(67 days)
Not Found
No
The summary describes standard CT technology and image processing techniques (MPR, volume rendering) without mentioning AI or ML. The performance studies focus on traditional CT metrics and iterative reconstruction, not AI/ML model performance.
No.
The "Intended Use / Indications for Use" states that the device provides "an aid to diagnosis." It is an imaging device used for diagnostic purposes, not for treating diseases or conditions.
Yes
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 explicitly lists hardware components such as a Gantry, Operator's Workstation, Patient Table, and High-Frequency X-ray Generator, indicating it is a physical system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Supria True64 system is an X-ray Computed Tomography (CT) system. It uses X-rays to create images of the inside of the body. This is an in vivo (within the living body) imaging technique, not an in vitro (in glass/outside the body) diagnostic test.
- Intended Use: The intended use clearly states it's for "head, whole body, and vascular X-ray Computed Tomography applications." This describes an imaging procedure, not a laboratory test on a sample.
- Device Description: The description details the components and operation of a CT scanner, including the X-ray tube, detector, gantry, and patient table. These are characteristic of an imaging device, not an IVD.
Therefore, the Supria True64 system falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Supria True64 system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes.
The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the Supria 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 Supria True64 is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 64-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions.
The Supria True64 system uses 64-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 Supria True64 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
Computed Tomography x-ray
Anatomical Site
head, whole body, 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)
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. Noise, Mean CT number, Uniformity and Spatial Resolution test results for the Supria True64 were compared to results from the Supria PHASE 3 (K163528). The findings determined the systems to be equivalent.
Clinical Testing: As part of design validation, Hitachi has provided 3 kinds of clinical image examples which were judged to be sufficient to judge clinical usability. In addition, a comparative evaluation was conducted of via FBP and Iterative Reconstruction. It resulted in finding the images from the Supria True64 realized both low dose and high quality through reduction of image noise and artifacts.
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.
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2017
Hitachi Healthcare Americas Corporation % Mr. Douglas J. Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K171738
Trade/Device Name: Supria True64 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: July 26, 2017 Received: July 28, 2017
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 of medical device
1
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.
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/ResourcesforYou/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,
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)
K171738
Device Name Supria True64 Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
Indications for Use (Describe)
The Supria True64 system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes.
The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the Supria 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)
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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3
510(k) Summary
4
Submitter Information
| Submitter: | Hitachi Healthcare Americas
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@hitachihealthcare.com |
| Date: | April 18, 2017 |
Subject Device Name
| Trade/Proprietary Name: | Supria True64 |
|---|---|
| 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): | HITACHI SUPRIA Whole-body X-ray CT System Phase 3 (K163528) |
|---|---|
| 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 |
Device Intended Use
The Supria True64 system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dvnamic modes,
The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the Supria 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 Supria True64 is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 64-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions.
5
Scientific Concepts
The Supria True64 system uses 64-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 Supria True64 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
As part of our design validation performance comparison analysis was conducted to demonstrate continued conformance with a special control or recognized standard.
A rationale analysis was then conducted and the results are contained in Table 1:
| Testing Type | Rationale Analysis |
|---|---|
| Validation Testing - Bench | There is no change about the following performance. |
| Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity | |
| Profile, Tomographic Plane Location, CT dose index | |
| Therefore, we judged that Supria is substantially equivalent to the predicate. | |
| Validation Testing - Clinical | We provide 3 kinds of clinical image example which we judged to be sufficient to judge a clinical usability. |
Table 1 Performance Comparison Analysis
The analysis confirms the performance characteristics of the Supria True64 are comparable to the predicate device and support our conclusion that the subject system is substantially equivalent.
Device Technological Characteristics
The technological characteristics of the Supria True64 and the predicate device are listed in Table 2.
| ITEM | Supria True64 | HITACHI Supria PHASE 3 (K163528) | Difference |
|---|---|---|---|
| Gantry | |||
| Geometry | Rotate-rotate with offset detector system, | ||
| slip ring | Rotate-rotate with offset detector system, | ||
| slip ring | No | ||
| Scan Time | 0.75, 1.0, 1.5, 2.0 [s] | 0.75, 1.0, 1.5, 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 | 1990 x 920 x 1842.5 [mm] | 1990 x 920 x 1842.5 [mm] | No |
| Gantry Weight | 1600 [kg] | 1600 [kg] | No |
| Scan Localizer | Laser | Laser | No |
| ITEM | Supria True64 | HITACHI Supria PHASE 3 (K163528) | Difference |
| Detector | |||
| Type | Solid state | Solid state | No |
| Number of Channels | 880 [ch] (16 slice) | ||
| 888 [ch] (64 slice) | 880 [ch] (8ch reference) | No | |
| Number of Rows | 16 (16 slice) | ||
| 64 (64 slice) | 16 | See 01 | |
| Number of Slices | 16 [slice/scan] (Axial) (16 slice) | ||
| 64 [slice/scan] (Axial) (64 slice) | 16 [slice/scan] (Axial) | No | |
| X-ray Tube | |||
| Anode Heat Storage | 5 [MHU] | 5 [MHU] | No |
| Dissipation Rate | 470 [kHU/min] | 470 [kHU/min] | No |
| Tube cooling | Oil/air | Oil/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 | System Maximum 48[kW] / | ||
| Generator Maximum 51 [kW] | System Maximum 48[kW] / | ||
| Generator Maximum 51 [kW] | No | ||
| Max. Power Input | 75 [kVA] | 75 [kVA] | No |
| kVp Range | 80, 100, 120, 140 [kVp] | 80, 100, 120, 140 [kVp] | No |
| mA Range | 10 to 400 [mA] @120kV, 48kW | 10 to 400 [mA] @120kV, 48kW | No |
| Patient Table | |||
| Range of Movement, | |||
| Vertical | 450 to 1000 [mm] (CT-WT-21) | 450 to 1000 [mm] (CT-WT-21) | No |
| Range of Movement, | |||
| Longitudinal | 1910 [mm] (CT-WT-21) | 1910 [mm] (CT-WT-21) | No |
| Range of Movement, | |||
| Lateral | N/A | N/A | No |
| Scannable Range | 155 cm | 155 cm | No |
| Maximum Load Capacity | 227 [kg] | 227 [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 | 110 [GB] (images), | ||
| 200 [GB] (raw data) (16 slice) | |||
| 800 [GB] (raw data) (64 slice) | 110 [GB] (images), | ||
| 200 [GB] (raw data) | See 02 | ||
| Storage Images | 200,000 | 200,000 | No |
| Archival Storage (Media) | DVD-R/RW, CD-R/RW | DVD-R/RW, CD-R/RW | No |
| ITEM | Supria True64 | HITACHI Supria PHASE 3 (K163528) | Difference |
| Scanning, Reconstruction | |||
| Localization Scan | Real time | Real time | No |
| Localization Scan Length | 150, 250, 350, 500, 750, | ||
| 1000, 1250, 1500, 1750 [mm] | 150, 250, 350, 500, 750, | ||
| 1000, 1250, 1500, 1750 [mm] | No | ||
| Max. Scan Time | 100 [s] | 100 [s] | No |
| Helical Beam Pitch | 0.56, 0.81, 1.06, 1.31, 1.56 (16 slice) | ||
| 0.58, 0.83, 1.08, 1.33, 1.58 (64 slice) | 0.56, 0.81, 1.06, 1.31, 1.56 | See 03 | |
| Collimation | 1.25, 5, 10, 15, 20 [mm] | 1.25, 5, 10, 15, 20 [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) | ||
| -32768 to +32767 (16bit) | -2000 to +4000 (13bit) | ||
| -32768 to +32767 (16bit) | No | ||
| Reconstruction Time | 0.1 seconds per image or less | 0.1 seconds per image or less | No |
| Performance | |||
| High-contrast spatial resolution | 0.35 [mm] | 0.35 [mm] | No |
| Low-contrast resolution mm at | |||
| % at |