(258 days)
Yes
The summary explicitly mentions "ClearInfinity Deep Learning Image Reconstruction" and describes performance studies evaluating this technology.
No
The device is described as an imaging system (CT scanner) used to create cross-sectional images of the body for diagnostic purposes, not for treating a disease or condition.
Yes
Explanation: The device is a CT scanner system which acquires X-ray transmission data to reconstruct cross-sectional images of the body. These images are explicitly stated to be used by radiologists for "diagnostic use" in the description of the performance studies, indicating its role in diagnosis.
No
The device description explicitly states it is composed of hardware components like a gantry, patient couch, and operator console, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is a "whole body computed tomography X-ray system" used to acquire and reconstruct images of the body. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body.
- Device Description: The components listed (gantry, patient couch, operator console) are typical of a CT scanner, which is an in-vivo imaging device.
- Input Imaging Modality: Computed Tomography X-Ray is an in-vivo imaging modality, meaning it images the body directly.
- Anatomical Site: Whole body refers to imaging the patient directly.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or treatment. This device operates by sending X-rays through the patient's body and detecting the transmission data, which is then used to create images. This is a fundamentally different process than an in-vitro diagnostic test.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The NeuViz 128 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Product codes
JAK
Device Description
The proposed NeuViz 128 Multi-slice CT Scanner System is composed of a gantry, a patient couch, an operator console and includes image acquisition hardware and software, and associated accessories. It is designed to be a head and whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.
Same as the predicate, The gantry has a 72cm bore with a maximum FOV of 50 cm and available rotation speeds are still 0.374s,0.5s, 0.6s.0.8s,1.0s,1.5s,2.0s per 360° rotation.
The proposed NeuViz 128 has three types of reconstruction methods available: FBP(filter back-projection), ClearView(iterative reconstruction algorithm), and Clearlnfinity . ClearInfinity is a new added recon mode where the system uses a trained deep learning neural network to generate noise reduction images and improve low contrast detectability with reduced dose compared with standard FBP recon mode.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Computed Tomography X-ray
Anatomical Site
Whole body, head and lungs
Indicated Patient Age Range
Not Found. Note: Auto FOV has not been thoroughly tested on pediatric under 3 years old. ClearView has not been thoroughly tested in pediatric population. ClearInfinity has not been thoroughly tested in pediatric population.
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
Clinical Image Evaluation for ClearInfinity:
The reader study used a total of 30 retrospectively collected clinical cases. The raw data from each of these cases was reconstructed with both Filtered Back Projection and ClearInfinity Deep Learning Image Reconstruction. The images generated by the two reconstruction methods of the same raw data are presented to the reader in pairs. Each image was read by 3 board-certified radiologists who provided an assessment of image quality related to diagnostic use according to a 5-point Likert scale.
An additional study used a total of 20 retrospectively collected clinical cases which raw data were processed at simulated low doses to produce low-dose images. Each of the low dose images was reconstructed with both Filtered Back Projection and ClearInfinity Deep Learning Image Reconstruction. Each image was read by 3 board-certified radiologists who provided an assessment of image quality related to diagnostic use according to a 5-point Likert scale.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Verification for ClearView:
Engineering bench testing was performed. The evaluation and analysis used the raw datasets obtained on NeuViz 128 and then applies both ClearView and Filtered Back Projection reconstruction.
- Quantitative dose reduction: Compared with FBP, ClearView may enable lower radiation dose of head by 40% to 50% at the same image quality; Compared with FBP, ClearView may enable lower radiation dose of body by 45% to 60% at the same image quality.
- Quantitative low-contrast resolution improvement: Compared with FBP, ClearView may enable improve low contrast detectability of head by 30% to 35% at the same dose; Compared with FBP, ClearView may enable improve low contrast detectability of body by 35% to 45% at the same dose.
- Quantitative noise reduction: Compared with FBP, ClearView may enable reduce image noise up to 55% at the same dose.
Performance Verification for ClearInfinity:
Engineering bench testing was performed. The evaluation and analysis used the raw datasets obtained on NeuViz 128 and then applies both Clearlnfinity and Filtered Back Projection reconstruction.
- Quantitative dose reduction: Compared with FBP, Clearlnfinity may enable lower radiation dose of head by 50% to 60% at the same image quality; Compared with FBP, Clearlnfinity may enable lower radiation dose of body by 75% to 85% at the same image quality.
- Quantitative low-contrast resolution improvement: Compared with FBP. Clearlnfinity may enable improve low contrast detectability of head by 35% to 65% at the same dose; Compared with FBP, Clearlnfinity may enable improve low contrast detectability of body by 60% to 115% at the same dose.
- Quantitative noise reduction: Compared with FBP, ClearInfinity may enable reduce image noise up to 90% at the same dose.
- Quantitative improvement of spatial resolution: Compared with FBP, ClearInfinity may enable improve spatial resolution up to 1.88X (88%) at same image noise.
Clinical Image Evaluation for ClearInfinity:
Reader study (30 cases, 3 radiologists) and additional study (20 cases, 3 radiologists).
- The results of the study indicate that ClearInfinity is equivalent or better than Filtered Back Projection in diagnostic quality.
- The results of the study indicate that Clearlnfinity is equivalent or better than Filtered Back Projection in diagnostic quality at low doses.
Clinical Testing: No Clinical Study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Note: Low Contrast Detectability (LCD), Image Noise, Spatial Resolution are mentioned as assessed metrics.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
October 11, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
Neusoft Medical Systems Co., Ltd. % Tian Yuehui Q&R Manager No. 177-1 Chuangxin Road, Hunnan District SHENY ANG, LIAONING 110167 CHINA
Re: K230220
Trade/Device Name: NeuViz 128 Multi-Slice CT Scanner System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: September 8, 2023 Received: September 11, 2023
Dear Tian Yuehui:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K230220
Device Name NeuViz 128 Multi-Slice CT Scanner System
Indications for Use (Describe)
The NeuViz 128 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
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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3
510(K) Summary
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92
1. General Information:
| Manufacturer: | Neusoft Medical Systems Co., Ltd.
No.177-1 Chuangxin Road, Hunnan District,
Shenyang, Liaoning, China, 110167. |
|-----------------|----------------------------------------------------------------------------------------------------------------------|
| Contact person: | Tian Yuehui
Title : Q&R Manager
Tel : 86-24-23358105
E-Mail : tianyh@neusoftmedical.com |
Date of Preparation: October 8, 2023
2. Device Name and Classification:
Trade Name: | NeuViz 128 Multi-Slice CT Scanner System |
---|---|
Common Name: | CT Scanner |
Regulation Number: | 21 CFR 892.1750 |
Regulation Name: | Computed tomography x-ray system |
Product Code: | JAK |
Classification: | Class II |
Performance Standard: | 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard |
3. Predicate device:
Trade Name: | NeuViz 128 Multi-Slice CT Scanner System |
---|---|
510(k) number: | K151383 |
Clearance Date: | 11/04/2015 |
Regulation Number: | 21 CFR 892.1750 |
Classification Name: | Computed tomography x-ray system |
Product Code: | JAK |
Classification: | Class II |
Manufacturer: | Neusoft Medical Systems Co., Ltd. |
Recall Information: | All predicate device recalls have been considered in the |
subject | |
device design |
4. Reference Device:
Trade Name: | NeuViz Prime Multi-Slice CT Scanner System |
---|---|
510(k) number: | K171201 |
Clearance Date: | 09/13/2017 |
Regulation Number: | 21 CFR 892.1750 |
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Neusoft 东软医疗
Classification Name: Product Code: Classification: Manufacturer:
Computed tomography x-ray system JAK Class II Neusoft Medical Systems Co., Ltd.
5. Reason for submission:
Modification of existing medical device
6. Device Description:
The proposed NeuViz 128 Multi-slice CT Scanner System is composed of a gantry, a patient couch, an operator console and includes image acquisition hardware and software, and associated accessories. It is designed to be a head and whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.
Same as the predicate, The gantry has a 72cm bore with a maximum FOV of 50 cm and available rotation speeds are still 0.374s,0.5s, 0.6s.0.8s,1.0s,1.5s,2.0s per 360° rotation.
The proposed NeuViz 128 has three types of reconstruction methods available: FBP(filter back-projection), ClearView(iterative reconstruction algorithm), and Clearlnfinity . ClearInfinity is a new added recon mode where the system uses a trained deep learning neural network to generate noise reduction images and improve low contrast detectability with reduced dose compared with standard FBP recon mode.
7. Indications for use
The NeuViz 128 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
8. Indications for use comparison
The indications for use of the proposed Neu/iz 128 is the same as that of the predicate device.
9. Comparison of Technological Characteristics with the Predicate Devices
The proposed NeuViz 128 includes most of the available features on the current production predicate device and employs the same fundamental technologies as those of the predicate device.
A tabular summary of the comparable hardware ,software properties and features between the proposed device with predicate device are listed in Table 1and 2 below (modifications are in gray shaded sections).
5
| Hardware property | Proposed device
NeuViz 128 | Predicate device
NeuViz 128 (K151383) |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Gantry
Aperture | 720mm | 720mm |
| Gantry
Tilt | +/-30° | +/-30° |
| Gantry
Scan Speed (s / 360°) | 0.374s、0.5s、0.6s、0.8s、
1.0s、1.5s、2.0s | 0.374s、0.5s、0.6s、0.8s、
1.0s、1.5s、2.0s |
| Detector Type | Solid-state GOS ceramic | Solid-state GOS ceramic |
| Detector Number of
Detector Rows | 64 | 64 |
| Maximum slices generated
per rotation (multislice
capability) | 128 | 128 |
| Generator Max. Power | 80kW | 80kW |
| Generator mA Range | 10mA667mA | 30mA667mA |
| Generator kV Settings | 80kV, 100kV, 120kV,
140kV | 80kV, 100kV, 120kV,
140kV |
| Tube
Focal Spots | 0.6×1.2 (small)
1.1×1.2 (large) | 0.6×1.2 (small)
1.1×1.2 (large) |
| Tube
heat capacity | 8.0MHU | 8.0MHU |
| Couch
Type/max. moving
length/max. table
loading/max. horizontal
speed | standard couch(option):
211kg/225mm/s
long couch(option):
211kg/310mm/s
300kg couch(option): | standard couch:
205kg/160mm/s
300kg couch (option):
300kg/160mm/s |
| | 300kg/225mm/s | |
| Intelligent Positioning
Device
(optional) | option for Intelligent
Positioning feature | N/A |
Table 1:Technical hardware characteristics for subject device compared to the predicate devices.
6
Table 2: Software characteristics and features for subject device compared to the predicate devices.
| Software property
and Feature | Proposed device
NeuViz 128 | Predicate device
NeuViz 128 (K151383) |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Recon FOV | 50mm500mm;500mm |
Extended FOV 700mm(Optional) | 50mm
| Spiral Scan Range of
Pitch | 0.1-2.1 | 0.13-1.5 |
| Reconstruction
Algorithm | Filtered back-projection (FBP);
ClearView;
ClearInfinity (Optional); | Filtered back-projection
(FBP) ;
ClearView |
| O-Dose | Support | Support |
| Bolus tracking | Support | Support |
| SAS | Support | Support |
| Home | Support | Support |
| Film | Support | Support |
| Report | Support | Support |
| Image Review | Support | Support |
| MPR | Support | Support |
| 3D | Support | Support |
| Virtual Endoscopy | Support | Support |
| Dental Analysis | Support | Support |
| (Optional) | | |
| Vessel Analysis | Support | Support |
| DICOM Viewer | Support | Support |
| Virtual
Colonoscopy(Optional
) | Support | Support |
| Brain
Perfusion(Optional) | Support | Support |
| Body
Perfusion(Optional) | Support | Support |
| Lung Nodule
Analysis(Optional) | Support | Support |
| Lung
Density(Optional) | Support | Support |
| Coronary
Analysis(Optional) | Support | Support |
| Cardiac Calcium
Scoring(Optional) | Support | Support |
| Cardiac Function
Analysis(Optional) | Support | Support |
| Cardiac
Viewer(Optional) | Support | Support |
| Fat Analysis(Optional) | Support | Support |
| CTDSA(Optional) | Support | Support |
| Tumor
Assessment(Optional) | Support | Support |
| Real-time
MPR(Optional) | Support. Real-time MPR reconstruction is a recon mode, in the clinical scanning, automatically generate sagittal or coronal MPR images based on the CT axial images. Reduce secondary loading reconstruction time. | N/A |
| 4D scanning(Optional) | Support.
It is a kind of fast spiral perfusion
scan.The table top of couch
moves back and forth repeatedly
in the area of interest when the
patient is injected with contrast
agent. So as to track the dynamic
images of contrast agent
changing in the same part at
different times. | N/A |
| Dual Energy Imaging
( Prism Imaging)
(Optional) | Support.
Dual-energy imaging uses two
energies during one CT
examination, performs image
reconstruction of data originated
by the two energy separately and
then decomposes the two kinds
of images into a set of basis
images of pre-defined materials
(the decomposition parameters
are pre-set by the manufacturer) ,
according to which the next
process is conducted. | N/A |
| Prism
Viewer(Optional) | Support
Prism Viewer application is used
to view and analysis multi energy
images. Display a variety of
images with different parameters
and provide visual tools, to help
users to locate the lesion
accurately. | N/A |
| Intelligent
Positioning(Optional) | Support.
The system collects and displays
the natural image information of
the human body. The system can
use the human body image
information to automatically
calculates the scanning position
according to the scanning
protocol and using artificial
intelligence
technology. At the same time,
User can also manually draw the
scan frame on the human
body Image, And Then, the
system calculates the scanning
position by the scan frame. | N/A |
| | According to the scanning
protocol, the system can
automatically adjust the couch
height from intelligence setting.
The system support patient
position, posture and collision
Detection. | |
| Coronary Motion
Clear(Optional) | Support.
Coronary Motion Clear functi
on is used to generate imag
e dateset with less motion ar
tefact in coronary area. | N/A |
| Metal artifact
removal(Optional) | MAR,MAR+.
MAR/MAR+ stands for metal
artifact reduction. It's the post
processing algorithm that can
remove the artifacts caused by
metal or high CT value. MAR
method only needs image
data, while MAR+ method needs
both image data and raw data. | MAR |
| Arrhythmia
Handling(Optional) | Support.
Recognize and ignore the ar
rhythmia R-peak during card
iac scan, and trigger the sca
n while normal R-peak recog
nized. | N/A |
| Auto FOV+(Optional) | Support.
Auto FOV is automatically mark t
he FOV range on the surview im
age based on Al technology, and
the FOV range can be adjusted
manually. Supported scan parts i
nclude head and lungs | N/A |
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Neusoft 东软医疗
8
Neusoft 东软医疗
9
Any differences in technological characteristics do not raise different questions of safety and effectiveness. Testing and validation is completed. Test results show that the subject device is substantially equivalent to the predicate devices.
Note:
- Auto FOV has not been thoroughly tested on pediatric under 3 years old. A consultation with a radiologist and a physicist should be made to determine the appropriate scan FOV for perform the particular clinical task.
10
10. Performance Data
Summary of Non-Clinical Testing:
The device has successfully completed all testing per our quality system as well as addition engineering bench testing in support of this submission. It was designed and is manufactured under the Quality System Regulations of 21 CFR 820 and ISO 13485 .
This device is in conformance with the applicable parts of the following standards: --ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
--ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)] --IEC 60601-1-3 Edition 2.2 2021-01 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
--IEC 60601-1-6 Edition 3.2 2020-07 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability --IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
--IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
--IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - Part 1: Equipment classification, and requirements
-- IEC 61223-3-5:2019 Evaluation and routine testing in medical imaging departments -Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-rav equipment
--IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes --IEC 62366-1 2020 Medical devices Part 1: Application of usability enqineering to medical devices
--ISO 14971:2019 Medical devices - Application of risk management to medical devices --NEMA XR 25: 2019, Computed tomography dose check
--NEMA XR 28: 2013, Supplemental Requirements for User Information and System Function Related to Dose in CT
Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.
Risk analysis and verification/validation activities conducted through bench testing which is included in this submission demonstrate that the established specifications for the device have been met. Additional performance testing, using phantom studies, were conducted to assess the improvements to existing features. Results of all these studies demonstrate that the features included in this submission meet specifications and perform as intended.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document,"Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also referenced as for this submission.
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Neusoft Medical Systems Co., Ltd conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the 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 Medical Devices issues on October 2. 2014" is included within this submission.
Additional Non-Clinical Testing for ClearView and ClearInfinity
Performance Verification for ClearView*
Engineering bench testing was performed to support substantial equivalence and the product performance claims. The evaluation and analysis used the raw datasets obtained on NeuViz 128 and then applies both ClearView and Filtered Back Projection reconstruction. The content and results of the test are as follows:
Quantitative dose reduction test using the CCT189 and CCT191 MITAIQ LC Phantoms and the channelized Hotelling observer. Compared with FBP, ClearView may enable lower radiation dose of head by 40% to 50% at the same image quality*; Compared with FBP, ClearView may enable lower radiation dose of body by 45% to 60% at the same image quality*.
Quantitative low-contrast resolution improvement test using the CCT189 and CCT191 MITAIQ LC Phantoms and the channelized Hotelling observer. Compared with FBP, ClearView may enable improve low contrast detectability of head by 30% to 35% at the same dose*; Compared with FBP, ClearView may enable improve low contrast detectability of body by 35% to 45% at the same dose *.
Quantitative noise reduction test using the water layer of the QA phantom. Compared with FBP, ClearView may enable reduce image noise up to 55% at the same dose*.
Note:
- ClearView has not been thoroughly tested on advanced post-processing application. A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task Performance Verification for ClearView:
ClearView has not been thoroughly tested in pediatric population. A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task;
Clinicians or dosimetrists should only be allowed to reduce patient dose in clinical practice.
- In clinical practice, the use of ClearView may reduce CT patient dose depending on the clinical task, patient size, anatomical location, and clinical practice. A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task. Low Contrast Detectability (LCD), Image Noise were assessed using normal dose comparing ClearView and FBP. The LCD and Image Noise measured in smooth kernel and 0.625 mm slices. The claims are based on ClearView 90% level.
Performance Verification for ClearInfinity*
Enqineering bench testing was performed to support substantial equivalence and the product performance claims. The evaluation and analysis used the raw datasets obtained on NeuViz 128 and then applies both Clearlnfinity and Filtered Back Projection reconstruction. The content and results of the test are as follows:
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Quantitative dose reduction test using the CCT189 and CCT191 MITAIQ LC Phantoms and the channelized Hotelling observer. Compared with FBP, Clearlnfinity may enable lower radiation dose of head by 50% to 60% at the same image quality*; Compared with FBP, Clearlnfinity may enable lower radiation dose of body by 75% to 85% at the same image quality*.
Quantitative low-contrast resolution improvement test using the CCT189 and CCT191 MITAIQ LC Phantoms and the channelized Hotelling observer. Compared with FBP. Clearlnfinity mav enable improve low contrast detectability of head by 35% to 65% at the same dose*; Compared with FBP, Clearlnfinity may enable improve low contrast detectability of body by 60% to 115% at the same dose *.
Quantitative noise reduction test using the water layer of the QA phantom. Compared with FBP, ClearInfinity may enable reduce image noise up to 90% at the same dose*.
Quantitative improvement of spatial resolution test using the high-contrast test device in the physical layer and water layer of the QA phantom. Compared with FBP, ClearInfinity may enable improve spatial resolution up to 1.88X (88%) at same image noise*.
Note:
- US patient-based testing data for Clearlnfinity collected from three sites of OK and one site of TX, a total of 445 clinical cases of 297 independent patients;
ClearInfinity has not been thoroughly tested on advanced post-processing application. A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task Performance Verification for ClearInfinity;
ClearInfinity has not been thoroughly tested in pediatric population. A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task;
Clinicians or dosimetrists should only be allowed to reduce patient dose in clinical practice.
- In clinical practice, the use of Clearlnfinity may reduce CT patient dose depending on the clinical task, patient size, anatomical location, and clinical practice. A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task. Low Contrast Detectability (LCD),Image Noise, Spatial Resolution were assessed using normal dose comparing ClearInfinity and FBP. The LCD and Image Noise measured in smooth kernel and 0.625 mm slices; Spatial Resolution measured in sharp kernel and 0.625 mm slices. The claims are based on ClearInfinity 90% level.
Clinical Image Evaluation for ClearInfinity
The reader study used a total of 30 retrospectively collected clinical cases (Determine the sample size according to Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices) . The raw data from each of these cases was reconstructed with both Filtered Back Projection and ClearInfinity Deep Learning Image Reconstruction. The images generated by the two reconstruction methods of the same raw data are presented to the reader in pairs. Each image was read by 3 board-certified radiologists who provided an assessment of image quality related to diagnostic use according to a 5-point Likert scale. The results of the study indicate that ClearInfinity is equivalent or better than Filtered Back Projection in diagnostic quality. An additional study used a total of 20 retrospectively collected clinical cases which raw data were processed at simulated low doses to produce low-dose images. Each of the low dose images
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was reconstructed with both Filtered Back Projection and ClearInfinity Deep Learning Image Reconstruction. Each image was read by 3 board-certified radiologists who provided an assessment of image quality related to diagnostic use according to a 5-point Likert scale. The results of the study indicate that Clearlnfinity is equivalent or better than Filtered Back Projection in diagnostic quality at low doses.
Testing for verification and validation support the claims of substantial equivalence.
Clinical Testing
No Clinical Study is included in this submission.
11.Substantial equivalence Conclusions
Based on the conformance to standards, development under our quality system, and the engineering testing provided, we believe that the modified NeuViz 128 is as safe and effective, and performs in a substantially equivalent manner to the predicate device (K151383)