(180 days)
The system is used to perform image guidance in diagnostic, intervention and surgical procedures. Procedures that can be performed with the system include cardiac angiography, neuro-angiography, vascular and non-vascular angiography, rotational angiography and whole body radiographic/fluoroscopic procedures.
The uAngio AVIVA CX is an angiographic X-ray system that generates X-rays through the X-ray tube, receives the signal through the flat panel detector and presents the image after D/A conversion and image post-processing.
The uAngio AVIVA CX is designed to provide intelligent, safe, and precise image guidance in cardiac, neuro, oncology, peripheral interventional, and surgical procedures.
The main components of the uAngio AVIVA CX include a C-arm stand, patient table, generator, X-ray tube, flat panel detector, collimator, grid, monitors, control module, control panel, foot switch, hand switch, V-box, and intercom.
The main software characteristics of the uAngio AVIVA CX include patient registration, patient administration, 2D&3D image viewing and post-processing, data import/archiving, filming, camera-assisted recognition function (uSpace), and voice control function (uLingo).
The provided FDA 510(k) clearance letter and summary for the uAngio AVIVA CX device do not contain detailed information about specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI-driven diagnostic tools. Instead, the document focuses on non-clinical testing to ensure the device meets safety and operational specifications, as well as satisfactory image quality for clinical use.
However, based on the non-clinical testing section, we can infer some performance criteria and how the device reportedly meets them.
Here's an attempt to extract and synthesize the information provided, keeping in mind the limitations of the input regarding specific "acceptance criteria" as they would apply to an AI-driven image interpretation system:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a fluoroscopic X-ray system, the "acceptance criteria" are related to technical performance and image quality rather than diagnostic AI algorithm metrics like sensitivity or specificity.
| Feature/Metric | Acceptance Criterion (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Cone Beam CT (CBCT) | ||
| C-arm positioning accuracy | Acceptable and repeatable position error. | "The position error of the C-arm is acceptable and the position is repeatable." |
| CBCT imaging performance | Fulfills requirements for in-plane uniformity, spatial resolution, reconstruction section thickness, noise, contrast to noise ratio, artifact analyses. | "The imaging performance of CBCT fulfills the requirements." |
| Radiation dose (CBCT) | CTDI of CBCT protocols fulfills the requirement. | "CTDI of CBCT protocols fulfills the requirement." |
| Fusion (Image Registration Algorithm) | ||
| Accuracy of Image Registration Algorithm (mTRE) | Mean target registration error (mTRE) less than the pixel diagonal distance. | "All the mTREs of the test cases are smaller than the voxel diagonal distance, which can achieve sub-pixel accuracy registration. Image Registration Algorithm is able to meet the verification criteria, the verification result is passed." |
| DSA (Digital Subtraction Angiography) | ||
| Dynamic range (submillimeter vessel visibility) | Submillimeter vessel simulation component is visible across all copper step wedges of the subtracted image. | "submillimeter sized blood vessels can be seen in all copper step wedges" (for four typical groups: Body, Head, Vascular, Pediatric). |
| Contrast sensitivity (low millimeter vessel visibility) | Low millimeter vascular simulation component should be visible in a copper step wedge of sufficient thickness in the subtraction image. | "the thickness of blood vessels visible in sufficiently thick copper step wedges meets the requirements." |
| 3D Roadmap (Neuro Registration Algorithm) | ||
| Accuracy of neuro registration (mTRE) | A precision of at least 1 mm (mTRE < 1mm). | "The registration results of neuro registration algorithm is that the mTRE is less than 1mm. The neuro registration was able to meet a precision of at least 1 mm, the verification was passed." |
| uChase (Stitching Algorithm) | ||
| Accuracy of Image Registration Algorithm in Stitching (mTRE) | Mean target registration error (mTRE) less than the pixel diagonal distance. | "All the mTREs of the test cases are smaller than the pixel diagonal distance" |
| Clinical utility of stitching results | Average score from clinical specialists higher than 2. | "the average score of stitching results is 2.95, which is higher than 2.The Stitching Algorithm was able to meet the verification criteria and the verification of the algorithm was passed." |
| uSpace (Camera-assisted recognition) | ||
| Human key point detection accuracy | Required accuracy for not deviating from the range of the acquisition field of view. | "Human key point detection achieves the required accuracy for not deviating from the range of the acquisition field of view." |
| Collision detection rate | Specified detection rate. | "Collision detection achieves the specified detection rate." |
| Auto SID adjustment accuracy | Required accuracy for maintaining a distance from detector to the patient during C-arm rotation or patient table lifting. | "Auto SID adjustment achieves the required accuracy for maintaining a distance from detector to the patient during C-arm rotation or patient table lifting." |
| Radiation safety (different SID) | Tested within allowable adjustment range; meets requirements. | "The radiation safety test results of the uAngio AVIVA CX under different SID. [...] meet the requirements." |
| Image quality (different SID) | Meets requirements based on clinical evaluation and objective physical characteristics. | "The image quality evaluation was tested through the clinical evaluation and objective physical characteristics. According to the acceptable criteria in the regulations, the image quality test results of the uAngio AVIVA CX under different SID meet the requirements." |
| uLingo (Voice control) | ||
| Wake-up algorithm recognition rate (SNR ≥ 15 dB(A)) | ≥95% accuracy rate. | "The recognition rate of voice wake-up is tested as below: When the environmental signal-to-noise ratio (SNR) is ≥15 dB(A), the wake-up accuracy rate reaches ≥95%" |
| Wake-up algorithm recognition rate (SNR = 10 dB(A)) | ≥85% accuracy rate. | "When environmental SNR is 10 dB(A), the wake-up accuracy rate reaches ≥85%." |
| Voice command recognition rate (SNR ≥ 15 dB(A)) | ≥95% success rate for each command. | "When the environmental SNR is ≥15 dB(A), the recognition success rate for each command reaches ≥95%" |
| Voice command recognition rate (SNR = 10 dB(A)) | ≥85% success rate for each command. | "When the environmental SNR is 10 dB(A), the recognition success rate for each command reaches ≥85%" |
| Clinical Image Evaluation | Image quality fulfills the needs for diagnostic, intervention, and surgical procedures (score ≥ 3 on a five-point scale for spatial detail, contrast-noise performance, clinical motion, and clinical features of interest). | "Each image received a score of ≥ 3 and received a PASS result, indicating that image quality fulfills the need for diagnostic, intervention, and surgical procedures." |
2. Sample size(s) used for the test set and the data provenance
- CBCT, Fusion, DSA, 3D Roadmap, uChase (Stitching Algorithm): These refer to various "test cases" or "test data." The exact number of images/cases is not specified for most, but:
- Fusion: "Each group has three sets of test data." (Groups refer to DSA mask registered with DSA mask, CBCT, CT, CTA, and MR).
- DSA: Four typical groups (Body, Head, Vascular, Pediatric) were tested, with "each group applying two sets of test data."
- 3D Roadmap: "It has eight sets of test data in the group."
- uChase: Refers to "test cases," specific number not listed.
- uLingo (Voice control): "For U.S. Participants, 18 talkers were invited to record the voice commands for verification."
- Clinical Image Evaluation: "Sample images were obtained from hospitals to meet the following requirements: contained images of the head, cardiac, body, and extremities with different acquisition protocols representative of US clinical use and populations. Typical cases have been selected such as Internal carotid artery angioplasty and stenting, internal carotid artery stenosis and aneurysm, PCI, radiofrequency ablation, TACE, TIPS, lower extremity arterial angioplasty and so on." The document does not specify the exact number of images or cases in this clinical image evaluation.
- Data Provenance:
- uLinkgo: "U.S. Participants."
- Clinical Image Evaluation: "obtained from hospitals," "representative of US clinical use and populations." This suggests retrospective data from US clinical settings. Other technical tests do not explicitly state data provenance but imply internal testing environments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- uChase (Stitching Algorithm): "average score from clinical specialists." The number of specialists and their specific qualifications are not provided, only stating "clinical specialists."
- Clinical Image Evaluation: "[images] evaluated by an ADR certified radiologist." This indicates one expert. The qualification specified is "ADR certified radiologist."
4. Adjudication method for the test set
- uChase (Stitching Algorithm): Ground truth seems to be implicitly established by "clinical specialists" providing an "average score." The method of combining scores (e.g., majority vote, consensus) or a formal adjudication process is not detailed.
- Clinical Image Evaluation: "evaluated by an ADR certified radiologist." This implies a single reader assessment rather than an adjudication process involving multiple experts for consensus.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not describe a multi-reader, multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance for device functionality like image interpretation. The AI components mentioned (uSpace for auto-positioning, uLingo for voice control, image quality algorithms) are primarily aimed at workflow enhancement and physical control of the device, not direct diagnostic interpretation or assistive reading. Therefore, no effect size of human reader improvement with AI assistance is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, various standalone algorithm performances were evaluated:
- CBCT imaging performance metrics.
- Fusion algorithm accuracy (mTRE).
- DSA algorithm performance (vessel visibility).
- 3D Roadmap algorithm accuracy (mTRE).
- uChase Stitching Algorithm accuracy (mTRE).
- uSpace performance (human key point detection, collision detection, Auto SID adjustment).
- uLingo algorithm performance (wake-up and command recognition rates).
These evaluations assess the algorithms' intrinsic performance without direct human-in-the-loop diagnostic interpretation.
7. The type of ground truth used
- CBCT, Fusion, DSA, 3D Roadmap, uChase (Stitching Algorithm): For these technical measurements, the ground truth is established through physical phantoms (Geometric phantom, Catphan700 phantom, chest phantom, head phantom, CTDI dosimetry phantom, body phantom, digital subtraction angiography phantom with compensation test step wedge) and objective quantitative metrics (e.g., mTRE, pixel diagonal distance, stated requirements for vessel visibility, accuracy thresholds).
- uSpace (Camera-assisted recognition): Inferred to be based on objective measurements of physical distance, field of view, and collision events.
- uLingo (Voice control): Based on objective recording and analysis of recognition rates against known voice commands and environmental conditions.
- Clinical Image Evaluation: "image quality was evaluated by an ADR certified radiologist using a five-point scale," indicating expert opinion/consensus on image quality, rather than pathology or outcomes data.
8. The sample size for the training set
The document does not specify the sample size for the training set for any of the machine learning components (uSpace, uLingo, image registration algorithms). It only mentions "machine learning methods" are used.
9. How the ground truth for the training set was established
The document does not describe how the ground truth for the training set was established for any of the machine learning components. It only mentions the "machine learning methods" are used for uSpace and uLingo but provides no details on their training data or labels.
FDA 510(k) Clearance Letter - uAngio AVIVA CX
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 28, 2025
Shanghai United Imaging Healthcare Co.,Ltd.
℅ Xin Gao
Regulatory Affairs Manager
No.2258 Chengbei Rd. Jiading District
SHANGHAI, 201807
CHINA
Re: K243376
Trade/Device Name: uAngio AVIVA CX
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Code: OWB, JAA
Dated: October 28, 2024
Received: March 18, 2025
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.
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K243376 - Xin Gao
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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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K243376 - Xin Gao
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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 Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243376
Device Name: uAngio AVIVA CX
Indications for Use (Describe):
The system is used to perform image guidance in diagnostic, intervention and surgical procedures. Procedures that can be performed with the system include cardiac angiography, neuro-angiography, vascular and non-vascular angiography, rotational angiography and whole body radiographic/fluoroscopic procedures.
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:
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"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."
Page 5
510 (k) SUMMARY
Shanghai United Imaging Healthcare Co., Ltd.
Tel: +86 (21) 67076888 Fax：+86 (21) 67076889
www.united-imaging.com
1. Date of Preparation:
October 21, 2024
2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd.
No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Establishment Registration Number: 3011015597
Contact Person: Xin GAO
Position: Regulatory Affairs Manager
Tel: +86-021-67076888-5386
Fax: +86-021-67076889
Email: xin.gao@united-imaging.com
3. Identification of Proposed Device
Trade/Device Name: uAngio AVIVA CX
Common Name: Interventional Fluoroscopic X-ray system
Model(s): uAngio AVIVA CX
Regulatory Information
Classification Name: Image-intensified fluoroscopic x-ray system
Classification: II
Product Code: Primary Code: OWB
Subsequent Code: JAA
Regulation Number: 21 CFR 892.1650
Review Panel: Radiology
4. Identification of Predicate Device(s)
Predicate Device
Trade/Device Name: Azurion R2.1
510(k) Number: K200917
Manufacturer: Philips Medical Systems Nederland B.V.
Regulatory Information
Classification Name: Image-intensified fluoroscopic x-ray system
Regulation Number: 21 CFR 892.1650
Review Panel: Radiology
Device Class: Class II
Page 1 of 12
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Shanghai United Imaging Healthcare Co., Ltd.
Tel: +86 (21) 67076888 Fax：+86 (21) 67076889
www.united-imaging.com
Product Code: Primary Code: OWB
Secondary product Code: JAA
Reference Device #1:
Trade/Device Name: SmartCT
510(k) Number: K201583
Manufacturer: Philips Medical Systems Nederland B.V.
Regulatory Information
Classification Name: Interventional fluoroscopic x-ray system
Regulation Number: 21 CFR 892.1650
Review Panel: Radiology
Device Class: Class II
Product Code: Primary Code: OWB
Subsequent Codes: JAK, LLZ
5. Device Description
The uAngio AVIVA CX is an angiographic X-ray system that generates X-rays through the X-ray tube, receives the signal through the flat panel detector and presents the image after D/A conversion and image post-processing.
The uAngio AVIVA CX is designed to provide intelligent, safe, and precise image guidance in cardiac, neuro, oncology, peripheral interventional, and surgical procedures.
The main components of the uAngio AVIVA CX include a C-arm stand, patient table, generator, X-ray tube, flat panel detector, collimator, grid, monitors, control module, control panel, foot switch, hand switch, V-box, and intercom.
The main software characteristics of the uAngio AVIVA CX include patient registration, patient administration, 2D&3D image viewing and post-processing, data import/archiving, filming, camera-assisted recognition function (uSpace), and voice control function (uLingo).
6. Indications for use
The system is used to perform image guidance in diagnostic, intervention and surgical procedures.
Procedures that can be performed with the system include cardiac angiography, neuro-angiography, vascular and non-vascular angiography, rotational angiography and whole body radiographic/fluoroscopic procedures.
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Shanghai United Imaging Healthcare Co., Ltd.
Tel: +86 (21) 67076888 Fax：+86 (21) 67076889
www.united-imaging.com
7. Comparison of Technological Characteristics with the Predicate Devices
A comparison between the technological characteristics of the proposed and predicate device and reference devices is provided as below.
| ITEM | Proposed Device: uAngio AVIVA CX | Predicate Device: Azurion R2.1(K200917) | Remark |
|---|---|---|---|
| Classification Name | Image-intensified fluoroscopic x-ray system | Image-intensified fluoroscopic x-ray system | Same |
| Classification Regulation | 21 CFR, Part 892.1650 | 21 CFR, Part 892.1650 | Same |
| Classification Panel | Radiology | Radiology | Same |
| Device Class | II | II | Same |
| Product Code | OWB, JAA | OWB, JAA | Same |
| Indications for Use | The system is used to perform image guidance in diagnostic, intervention and surgical procedures. Procedures that can be performed with the system include cardiac angiography, neuro-angiography, vascular and non-vascular angiography, rotational angiography and whole body radiographic/fluoroscopic procedures. | The Azurion series (within the limits of the used operating room table) is intended for use to perform: • Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedures. • Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: • The Azurion series can be used in a hybrid operating room. • The Azurion series contains a number of features to support a flexible and patient-centric | Note1 |
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Shanghai United Imaging Healthcare Co., Ltd.
Tel: +86 (21) 67076888 Fax：+86 (21) 67076889
www.united-imaging.com
| procedural workflow. Patient Population: All human patients of all ages. Patient weight is limited to the specification of the patient table. | |||
|---|---|---|---|
| Specifications | |||
| Generator | |||
| Max. generator power | 100 KW | 100 KW | Same |
| Max. current | 1000 mA at 100 kV | 1000 mA at 100 kV | Same |
| X-ray tube | |||
| Focal spot | 0.4mm, 0.6mm, 1.0mm | 0.4mm, 0.7mm | Note2 |
| Continuous anode input power | 3500W | 3500W | Same |
| Flat panel detector-config.1 | |||
| Max. field of view | 48 cm diagonal | 48 cm diagonal | Same |
| Pixel pitch | 154 μm | 154 μm | Same |
| DQE (at 0lp/mm) | 77% | 77% | Same |
| Flat panel detector-config.2 | |||
| Max. field of view | 48 cm diagonal | 48 cm diagonal | Same |
| Pixel pitch | 150 μm | 154 μm | Note3 |
| DQE (at 0lp/mm) | 77% | 77% | Same |
| Collimator | YES | YES | Same |
| Removable anti-scatter grid | YES | YES | Same |
| Stand | |||
| longitudinal movement | Max. 6350 mm | Max. 6350 mm | Same |
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Shanghai United Imaging Healthcare Co., Ltd.
Tel: +86 (21) 67076888 Fax：+86 (21) 67076889
www.united-imaging.com
| lateral movement range | Max. 2360 mm | Max. 2360 mm | Same |
|---|---|---|---|
| L-arm rotation | ±135° | ±135° | Same |
| Patient table - config.1 Floating table | |||
| max. table load | 340 kg | 325 kg | Note4 |
| max. patient weight | 280 kg + 600 N for CPR CPR can be done in any position of the table top | 250 kg + 500 N for CPR. CPR can be done in any position of the table top | Note5 |
| Pivot | ±180° | - 90°/+180° or -180°/+90° | Note6 |
| Patient table - config.2 Multi-tilt table | |||
| max. table load | 380 kg | 325 kg | Note7 |
| max. patient weight | 280 kg + 600 N for CPR | 250 kg + 500 N for CPR. | Note8 |
| Pivot | ±180° | -90°/+180° or -180°/90° | Note9 |
| tilt | +15°，-20° | ±16.5° | Note10 |
| cradle | ±15° | ±15° | Same |
| Image acquisition protocol | |||
| Fluoroscopy | YES | YES | Same |
| Roadmap | YES | YES | Same |
| Dynamic DR | YES | YES | Same |
| 2D DSA | YES | YES | Same |
| Singleshot | YES | YES | Same |
| Cine | YES | YES | Same |
| Bolus Chase and Bolus Chase Reconstruction | YES | YES | Same |
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Shanghai United Imaging Healthcare Co., Ltd.
Tel: +86 (21) 67076888 Fax：+86 (21) 67076889
www.united-imaging.com
| Protocol for Pediatric | YES | YES | Same |
|---|---|---|---|
| Software function | |||
| Camera-assisted recognition (uSpace) | YES | NO | Note11 |
| Voice control (uLingo) | YES | NO | Note12 |
| Safety | |||
| basic safety and essential performance | ANSI/AAMI ES60601-1:2005/A2:2021 | IEC 60601-1, 2nd Ed. + Amendment No. 1 + Amendment No. 2 + Corrigendum | Same |
| Electro Magnetic Compatibility | ANSI/AAMI/IEC 60601-1-2:2014/A1:2021 | IEC 60601-1-2, ed.2.1 | Same |
| ITEM | Proposed Device: uAngio AVIVA CX | Reference Device: SmartCT R1.0(K201583) | Remark |
|---|---|---|---|
| 3D rotational angiography | YES | YES | Same |
| Cone Beam CT (CBCT) | YES | YES | Same |
| High-resolution Cone Beam CT | YES | YES | Same |
| 3D Roadmap | YES | YES | Same |
Justification
Note1
In general, both products are used to perform image guidance in diagnostic, interventional, and surgery procedures, and are suitable for all human patients of all ages. The description differences between the two products do not affect safety and effectiveness.
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Shanghai United Imaging Healthcare Co., Ltd.
Tel: +86 (21) 67076888 Fax：+86 (21) 67076889
www.united-imaging.com
Note2
uAngio AVIVA CX has one more focal spot than the predicate device. Even if one focal filament fails, the others remain operational, and the drive circuits for all three focal filaments are independent. The difference does not introduce safety and effectiveness issues.
Note3
The smaller the pixel pitch, the greater the capability to capture fine structures, which means the ability to identify smaller lesions and tissues. The difference does not introduce safety and effectiveness issues.
Note4
The patient table (config.1 Floating table) of the proposed device has a higher weight capacity, meeting the needs of more clinical scenarios. The difference does not introduce safety and effectiveness issues.
Note5
The patient table (config.1 Floating table) of the proposed device has a higher patient weight capacity, enabling it to serve a broader patient population. The difference does not introduce safety and effectiveness issues.
Note6
The patient table (config.1 Floating table) of the proposed device has a larger rotation range, meeting the needs of more clinical scenarios. The difference does not introduce safety and effectiveness issues.
Note7
The patient table (config.2 Multi-tilt table) of the proposed device has a higher weight capacity, meeting the needs of more clinical scenarios. The difference does not introduce safety and effectiveness issues.
Note8
The patient table (config.2 Multi-tilt table) of the proposed device has a higher patient weight capacity, enabling it to serve a broader patient population. The difference does not introduce safety and effectiveness issues.
Note9
The patient table (config.2 Multi-tilt table) of the proposed device has a larger rotation range, meeting the needs of more clinical scenarios. The difference does not introduce safety and effectiveness issues.
Note10
The patient table (config.2 Multi-tilt table) of the proposed device has a broader total tilt range than that of the predicate device. The difference does not introduce safety and effectiveness issues.
Note11
uSpace uses multi-view cameras with machine learning methods and includes the following features:
- uSpace Auto Positioning: it allows users to send a specific body part of the patient to the system and automatically position it by long-pressing a button.
- uSpace VeraCT: it allows users to skip the process of conventional AP and lateral positioning and Test Run during the VeraCT acquisition, and get to the acquisition start point only by long-pressing one button.
- uSpace Auto SID: adjust the SID within a certain range to make it closer to the patient's surface.
- uSpace Auto Parameter: reduce the process of parameters setting based on the patient's actual body thickness.
- uSpace Iso Tracking: adjust the table height to align the patient's isocenter with the C-arm isocenter.
System motion is initiated only by the user's continuous triggering and the system is equipped with hardware-based collision prevention features to ensure safety. The difference does not introduce safety and effectiveness issues.
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Note12
uLingo is based on a machine learning method and it allows the system to be controlled via user's voice command, such as protocol selection, image browsing, motion control, and tool utilization, to enhance the system's usability. uLingo will not directly trigger radiation or motion. The system provides voice confirmation/feedback for the functions related to radiation and motion, for example motion lock/unlock, radiation lock/unlock, protocol selection, motion control, etc. The difference does not affect safety and effectiveness.
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8. Performance Data
Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as it is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
[1]. ANSI/AAMI ES60601-1:2005/A2:2021 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Amendment 2
[2]. ANSI/AAMI/IEC 60601-1-2:2014/A1:2021 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests - Amendment 1
[3]. IEC 60601-1-3:2021 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
[4]. IEC 60601-2-54:2022 Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
[5]. IEC 60601-2-43：2022 Medical Electrical Equipment - Part 2-43: Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment For Interventional Procedures
[6]. IEC 60601-2-28:2017 Medical electrical equipment-Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
[7]. IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
Additional non-clinical tests are conducted for each key feature to ensure safe and effective integration into the system:
| Feature | Bench Testing Performed |
|---|---|
| Cone Beam CT | The bench tests evaluate the performance of CBCT. The objectives of the tests are to demonstrate: i. C-arm positioning accuracy; ii. Imaging performance of CBCT (including in-plane uniformity, spatial resolution, reconstruction section thickness, noise, contrast to noise ratio, artifact analyses) can meet the requirements. iii. Radiation dose can meet the requirements. The geometric phantom, Catphan700 phantom, chest phantom, head phantom, CTDI dosimetry phantom, body phantom and head phantom are used in the tests above. The test results show: |
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| - The position error of the C-arm is acceptable and the position is repeatable. - The imaging performance of CBCT fulfills the requirements. - CTDI of CBCT protocols fulfills the requirement. Note: CBCT images are not for quantitative use. | |
|---|---|
| Fusion | The tests evaluate the performance of the Image Registration Algorithm. The objectives of the tests are to demonstrate: - The accuracy of the Image Registration Algorithm can meet the requirement of mean target registration error (mTRE) less than the pixel diagonal distance. The test results show: - Using DSA mask to regist with DSA mask, CBCT, CT, CTA, and MR for testing image registration. Each group has three sets of test data. - All the mTREs of the test cases are smaller than the voxel diagonal distance, which can achieve sub-pixel accuracy registration. Image Registration Algorithm is able to meet the verification criteria, the verification result is passed. |
| DSA | The tests evaluate the performance of the DSA Algorithm. The objectives of the tests are to demonstrate: Dynamic range meets the submillimeter vessel simulation component is visible across all copper step wedges of the subtracted image. Contrast sensitivity meets the low millimeter vascular simulation component should be visible in a copper step wedge of sufficient thickness in the subtraction image. The test results show: Using digital subtraction angiography phantom with compensation test step wedge to test subtracted image of DSA，four typical groups（Body，Head，Vascular，Pediatric） are tested ,each group applying two sets of test data. From the testing results, submillimeter sized blood vessels can be seen in all copper step wedges, and the thickness of blood vessels visible in sufficiently thick copper step wedges meets the requirements. |
| 3D Roadmap | The tests evaluate the performance of Neuro Registration Algorithm. The objectives of the tests are to demonstrate: - The accuracy of neuro registration can meet a precision of at least 1 mm. The test results show: - Using 3D DSA mask to register with an FL image for testing neuro registration. It has eight sets of test data in the group. |
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| - The registration results of neuro registration algorithm is that the mTRE is less than 1mm. The neuro registration was able to meet a precision of at least 1 mm, the verification was passed. | |
|---|---|
| uChase | The tests evaluate the performance of the Stitching Algorithm. The objectives of the tests are to demonstrate: - The accuracy of the Image Registration Algorithm in Stitching can meet the requirement of mean target registration error (mTRE) less than the pixel diagonal distance. - The stitching results meet the clinical needs, with an average score from clinical specialists higher than 2. The test results show: - All the mTREs of the test cases are smaller than the pixel diagonal distance, and the average score of stitching results is 2.95, which is higher than 2.The Stitching Algorithm was able to meet the verification criteria and the verification of the algorithm was passed. |
| uSpace | The tests evaluate the performance of uSpace futures. The objectives of the tests are to demonstrate: - Test the performance of the human key point detection accuracy. - Test the performance of the collision detection rate. - The performance of the auto SID meets the distance maintenance accuracy. And the adjustment of SID meets the requirements of radiation safety and image quality. The test results show: - Human key point detection achieves the required accuracy for not deviating from the range of the acquisition field of view. - Collision detection achieves the specified detection rate. - Auto SID adjustment achieves the required accuracy for maintaining a distance from detector to the patient during C-arm rotation or patient table lifting. Primary protective barrier, Field limitation and Air kerma rates were tested within the allowable adjustment range of the system. The radiation safety test results of the uAngio AVIVA CX under different SID. The image quality evaluation was tested through the clinical evaluation and objective physical characteristics. According to the acceptable criteria in the regulations, the image quality test results of the uAngio AVIVA CX under different SID meet the requirements. |
| uLingo | The tests evaluate the performance of the uLingo algorithm. The objectives of the tests are to demonstrate: - Test the performance of wake-up algorithm. - Test the performance of voice commands recognition algorithm. |
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| The test results show: For U.S. Participants, 18 talkers were invited to record the voice commands for verification. - The recognition rate of voice wake-up is tested as below: When the environmental signal-to-noise ratio (SNR) is ≥15 dB(A), the wake-up accuracy rate reaches ≥95%; When environmental SNR is 10 dB(A), the wake-up accuracy rate reaches ≥85%. - The recognition rate of voice commands is tested as below: When the environmental SNR is ≥15 dB(A), the recognition success rate for each command reaches ≥95%; When the environmental SNR is 10 dB(A), the recognition success rate for each command reaches ≥85% |
|---|
Clinical Image Evaluation
The clinical image evaluation was performed under the proposed device. Sample images were obtained from hospitals to meet the following requirements: contained images of the head, cardiac, body, and extremities with different acquisition protocols representative of US clinical use and populations. Typical cases have been selected such as Internal carotid artery angioplasty and stenting, internal carotid artery stenosis and aneurysm, PCI, radiofrequency ablation, TACE, TIPS, lower extremity arterial angioplasty and so on. The image quality was evaluated by an ADR certified radiologist using a five-point scale, evaluation on image quality aspects: spatial detail, contrast-noise performance, clinical motion and clinical features of interest. Each image received a score of ≥ 3 and received a PASS result, indicating that image quality fulfills the need for diagnostic, intervention, and surgical procedures.
9. Conclusion
Based on the comparison and analysis above, the proposed device uAnigo AVIVA CX has the equivalent intended use, safety, and effectiveness as the predicate device Philips Azurion R2.1 and the reference device SmartCT. The differences in technical specifications between the proposed device and the predicate device do not negatively affect the system's safety and effectiveness. The proposed device uAngio AVIVA CX is determined to be Substantially Equivalent (SE) to the predicate device and the reference device.
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§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.