(235 days)
The SCENARIA Phase 3 system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes.
The volume datasets acquired by the SCENARIA Phase 3 can be post processed by the SCENARIA Phase 3 to provide additional information. Post processing capabilities included in the SCENARIA Phase 3 software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the SCENARIA Phase 3 can be transferred to external devices via a DICOM standard interface.
The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
The SCENARIA Phase 3 is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles. The system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories. The 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.
The provided text describes the 510(k) premarket notification for the HITACHI SCENARIA Phase 3 Whole-body X-ray CT System, asserting its substantial equivalence to a predicate device (SCENARIA Phase 2 Whole-body X-ray CT System, K123509). The document focuses on demonstrating that the new device has comparable performance and technological characteristics to the predicate device, rather than proving that it meets specific, quantitative acceptance criteria for diagnostic accuracy through a controlled study.
Therefore, many of the requested items (e.g., sample size for test set, ground truth experts, adjudication methods, MRMC study, standalone performance, training set size) are not explicitly detailed in the provided document, as the submission strategy is based on demonstrating substantial equivalence to a previously cleared device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not presented in a traditional "pass/fail" format with numerical thresholds for diagnostic accuracy metrics. Instead, the "acceptance criteria" are implied by the demonstration of comparable performance to the predicate device for various technical parameters and a judgment of clinical usability of example images.
| Testing Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Performance Testing - Bench | Meeting the conditions of 21 CFR 1020.33(c) or (g) for specific parameters, and demonstrating equivalent basic performance as the predicate device (SCENARIA Phase 2). This includes: Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, CT dose index. | Confirmed that the tested items (Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, CT dose index) met the conditions of 21 CFR 1020.33(c) or (g). Showed equivalent basic performance as the predicate device. |
| Performance Testing - Clinical Usability | Sufficient clinical image examples to judge clinical usability, covering the general anatomy outlined in the indications for use, and comparable to the anatomy examples provided for the predicate device. | Five clinical image examples were provided and judged to be sufficient to judge clinical usability. These examples covered general anatomy and were comparable to the predicate. |
| Technological Characteristics | The technological characteristics should not impact safety and effectiveness, and the device should be generally equivalent to the predicate device in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Any differences from the predicate device (e.g., in reconstruction time, dose controls, or specific features) must be analyzed to show no significant changes in technological characteristics or new intended use, and that they do not affect system image performance. | The analysis concluded that the new features and minor differences (e.g., reduced reconstruction time, new IntelliEC Plus, ECG Dose Modulation, Access Control, Preview Scan, Priority Recon, Exam Split, Quality Exam) do not constitute a new intended use, a significant change in technological characteristics, or do not affect system image performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: "Five clinical image examples" were provided for the clinical evaluation. This is a very small sample, used for qualitative judgment of usability and comparability, not for statistical performance evaluation.
- Data Provenance: The document does not specify the country of origin of the clinical data. It is implied these were collected as part of the device's development or validation. It is a prospective collection for the purpose of this submission as "Clinical images were collected and analyzed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states: "We provide five clinical image examples which we judged to be sufficient to judge a clinical usability." It does not specify the number or qualifications of the individuals who performed this judgment.
4. Adjudication Method (for the test set)
No adjudication method is described. The text only mentions that "we judged" the examples to be sufficient.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed to assess human reader improvement with or without AI assistance. The device is a CT system itself, not an AI-assisted diagnostic tool that augments human interpretation in the sense of comparing human performance with and without an AI algorithm.
6. Standalone (Algorithm Only) Performance
This document describes a CT imaging system. The performance metrics reported (e.g., spatial resolution, low-contrast resolution) are for the system's image acquisition and reconstruction capabilities themselves, which represent its "standalone" performance as an imaging device. The device itself is the "algorithm only" in the context of image generation. It's not an AI diagnostic algorithm that processes images; it's the image acquisition and processing hardware and software for a CT scanner.
7. Type of Ground Truth Used
For the clinical evaluation, the "ground truth" was a subjective assessment of "clinical usability" and "comparability" to the predicate device's examples. For bench testing, the ground truth was based on adherence to regulatory standards (21 CFR 1020.33) and technical specifications (e.g., IEC standards, NEMA standards) for image quality parameters (dose, noise, spatial resolution, etc.), established through phantom studies and measurements.
8. Sample Size for the Training Set
There is no mention of a "training set" in the context of machine learning, as this device is a CT imaging system and not primarily an AI algorithm for diagnostic interpretation that would require a distinct training set of labeled data in the sense of deep learning. The "training" for the device's image reconstruction algorithms would be inherent in its design and engineering based on physics and mathematical principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a traditional machine learning training set with external ground truth labels is not described or relevant for this type of device submission. The device's performance is validated against physical and regulatory standards.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping and connected by flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2015
Hitachi Medical Systems America, Inc. % Mr. Doug Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K150595
Trade/Device Name: HITACHI SCENARIA Phase 3 Whole-body X-ray CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 2, 2015 Received: October 6, 2015
Dear Mr. Thistlethwaite:
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.
{1}------------------------------------------------
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 Oaks
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150595
Device Name
HITACHI SCENARIA Phase 3 Whole-body X-ray CT System
Indications for Use (Describe)
The SCENARIA Phase 3 system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes.
The volume datasets acquired by the SCENARIA Phase 3 can be post processed by the SCENARIA Phase 3 to provide additional information. Post processing capabilities included in the SCENARIA Phase 3 software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the SCENARIA Phase 3 can be transferred to external devices via a DICOM standard interface.
The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
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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Section 5
510(k) Summary
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| Submitter: | Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44087-2371 |
|---|---|
| Contact: | Douglas J. Thistlethwaite |
| Telephone number: | 330-425-1313 |
| Telephone number: | 330-963-0749 |
| E-mail: | thistlethwaited@hitachimed.com |
| Date: | February 26, 2015 |
Submitter Information
Device Name
| 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 |
| Trade/Proprietary Name: | SCENARIA Phase 3 Whole-body X-ray CT System |
| Predicate Device(s): | SCENARIA Phase 2 Whole-body X-ray CT System (K123509) |
Device Intended Use
The SCENARIA Phase 3 system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes,
The volume datasets acquired by the SCENARIA Phase 3 can be post processed by the SCENARIA Phase 3 to provide additional information. Post processing capabilities included in the SCENARIA Phase 3 software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the SCENARIA Phase 3 can be transferred to external devices via a DICOM standard interface.
The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
Device Description
Function
The SCENARIA Phase 3 is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles.
Scientific Concepts
The SCENARIA Phase 3 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.
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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 Phase 3 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
Evaluations were conducted for dose profile, image noise, Modulation Transfer Function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index and also found to be substantially equivalent.
A clinical evaluation comparison was conducted with the SCENARIA Phase 3 system and the SCENARIA Phase 2 System (K123509) and found to be substantially equivalent.
A rationale analysis was then conducted and the results are contained in Table 1.
| Testing Type | Rationale Analysis |
|---|---|
| Performance Testing - Bench | We generated bench data based on IEC61223-3-5.We confirmed that the items (Dose Profile, Noise, Mean CT number and Uniformity, Sparial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, CT dose index) which we tested met the conditions of 21 CFR 1020.33(c) or (g).This shows that SCENARIA Phase3 has equivalent basic performance as the predicate device, SCENARIA Phase2. |
| Performance Testing - Clinical | We provide five clinical image examples which we judged to be sufficient to judge a clinical usability. The five covered the general anatomy outlined in the indications for use and are comparable to the anatomy examples provided for the predicate. |
Table 1 Performance Comparison Analysis
The analysis confirms the performance characteristics of the SCENARIA Phase 3 system are comparable to the predicate device and support our conclusion that the SCENARIA Phase 3 system is substantially equivalent.
Device Technological Characteristics
The technological characteristics of the SCENARIA Phase 3 and the predicate device are listed in Table 2.
| ITEM | HITACHI SCENARIA PHASE 3 | HITACHI SCENARIA PHASE 2 (K123509) | Difference Analysis |
|---|---|---|---|
| Gantry | |||
| Geometry | Rotate-rotate with offset detector system,slip ring | Rotate-rotate with offset detector system,slip ring | No |
| Scan Time | 0.35, 0.4, 0.5, 0.75, 1.0, 2.0 [s] | 0.35, 0.4, 0.5, 0.75, 1.0, 2.0 [s] | No |
| X-ray Fan Beam Angle | 51[deg] | 51[deg] | No |
| Gantry Tilt | -30 to +30 [deg] | -30 to +30 [deg] | No |
| Gantry Aperture | 750 [mm] | 750 [mm] | No |
| Gantry Dimensions | 2350 x 880 x 2030 [mm] | 2350 x 880 x 2030 [mm] | No |
| Gantry Weight | 2235 [kg] | 2235 [kg] | No |
| Scan Localizer | Laser | Laser | No |
| ITEM | HITACHI SCENARIA PHASE 3 | HITACHI SCENARIA PHASE 2 (K123509) | Difference Analysis |
| Detector | |||
| Type | Solid state | Solid state | No |
| Number of Channels | 888 [ch] (8ch reference) | 888 [ch] (8ch reference) | No |
| Number of Rows | 64 | 64 | No |
| Number of Slices | 64, 128 [slice/scan] (Axial) | 64, 128 [slice/scan] (Axial) | No |
| X-ray Tube | |||
| Anode Heat Storage | 7.5 [MHU] | 7.5 [MHU] | No |
| Dissipation Rate | 1,386 [kHU/min] | 1,386 [kHU/min] | No |
| Tube cooling | Cooling Fluid/air | Cooling Fluid/air | No |
| Tube focal spot | Dual 0.7 x 0.8, 1.2 x 1.4 [mm] | Dual 0.7 x 0.8, 1.2 x 1.4 [mm] | No |
| X-ray Generator | |||
| kW Output | 72 [kW] | 72 [kW] | No |
| Max. Power Input | 100 [kVA] | 100 [kVA] | No |
| kVp Range | 80, 100, 120, 140 [kVp] | 80, 100, 120, 140 [kVp] | No |
| mA Range | 10 to 600 [mA] @120kV, 72kW | 10 to 600 [mA] @120kV, 72kW | No |
| Patient Table | |||
| Range of Movement, Vertical | 465 to 1050 [mm] (CT-WT-19) | 465 to 1050 [mm] (CT-WT-19) | No |
| Range of Movement, Longitudinal | 2110 [mm] | 2110 [mm] | No |
| Range of Movement, Lateral | -80 to +80 [mm] (CT-WT-19) | -80 to +80 [mm] (CT-WT-19) | No |
| Scannable Range | 175 cm | 175 cm | No |
| Maximum Load Capacity | 230 [kg] | 230 [kg] | No |
| Display | |||
| Monitor Type | 24" LCD | 24" LCD | No |
| Matrices, Pixels | 1920 x 1200 | 1920 x 1200 | No |
| Image Enlargements | Up to 9.99x | Up to 9.99x | No |
| Max. Slices Displayed at Once | 25 | 25 | No |
| Image Storage | |||
| Hard Disk | 250 [GB] (images), | 250 [GB] (images), | No |
| 750 [GB] (raw data) | 750 [GB] (raw data) | ||
| Storage Images | 200,000 | 200,000 | No |
| Archival Storage (Media) | DVD-RAM, DVD-R/RW, | DVD-RAM, DVD-R/RW, | No |
| CD-R/RW | CD-R/RW | ||
| Scanning, Reconstruction | |||
| Localization Scan | Real time | Real time | No |
| Localization Scan Length | 150, 250, 350, 500, 750, | 150, 250, 350, 500, 750, | No |
| 1000, 1250, 1500, 1750 [mm] | 1000, 1250, 1500, 1750 [mm] | ||
| Max. Scan Time | 100 [s] | 100 [s] | No |
| Helical Beam Pitch | 0.58, 0.83, 1.08, 1.33, 1.58 | 0.58, 0.83, 1.08, 1.33, 1.58 | No |
| @40mm Collimation | @40mm Collimation | ||
| Collimation | 1.25, 5, 10, 15, 20, 40 [mm] | 1.25, 5, 10, 15, 20, 40 [mm] | No |
| Reconstruction Matrix | 512 x 512 [pix] | 512 x 512 [pix] | No |
| Reconstruction FOVs | 20 to 500 [mm] | 20 to 500 [mm] | No |
| Slice Thickness | 0.625, 1.0, 1.25, 2.5, 3.75,5.0, 7.5, 10.0 [mm] | 0.625, 1.0, 1.25, 2.5, 3.75,5.0, 7.5, 10.0 [mm] | No |
| Range of CT numbers | -2000 to +4000 (13bit) | -2000 to +4000 (13bit) | No |
| -32768 to +32767 (16bit) | -32768 to +32767 (16bit) | ||
| Reconstruction Time | 0.056 seconds per image or less | 0.056 seconds per image or less | See 01 |
| Performance | |||
| High-contrast spatial resolution | 0.35 [mm] | 0.35 [mm] | No |
| Low-contrast resolution mm at % | 2.5 [mm] @ 0.25% | 2.5 [mm] @ 0.25% | No |
| at <4 rads | |||
| 10% MTF | 14.7 [lp/cm] | 14.7 [lp/cm] | No |
| 50% MTF | 12.2 [lp/cm] | 12.2 [lp/cm] | No |
| Dose Controls | |||
| Bow Tie Filter | Yes. Small / Normal | Yes. Small / Normal | No |
| Automatic Exposure Control | Yes. IntelliEC, IntelliEC Plus | Yes. IntelliEC | See 02 |
| ITEM | HITACHI SCENARIA PHASE 3 | HITACHI SCENARIA PHASE 2 (K123509) | Difference Analysis |
| Longitudinal Modulation | Yes | Yes | No |
| Angular Modulation | Yes | Yes | No |
| Iterative Reconstruction | Yes. Intelli IP Advanced Mode. | Yes. Intelli IP Advanced Mode | No |
| Maximum possible pitch with fullimage quality | 1.58 | 1.58 | No |
| Dose Displays | |||
| CTDIv | Yes | Yes | No |
| DLP | Yes | Yes | No |
| Features | |||
| Axial Scan | Yes | Yes | No |
| Helical Scan | Yes | Yes | No |
| Dynamic Scan | Yes | Yes | No |
| Predict Scan | Yes | Yes | No |
| ECG Retrospective Scan(Helical) | Yes | Yes | No |
| ECG Prospective Scan(Axial) | Yes | Yes | No |
| guideShot Scan | Yes | Yes | No |
| Automatic Exposure Control | Yes. IntelliEC | Yes. IntelliEC | No |
| Automatic Exposure Controlconsidering the level of IterativeReconstruction | Yes. IntelliEC Plus | No. | See 03 |
| ECG Dose Modulation | Yes. IntelliEC Cardiac | No. | See 04 |
| Adaptive Filter | Yes. Intelli IP Normal | Yes. Intelli IP Normal | No |
| Iterative Reconstruction | Yes. Intelli IP Advanced | Yes. Intelli IP Advanced | No |
| Injector Synchronization | Yes | Yes | No |
| Dose Check | Yes | Yes | No |
| Access Control | Yes | No | See 05 |
| Automatic Cardiac Phase Search | Yes. CardioHarmony | Yes. CardioHarmony | No |
| Preview Scan | Yes | No | See 06 |
| Double Slice at Axial Scan | Yes. Fine Recon | Yes. Fine Recon | No |
| Priority Recon. | Yes | No | See 07 |
| Dose Report | Yes. Simple Dose Report | Yes. Simple Dose Report | No |
| DICOM | Yes | Yes | No |
| ID Reader | No | No | No |
| Exam Split | Yes | No | See 08 |
| Multi-Planar Reconstruction (MPR) | Yes | Yes | No |
| Volume Rendering | Yes | Yes | No |
| CT Angiography (CTA) | Yes | Yes | No |
| Segmentation | Yes | Yes | No |
| Retouch | Yes | Yes | No |
| Quality Exam | Yes | No | See 09 |
Table 2 Technological Characteristic Differences
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The differences from the predicate device to SCENARIA Phase 3 are explained in Table 3. Table 3 Analysis of Differences
| Scanning, Reconstruction | ||
|---|---|---|
| 01 | Image reconstruction time is reduced by enhancing usage efficiency of the image reconstruction system hardware. | |
| Dose Controls | ||
| 02 | This function had been added to SCENARIA Phase 3 by modifying IntelliEC installed in SCENARIA Phase 2. Thisfunction performs IntelliEC with previously factored-in noise reduction rate of Intelli IP Advanced. | |
| Features | ||
| 03 | This new feature function had been added by modifying IntelliEC installed in SCENARIA Phase 2. This functionperforms IntelliEC with previously factored-in noise reduction rate of Intelli IP Advanced. |
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| 04 | This new feature function had been added to SCENARIA Phase 3. This feature modulates tube current corresponding to cardiac phases in ECG Retrospective Scan. |
|---|---|
| 05 | This new feature function had been added by modifying Data Security installed in SCENARIA Phase 2. This function monitors device performance in accordance with IEC62351-8 and NEMA XR-26. |
| 06 | This new feature displays an image at the scan position while scanning in Volume Scan. The system image performance is not affected, as shown in the results of design validation. |
| 07 | This new feature sets the priority of queue recon registration. The system image performance is not affected, as shown in the results of design validation. |
| 08 | This new feature splits the series of scanned images into multiple series. The system image performance is not affected, as shown in the results of design validation. |
| 09 | This new feature function had been added to SCENARIA Phase 3. This function monitors the system performance in accordance with IEC61223-3-5/IEC61223-2-6. The system image performance is not affected, as shown in the results of design validation. |
Therefore, based on a thorough analysis and comparison of the SCENARIA Phase 3 and the predicate device, the technological characteristics do not impact safety and effectiveness.
Substantial Equivalence
A summary decision was based on analysis of Table 4
Table 4 Rationale Analysis: SCENARIA Phase 3 vs. Predicate
| ITEM | Overall Rationale Analysis |
|---|---|
| Gantry | |
| Detector | There are no functional differences in this item. |
| X-ray Tube | |
| Patient Table | There are no functional differences in this item. |
| Display | There are no functional differences in this item. |
| Image Storage | |
| Scanning, | There are no functional differences in this item. |
| Reconstruction | |
| Performance | There are no substantial differences in this category based on the performance test results. |
| Dose Controls | Different specifications do not constitute a new intended use. There are no significant changes in technologicalcharacteristics. For safety, these items are controlled and tested according to same regulations and/or standards as thePredicate. |
| Dose Displays | There are no functional differences in this item. |
| Features | Different specifications do not constitute a new intended use. There are no significant changes in technologicalcharacteristics and the feature set of the device is generally equivalent to the Predicate. |
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 Phase 3 is considered substantially equivalent to the currently marketed predicate device (SCENARIA Phase 2 Whole-body X-ray CT System K123509) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
{9}------------------------------------------------
Summary of Non-Clinical Testing
Non-Clinical Testing
The SCENARIA Phase 3 Whole-body X-ray CT System was subjected to the following laboratory testing:
-
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 3: 2007 ● 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 2.0 2008-01 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
-
IEC 60601-2-44 Edition 3.0 2009-02 Medical electrical equipment Part 2-44: particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography.
-
NEMA XR 25 Computed Tomography Dose Check
-
. NEMA XR26 Access Controls for Computer Tomography: Identification, Interlocks, and Logs
-
IEC 62304 First edition 2006-05, Medical device software Software life cycle processes ●
In addition, the 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.
Summary of Clinical Testing
Clinical images were collected and analyzed, to ensure that images constructed by the SCENARIA Phase 3 Whole-body X-ray CT System meet user needs.
As a result of the analysis:
| Testing Type | Rationale Analysis |
|---|---|
| Performance Testing -Clinical | We provide five clinical image examples which we judged to be sufficient to judge a clinical usability. The fivecovered the general anatomy outlined in the indications for use and are comparable to the anatomy examplesprovided for the predicate. |
Conclusions
Hitachi believes that, based on the information included in the submission. SCENARIA Phase 3 Whole-body X-ray CT System is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the SCENARIA Phase 2 Whole-body X-ray CT System (K123509).
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.