Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 31, 2017 FUJIFILM Medical Systems U.S.A., Inc. % Dharaben Desai Sr. Regulatory Affairs Specialist 419 West Avenue STAMFORT CT 06902 Re: K163624 Trade/Device Name: Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: May 23, 2017 Received: May 24, 2017 Dear Dharaben Desai: This letter corrects our substantially equivalent letter of June 30th, 2017. 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. 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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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) ### Device Name Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600). ### Indications for Use (Describe) Dynamic Visualization II Image Processing is an optional software for the FDX Console, intended to provide optimized image quality over a wide range of patient thicknesses, especially for bariatric imaging. The device is not intended for mammography use. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary # Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of DR-ID600) ## Date: May 23, 2017 ## Submitter's Information: FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT, 06902, USA ## Contact Person: | Name: | Dharaben Desai | |------------|-----------------------------------| | Title: | Sr. Regulatory Affairs Specialist | | Telephone: | (203) 276-3445 | | Facsimile: | (203) 602-3785 | ## Identification of the Device: | Proprietary/Trade Name: | Dynamic Visualization II Image Processing Option<br>for the FDX Console (DR-ID300CL of DR-ID600) | |-------------------------|--------------------------------------------------------------------------------------------------| | Classification Name: | Stationary X-ray system | | Regulations Number: | 21 CFR 892.1680 | | Product Codes: | MQB | | Device Class: | Class II | | Review Panel: | Radiology | | Common Name: | Flat Panel Digital Detector System | # Identification of the Legally Marketed Predicate Device: FDR D-EVO Flat Panel Detector System (DR-ID600) with Improved Virtual Grid Software, K153464 cleared 4/8/2016 #### l. DEVICE DESCRIPTION Fujifilm's FDR D-EVO Flat Panel Detector System (DR-ID600) is a portable digital detector system that interfaces with, and acquires and digitizes x-ray exposures, from standard radiographic svstems. The FDR D-EVO is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, pediatrics and neonates. The detector models support both wireless and wired/tethered data communication between the detector and the system. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid exams. The Acquisition Workstation for the DR-ID600 is the FDX Console. Dynamic Visualization II Image Processing (DVII) is optional software included in v9.0 of the FDX Console. The FDX Console and Dynamic Visualization II software may be used with Fujifilm DR and CR X-ray systems. {4}------------------------------------------------ Dynamic Visualization II is an enhanced version of Fujifilm's Dynamic Visualization™ (DV) image processing software. The enhancements made to DVII are designed to provide optimized image quality over a wide range of patient thicknesses, and can be particularly useful when imaging bariatric patients. DVII uses the same image processing sequence as the predicate DV, but the EDR (Exposure Data Recognition) and MFP (Multi-objective Frequency Processing) algorithms have been modified. When compared to the current EDR and MFP algorithms, the corresponding new algorithms (EDR2, MFP2) have been modified as follows: EDR2 - to identify and optimize various anatomic structures in an acquired image prior to the subsequent application of contrast and sharpness image processing steps, EDR2 uses a feature recognition method as opposed to conventional EDR's histogram analysis method. MFP2 - similar to MFP, MFP2 sharpens and balances contrast in anatomic structures in an image after being subject to Exposure Data Recognition. MFP2 uses additional low frequency tables and a combination of automatic and preset dynamic range control operations. #### II. INDICATIONS FOR USE Dynamic Visualization II Image Processing is an optional software for the FDX Console, intended to provide optimized image quality over a wide range of patient thicknesses, especially for bariatric imaging. The device is not intended for mammography use. #### . SUMMARY OF TECHNOLOGICAL CHARACTERISTICS FDR D-EVO FPD System (DR-ID600) continues to offer 600 series detectors with two different scintillator materials - GOS (Gadolinium oxysulfide) or Csl (Cesium lodide) - and various detector sizes to choose from. All detector characteristics including indirect conversion method using Fujifilm's unique Irradiated Side Sampling (ISS) technology, pixel pitch (150µm), resolution (16 bit), DQE (Detective Quantum Efficiency) measurements, MTF (Modulation Transfer Function) performance remains the same. The wireless communication feature, and automatic x-ray detection function (known as 'SmartSwitch' in the US) also stay unaffected by the changes. The same acquisition workstation, FDX Console will continue to support FDR D-EVO FPD System (DR-ID600). FDX Console v9.0 or later will release the Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600). | | Subject/Modified Device<br>Dynamic Visualization II Image<br>Processing Option for the FDX<br>Console (DR-ID300CL of the DR-<br>ID600) | Predicate Device<br>FDX Console (DR-ID300CL) With<br>Virtual Grid Software Option<br>for the FDR D-EVO FPD system (DR-<br>ID600)<br>(K153464 cleared 4/8/2016) | |-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use<br>of the DR D-EVO<br>FPD system DR-<br>ID600 | The Wireless/Wired FDR D-EVO flat<br>panel detector system is intended to<br>capture for display radiographic<br>images of human anatomy. It is | The Wireless/Wired FDR D-EVO flat<br>panel detector system is intended to<br>capture for display radiographic<br>images of human anatomy. It is | | | Subject/Modified Device | Predicate Device | | | Dynamic Visualization II Image<br>Processing Option for the FDX<br>Console (DR-ID300CL of the DR-<br>ID600) | FDX Console (DR-ID300CL) With<br>Virtual Grid Software Option<br>for the FDR D-EVO FPD system (DR-<br>ID600)<br>(K153464 cleared 4/8/2016) | | (unchanged) | intended for use in general projection<br>radiographic applications including<br>pediatric and neonatal exams<br>wherever conventional film /screen<br>or CR systems may be used. The<br>FDR D-EVO is not intended for<br>mammography, fluoroscopy,<br>tomography, and angiography<br>applications. | intended for use in general projection<br>radiographic applications including<br>pediatric and neonatal exams<br>wherever conventional film /screen or<br>CR systems may be used. The FDR<br>D-EVO is not intended for<br>mammography, fluoroscopy,<br>tomography, and angiography<br>applications. | | Indications for use<br>for option | Dynamic Visualization II Image<br>Processing is an optional software<br>for the FDX Console, intended to<br>provide optimized image quality over<br>a wide range of patient thicknesses,<br>especially for bariatric imaging. The<br>device is not intended for<br>mammography use. | The FDR D-EVO can be used with<br>Virtual Grid Software, which is<br>optional image processing software<br>installed on Fujifilm's FDX Console.<br>Virtual Grid Software can be used in<br>lieu of an anti-scatter grid to improve<br>image contrast in general<br>radiographic images by reducing the<br>effects of scatter radiation. | | Option for | Same as Predicate | FDX Console of the Wireless/Wired<br>FDR D-EVO flat panel detector<br>system DR-ID600 | | | Image Processing Characteristics | | | Dynamic<br>Visualization<br>Algorithm | DV II uses a combination of EDR2<br>and MFP2 | DV uses a combination of EDR and<br>MFP | | Exposure Data<br>Recognizer<br>Algorithm (EDR) | EDR2- to identify and optimize<br>various anatomic structures in an<br>acquired image prior to the<br>subsequent application MFP2<br>processing, EDR2 uses a feature<br>recognition method to identify<br>direct x-ray, bone, tissue, and<br>artificial object regions | EDR- uses the conventional histogram<br>analysis method prior to the<br>subsequent application MFP<br>processing. | | Frequency Noise<br>Control (FNC) | Same as Predicate | Performs noise suppression | | Multi objective<br>Frequency<br>Processing (MFP) | MFP2 performs Spatial Frequency<br>Enhancement and Dynamic<br>Range Control similar to that of<br>MFP, but with two new lower<br>frequency bands and automated<br>Dynamic Range Control Features. | MFP performs Spatial Frequency<br>Enhancement and Dynamic Range<br>Control using six frequency bands and<br>fixed Dynamic Range Control<br>Features. | | Gradation<br>Processing (Gp) | Same | Performs global brightness and<br>contrast adjustment following MFP<br>processing. | | | Miscellaneous | | | Available flat panel<br>detectors | Same | Same | | Detector Wireless<br>Features | Same | Same | | | Subject/Modified Device | Predicate Device | | | Dynamic Visualization II Image<br>Processing Option for the FDX<br>Console (DR-ID300CL of the DR-<br>ID600) | FDX Console (DR-ID300CL) With<br>Virtual Grid Software Option<br>for the FDR D-EVO FPD system (DR-<br>ID600)<br>(K153464 cleared 4/8/2016) | | Auto X-ray detection<br>feature | Same | Same | | Workstation<br>Software Version | Same as Predicate | FDX Console Version 9.0 | | Minimum Basic<br>Computer<br>Configuration (as<br>provided in US) | Model: HP ProDesk 600 G2 Series<br>Small Form Factor PC<br>Processor: Intel Core i5-6500 with<br>3.2GHz<br>RAM: 4GB (4x1GB)<br>Hard Drive: 500GB<br>CD/DVD: Slim SuperMulti DVD<br>drive<br>Display: 17 " or 21" color<br>(touchscreen optional) Monitor.<br>Accessories: Keyboard, Mouse,<br>Barcode scanner | Model: Mini Tower<br>Processor: Core 2 Duo<br>RAM: 2GB<br>Hard Drive: 80GB<br>CD/DVD: DVD drive<br>Display: 17 " or 21" color (touchscreen<br>optional) Monitor.<br>Accessories: Keyboard, Mouse,<br>Barcode scanner | | Operating System | Windows 7 Professional 32-bit | Windows Vista/Windows 7<br>Professional 32-bit | | Image Transfer | Same as Predicate | Standard network connectivity via<br>DICOM protocol & via Fuji DMS<br>Network | {5}------------------------------------------------ {6}------------------------------------------------ #### IV. SUBSTANTIAL EQUIVALENCE The FDR D-EVO FPD System (DR-ID600) with the Dynamic Visualization II Image Processing Option is substantially equivalent to the following legally marketed device: | Legally Marketed Device | 510(k) # | Clearance Date | |----------------------------------------------------------------------------------------|----------|----------------| | FDR D-EVO Flat Panel Detector System (DR-ID600)<br>with Improved Virtual Grid Software | K153464 | 4/8/2016 | The FDX Console version 9.0 software was cleared with the FDR D-EVO FPD System (DR-ID600) in K153464. The FDR D-EVO's detector characteristics as well as other maior features such as wireless communication and automatic x-rav detection function ('SmartSwitch') remain unchanged. The FDR D-EVO can be used with or without the Dynamic Visualization II Image Processing Option, and the improvements do not affect the intended use or alter the fundamental scientific technology of the legally marketed device. The only change between the predicate device and the proposed device of this submission is the addition of the Dynamic Visualization II Image Processing Option, which is an improvement of the Dynamic Visualization option available with the predicate device. #### V. SUMMARY OF STUDIES Non-clinical Performance Data: The conformity to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, IEC 62494-1 and DICOM remains unaffected. As required by the risk analysis, all verification and validation activities related to the improvements made to the {7}------------------------------------------------ Dynamic Visualization II Image Processing Option were performed and the results were satisfactory. FUJIFILM conducted a comparative image quality evaluation between the predicate device Dynamic Visualization (DV) and the proposed modified device, Dynamic Visualization II (DV2). Raw clinical images were processed with the predicate image processing algorithms (DV), and then the raw images were processed using the proposed image processing algorithms (DV2). Randomized image pairs (DV vs. DV2) were then evaluated by three readers. Slightly more than half of the images were of bariatric patients. The results of the evaluation demonstrates that DV2 optimizes image quality for all patients, even when images of larger patients are processed using the proposed, modified device. Clinical Performance Data: The changes do not require clinical studies. The substantial equivalence has been demonstrated by non-clinical studies. #### VI. CONCLUSION Based upon the supporting data summarized above. FMSU concludes the Dynamic Visualization II Image Processing Option offered with FDR D-EVO Flat Panel Detector System (DR-ID600) is as safe and effective as the legally marketed device K153464 and does not raise different questions of safety and effectiveness than K153464.