(208 days)
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.
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 consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for clinical performance in a structured table. Instead, it relies on a qualitative assessment against a predicate device. The performance comparisons for the Supria CT system are primarily against the SCENARIA Phase 2 Whole-body X-ray CT System (K123509).
| Acceptance Criteria Category | Reported Device Performance (Supria Whole-body X-ray CT System) |
|---|---|
| Clinical Usability / Image Quality (Implicit) | Clinical Performance Testing:- Six clinical image examples were provided and judged sufficient to demonstrate clinical usability across general anatomy outlined in indications for use. These were deemed comparable to the predicate's examples, with the exception of cardiac images due to lack of ECG support in Supria.- A radiologist validated that clinical images using image quality optimization technology (Intelli IP Advanced and IntelliEC) exhibited "acceptable image quality for clinical use." |
| Physical and Performance Characteristics (General equivalence to predicate and regulatory compliance) | Bench Performance Testing:- Evaluation for dose profile, image noise, Modulation Transfer Function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index were conducted.- Found to be "substantially equivalent" to the predicate device for these parameters.- Confirmed that these items met the conditions of 21 CFR 1020.33(c) or (g).- Performance characteristics are comparable to the predicate device. |
| Technological Characteristics (No significant impact on safety and effectiveness despite differences from predicate) | Demonstrated through a detailed comparison (Table 2 & 3) that differences in Gantry, Detector, X-ray Tube, X-ray Generator, Patient Table, Image Storage, Scanning/Reconstruction, Dose Controls, and Features do not "substantially affect the intended use of the device and does not impact the effectivity and safety of this device". For example, the lack of ECG function is acknowledged but deemed not to impact safety/effectiveness for the device's general-purpose use. |
| Compliance with Standards | Conformance with a list of applicable standards, including AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-44, NEMA XR 25, NEMA XR26, and IEC 62304. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Clinical Test Set: "Six clinical image examples" were used. This is a very small sample size for a clinical evaluation.
- Data Provenance: Not explicitly stated, but it's implied that these images were generated by the Supria system itself during its development or testing. No information on country of origin or whether it was retrospective/prospective is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: "A radiologist" (singular) was used to validate the clinical images.
- Qualifications of Experts: The document explicitly states "a radiologist." No further details on experience level (e.g., "10 years of experience") are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: "A radiologist validated" the images. This implies a single-reader assessment rather than a multi-reader adjudication process. No mention of 2+1, 3+1, or any other consensus method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This device is an X-ray CT system, not an AI-powered diagnostic tool, and the evaluation focuses on the inherent performance and image quality of the hardware and software without specific "AI assistance" for human readers in a comparative effectiveness study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is an X-ray CT system. Its primary output is images, which are then interpreted by human physicians. Therefore, the concept of "standalone (algorithm only) performance" as it might apply to an AI diagnostic algorithm is not directly applicable here. The performance tests (dose profile, noise, MTF, etc.) are inherent to the machine's operation, and the clinical image assessment validates the output of the machine for human interpretation.
7. The Type of Ground Truth Used
- Ground Truth Type:
- For bench performance testing, the ground truth was regulatory standards (21 CFR 1020.33(c) or (g)) and physical measurements against known values (e.g., for spatial resolution, MTF).
- For clinical image examples, the "ground truth" was a qualitative assessment by "a radiologist" that the images had "acceptable image quality for clinical use" and were "sufficient to judge a clinical usability." This is effectively expert consensus (from a single expert) on image quality suitable for diagnosis, rather than pathology, or outcomes data resolving the presence/absence of a specific condition.
8. The Sample Size for the Training Set
- The document does not explicitly mention a "training set" in the context of an AI/machine learning model. The Supria is a CT imaging system. While it has "image quality optimization technology (Intelli IP Advanced and IntelliEC)" and "Iterative Reconstruction," these are typically engineered features based on physics and signal processing principles, not necessarily machine learning models that require a distinct "training set" in the way a diagnostic AI algorithm would. If these features involved machine learning, the training data used is not disclosed.
9. How the Ground Truth for the Training Set Was Established
- As a "training set" is not explicitly mentioned or implied for a machine learning context, the method for establishing its ground truth is not provided.
{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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
{3}------------------------------------------------
Section 5
510(k) Summary
{4}------------------------------------------------
| 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 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 thegeneral anatomy outlined in the indications for use and are comparable to the anatomy examples provided for the Predicatewith 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 Advancedand 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 SectionThickness and Sensitivity Profile, Tomographic Plane Location, CT dose index) which we tested met the conditions of 21 CFR1020.33(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 detectorsystem, slip ring | Rotate-rotate with offset detectorsystem, 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 ≤4rads | 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 IterativeReconstruction | 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. Thischange 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 thePredicate.However, as the device weighs less and has a smaller footprint than the Predicate, we judge that these changes do not impact theintended use. |
| Detector | |
| 03 | Because the number of provided slices for one rotational scan is different per equipment specifications, there are fewer number ofdetectors 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 performancecharacteristics 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 IEC60601-2-44-2009requirements 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 approximately25% 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 togive 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 specificationrequirements. |
| Scanning, Reconstruction | |
| 08 | The helical scan pitch specification is based on the table movement distance and collimation width, but is nearly identical to thePredicate. |
| 09 | The data processing load of this device is approximately 25% of Predicate and the computing capacity was defined to achieve anequivalent 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 tothe 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 performanceas 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 notsubstantially affect the intended use of the device and does not impact the effectivity and safety of this device ascompared 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 ofthis device as compared to the Predicate. |
| 14 | This device is not equipped with an Adaptive Filter function, but has an Iterative Reconstruction feature which providesan 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 anoperator 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 |
|---|---|
| GantryDetector | Different specifications do not constitute a new intended use. There are no significant changes in technologicalcharacteristics. The gantry and detector design was based on the same technology as the Predicate. These sub-systemshave 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-rayGenerator | This item conforms to IEC60601-2-44-2009 requirements for CT systems and has the same level of general effectivenessas the Predicate based on the performance test results shown in Section 10. For safety, this item is controlled and testedaccording 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 technologicalcharacteristics. 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. Theperformance of these sub-systems does not substantially affect the effectivity and safety as compared to the Predicate andwere 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 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 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 thegeneral anatomy outlined in the indications for use and are comparable to the anatomy examples provided for the Predicatewith 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 Advancedand 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).
§ 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.