(51 days)
Not Found
No
The description mentions standard image reconstruction algorithms (filter back-projection, iterative denoising, metal artifact correction) but does not explicitly mention AI or ML technologies. The performance studies also do not indicate AI/ML-specific evaluations.
No
This device is a computed tomography X-ray system used to produce images of the body, which is a diagnostic function, not a therapeutic one. It provides information for diagnosis rather than directly treating a condition.
Yes.
The device's intended use is to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data, which are then used by post-processing applications. This process of creating images of the body's internal structures is a fundamental diagnostic activity in medicine.
No
The device description explicitly lists multiple hardware components (Gantry, X-ray System, Data Management System, Patient Table, Console, Power Supply Cabinet, Image Processing Computer) in addition to the software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for producing cross-sectional images of the body using X-ray transmission data. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, or tissue) outside of the body.
- Device Description: The description details a CT scanner, which is a medical imaging system that interacts directly with the patient to acquire images. IVDs, on the other hand, are used to perform tests on biological samples.
- Input Imaging Modality: The input is Computed Tomography X-ray, which is an in-vivo imaging technique. IVDs work with in-vitro samples.
The information provided consistently describes a medical imaging device used for in-vivo diagnosis, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The uCT Computed Tomography X-ray System uCT 520/uCT 528 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The uCT 520/uCT 528 is a multi-slice X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system provides the filter back-projection (FBP) algorithm to reconstruct images in DICOM format, which can be used by post-processing applications.
The system consists of the Gantry, X-ray System, Data Management System, Patient Table, Console, Power Supply Cabinet, Image Processing Computer, and Software. The system software is a program used for patient management, data management, Xray scan control, image reconstruction, and image archive.
A motorized patient table moves the patient through a circular opening in the Gantry. As the patient passes through the Gantry, a source of x rays rotates around the inside of the circular opening. Detectors on the exit side of the patient record the X rays exiting the section of the patient's body being irradiated as an X-ray "snapshot". Many different "snapshots" (angles) are collected during one complete rotation. The data are sent to a computer to reconstruct all of the individual "snapshots" into a crosssectional image (slice) of the internal organs and tissues for each complete rotation of the source of x rays.
There are two key features of data processing for denoising and reduce metal artifact, which are KARL iterative denoising reconstruction algorithm and MAC Metal artifact correction algorithm.
This proposed device includes two models: uCT 520, uCT 528.The differences between the two models are as follows:
Spec. Model | Tube anode storage capacity (MHU) |
---|---|
uCT 520 | 2 |
uCT 528 | 3.5 |
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray transmission data
Anatomical Site
whole body (including head, neck, vascular)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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:
Non-clinical testing including dosimetry and image performance tests were conducted for the uCT 520/uCT 528 during the product development.
The tests included:
- Electrical Safety and Electromagnetic Compatibility (EMC) testing in accordance with ES 60601-1, IEC 60601-2-44, IEC 60601-1-2, IEC 60825-1.
- Product Particular Standards: NEMA XR 25-2010, NEMA XR 28-2013, NEMA XR 29-2013, IEC 60601-1-3, IEC 61223-3-5.
- Performance Verification: Clinical Evaluation for sample clinical images evaluation; AEC Test Report for AEC performance study; MAC Performance Evaluation Report.
- Software: NEMA PS 3.1-3.20(2011) (DICOM), IEC 62304, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
- Biocompatibility: ISO 10993-5, ISO 10993-10.
- Other Standards and Guidances: ISO 14971, 21 CFR Part 820, 21 CFR Subchapter J - Radiological Health, Laser Notice No. 50, Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI).
Software Verification and Validation:
Software documentation for a Moderate Level of Concern software was included. Risk analysis was completed and risk control implemented. Testing results show that all software specifications met acceptance criteria. Verification and validation testing found acceptable to support substantial equivalence.
Clinical Testing:
No Clinical Study is included in this submission.
Key Results:
The uCT 520/uCT 528 was found to have a safety and effectiveness profile that is similar to the predicate device. The proposed device has the same intended use, similar performance, equivalence safety and effectiveness as the predicate device. The differences between the proposed device and predicate device do not affect the intended use, technology characteristics, safety and effectiveness.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
January 3, 2019
Shangai United Imaging Healthcare Co., Ltd. Shumei Wang QM & RA VP No. 2258 Chengbei Rd., Jiading Industrial District SHANGHAI, 201807 CHINA
Re: K183143
Trade/Device Name: uCT 520, uCT 528 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: November 14, 2018 Received: November 15, 2018
Dear Shumei Wang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hole 2. Nils
for Robert A. 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)
Device Name
uCT 520, uCT 528
Indications for Use (Describe)
The uCT Computed Tomography X-ray System uCT 520/uCT 528 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).
☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
---|---|
----------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------ |
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3
Image /page/3/Picture/2 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a bold, sans-serif font. The color of the logo is a dark teal.
510 (k) SUMMARY
1. Date of Preparation November 10, 2018
2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Contact Person: Shumei Wang Position: QM&RA VP Tel: +86-021-67076888-6776 Fax: +86-021-67076889 Email: shumei.wang@united-imaging.com
3. Identification of Proposed Device
Trade Name: uCT 520, uCT 528 Common Name: Computed Tomography X-ray System Model(s): uCT 520, uCT 528
Regulatory Information Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
4. Identification of Predicate Device(s)
Predicate Device
510(k) Number: K181414 Device Name: uCT Computed Tomography X-Ray System Model(s): uCT 530, uCT 550
Regulatory Information
Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
4
Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is formed by two vertical lines connected by a horizontal line in the middle. The logo is simple and modern, with a focus on the company name and a clean design.
5. Device Description:
The uCT 520/uCT 528 is a multi-slice X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system provides the filter back-projection (FBP) algorithm to reconstruct images in DICOM format, which can be used by post-processing applications.
The system consists of the Gantry, X-ray System, Data Management System, Patient Table, Console, Power Supply Cabinet, Image Processing Computer, and Software. The system software is a program used for patient management, data management, Xray scan control, image reconstruction, and image archive.
A motorized patient table moves the patient through a circular opening in the Gantry. As the patient passes through the Gantry, a source of x rays rotates around the inside of the circular opening. Detectors on the exit side of the patient record the X rays exiting the section of the patient's body being irradiated as an X-ray "snapshot". Many different "snapshots" (angles) are collected during one complete rotation. The data are sent to a computer to reconstruct all of the individual "snapshots" into a crosssectional image (slice) of the internal organs and tissues for each complete rotation of the source of x rays.
There are two key features of data processing for denoising and reduce metal artifact, which are KARL iterative denoising reconstruction algorithm and MAC Metal artifact correction algorithm.
This proposed device includes two models: uCT 520, uCT 528.The differences between the two models are as follows:
| Spec.
Model | Tube anode storage capacity
(MHU) |
|----------------|--------------------------------------|
| | uCT 520 |
| uCT 528 | 3.5 |
Indications for Use 6.
The uCT Computed Tomography X-ray System uCT 520/uCT 528 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).
7. Comparison of Technological Characteristics with the Predicate Devices
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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is also in a bold font. The color of the logo is a dark teal.
The uCT 520/uCT 528 Computed Tomography X-ray system has the same indications for use as the predicate device uCT 530/uCT 550. The fundamental scientific technology of the proposed device is same as the predicate device.
Table 1 below provides a comparison of the technological characteristics of the proposed device in comparison to the predicate device.
| ITEM | Proposed Device
uCT 520, uCT 528 | Predicate Device
uCT 530, uCT 550 | Remark |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | General | | |
| Product Code | JAK | JAK | Same |
| Regulation No. | 21 CFR 892.1750 | 21 CFR 892.1750 | Same |
| Class | II | II | Same |
| Intended Use | The uCT Computed
Tomography X-ray System
uCT520/uCT528 is a computed
tomography X-ray system
intended to produce cross-
sectional images of the body
by computer reconstruction of
X-ray transmission data taken
at different angles and planes
and indicated for the whole
body (including head, neck,
vascular). | The uCT Computed
Tomography X-ray System
uCT530/uCT550 is a
computed tomography X-ray
system intended to produce
cross-sectional images of the
body by computer
reconstruction of X-ray
transmission data taken at
different angles and planes
and indicated for the whole
body (including head, neck,
vascular). | Same |
| Specifications | | | |
| Scan Regime | Continuous Rotation | Continuous Rotation | Same |
| Scan Modes | Scout
Axial Scan
Helical Scan | Scout
Axial Scan
Helical Scan | Same |
| Detector
Material | Solid-state GOS | Solid-state GOS | Same |
| Z-plane
coverage | 22mm | 22mm | Same |
| Size of detector
element in Z-
plane | 0.55mm | 0.55mm | Same |
| Number of
element per row | 864 | 864 | Same |
| Number of
detector row | 40 | 40 | Same |
| Maximum slices | 80 for uCT 520 | 40 for uCT 530 | Note |
| generated per | 80 for uCT 528 | 80 for uCT 550 | No.1 |
| rotation (multi-slice capability) | | | |
| Minimum slice thickness | 0.55mm | 0.55mm | Same |
| Maximum sampling rate | Up to 4800 views per 360° | Up to 4800 views per 360° | Same |
| Tube anode storage capacity | 2MHU for uCT 520
3.5MHU for uCT 528 | 5.3MHU | Note No.2 |
| Maximum cooling rate | 336 kHU/min for uCT 520
395 kHU/min for uCT 528 | 815 kHU/min | Note No.3 |
| Focal spot size | 0.7x0.8mm
1.2x1.4mm | 0.5x1.0mm
1.0x1.0mm | Note No.4 |
| Power | 42kW | 50kW | Note No.5 |
| mA Range | 10-350mA | 10-420mA | Note No.6 |
| kV Settings | 70, 80, 100, 120, 140 | 70, 80, 100, 120, 140 | Same |
| Aperture | 700mm | 700mm | Same |
| Rotation speed | Up to 0.75 sec per 360° rotation | Up to 0.5 sec per 360° rotation | Note No.7 |
| Gantry Tilt | ± 30°with 0.5 increment | ± 30°with 0.5 increment | Same |
| Scannable range | 1600 mm | 1700 mm | Note No.8 |
| Horizontal motion range | 1930 mm | 2180 mm | Note No.9 |
| Table Horizontal Speed | Up to 200mm/sec | Up to 200mm/sec | Same |
| Vertical motion range | 600 mm-950 mm from the floor | 480 mm-950 mm from the floor | Note No.10 |
| Vertical speed | Up to 20 mm/sec | Up to 40 mm/sec | Note No.11 |
| Table Horizontal Position accuracy | ±0.25mm | ±0.25mm | Same |
| Table Maximum table load | 205kg | 205kg | Same |
| Image Spatial Resolution | High mode:
19 lp/cm @ MTF 0%
15.6±1.6 lp/cm @ MTF10%
11.3±1.2 lp/cm @ MTF50% | High mode:
20 lp/cm @ MTF 0%
16.5±1.7 lp/cm @ MTF10%
11.5±1.2 lp/cm @ MTF50% | Note No.12 |
| Image Noise | 3.0±0.5 HU at 120 kV, 5.5 mm slice thickness, CTDIvol 24.32 | 3.0±0.5 HU at 120 kV, 5 mm slice thickness, CTDIvol 28.9 | Note No.13 |
| 3.0±0.5 HU at 120 kV, 5.5 mm
slice thickness, CTDIvol 25.95
mGy for uCT 528 | | | |
| CT Number
Display Range | -1024+8191 HU | Same | |2.0 | Same | |
| Scan Field of
View | Up to 500 mm | Same | |
| Reconstruction
Field of View | 40mm-500mm
40mm-600mm with extend FOV | Same | |
| Image Matrix | Up to 1024 x 1024 | Same | |
| Reconstructed
slice thickness | 0.55mm,1.1mm,2.2mm,5.5mm,11mm (axial)
0.55-10mm(helical) | Same | |
| Pitch | 0.1
| Maximum
continuous
exposure time | Up to 100seconds | Same | |
| Safety | | | |
| Electrical Safety | Comply with ES60601-1 | Same | |
| EMC | Comply with IEC60601-1-2 | Same | |
| Biocompatibility | Patient Contact Materials were
tested and demonstrated no
cytotoxicity (ISO 10993-5), no
evidence for irritation and
sensitization (ISO 10993-10). | Same | |
| Clinical | Sample clinical image for both proposed and predicate devices are
provided in Section 37 Clinical Evaluation. Electronic file for each image
are provide in MISC Folder. | | |
| Justification | Justification | | |
| Note ID | With a reconstruction process, 40 slices or 80 slices can be achieved from
the 40 rows detector. Provides the smaller slice number in one rotation
induces longer scanning time for CT imaging, which does not affect
safety and effectiveness. | | |
| Note 1 | Tube anode storage capacity is a kind of measurement about the
maximum throughput of CT scanner. When an independent scan is
implemented, the tube is heated and if the time interval between two
independent scans is long enough, the heat can be dissipated timely but
for short scan time interval, the heat which has not been dissipated timely
should be stored within tube device and thus for the continuous scans (for
short scan time intervals), higher storage capacity means that more
continuous scan numbers can be supported. However, tube anode storage
capacity has no effect on each independent scan | | |
| Note 2 | | | |
Table 1 Comparison of Technological Characteristics
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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is formed by two vertical lines and a horizontal line in the middle, creating a shape that resembles a shield or a stylized "U".
7
Image /page/7/Picture/0 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is divided into two halves by a vertical line. A horizontal line connects the vertical line to the right side of the "U" shape.
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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is formed by a thick, vertical line with a horizontal line cutting through the middle, creating a negative space in the shape of a "T".
| Note 3 | Maximum cooling rate is a kind of measurement about the maximum
throughput of CT scanner. For the continuous scans, higher maximum
cooling rate means that the tube heat can be dissipated faster and thus
shorter scan time interval and more continuous scan numbers can be
supported. However, it has no effect on each independent scan. |
|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 4 | Focus spot size has effect on image spatial resolution and smaller size is
helpful for resolution improvement. However, the image spatial resolution
between the two kinds of devices is equivalent substantially. |
| Note 5 | Provides the smaller power output that induces lower ability of x-ray
penetration when scanning the object with high BMI with higher
possibility of photon starvation, and the safety has been evaluated by the
related testing and verification. |
| Note 6 | Provides the smaller mA output that induces lower ability of x-ray
penetration when scanning the object with high BMI with higher
possibility of photon starvation, and the safety has been evaluated by the
related testing and verification. |
| Note 7 | Provides slower rotation speed that induces longer scan time for
examination which does not affect safety and effectiveness. |
| Note 8 | A typical CT scan is to scan a specific length of the anatomical structure.
1600mm scannable range capability of the proposed device have satisfied
most of size of human anatomical structure. The scannable range
difference does not affect safety and effectiveness. |
| Note 9 | The horizontal motion range of the device affects the size of the scanning
room, in other words, it will affect site planning. The difference of
horizontal motion range does not affect safety and effectiveness. |
| Note 10 | Vertical motion range is decided by device gantry and couch design
which does not affect safety and effectiveness. |
| Note 11 | The Vertical speed of proposed device is lower than the predicated
device, that only affect expected scanner scan throughput.
The vertical difference does not affect safety and effectiveness. |
| Note 12 | Three values of resolution performance are compared, the 0% response of
the MTF, 10% response of the MTF, and the 50% response. For some
resolution studies, the 10% MTF has more value in relating the numerical
performance to visual assessment of resolution. The detectability of the
spatial resolution of the proposed device is 0.32mm (15.6 lp/cm @
MTF10%). The detectability of the spatial resolution of the predicate
device is 0.30mm (16.5 lp/cm @ MTF 10%). The size of 0.32mm is
equivalent to that of 0.30mm in visual assessment of resolution, which
does not affect safety and effectiveness. |
| Note 13 | With 120 kV and 5.5mm slice thickness, the image noise for typical head
is 3HU on CTDIvol 24.32 mGy & on CTDIvol 25.95 mGy. The image
noise level is equivalent substantially considering the proposed device has
measured its noise based on the smaller CTDIvol than the Predicate
Device. |
9
Image /page/9/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font, stacked vertically. To the right of the text is a stylized graphic, which appears to be a letter "U" with a horizontal line through the middle, creating a cross-like shape within the "U". The logo is simple and modern in design.
The proposed device and the predicate device are the same in regard to most of application features.
Table 2 below provides a comparison of the application features of the proposed device in comparison to the predicate device.
| Key Items | Proposed Device
uCT 520, uCT 528 | Predicate Device
uCT 530, uCT 550 | Remark |
|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Scan Mode | ● Scout Scan
● Axial Scan
● Helical Scan
● Contrast enhanced scan
■ Manual scan
■ Timed scan
■ Bolus Tracking
■ TIBT
● Stationary perfusion scan | ● Scout Scan
● Axial Scan
● Helical Scan
● Contrast enhanced scan
■ Manual scan
■ Timed scan
■ Bolus Tracking
■ TIBT
● Stationary perfusion scan | Same |
| | Iterative noise
reduction | KARL 3D
Adaptive Filter | KARL 3D
Adaptive Filter |
| | Metal artifact
reduction | MAC | MAC |
| | Automatic
exposure control
(AEC) | uDose | uDose |
| | Fast workflow | uECO Energy-Saving
Module
Easy-Logic Intelligent
Prediction Platform | uECO Energy-Saving
Module
Easy-Logic Intelligent
Prediction Platform |
Table 2 Comparison of Application Features
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Testing
Non-clinical testing including dosimetry and image performance tests were conducted for the uCT 520/uCT 528 during the product development.
UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance:
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the uCT 520/528 in accordance with the following standards:
10
Image /page/10/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized "U" symbol, which is made up of two vertical lines and a horizontal line in the middle. The logo is simple and modern, and the use of bold font and the stylized "U" symbol make it easily recognizable.
-
ES 60601-1:2005(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
IEC 60601-2-44 Edition 3.0 2009, Medical Electrical Equipment - Part 2-44: Particular Requirements For The Basic Safety And Essential Performance Of Xray Equipment For Computed Tomography
- A IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
- A IEC 60825-1 Edition 3.0 2014, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements
Product Particular Standards
- A NEMA XR 25-2010, Computed Tomography Dose Check
- A NEMA XR 28-2013, Supplemental Requirements For User Information And System Function Related To Dose In CT
-
NEMA XR 29-2013, Standard Attributes on CT Equipment Related to Dose Optimization and Management
- A IEC 60601-1-3 Edition 2.1 2013-04, Medical Electrical Equipment - Part 1-3: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation Protection In Diagnostic X-ray Equipment
- A IEC 61223-3-5 First Edition 2004-08, Evaluation And Routine Testing In Medical Imaging Departments - Part 3-5: Acceptance Tests - Imaging Performance Of Computed Tomography X-ray Equipment
Performance Verification
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Clinical Evaluation for sample clinical images evaluation;
- A AEC Test Report for AEC performance study.
- A MAC Performance Evaluation Report
Software
- NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine A (DICOM)
- A IEC 62304: Medical Device Software - software life cycle process
- A Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- A Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Biocompatibility
- A ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
Other Standards and Guidances
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Image /page/11/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the words is a stylized "U" shape, which is also in bold. The logo is simple and modern, and the colors are muted.
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ISO 14971: Medical Devices - Application of risk management to medical devices
- Code of Federal Regulations, Title 21, Part 820 Quality System Regulation A
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Code of Federal Regulations, Title 21, Subchapter J - Radiological Health
- A Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)
- A Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography
Software Verification and Validation
Software documentation for a Moderate Level of Concern software per FDA' Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as a part of this submission.
The risk analysis was completed and risk control was implemented to mitigate identified hazards. The testing results show that all the software specifications have met the acceptance criteria. Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence.
UNITED IMAGING HEALTHCARE conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modification, misuse or denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" is included in this submission.
Clinical Testing
No Clinical Study is included in this submission.
Summarv
The features described in this premarket submission are supported with the results of the testing mentioned above, the uCT 520/uCT 528 was found to have a safety and effectiveness profile that is similar to the predicate device.
9. Conclusions
Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety and effeteness as the predicate device. The differences above between the proposed device and predicate device do not affect the intended use, technology characteristics, safety and effectiveness. And no issues are raised regarding to safety and effectiveness. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device.