(263 days)
The uCT 550 is a computed tomography X-ray system intended to produce crosssectional 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, cardiac and vascular.
The Computed Tomography X-ray system, uCT 550, is intended to produce crosssectional images of the patient by computer reconstruction of X-ray transmission data taken at different angles and planes. These images may be obtained either with or without contrast. The proposed device consists of CT scan gantry (including high voltage generator, X-ray tube, collimator and detectors), patient table, operating console (including console PC, monitor and Control Box), power supply cabinet (PSC), vital signal monitoring gated control unit (VSM), 3D camera, system software, and accessories.
The provided document describes the uCT 550, a Computed Tomography (CT) X-ray system, and specifically details the performance evaluation of its DELTA (Deep Recon) algorithm.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance (DELTA Algorithm)
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Bench Testing) |
|---|---|
| DELTA should pass the General IQ test according to IEC 61223-3-5. | DELTA passed the basic general IQ test, satisfying IEC 61223-3-5 requirements. |
| Compared with FBP, DELTA should have better LCD and noise under same scanning dose, and DELTA can reduce scanning dose keep similar LCD compared with FBP. | DELTA showed better LCD and noise compared with FBP at the same scanning dose AND can reduce scanning dose compared with FBP at the same LCD. |
| Compared with FBP, DELTA should have better high contrast spatial resolution. | DELTA showed better spatial resolution compared with FBP at the same scanning dose. |
| Acceptance Criteria (Clinical Evaluation) | Reported Device Performance (Clinical Evaluation) |
| The mean score of simulated low dose DELTA image is equal or higher than the mean score of normal dose FBP. | Accepted (Results indicate acceptance criteria were met). |
| The mean score of DELTA is better than the mean score of FBP under same dose. | Accepted (Results indicate acceptance criteria were met). |
| DELTA image should satisfy diagnosis requirements. | DELTA images satisfy diagnosis requirements. |
| Overall Conclusion | All study results show that the acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Evaluation Test Set:
- Size: 30 cases (10 for abdomen, 10 for chest, 10 for head).
- Data Provenance: Not explicitly stated as retrospective or prospective, nor the country of origin. It mentions "gathering from different scanning doses and a wide range of population" for the overall clinical dataset.
- Clinical Evaluation Validation Set (used to inform the test set, but separate):
- Size: 14 cases (5 for abdomen, 4 for chest, 5 for head).
- Data Provenance: Same as above, not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The clinical evaluation mentions that "different board-certified U.S. radiologists" scored the image quality.
- The exact number of radiologists is not specified, but the qualification is "board-certified U.S. radiologists." No experience level (e.g., "10 years of experience") is provided.
4. Adjudication Method for the Test Set
- The document states that the radiologists "perform a five-point scale evaluation of both image sets on three image quality aspects: noise, image structure fidelity and overall image quality."
- It does not specify an adjudication method such as 2+1 or 3+1 for resolving discrepancies among readers. It implies that individual scores were collected and mean scores were calculated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A reader study was performed where "different board-certified U.S. radiologists" evaluated image quality. This is inherently a multi-reader study.
- The study compared DELTA images (simulated low dose or same dose) against FBP (normal dose or same dose) to assess improvement in image quality aspects (noise, image structure fidelity, overall image quality).
- Effect Size: The document states that the "mean score of simulated low dose DELTA image is equal or higher than the mean score of normal dose FBP" and "The mean score of DELTA is better than the mean score of FBP under same dose." While it indicates a positive effect (improvement or equivalence with dose reduction), a specific quantifiable effect size (e.g., AUC difference, percentage improvement) is not provided in this summary.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, a standalone study was performed. The "Bench Testing" section (8.1) directly evaluates the DELTA algorithm's image quality metrics (LCD, noise, spatial resolution, HU value, thickness section) using phantoms, comparing it quantitatively to FBP. This is an algorithm-only evaluation.
7. Type of Ground Truth Used (DELTA Algorithm)
- Bench Testing: Phantom-based measurements (MITA CCT189, MITA CCT191, Catphan 700, water phantom) are used, effectively creating a known and reproducible "ground truth" for physical image quality metrics.
- Clinical Evaluation: Expert consensus/opinion from "board-certified U.S. radiologists" through a five-point scale evaluation of image quality aspects (noise, image structure fidelity, overall image quality). It also states that "DELTA image should satisfy diagnosis requirements," implying that clinical utility against diagnostic benchmarks is a component of the ground truth.
8. Sample Size for the Training Set (DELTA Algorithm)
- The document states for the DELTA algorithm: "The dataset was increased to 127 cases compared with the original dataset." This refers to the dataset used for the algorithm's development/training, indicating a training set size of 127 cases.
9. How the Ground Truth for the Training Set Was Established (DELTA Algorithm)
- The document does not explicitly describe how the ground truth for the training set was established. It only states that the dataset size was increased. For deep learning algorithms, ground truth for training data typically involves expert annotations or meticulously prepared reference images, often by comparing with a higher-quality imaging standard or expert-labeled findings. However, this specific detail is not present in the provided text.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 14, 2025
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Manager No. 2258 Chengbei Rd. Jiading District Shanghai, 201807 CHINA
Re: K241166
Trade/Device Name: uCT 550 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: December 20, 2024 Received: December 20, 2024
Dear Xin Gao:
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.
{1}------------------------------------------------
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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
{2}------------------------------------------------
assistance/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 Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
uCT 550
| Indications for Use (Describe) |
|---|
| -------------------------------- |
The uCT 550 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, cardiac and vascular.
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."
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is stacked on top of each other and is in bold, sans-serif font. To the right of the text is a stylized letter "U" that is split into two vertical bars with a horizontal bar connecting them at the top.
510 (K) SUMMARY
1. Date of Preparation
January 15, 2025
2. Sponsor Identification
Shanghai United Imaging Healthcare Co. Ltd.
No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Contact Person: Xin GAO Position: Regulatory Affair Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Proposed Device
Trade Name: uCT 550 Model(s): uCT 550 Regulation Name: Computed Tomography X-ray System Regulation Number: 21 CFR 892.1750 Regulatory Class: II Product Code: JAK Review Panel: Radiology
4. Identification of Predicate/Reference Device
Predicate Device Device Name: uCT 530, uCT 550 510(k) Number: K200016 Regulation Name: Computed Tomography X-ray System Regulation Number: 21 CFR 892.1750 Regulatory Class: II
Page 1 of 12
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image contains 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 logo that appears to be a geometric shape, possibly representing the letter "U" or a window-like design. The overall impression is that of a corporate logo for a company named United Imaging.
Product Code: JAK Review Panel: Radiology
Reference device:
Device Name: uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis 510(k) Number: K230162 Regulation Name: Computed Tomography X-ray System Regulation Number: 21 CFR 892.1750 Regulatory Class: II Product Code: JAK Review Panel: Radiology
5. Device Description:
The Computed Tomography X-ray system, uCT 550, is intended to produce crosssectional images of the patient by computer reconstruction of X-ray transmission data taken at different angles and planes. These images may be obtained either with or without contrast. The proposed device consists of CT scan gantry (including high voltage generator, X-ray tube, collimator and detectors), patient table, operating console (including console PC, monitor and Control Box), power supply cabinet (PSC), vital signal monitoring gated control unit (VSM), 3D camera, system software, and accessories.
Compared with K200016, the proposed device was added more application features which were discussed in Chapter 7.
6. Indications for Use
The uCT 550 is a computed tomography X-ray system intended to produce crosssectional 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, cardiac and vascular.
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image contains 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 logo that resembles a shield with a cross in the middle. The logo is a solid color, and the overall design is simple and modern.
7. Comparison of Technological Characteristics with the Predicate Device
Tables below provide comparisons of the technological characteristics between the proposed device and the reference device:
| ITEM | Proposed Device | Predicate Device (K200016) | Reference Device #1(K230162) | Discussion ofDifferences |
|---|---|---|---|---|
| uCT 550 | uCT 530, uCT 550 | uCT 760 with uWS-CT-Dual EnergyAnalysis,uCT 780 with uWS-CT-Dual EnergyAnalysis | ||
| Gantry | Rotation speed: up to 0.5s/rotation; 70cm bore | Rotation speed: up to 0.5s/rotation; 70cm bore | -- | Same |
| Detector | 22mm Detector Material: Solid-state GOS 40 rows, 864 channels/row Size of detector element in Z-plane: 0.55mm | 22mm Detector Material: Solid-state GOS 40 rows, 864 channels/row Size of detector element in Z-plane: 0.55mm | -- | Same |
| X-ray Tube | 70, 80, 100, 120, 140 kV• mA range: 10 mA-420 mA• Anode heat capacity: 5.3MHU• Maximum anode heat dissipation:9.6kW(815kHU/min)• Focal spot size:0.5mm × 1.0mm1.0mm × 1.0mm | • 70, 80, 100, 120, 140 kV• mA range: 10 mA-420 mA• Anode heat capacity: 5.3MHU• Maximum anode heat dissipation:9.6kW(815kHU/min)• Focal spot size:0.5mm × 1.0mm1.0mm × 1.0mm | -- | Same |
| High Voltage Generator | • 50kW Power• 70, 80, 100, 120, 140 kV | • 50kW Power• 70, 80, 100, 120, 140 kV | -- | Same |
| Patient Table | • Maximum load capacity205kg | • Maximum load capacity205kg | -- | Same |
| Maximum SlicesGenerated per Rotation | 80 for uCT 550 | 40 for uCT 53080 for uCT 550 | -- | Same |
| Reconstruction Field ofView | 40-500mm40-700mm with extended FOV | 40-500mm40-600mm with extended FOV | -- | SubstantiallyEquivalent,The difference willnot raise safety andeffectivenessconcerns. |
| Application Features | ||||
| KARL 3D | Yes | Yes | -- | Same |
| Metal Artifact Correction(MAC) | Yes | Yes | -- | Same |
| Auto ALARA mA | Yes | -- | Yes | Same |
| Auto ALARA kVp | Yes | -- | Yes | Same |
| Organ-Based AutoALARA mA | Yes | -- | Yes | Same |
| DELTA (Deep Recon) | Yes | -- | Yes | SubstantialEquivalentNote 1 |
| It is an AI-based deep learningalgorithm to effectively reduceimage noise, enhance high-contrastspatial resolution, improve low-contrast detectability, andcorrespondingly decrease the doserequired for diagnostic CT images. | ||||
| CardioXphase | Yes | -- | Yes | Same |
| Online MPR | Yes | -- | Yes | Same |
| EasyRange | Yes | -- | Yes | SubstantialEquivalentNote 2 |
| It is an AI-based deep learningalgorithm to automaticallyrecommend the scan range. | ||||
| uAI Vision | Yes | -- | Yes | Same |
| Motion Freeze | Yes | -- | -- | SubstantialEquivalentNote 3 |
| It is an AI-based deep learning algorithm to reduce the artifacts caused by head motion. | ||||
| Injector Linkage | Yes | -- | Yes | Same |
| CT-guided Intervention | Yes | -- | Yes | Same |
| Low Dose CT LungCancer ScreeningProtocol (LDCTLCS) | Yes | -- | Yes | Same |
| Remote Assistance | Yes | -- | Yes | Same |
{7}------------------------------------------------
Image /page/7/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 text is a stylized symbol that resembles a shield or emblem. The symbol is divided into sections, with a vertical line and a horizontal line creating a geometric design.
{8}------------------------------------------------
Image /page/8/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 text is a stylized graphic element that appears to be a combination of geometric shapes, possibly representing the letters "U" and "I" in a modern, abstract way. The overall design is clean and professional, suggesting a company in the technology or medical imaging field.
{9}------------------------------------------------
Image /page/9/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 text is a stylized symbol that resembles a shield or a stylized letter 'U' with a horizontal line through the middle. The text and symbol are in a dark color, possibly black or a dark shade of blue.
• • Note 1:
Compared with DELTA (Deep Recon) algorithm cleared by K230162, detailed discussion about the difference are as follows:
| Proposed deviceuCT 550 | Reference deviceuCT 760/780 with uWS-CT-Dual Energy Analysis(K230162) | Discussion | |
|---|---|---|---|
| Technology | AI-based deep learning algorithm | AI-based deep learning algorithm | Same |
| Applicable Body Parts | Head, chest, abdomen and vascularCT applications for adults | Head, chest, abdomen, cardiacand vascular CT applications foradults | The proposed device does not supportcardiac. This difference will not introducesafety and effectiveness issues. |
| User Interface | 5 noise reduction levels | 4 noise reduction levels | Increased noise reduction. This differencewill not introduce safety and effectivenessissues. |
{10}------------------------------------------------
Image /page/10/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 graphic, which is a geometric shape that resembles the letter "U" or a shield, with a vertical line running down the center, dividing the shape into two halves.
| Dataset Size | The dataset was increased to 127cases compared with the originaldataset. | Original Dataset | Dataset was increased to improve algorithmrobustness. This difference will notintroduce safety and effectiveness issues. |
|---|---|---|---|
| Clinical workflow | Select recon type, strength (noiseindex level) | Select recon type and strength(noise index level) | Same |
| Bench test | Bench test for dose reduction,LCD, noise reduction and spatialresolution improving test. Basic IQperformance test including HUvalue on water phantom, thicknesssection test. | Bench test for dose reduction,LCD, noise reduction and spatialresolution improving test. BasicIQ performance test including HUvalue on water phantom,thickness section test. | Same |
| Conclusion | DELTA supplies diagnostic imagequality at lower dose in the lowdose simulation validation andequivalent or better image qualitycompared with FBP in theevaluation of clinical cases covering avariety of dose level. | DELTA is able to generate CTimages with lower image noiseand improved low contrastdetectability, also reduce the doserequired for diagnostic CTimaging. | Substantially EquivalentThe function of DELTA has beenoptimized in the uCT 550. The differencewill not raise new safety and effectivenessconcerns. |
• Note 2:
EasyRange was optimized in this submission, adding supported body parts. The difference will not raise new safety and effectiveness concerns.
- Note 3:
Motion Freeze is an image reconstruction which is intended to correct patient head motion. The difference will not raise new safety and effectiveness concerns.
{11}------------------------------------------------
Image /page/11/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the text is a stylized "U" logo, which is composed of two vertical bars and a horizontal bar, creating a blocky, geometric design. The logo is simple and modern.
8. Performance Data
The performance testing for DELTA (Deep Recon) algorithm was based on Bench Testing and the Clinical Evaluation.
8.1 Bench Testing
The bench testing has been performed to quantitatively evaluate the image quality with DELTA compared to FBP. The proposed device image quality (IQ) with DELTA was tested by the following evaluation methods.
8.1.1 Bench Test
The bench test includes different phantom tests, all phantom tests were based on 512*512 matrix sizes:
- General IO Performance testing of metrics identified in IEC 61223-3-5 to study . overall performance in a standardized and referenceable manner. General IO tests include CT HU number test and thickness section test based on water phantom and Catphan 700 phantom.
- A low contrast detectability (LCD) test was performed to evaluate the LCD ● enhancement, dose reduction and noise reduction on MITA CCT189 and MITA CCT191 phantom.
- A high contrast spatial resolution test was performed under the guidance of IEC ● 61223-3-5 to evaluate the improvement of high contrast spatial resolution compared with FBP.
8.1.2 Study pass criteria
- DELTA should pass the General IQ test according to IEC 61223-3-5.
- Compared with FBP, DELTA should have better LCD and noise under same ● scanning dose, and DELTA can reduce scanning dose keep similar LCD compared with FBP.
- . Compared with FBP, DELTA should have better high contrast spatial resolution.
8.1.3 Bench Testing Results and conclusion
- DELTA passed the basic general IQ test which satisfied the requirement of IEC ● 61223-3-5.
- DELTA showed better LCD and noise compared with FBP at same scanning ● dose and can reduce scanning dose compared with FBP at same LCD.
{12}------------------------------------------------
Image /page/12/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED" is stacked on top of the word "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized logo that resembles a blocky letter "U" or a shield-like shape, with a horizontal line cutting through the upper portion of the shape. The logo and text are in a dark color, possibly black or a dark shade of gray.
- DELTA showed better spatial resolution compared with FBP at same scanning ● dose.
In summary, the bench testing result shows that DELTA had better image noise, LCD and spatial resolution at same scanning dose compared with FBP, and DELTA can keep the image quality (LCD) under lower scanning dose compared with FBP under the above conditions/using the MITA phantom.
8.2 Clinical Evaluation
8.2.1 Clinical Evaluation Method
The proposed device was evaluated through a reader study using a sample clinical dataset. The image quality was scored by different board-certified U.S. radiologists to perform a five-point scale evaluation of both image sets on three image quality aspects: noise, image structure fidelity and overall image quality.
8.2.2 Testing Data Information
The clinical dataset comprised of different body parts, including head, chest, abdomen with disease and non-disease, gathering from different scanning doses and a wide range of population. Then, the clinical dataset was reconstructed by DELTA and FBP separately.
There were 44 datasets in total.
- The validation dataset includes 14 cases: ●
- -5 cases for abdomen.
- -4 cases for chest.
- -5 cases for head.
All cases were scanned at a normal dose using FBP and simulated low-dose DELTA images.
- The test dataset includes 30 cases with 10 cases for each body part-abdomen, . chest, head-scanned at various doses and reconstructed using FBP and DELTA.
Validation data and Testing Data are completely independent. The distribution of validation and test data was shown below:
| Body Part | Number | Age | Sex | Dose Distribution |
|---|---|---|---|---|
| Head | 15 | 19-79 | 8 male7 female | ≥70%: 1330%-70%: 2≤30%: 0 |
| Chest | 14 | 29-78 | 9 male5 female | ≥70%: 230%-70%: 4≤30%: 8 |
{13}------------------------------------------------
Image /page/13/Picture/1 description: The image contains the words "UNITED IMAGING" in bold, sans-serif font. To the right of the words is a stylized logo. The logo is dark blue and consists of two vertical bars with a horizontal bar connecting them at the top. The bottom of the logo is curved.
| Abdomen | 15 | 29-87 | 9 male6 female | ≥70%:30%-70%≤30% | 3120 |
|---|---|---|---|---|---|
| --------- | ---- | ------- | -------------------- | -------------------------- | -------------- |
8.2.3 Clinical Acceptance Criteria
- The mean score of simulated low dose DELTA image is equal or higher than the ● mean score of normal dose FBP.
- The mean score of DELTA is better than the mean score of FBP under same ● dose.
- . DELTA image should satisfy diagnosis requirements.
8.2.4 Clinical Evaluation Results and Conclusion
In general, DELTA images satisfy diagnosis requirements. All study results show that the acceptance criteria were met and that dose reductions in the clinic with DELTA should be under the supervision of a clinical medical physicist.
8.3 Declaration of Conformity
UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance:
Electrical Safety and Electromagnetic Compatibility (EMC)
- A ANSI AAMI ES60601-1:2005+A1:2012+A2:2021, Medical electric for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)].
- A 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)]
- A IEC 60601-1-3: 2008+AMD1:2013+A2:2021, Edition 2.2, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
{14}------------------------------------------------
Image /page/14/Picture/1 description: The image shows 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 words is a stylized "U" shape, which is made up of a vertical bar and a horizontal bar. The logo is simple and modern, and the use of bold font and a strong color makes it easily recognizable.
- IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment Part 2-44: A Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
- IEC 60825-1: 2014, Edition 3.0, Safety of laser products Part 1: Equipment A classification and requirements.
- IEC 60601-1-6:2010+A1:2013+A2:2020, Edition 3.2, Medical electrical A equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
- NEMA XR 25-2019, Computed Tomography Dose Check A
- A NEMA XR 28-2018, Supplemental Requirements For User Information And System Function Related To Dose In CT
- A NEMA XR 29-2013, Standard Attributes on CT Equipment Related to Dose Optimization and Management
- A 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-ray equipment
Software
- A NEMA PS 3.1-3.20(2016): Digital Imaging and Communications in Medicine (DICOM)
- 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: 2009, Edition 3.0, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- A ISO 10993-10: 2010, Edition 3.0, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- A ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation
{15}------------------------------------------------
Image /page/15/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 text is a stylized "U" symbol, which is made up of several rectangles. The logo is simple and modern in design.
and testing within a risk management process
Other Standards and Guidance
- A ISO 14971: 2019, Edition 3.0, Medical Devices - Application of risk management to medical devices
- A Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation
- A Code of Federal Regulations, Title 21, Subchapter J - Radiological Health
-
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
Summary
The features described in this premarket submission are supported with the results of the testing mentioned above, the proposed device 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 the same intended use, similar performance, safety equivalence, and effectiveness 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. No issues are raised regarding the safety and effectiveness. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
§ 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.