(208 days)
Not Found
No
The summary describes standard CT image processing techniques (CTA, MPR, volume rendering, iterative reconstruction) and does not mention AI, ML, or related concepts. The performance studies focus on traditional image quality metrics and clinical usability comparisons, not AI/ML performance.
No.
The document states that "The device output can provide an aid to diagnosis", indicating it is a diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states, "The device output can provide an aid to diagnosis when used by a qualified physician."
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Supria System Function: The Supria system is an X-ray Computed Tomography (CT) system. It uses X-rays to create cross-sectional images of the inside of the body. It does not analyze samples 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." This involves imaging the body directly, not analyzing biological samples.
- Device Description: The device description details components like a Gantry, Operator's Workstation, Patient Table, and X-ray Generator, all consistent with an imaging system, not an IVD.
The Supria system is a medical imaging device used for diagnostic purposes, but it falls under the category of in vivo diagnostics (diagnostics performed on a living organism), not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Supria 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 Supria can be post processed by the system to provide additional information and can be transferred to external devices via a DICOM standard interface.
Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
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 is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 16-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 system uses 16-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 16 slices of data simultaneously. The Xray 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 system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.
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
A clinical evaluation comparison was conducted with the Supria system and the SCENARIA Phase 2 System (K123509) and found to be substantially equivalent.
Six clinical image examples were provided, covering general anatomy outlined in the indications for use, comparable to the predicate's examples, with the exception of cardiac images due to the Supria not supporting ECG imaging.
A radiologist validated that clinical images which applied image quality optimization technology (Intelli IP Advanced and IntelliEC) have acceptable image quality for clinical use.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical evaluation and bench testing.
Sample Size: Not specified for clinical evaluation beyond "six clinical image examples".
Key Results (Clinical): The Supria system was found to be substantially equivalent to the SCENARIA Phase 2 System (K123509). Clinical images were judged sufficient for clinical usability and were comparable to the predicate, with a radiologist validating acceptable image quality.
Key Results (Bench): 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. Bench data based on IEC61223-3-5 confirmed that tested items met the conditions of 21 CFR 1020.33(c) or (g), showing equivalent basic performance to the predicate device.
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing, ribbon-like element extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2015
Hitachi Medical Systems America, Inc. % Mr. Doug Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K150565
Trade/Device Name: Supria 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: August 26, 2015 Received: August 27, 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 Oels
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)
K150565
Device Name
HITACHI Supria Whole-body X-ray CT System
Indications for Use (Describe)
The Supria 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 Supria can be post processed by the system to provide additional information and can be transferred to external devices via a DICOM standard interface.
Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
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)
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See PRA Statement below.
3
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 12, 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: | Supria Whole-body X-ray CT System |
| Predicate Device(s): | SCENARIA Phase 2 Whole-body X-ray CT System (K123509) |
Device Intended Use
The Supria 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 device output can provide an aid to diagnosis when used by a qualified physician.
Device Description
Function
The Supria is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 16-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions.
Scientific Concepts
The Supria system uses 16-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 16 slices of data simultaneously. The Xray 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 Supria 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 Supria system and the SCENARIA Phase 2 System (K123509) and found to be substantially equivalent.
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 and also 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 - Clinical | We provide six clinical image examples which we judged to be sufficient to judge a clinical usability. The six covered the |
| general anatomy outlined in the indications for use and are comparable to the anatomy examples provided for the Predicate | |
| with the exception of cardiac images due to the fact that the Supria does not support imaging with ECG. |
In addition, a radiologist validated that clinical images which applied image quality optimization technology (Intelli IP Advanced
and IntelliEC) have acceptable image quality for clinical use. |
| 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 Supria has equivalent basic performance as the predicate device, SCENARIA Phase2. |
Table 1 Performance Comparison Analysis
The analysis confirms the performance characteristics of the Supria are comparable to the predicate device and support our conclusion that the Supria system is substantially equivalent.
Device Technological Characteristics
The technological characteristics of the Supria and the predicate device are listed in Table 2.
| ITEM | HITACHI Supria 16 Slice | 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 | 0.75, 1.0, 1.5, 2.0 [s] | 0.35, 0.4, 0.5, 0.75, 1.0, 2.0 [s] | Table 2: 01 |
| 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] | 2350 x 880 x 2030 [mm] | Table 2: 02 |
| Gantry Weight | 1600 [kg] | 2235 [kg] | Table 2: 02 |
| Scan Localizer | Laser | Laser | No |
| Detector | | | |
| Type | Solid state | Solid state | No |
| Number of Channels | 880 [ch] (8ch reference) | 888 [ch] (8ch reference) | Table 2: 03 |
| Number of Rows | 16 | 64 | Table 2: 03 |
| Number of Slices | 16 [slice/scan] (Axial) | 64, 128 [slice/scan] (Axial) | Table 2: 03 |
| X-ray Tube | | | |
| Anode Heat Storage | 5 [MHU] | 7.5 [MHU] | Table 2: 04 |
| Dissipation Rate | 748 [kHU/min] | 1,386 [kHU/min] | Table 2: 04 |
| ITEM | HITACHI Supria 16 Slice | HITACHI SCENARIA PHASE 2
(K123509) | Difference Analysis |
| Tube cooling | Oil/air | Cooling Fluid/air | Table 2: 04 |
| 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] | 72 [kW] | Table 2: 05 |
| Max. Power Input | 75 [kVA] | 100 [kVA] | Table 2: 05 |
| kVp Range | 80, 100, 120, 140 [kVp] | 80, 100, 120, 140 [kVp] | No |
| mA Range | 10 to 400 [mA] @120kV, 48kW | 10 to 600 [mA] @120kV, 72kW | Table 2: 05 |
| Patient Table | | | |
| Range of Movement,
Vertical | 450 to 1000 [mm] (CT-WT-21) | 465 to 1050 [mm] (CT-WT-19)
450 to 1050 [mm] (CT-WT-18L) | Table 2: 06 |
| Range of Movement,
Longitudinal | 1910 [mm] (CT-WT-21) | 2110 [mm] | Table 2: 06 |
| Range of Movement,
Lateral | N/A | -80 to +80 [mm] (CT-WT-19) | Table 2: 06 |
| Scannable Range | 155 cm | 175 cm | Table 2: 06 |
| Maximum Load Capacity | 227 [kg] | 230 [kg] | Table 2: 06 |
| 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) | 250 [GB] (images),
750 [GB] (raw data) | Table 2: 07 |
| Storage Images | 200,000 | 200,000 | No |
| Archival Storage (Media) | DVD-R/RW, CD-R/RW | DVD-RAM, DVD-R/RW,
CD-R/RW | Table 2: 07 |
| 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 | 0.58, 0.83, 1.08, 1.33, 1.58
@40mm Collimation | Table 2: 08 |
| Collimation | 1.25, 5, 10, 15, 20 [mm] | 1.25, 5, 10, 15, 20, 40 [mm] | Table 2: 08 |
| 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 | 0.056 seconds per image or less | Table 2: 09 |
| Performance | | | |
| High-contrast spatial resolution | 0.35 [mm] | 0.35 [mm] | No |
| Low-contrast resolution mm at % at ≤4
rads | 2.5 [mm] @ 0.25% | 2.5 [mm] @ 0.25% | No |
| 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. Normal | Yes. Small / Normal | Table 2: 10 |
| Automatic Exposure Control | Yes. IntelliEC | Yes. IntelliEC | No |
| Longitudinal Modulation | Yes | Yes | No |
| Angular Modulation | Yes | Yes | No |
| Iterative Reconstruction | Yes. Intelli IP Advanced Mode | Yes. Intelli IP Advanced Mode | No |
| ITEM | HITACHI Supria 16 Slice | HITACHI SCENARIA PHASE 2 (K123509) | Difference Analysis |
| Maximum possible pitch with full image quality | 1.56 | 1.58 | Table 2: 11 |
| 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) | No | Yes | Table 2: 12 |
| ECG Prospective Scan
(Axial) | No | Yes | Table 2: 12 |
| guideShot Scan | No | Yes | Table 2: 13 |
| Automatic Exposure Control | Yes. | Yes. IntelliEC | No |
| Automatic Exposure Control using Iterative
Reconstruction | No. | No. | No |
| ECG Dose Modulation | No | No. | No |
| Adaptive Filter | No | Yes. Intelli IP Normal | Table 2: 14 |
| 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 | Table 2: 15 |
| Automatic Cardiac Phase Search | No | Yes. CardioHarmony | Table 2: 12 |
| Preview Scan | No | No | No |
| Double Slice at Axial Scan | No | Yes. Fine Recon | Table 2: 16 |
| Priority Recon. | No | No | No |
| Dose Report | Yes. Simple Dose Report | Yes. Simple Dose Report | No |
| DICOM | Yes | Yes | No |
| ID Reader | Yes | No | Table 2: 17 |
| Exam Split | Yes | No | Table 2: 18 |
| 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 | Table 2: 19 |
Table 2 Technological Characteristic Differences
6
7
The differences from the predicate device to Supria are explained in Table 3.
Table 3 Analysis of Differences
| Gantry | |
|---|---|
| 01 | Because the specifications of the device are different, the minimum scan time of this device is not as short as the Predicate. This |
| change does not affect overall technological characteristics compared to the Predicate. | |
| 02 | Because the specifications of the device are different, the size and the weight of the Gantry of this device are different from the |
| Predicate. | |
| However, as the device weighs less and has a smaller footprint than the Predicate, we judge that these changes do not impact the | |
| intended use. | |
| Detector | |
| 03 | Because the number of provided slices for one rotational scan is different per equipment specifications, there are fewer number of |
| detectors and number of the channels than the Predicate. | |
| X-ray Tube | |
| 04 | The X-ray tube of this device is different from Predicate only in heat capacity. The X-ray tube focal spot and general performance |
| characteristics are the same as the Predicate. | |
| X-ray Generator | |
| 05 | The X-ray generator was selected to match the performance specifications of this device and conforms to IEC60601-2-44-2009 |
| requirements for CT systems. The kVp and mA output of the device is comparable to the Predicate. | |
| Patient Table | |
| 06 | The scannable range specification was defined assuming the number of the provided slices by one rotational scan is approximately |
| 25% of Predicate, and the table travel and weight capacity specifications are generally equivalent to the Predicate. | |
| Image Storage | |
| 07 | The data output volume of this device is approximately 25% of Predicate and the volume of the hard disk drive (HDD) was defined to |
| give an equivalent exam capacity as the Predicate. | |
| In addition, we select commonly available external output media that is both easy to obtain and meets the device specification | |
| requirements. | |
| Scanning, Reconstruction | |
| 08 | The helical scan pitch specification is based on the table movement distance and collimation width, but is nearly identical to the |
| Predicate. | |
| 09 | The data processing load of this device is approximately 25% of Predicate and the computing capacity was defined to achieve an |
| equivalent performance specification compared to the Predicate. | |
| Dose Controls | |
| 10 | While this device is not equipped with a small Bow-Tie Filter, the normal Bow-Tie Filter provides generally equivalent performance to |
| the Predicate and does not substantially impact the effectivity and safety of this device. | |
| 11 | As noted above, the pitch specification is only marginally different and therefore does not substantially alter the device performance |
| as compared to the Predicate. | |
| Features | |
| 12 | This device is a general purpose CT system that is not equipped with an ECG function. The lack of ECG does not |
| substantially affect the intended use of the device and does not impact the effectivity and safety of this device as | |
| compared to the Predicate. | |
| 13 | This device is a general purpose CT system that is not equipped with the guideShot option for in-room image viewing. |
| The lack of guideShot does not affect the intended use of the device and does not impact the effectivity and safety of | |
| this device as compared to the Predicate. | |
| 14 | This device is not equipped with an Adaptive Filter function, but has an Iterative Reconstruction feature which provides |
| an equivalent image processing function. | |
| 15 | This function is intended to confirm device performance according to IEC 62351-8 and NEMA XR-26. |
| 16 | This device is not equipped with a Fine Recon function which does not impact the effectivity and safety of this device. |
| 17 | This function supports the input of patient information by a bar code reader. |
| 18 | This function is for dividing one examination into multiple examinations (with unique Accession numbers) as an |
| operator convenience. | |
| 19 | This function is intended to confirm device performance according to IEC 61223-3-5/IEC 61223-2-6. |
8
Therefore, based on a thorough analysis and comparison of the Supria and the predicate device, the technological characteristics do not impact safety and effectiveness.
9
Substantial Equivalence
A summary decision was based on analysis of Table 4.
Table 4 Rationale Analysis: Supria vs. Predicate
| ITEM | Overall Rationale Analysis |
|---|---|
| Gantry | |
| Detector | Different specifications do not constitute a new intended use. There are no significant changes in technological |
| characteristics. The gantry and detector design was based on the same technology as the Predicate. These sub-systems | |
| have the same level of general effectiveness as the Predicate based on the performance test results shown in Section 10. | |
| For safety, these items are controlled and tested according to same regulations and/or standards as the Predicate. | |
| X-ray Tube | |
| X-ray | |
| Generator | This item conforms to IEC60601-2-44-2009 requirements for CT systems and has the same level of general effectiveness |
| as the Predicate based on the performance test results shown in Section 10. For safety, this item is controlled and tested | |
| according to same regulations and/or standards as the Predicate. | |
| Patient Table | Different specifications do not constitute a new intended use. There are no significant changes in technological |
| characteristics. The table travel and weight capacity characteristics are generally equivalent to the Predicate. For safety, | |
| this item is controlled and tested according to same regulations and/or standards as the Predicate. | |
| Display | There are no functional differences in this item. |
| Image Storage | Different specifications do not constitute a new intended use. There are no significant changes in technological |
| Scanning, | |
| Reconstruction | characteristics. The design criteria for these elements were set to allow comparable performance to the Predicate. The |
| performance of these sub-systems does not substantially affect the effectivity and safety as compared to the Predicate and | |
| were verified by design V&V. | |
| Performance | There are no substantial differences in this category based on the performance test results shown in Section 10. |
| Dose Controls | Different specifications do not constitute a new intended use. There are no significant changes in technological |
| characteristics. For safety, these items are controlled and tested according to same regulations and/or standards as the | |
| Predicate. | |
| 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 technological |
| characteristics 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 Supria Whole-body X-ray CT System 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.
10
Summary of Non-Clinical Testing
The Supria 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 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
- o 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 0
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 Supria Whole-body X-ray CT System meet user needs.
As a result of the analysis:
| Testing Type | Rationale Analysis |
|---|---|
| Performance Testing - Clinical | We provide six clinical image examples which we judged to be sufficient to judge a clinical usability. The six covered the |
| general anatomy outlined in the indications for use and are comparable to the anatomy examples provided for the Predicate | |
| with the exception of cardiac images due to the fact that the Supria does not support imaging with ECG. | |
| In addition, a radiologist validated that clinical images which applied image quality optimization technology (Intelli IP Advanced | |
| and IntelliEC) have acceptable image quality for clinical use. |
Conclusions
Hitachi believes that, based on the information included in the submission, Supria 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).