(235 days)
Not Found
No
The summary describes standard CT technology and image processing techniques (MPR, volume rendering) without mentioning AI or ML. The performance testing focuses on basic CT parameters and clinical image examples, not AI/ML performance metrics.
No
The device is described as a diagnostic imaging system (X-ray Computed Tomography) used to produce cross-sectional images of the body, which aids in diagnosis. It does not perform any therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "The device output can provide an aid to diagnosis when used by a qualified physician." This explicitly indicates its role in diagnosis.
No
The device description clearly outlines multiple hardware components including a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories, indicating it is a hardware system with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The SCENARIA Phase 3 system is an X-ray Computed Tomography (CT) system. It uses X-rays to create images of the inside of the body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages." This involves imaging the patient directly, not analyzing samples.
- Device Description: The description details the components of a CT scanner (Gantry, Operator's Workstation, Patient Table, etc.) and how it acquires images using X-rays. There is no mention of handling or analyzing biological specimens.
Therefore, the SCENARIA Phase 3 system falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
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 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.
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 WindowsTM operating system.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray Computed Tomography
Anatomical Site
head, whole body, cardiac and vascular
Indicated Patient Age Range
all ages
Intended User / Care Setting
qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Performance Testing - Bench
Sample Size: Not specified
Key Results: 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 Phase 2.
Study Type: Performance Testing - Clinical
Sample Size: Five clinical image examples
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SCENARIA Phase 2 Whole-body X-ray CT System (K123509)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
2
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
4
| Submitter: | Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, 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.
5
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 |