Software | FDX Console (DR-ID300CL) With Virtual GridSoftware Optionfor the FDR D-EVO FPDsystem (DR-ID600)(K153464 cleared4/8/2016) | Fuji CR Console (FlashIIP)(K041990 cleared8/6/2004) | |
| (MFP)Flexible Noise | |||
| Control (FNC) | Yes | Yes | Yes |
| Grid PatternRemoval (GPR) | Yes | Yes | Yes |
| ImageAutomaticCompositionProcessing(ImageStitching) | Yes | Yes | Yes |
| CoRrectionFilter (CRF) | Yes | Yes | No |
| Imageprocessingwithoutnormalization | Yes | Yes | No |
| TomosynthesisOption | Yes | Yes | No |
| Dual EnergySubtraction(DES) Option | Yes | Yes | No |
| Virtual GridOption | Yes | Yes | No |
| ImprovedVirtual GridSoftware (VG2) | Yes | Yes | No |
| Miscellaneous | |||
| WorkstationSoftwareVersion | 10.0 | 9.0 | A11 |
| Transferimages toPACS | Yes | Yes | Yes |
| Enter Patientinfo manually | Yes | Yes | Yes |
| Enter Patientinfo from RIS | Yes | Yes | Yes |
| Select Exam | Yes | Yes | Yes |
| MinimumBasicComputerConfiguration(as provided inUS) | Model: HP ProDesk600 G2 Series SmallForm Factor PCProcessor: Intel Corei5-6500 with 3.2GHzRAM: 4GB (4x1GB)Hard Drive: 500GBCD/DVD: SlimSuperMulti DVD driveDisplay: 17 " or 21"color (touchscreen) | Model: Mini TowerProcessor: Core 2 DuoRAM: 2GBHard Drive: 80GBCD/DVD: DVD driveDisplay: 17 " or 21" color(touchscreen optional)Monitor.Accessories: Keyboard,Mouse, Barcode scanner | Model:DELL OptiplexGX260Processor: Pentium 4,3.06GHzHard Drive: 40GBRAM: 512MBDisplay: 17 " or 21" color(touchscreen optional)Monitor. |
| Subject DeviceFDX Console (DR-ID300CL) Software | Predicate DeviceFDX Console (DR-ID300CL) With Virtual GridSoftware Optionfor the FDR D-EVO FPDsystem (DR-ID600)(K153464 cleared4/8/2016) | Predicate DeviceFuji CR Console (Flash IIP)(K041990 cleared8/6/2004) | |
| optional) Monitor.Accessories:Keyboard, Mouse,Barcode scanner | |||
| OperatingSystem | Windows 10/Windows7 Professional 32-bit | Windows Vista/Windows 7Professional 32-bit | Windows 2000Professional |
| ImageTransfer | Same as Predicates | Standard networkconnectivity via DICOMprotocol & via Fuji DMSNetwork | Standard networkconnectivity via DICOMprotocol & via Fuji DMSNetwork |
| RemoteOperationCapability ofConsole | SmartController andRemote Desktop | None | None |
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Image /page/6/Picture/0 description: The image shows the Fujifilm logo. The logo consists of the word "FUJIFILM" in bold, black letters, with a red square above the "I". Below the word is the tagline "Value from Innovation" in a smaller font. The logo is simple and modern, and the tagline suggests that Fujifilm is a company that values innovation.
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Image /page/7/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a small red square above the "I" in Fujifilm. Below the logo, the words "Value from Innovation" are written in a smaller, black font.
V. SUMMARY OF STUDIES
Non-clinical Performance Data: The FDX Console conforms to the following voluntary standards:
| Standard | Title |
|---|---|
| DICOM, V3.0 2007 | Digital Imaging and Communications inMedicine (DICOM) |
| IEC 62304: 2006 | Medical Device Software – Software LifeCycle Processes |
| IEC 62366: 2014 | Medical devices – Application of usabilityengineering to medical devices |
As required by the risk analysis, all verification and validation activities related to the FDX Console were performed and the results were satisfactory. The verification and validation results are provided in the submission.
Clinical Performance Data: Clinical studies were not required as there is no change in image processing. The substantial equivalence has been demonstrated by nonclinical studies.
VI. CONCLUSION
Based upon the supporting data summarized above, we concluded the FDX Console (DR-ID300CL) Software is as safe and effective as the legally marketed devices K041990 andK153464 and does not raise different questions of safety and effectiveness than the predicate devices.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).