SCENARIA View

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FUJIFILM Healthcare Corporation % Dennis Domoracki Senior Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 LEXINGTON MA 02421 ### Re: K213829 Trade/Device Name: SCENARIA View Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: April 26, 2022 Received: April 28, 2022 #### Dear Dennis Domoracki: 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. 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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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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 (QS) 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 medical devices and radiation-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 DHT 8B: Division of Radiological Imaging and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 4-1 510(k) Number (if known) #### K213829 Device Name SCENARIA View #### Indications for Use (Describe) The SCENARIA View system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The SCENARIA View system can also be used for interventional needle guidance. Volume datasets acquired by a SCENARIA View system can be post-processed in the SCENARIA View system to provide additional information. Post-processing capabilities of the SCENARIA View software include, multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by a SCENARIA View system can be transferred to external devices via a DICOM standard interface. The Low Dose CT Lung Cancer Screening Option for the SCENARIA View system is indicated for using low dose CT for lung cancer screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or FUJIFILM Healthcare Americas Corporation. Type of Use (Select one or both, as applicable) | ☑ Research Use Only (RUO) Labeling | ☐ For Further Manufacturing Use Only (FFMUO) Labeling | |------------------------------------|-------------------------------------------------------| |------------------------------------|-------------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Below the logo is the text 'Value from Innovation' in a smaller font. **Value from Innovation** # K213829 510(k) Summary ## Submitter Information | Submitter: | FUJIFILM Healthcare Corporation | |-------------------|--------------------------------------------------------| | | 2-1, Shintoyofuta, | | | Kashiwa-Shi, Chiba, JP 277-0804 | | Contact: | Dennis Domoracki, Senior Regulatory Affairs Specialist | | Telephone number: | (330)-425-1313 Ext:2792 | | E-mail: | dennis.domoracki@fujifilm.com | | Date: | December 3, 2021 | ## Subject Device Name | Trade/Proprietary Name: | SCENARIA View | |-------------------------|------------------------------------------| | Regulation Number: | 21 CFR 892.1750 | | Regulation Name: | Computed tomography x-ray system | | Product Code | JAK, System, X-Ray, Tomography, Computed | | Class | II | | Panel | Radiology | ## Predicate Device Name | Predicate Device(s): | SCENARIA View (K200498) | |----------------------|------------------------------------------| | Regulation Number: | 21 CFR 892.1750 | | Regulation Name: | Computed tomography x-ray system | | Product Code | JAK, System, X-Ray, Tomography, Computed | | Class | II | | Panel | Radiology | # Indications for Use The SCENARIA View system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The SCENARIA View system can also be used for interventional needle guidance. Volume datasets acquired by a SCENARIA View system can be post-processed in the SCENARIA View system to provide additional information. Post-processing capabilities of the SCENARIA View software include, multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by a SCENARIA View system can be transferred to external devices via a DICOM standard interface. The Low Dose CT Lung Cancer Screening Option for the SCENARIA View system is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or Hitachi. ## Device Description ## Function The SCENARIA View is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Fujifilm logo in black with a red square above the letter 'I'. The logo is in a bold, sans-serif font. The logo is simple and modern, and it is easily recognizable. **Value from Innovation** ### Scientific Concepts The SCENARIA View system uses 128-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 64 slices of data simultaneously. The X-ray sub-system features a high frequency generator, X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles. The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system. ### Physical and Performance Characteristics The SCENARIA View system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories. The system performance is similar to the predicate device. ### Performance Comparison A clinical evaluation comparison was conducted with the SCENARIA View system and the predicate device (K200498) and found to be substantially equivalent as documented in Section 10 - Performance. In addition, evaluations were conducted for dose profile, image noise, Modulation Transfer Function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index as documented in Section 10 - Performance. The evaluation results confirm the performance characteristics of the SCENARIA View are comparable to the predicate device and support our conclusion that the subject system is substantially equivalent. # Device Technological Characteristics A summary of the differences is listed in the following table. | Systems | SCENARIA View<br>Subject Device | SCENARIA View (K200498)<br>Predicate Device | |--------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------| | Physical characteristics | Image: SCENARIA View Subject Device | Image: SCENARIA View (K200498) Predicate Device | | Gantry | The only difference is the Input Voltage has changed to 380/400/480 from 380/400. | | | Detector | There are no differences between the two systems. | | | X-ray Tube | There are no differences between the two systems. | | | X-ray Generator | There are no differences between the two systems. | | | Patient Table | There are no differences between the two systems. | | | Display | There are no differences between the two systems. | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Fujifilm logo. The logo is black with a red accent on the "i". Below the logo, the words "Value from Innovation" are written in a smaller font. The logo is simple and modern. **Value from Innovation** | Systems | SCENARIA View | SCENARIA View (K200498) | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | | Subject Device | Predicate Device | | Image Storage | The Hard Disk has changed to Image: 1 [TB], Raw Data CT-OC-22 : 3 [TB], and<br>Raw Data CT-OC-23B : 2 [TB]. | | | Scanning, Reconstruction | There are no differences between the two systems. | | | Performance | There are no differences between the two systems. | | | Dose Controls | There are no differences between the two systems. | | | Dose Displays | There are no differences between the two systems. | | | Features | The Image Analysis on External PC (Hyper Q-net V, Exam Split on Hyper Q-Net V), Intelli IPV<br>Image Improvement, and Motion Compensate Reconstruction (MCR), features have been<br>added or improved. | | Therefore, based on a thorough analysis and comparison of subject device (SCENARIA View) and the predicate device, the technological characteristics do not impact safety and effectiveness. # Substantial Equivalence A summary decision was based on a thorough analysis and comparison of the functions, scientific concepts, physical and performance characteristics, performance comparison and technological characteristics. | ITEM | OVERALL RATIONALE ANALYSIS | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Gantry | Input Voltage 480V is added. | | Detector | No changes | | X-ray Tube | No changes | | X-ray Generator | No changes | | Patient Table | No changes | | Display | No changes | | Image Storage | Size of Raw Data Hard Disk (CT-OC-23B) is reduced. However, max number<br>of Raw Data (6000 scan) is not changed. | | Scanning,<br>Reconstruction | No changes | | Performance | No changes | | Dose Controls | No changes | | Dose Displays | No changes | | Features | Some of image analysis is allowed on external PC connected to the CT device.<br>These analyzes are the same as those implemented in the predicate device.<br>Low contrast enhancement for head is added. It is improvement of Intelli IPV<br>already implemented on the predicate device.<br>MCR is an image reconstruction feature that reduces motion artifacts. | Therefore, based on a thorough analysis and comparison of the functions, scientific concepts, physical and performance characteristics, performance comparison and technological characteristics, the proposed SCENARIA View is considered substantially equivalent to the currently marketed predicate device (SCENARIA View (K200498)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a red square on top of the letter "I". Below the logo is the text "Value from Innovation". **Value from Innovation** # Summary of Non-Clinical Testing This device complies with all applicable requirements for Dose Profile. Noise. Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, and CT dose index. In addition, the SCENARIA View system is in conformance with the applicable parts of the following standards: - 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 (IEC 60601-1:2005, MOD) - IEC 60601-1-2 Edition 4.0 . Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests - . IEC 60601-1-3 Edition 2.1 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment - . IEC 60601-1-6 Edition 3.1 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability - IEC 60601-2-44 Edition 3.2 Medical electrical equipment Part 2-44: particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography. - . IEC 62304 Edition 1.1 Medical device software - Software life cycle processes - . IEC 62366 Edition 1.1 Medical devices - Application of usability engineering to medical devices - NEMA XR 25 Computed Tomography Dose Check - NEMA XR-26 Access Controls for Computed Tomography - . NEMA XR29 Standard Attributes on CT Equipment Related to Dose Optimization and Management ## Summary of Performance Testing | Testing Type | Rationale Analysis | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Testing - Bench | There is no change is the following performance issues:<br>Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, Tomographic<br>Section Thickness and Sensitivity Profile, Tomographic Plane Location, CT Dose Index. | | Performance Testing - Clinical | FUJIFILM has conducted an evaluation to assess the effectiveness of the images<br>reconstructed by using MCR and a summary of the results is contained in an explanatory<br>document in the Specification section. | # Conclusions FUJIFILM believes that, based on the information included in the submission, SCENARIA View subject device is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the SCENARIA View (K200498).