(196 days)
The uDR 780i Digital Medical X-ray system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other anatomic sites. Applications can be performed with the subject sitting, standing, or lying in the prone or supine position. Not for mammography.
The uDR 780i is a digital radiography (DR) system that is designed to provide radiography examinations of sitting, standing or lying patients. It consists of the following components: Tube Ceiling Suspension with tube and collimator, Bucky Wall Stand, Elevating Table, High Voltage Generator, wireless flat panel detectors and an acquisition workstation. The system generates images which can be transferred through DICOM network for printing, review and storage.
The provided text describes the 510(k) summary for the uDR 780i Digital Medical X-ray system. This document outlines the device's technical specifications and compares it to a predicate device (also named uDR 780i, K173953) to demonstrate substantial equivalence, rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable metrics.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment from a clinical trial or performance study cannot be found in this document. This summary focuses on demonstrating that the new device is functionally identical or improved in a way that doesn't raise new safety or effectiveness concerns compared to a previously cleared device.
However, I can extract information related to the "Clinical Image Evaluation" which serves as the closest equivalent to a performance study in this regulatory context:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) for a diagnostic AI device, nor does it report specific device performance metrics against such criteria. The clinical image evaluation is qualitative.
| Acceptance Criteria (Implied) | Reported Device Performance (Qualitative) |
|---|---|
| Image Quality sufficient for clinical diagnosis | "Each image was reviewed with a statement indicating that image quality is sufficient for clinical diagnosis." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Sample images of chest, abdomen, spine, pelvis, upper extremity and lower extremity were provided..."
- Sample Size: Not specified beyond "Sample images." The exact number of images for each body part or the total number of images is not given.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). While the applicant is based in Shanghai, China, it's not stated where the clinical images originated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document states: "...provided with a board certified radiologist to evaluate the image quality in this submission."
- Number of Experts: One
- Qualifications of Expert(s): "board certified radiologist." Specific experience level (e.g., years) is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Only one radiologist evaluated the images; therefore, no adjudication method was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The evaluation was a qualitative assessment of image quality by a single radiologist, not a study of human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, a standalone algorithm-only performance study was not done. The evaluation focused on the clinical image quality of the output from the "uDR 780i Digital Medical X-ray system," not an AI algorithm within it. The system itself is a hardware device for capturing X-ray images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" concerning image quality was established by the qualitative assessment of a "board certified radiologist" who determined if the image quality was "sufficient for clinical diagnosis." This is a form of expert opinion/assessment rather than a definitive medical ground truth like pathology or patient outcomes.
8. The sample size for the training set
- Training Set Sample Size: Not applicable/not mentioned. The document describes an X-ray imaging system, not an AI software component that would typically involve a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable/not mentioned, as there is no mention of an AI component with a training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG" and "ADMINISTRATION".
November 1, 2024
Shanghai United Imaging Healthcare Co., Ltd. % Gao Xin Regulatory Affairs Manager No.2258 Chengbei Rd. Jiading District Shanghai, 201807 CHINA
Re: K241068
Trade/Device Name: uDR 780i Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: July 8, 2024 Received: September 30, 2024
Dear Gao Xin:
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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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
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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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Indications for Use
510(k) Number (if known) K241068
Device Name uDR 780i
Indications for Use (Describe)
The uDR 780i Digital Medical X-ray system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other anatomic sites. Applications can be performed with the subject sitting, standing, or lying in the prone or supine position. Not for mammography.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K241068
Image /page/4/Picture/2 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark gray. The logo is simple and modern in design.
510 (k) SUMMARY
- Date of Preparation: 1. July 5, 2024
-
- 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 Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
Identification of Proposed Device 3.
Trade Name: uDR 780i Common Name: Digital Medical X-ray System Model(s): uDR 780i
Regulatory Information Classification Name: Stationary X-Ray System Classification: II Product Code: KPR Regulation Number: 21 CFR 892. 1680 Review Panel: Radiology
-
- Identification of Predicate Device(s)
Predicate Device
- Identification of Predicate Device(s)
510(k) Number: K173953 Device Name: Stationary X-Ray System
Regulatory Information
Classification Name: Stationary X-Ray System Classification: II Product Code: KPR Regulation Number: 21 CFR 892. 1680 Review Panel: Radiology
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Shanghai United Imaging Healthcare Co., Ltd. Tel: +86 (21) 67076888 Fax: +86 (21) 67076889 www.united-imaging.com
Image /page/5/Picture/2 description: The image contains the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING", both in a bold, sans-serif font. To the right of the text is a stylized "U" shape, formed by two vertical lines connected by a curved base. The logo is presented in a dark gray color.
5. Device Description:
The uDR 780i is a digital radiography (DR) system that is designed to provide radiography examinations of sitting, standing or lying patients. It consists of the following components: Tube Ceiling Suspension with tube and collimator, Bucky Wall Stand, Elevating Table, High Voltage Generator, wireless flat panel detectors and an acquisition workstation. The system generates images which can be transferred through DICOM network for printing, review and storage.
Intended Use Statement: 6.
The uDR780i digital medical X-ray system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other anatomic sites. Applications can be performed with the subject sitting, standing, or lying in the prone or supine position. Not for mammography.
Substantially Equivalent (SE) Comparison 7.
A comparison between the technological characteristics of proposed and predicate devices is provided as below.
| Proposed Device | Predicate Device | Remark | |
|---|---|---|---|
| Item | uDR 780i | uDR 780iK173953 | |
| General | |||
| Product Code | KPR | KPR | Same |
| Regulation No. | 892.1680 | 896.1680 | Same |
| Class | II | II | Same |
| Intended Use | The uDR 780i Digital Medical X-ray system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other anatomic sites. Applications can be performed with the subject sitting, standing, or lying in the prone or supine position. Not for mammography. | The uDR 780i Digital Medical X-ray system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other anatomic sites. Applications can be performed with the subject sitting, standing, or lying in the prone or supine position. Not for mammography. | Same |
| Specifications | |||
| High Voltage Generator | |||
| Proposed Device | Predicate Device | Remark | |
| Item | uDR 780i | uDR 780iK173953 | |
| Max. Power/kW | 65kW/80kW | 65kW/80kW | Same |
| Max. tubeVoltage(kV) | 150kV | 150kV | Same |
| Shortest exposuretime | 1ms | 1 ms | Same |
| X-Ray Tube Assemble | |||
| Focus NominalValue | 0.6/1.2 | 0.6/1.2 | Same |
| Maximum peakvoltage | 150kV | 150kV | Same |
| Anode HeatContent | 65kw: ≥300kHU80kw: ≥400kHU | 65kw: ≥300kHU80kw:≥400kHU | Same |
| Anode TargetAngle | 12° | 12° | Same |
| X-ray tubeassembly Heatcontent | 65kw: ≥1250KHU80kw: ≥1500KHU | 65kw: ≥1250KHU80kw: ≥1500KHU | Same |
| Flat PanelDetector | |||
| Configurationof Digital Panels | Battery or DC operated | Battery or AC operated | Note1 |
| SemiconductormaterialAmorphous silicon(a-Si) | Semiconductor material Amorphoussilicon (a-Si) | SemiconductormaterialAmorphous silicon (a-Si) | Same |
| Scintillator Cesiumiodide (CsI) | Scintillator Cesium iodide (CsI) | Scintillator Cesium iodide (CsI) | Same |
| specifications | 3320x3408125µm | 3320x3408125µm | Same |
| Effectiveradiographic size | 41.5cm x 42.6cm | 41.5cm x 42.6cm | Same |
| Collimator | |||
| Inherent filtration | 1mm Al | 1mm Al | Same |
| without filter,0.1 mm,0.2 mm,0.3 mm; | without filter,0.1 mm,0.2 mm,0.3 mm; | Same | |
| Copper prefilter | |||
| Display | |||
| Specification | ≥21inch, ≥ 1080x1920 | 24inch, 1200x1920 | Note2 |
| Standards | |||
| DICOM | DICOM3 | DICOM3 | Same |
| Power Source | AC Line, Various voltages available | AC Line, Various voltages | Same |
| Item | Proposed DeviceuDR 780i | Predicate DeviceuDR 780iK173953available | Remark |
| Patient Table | |||
| Motorized verticaltravel | $\geq$ 38.2cm | $\geq$ 38.2cm | Same |
| X-ray absorption | < 0.8mmAl | < 0.8mmAl | Same |
| Tabletop travel | Longitudinal: $\geq$ 800mmTransverse: $\geq$ 250mm | Longitudinal: $\pm$ 40cmTransverse: $\pm$ 12.5cm | Note3 |
| Max. patientweight | 320kg | 225kg | Note4 |
| Detector travelrange | $\geq$ 67cm | $\leq$ 67cm | Note5 |
| Auto tracking foradjusting the tableheight ismaintained | Yes, X-ray tube follows table heightadjustment; source-image distanceis maintained. | Yes, X-ray tube follows tableheight adjustment; source-imagedistance is maintained. | Same |
| Auto tracking forlongitudinal tubetravel | Yes, detector follows tubemovement; centering maintained. | Yes, detector follows tubemovement; centering maintained. | Same |
| Auto tracking fortube rotation | Yes, detector follows tubemovement; centering maintained. | Yes, detector follows tubemovement; centering maintained. | Same |
| Software function | |||
| Import/Exportimages | Yes | Yes | Same |
| Image Searchavailable | Yes | Yes | Same |
| Image Viewing | Yes | Yes | Same |
| Imagemeasurement | Yes | Yes | Same |
| Image Annotation | Yes | Yes | Same |
| Image Operations | Yes | Yes | Same |
| Generator | Yes | Yes | Same |
| Raw image Dataprocessing | Yes | Yes | Same |
| Post image dataprocessing | Yes | Yes | Same |
| Safety | |||
| Electrical Safety | ANSI/AAMI ES 60601-1:2005 &A1:2012 & A2:2021 Medicalelectrical equipment - Part 1:General requirements for basic | AAMI ANSI ES60601-1:C1:2009/(R)2012 andA2:2010/(R)2012 (ConsolidatedText) Medical electrical equipment | Note6 |
| Item | Proposed DeviceuDR 780i | Predicate DeviceuDR 780iK173953 | Remark |
| safety and essential performance | - Part 1:General requirements for basicsafety and essential performance(IEC 60601-1:2005, MOD) | ||
| EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Same |
| Biocompatibility | Patient Contact Materials weretested and demonstrated nocytotoxicity (ISO 10993-5), noevidence for irritation andsensitization (ISO 10993-10). | Patient Contact Materials weretested and demonstrated nocytotoxicity (ISO 10993-5), noevidence for irritation andsensitization (ISO 10993-10).Comply with ISO10993-5,ISO10993-10 | Same |
| Clinical | Clinical Image Evaluation for the proposed device are provided in Section 28 ClinicalImage Evaluation. | ||
| Justification | |||
| Note ID | Justification | ||
| Note 1 | 1. The configuration of Digital Panel Detector of predicate device ispower by Battery or operate in DC power, but there was an error in thedescription in the previous submission of K173953;2. The configuration of Digital Panel Detector of the proposed deviceand predicate device is the same, which is power by Battery or operatein DC power. | ||
| Note 2 | Compare the predicted device, the proposed device has added multiple display optionsthrough design changes, and these display specification all meet the requirements. | ||
| Note 3 | Compare the predicted device, the proposed device design has not been changed, anda clearer definition of Tabletop travel has been provided to meet the productionrequirements. | ||
| Note 4 | Compare the predicted device, the proposed device has increased the max. patientweight of the Patient Table by design change, make patient table to have betterperformance. | ||
| Note 5 | Compare the predicted device, the proposed device design has not been changed,corrected description error in the predict device. | ||
| Note 6 | The proposed device meets the requirement of the latest ANSI/AAMI ES 60601-1standard. |
Table 1 Comparison of Technology Characteristics
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Shanghai United Imaging Healthcare Co., Ltd.
Tel: +86 (21) 67076888
Image /page/6/Picture/2 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized emblem that resembles a shield or a stylized letter U. The emblem is a solid color, and it has a vertical line running down the center, with a horizontal line connecting to it at the top.
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Shanghai United Imaging Healthcare Co., Ltd. Fax: +86 (21) 67076889 Tel: +86 (21) 67076888
www.united-imaging.com
Image /page/7/Picture/2 description: The image shows the logo for United Imaging. The words "UNITED" and "IMAGING" are 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 dark teal in color. The logo is simple and modern.
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K241068
Shanghai United Imaging Healthcare Co., Ltd.
Tel: +86 (21) 67076888
Image /page/8/Picture/2 description: The image shows the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized "U" shape, which is also in a bold font. The logo is simple and modern, and the colors are muted.
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Image /page/9/Picture/2 description: The image contains the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING", both in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is dark gray with a white line running vertically through the center, creating a visual effect of two vertical bars within the "U" shape. The overall design is clean and modern.
Non-Clinical Test Conclusion 8.
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:
- A ANSI/AAMI ES 60601-1:2005 & A1:2012 & A2:2021 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance.
-
IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
-
IEC 60601-1-3:2008+A1:2013+A2:2021 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment.
-
IEC 60601-2-54:2022 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.
-
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
9. Clinical Image Evaluation
The clinical image evaluation was performed under the proposed device. Sample images of chest, abdomen, spine, pelvis, upper extremity and lower extremity were provided with a board certified radiologist to evaluate the image quality in this submission. Each image was reviewed with a statement indicating that image quality is sufficient for clinical diagnosis.
10. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the technology characteristics of the modified uDR 780i, reflected in this 510(k) submission, do not alter the scientific technology of the devices and are substantially equivalent to those of the predicate devices.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and
based on the information provided in this premarket notification. we conclude that the
modified uDR 780i Stationary X-Ray Systems are substantially equivalent to the predicate devices. It does not introduce new indications for use, and has the same technological characteristics and does not introduce new potential hazards or safety risks.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.