OEC One ASD

K240828 · Ge Hualun Medical Systems Co. , Ltd. · OXO · Dec 27, 2024 · Radiology

Device Facts

• Record ID: K240828
• Device Name: OEC One ASD
• Applicant: Ge Hualun Medical Systems Co. , Ltd.
• Product Code: OXO · Radiology
• Decision Date: Dec 27, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The OEC One ASD mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatic patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, vascular, critical care, and emergency procedures.

Device Story

Mobile C-arm X-ray system for intraoperative imaging; provides fluoroscopic and digital spot images. System comprises mobile stand, articulating arm, widescreen monitor, TechView tablet, and C-arm with X-ray source and amorphous silicon (a-Si) flat panel detector. Operated by clinicians in OR, clinic, or emergency settings. User positions C-arm via manual mechanical controls; system captures X-ray data, processes via GPU-based algorithms (noise/motion reduction, ADRO, AutoTrak, ABS), and displays images on high-resolution monitor. Digital pen allows annotation. Output assists physician in visualizing anatomy and localizing regions of interest for surgical/interventional guidance. Benefits include improved image quality and workflow efficiency compared to image intensifier-based predecessors.

Clinical Evidence

Bench testing only; no clinical trials. Evidence includes verification and validation testing per design controls, conformance to IEC/NEMA standards, and comparative evaluation of clinical images against the predicate device to demonstrate equivalent performance.

Technological Characteristics

Mobile C-arm; 21cm a-Si flat panel detector; stationary anode X-ray source (40-110 kVp); squircle field of view. Connectivity: wired/wireless printing, DICOM-compatible. Software: platform-based architecture, IEC 62304 compliant. GPU-accelerated image processing. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, 60601-2-43.

Indications for Use

Indicated for adult and pediatric patients requiring fluoroscopic and digital spot imaging during diagnostic, interventional, and surgical procedures (orthopedic, GI, endoscopic, urologic, vascular, critical care, emergency).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• OEC One (K182626)

Reference Devices

• OEC Elite (K171565)

Submission Summary (Full Text)

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GE Hualun Medical Systems Co. Ltd. % Michelle Huettner Director, Regulatory Affairs - IGT and Oncology No 1 Yong Chang North Road. Beijing Economic Technological Development Zone, Beijing CHINA 100176

Re: K240828

Trade/Device Name: OEC One ASD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OXO, JAA, OWB Dated: November 28, 2024 Received: November 29, 2024

Dear Michelle Huettner:

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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed Gabriela M. by Gabriela M. Rodal -S for Rodal -S

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) K240828

Device Name OEC One ASD

Indications for Use (Describe)

The OEC One ASD mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatic patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, vascular, critical care, and emergency procedures.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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510(k) Number: K240828

# 510(k) Summary of Safety and Effectiveness

OEC One ASD

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) Summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).

In accordance with 21 CFR 807.92 the following summary of information is provided:

| Date: | December 27, 2024 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE HUALUN MEDICAL SYSTEMS CO., Ltd<br>No. 1 Yong Chang North Road,<br>Beijing Economic Technological Development Zone, Beijing 100176<br>China |
| Primary Contact: | Lifeng Wang<br>Regulatory Affairs Manager- IGT<br>Tel: [phone]<br>e-mail: [e-mail] |
| Secondary Contacts: | Michelle Huettner<br>Director, Regulatory Affairs - IGT and Oncology<br>GE HealthCare<br>Tel: [phone]<br>e-mail: [e-mail] |

#### PRODUCT IDENTIFICATION

| Device Trade Name: | OEC One ASD |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Name: | Image-intensified Fluoroscopic x-ray system |
| Classification Panel: | Radiology |
| Regulation: | 21CFR 892.1650 |
| Classification: | Class II |
| Product Code: | OXO |
| Subsequent Product Codes | JAA, OWB |
| Manufacturer: | GE HUALUN MEDICAL SYSTEMS CO., Ltd<br>No. 1 Yong Chang North Road,<br>Beijing Economic Technological Development Zone<br>Beijing 100176 China |

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#### Predicate Device:

| Device Name: | OEC One |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number: | K182626 |
| Manufacturer: | GE HUALUN MEDICAL SYSTEMS CO., Ltd<br>No. 1 Yong Chang North Road,<br>Beijing Economic Technological Development Zone,<br>Beijing 100176 China |
| Regulation Name: | Image-intensified Fluoroscopic x-ray system |
| Regulation: | 21CFR 892.1650 |
| Classification: | Class II |
| Product Code: | OWB |
| Subsequent Product Code: | OXO, JAA |

#### Device Description:

The OEC One ASD is a mobile C-arm X-ray system to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures. These images help the physician visualize the patient's anatomy and localize clinical regions of interest. The system consists of a mobile stand with an articulating arm attached to it to support an image display monitor (widescreen monitor) and a TechView tablet, and a "C" shaped apparatus that has a flat panel detector on the top of the C-arm and the X-ray Source assembly at the opposite end.

The OEC One ASD is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allows the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C- arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock.

The subject device is labelled as OEC One ASD.

The purpose of this premarket notification is to demonstrate that the subject device, OEC One ASD, is a modification of and is substantially equivalent to the predicate device OEC One (K182626).

#### Proposed Device Modification:

The modified OEC One ASD employs the same fundamental scientific technology as that of the unmodified predicate device (K182626). The primary change for the subject device is to introduce an amorphous silicon (a-Si) flat panel detector as the image receptor. Roadmap functionality, which is optional in the predicate device (K182626), has been removed and a printer shelf has been integrated into the subject device to place the applicable printer on.

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# Indications for Use:

The OEC One ASD mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.

The intended use and indications for use are unchanged from the predicate device.

# Technology:

The indications for use are identical and the technology is similar to the predicate device.

The primary change on the subject device is to introduce an Amorphous Silicon (a-Si) solid state flat panel X-ray detector. A printer shelf is integrated into the subject device for the user to place the applicable printer on. The electrical boards have been re-laid out or redesigned to be more compact to make space for the printer shelf. The image shape changed from a circle to a squircle by introducing the flat panel detector and squircle secondary collimator. The X-Ray source monoblock remains unchanged from that of the predicate device OEC One (K182626). The hardware changes also include using an up-to-date computer, tablet and monitor that offers more image storage, processing speed, and higher resolution display, driven by IT technology advancement.

Its software is based on the architecture, design and code base of the predicate device OEC One (K182626). The software architecture framework was updated to a platform-based architecture with no significant changes in order to support different OEC C-Arm products. The modifications were also being made to support the flat panel detector, the necessary imaging and post-processing applications related to the flat panel detector, and device specific features/functionality. The design followed the same design control process and software development lifecycle process that is compliant to IEC 62304 used in the predicate OEC One.

The table below compares the main performance data of the proposed device with the predicate device.

| | Predicate Device<br>OEC One (K182626) | Subject Device<br>OEC One ASD | Discussion of differences |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image<br>Receptor | Image Intensifier<br><br>Detective Quantum<br>Efficiency (DQE): 65%<br>Modulation Transfer<br>Function (MTF): 45% | 21cm Amorphous Silicon<br>(a-Si) Flat Panel Detector<br><br>DQE: 70% (0 lp/mm)<br>MTF: 46% (1.0 lp/mm) | Substantially Equivalent.<br><br>The change of the image receptor is<br>to enhance the device performance. |
| | Predicate Device<br>OEC One (K182626) | Subject Device<br>OEC One ASD | Discussion of differences |
| | Field of View:<br>• 9 inch<br>• 6 inch<br>• 4.5 inch | Field of View:<br>• 21 cm<br>• 15 cm<br>• 11 cm | No new hazards or hazard situations were raised due to this change.<br><br>The performance testing indicated that the subject device is still effective.<br><br>This change did not raise any new safety and effectiveness concerns. |
| Image Matrix Size | $1000\times1000$ | $1520\times1520$ | Substantially Equivalent.<br><br>This change is driven by the detector pixel matrix to get higher resolution.<br><br>This change did not raise any new safety and effectiveness concerns. |
| Image Shape | Circle | Squircle | Substantially Equivalent.<br><br>The squircle shape provides an enhanced viewing area without exposing the areas at the corners, which are not typically clinically needed.<br><br>The squircle design can maintain the identical size and shape even when the image is rotated.<br><br>This change did not raise any new safety and effectiveness concerns. |
| Anti-scatter Grid | Line Rate: 60 L/cm<br>Ratio: 10:1<br>Focal Distance: 100 cm | Line Rate: 74 L/cm<br>Ratio: 14:1<br>Focal Distance: 100 cm | Substantially Equivalent.<br><br>The grid's specification is defined based on the image receptor's pixel size, which has been updated because of the introduction of flat panel detector.<br><br>This change did not raise any new safety and effectiveness concerns. |
| | Predicate Device | Subject Device | Discussion of differences |
| | OEC One (K182626) | OEC One ASD | |
| Monoblock | Type: Stationary Anode | Type: Stationary Anode | Identical. |
| | Focal Spot: 0.6 x 1.4 & 1.4<br>(IEC60336) | Focal Spot: 0.6 x 1.4 & 1.4<br>(IEC60336) | |
| | Anode Heat Capacity:<br>76,000 H.U. | Anode Heat Capacity:<br>76,000 H.U. | |
| | Anode Cooling Rate:<br>37,000 H.U/min | Anode Cooling Rate:<br>37,000 H.U/min | |
| | Housing Heat Capacity:<br>900,000 H.U | Housing Heat Capacity:<br>900,000 H.U | |
| | Housing Cooling Rate:<br>12,500 H.U./min | Housing Cooling Rate:<br>12,500 H.U./min | |
| X-ray<br>Generator | 40 kHz High Frequency | 40 kHz High Frequency | Substantially Equivalent.<br>mA range changing in Fluoroscopy<br>mode is caused by different image<br>processing parameters of Auto<br>Brightness Stable (ABS) to get<br>optimized image quality.<br>mA range changing in Digital Spot<br>mode is to get optimized image<br>quality by increasing tube current<br>(mA) especially on thin anatomy<br>such as hands.<br>This change did not raise any new<br>safety and effectiveness concerns. |
| | Max Power 2.5 kW | Max Power 2.5 kW | |
| | Peak Tube Potential: 40-110 kVp | Peak Tube Potential: 40-110 kVp | |
| | Fluoroscopy: 0.1-4.0 mA | Fluoroscopy: 0.1-8.0 mA | |
| | High Level Fluoro: 0.2-25.0 mA | High Level Fluoro: 0.2-25.0 mA | |
| | Pulsed Fluoro: 1, 2, 4, 8, 12 pulses/sec | Pulsed Fluoro: 1, 2, 4, 8, 12 pulses/sec | |
| | Digital Spot: 0.2-10.0 mA<br>(for 100-120V system) | Digital Spot: 2-10.0 mA<br>(for 100-120V system) | |
| Collimator | Iris, Tungsten Dual Leaf<br>Shutter | Iris, Tungsten Dual Leaf<br>Shutter | Substantially Equivalent.<br>Secondary collimator has been<br>modified to achieve the squircle<br>field of view.<br>This change did not raise any new<br>safety and effectiveness concerns. |
| | Collimator Iris Preview | Collimator Iris Preview | |
| | Collimator Shutter<br>Preview | Collimator Shutter<br>Preview | |
| | Circle shape secondary<br>collimator | Squircle shape secondary<br>collimator | |
| X-ray Control<br>Modes | Auto Mode<br>Manual Mode<br>(Normal Fluoro, Low Dose Fluoro, High Level Fluoro) | Auto Mode<br>Manual Mode<br>(Normal Fluoro, Low Dose Fluoro, High Level Fluoro) | Identical. |
| | Predicate Device<br>OEC One (K182626) | Subject Device<br>OEC One ASD | Discussion of differences |
| Imaging<br>Modes | Continuous – Fluoroscopy Normal Dose High Level Dose Low Dose | Continuous – Fluoroscopy Normal Dose High Level Dose Low Dose | Substantially Equivalent. |
| | Pulsed Fluoroscopy Normal Dose High Level Dose Low Dose | Pulsed Fluoroscopy Normal Dose High Level Dose Low Dose | Digital Spot Low Dose mode will not be provided as Digital Spot mode creates a short-duration, high mA exposure to produce a single high quality image. Therefore, the low dose mode is not necessary for Digital Spot mode. The user can still get similar functionality by using Fluoroscopy. |
| | Digital Spot Normal Dose Low Dose | Digital Spot Normal Dose | Roadmap mode will not be provided based on marketing positioning, however, user can still get the similar functionality by applying the peak opacify function on contrast-agent-flowed cine. |
| | Roadmap Normal Dose Low Dose | Subtraction Normal Dose Low Dose | |
| | Subtraction Normal Dose Low Dose | | This change did not raise any new safety and effectiveness concerns. |
| Imaging<br>Features | Auto X-Ray technique control | Auto X-Ray technique control | Substantially Equivalent. |
| | Noise and motion reduction (TNR) | Noise and motion reduction (TNR) | Digital Pen (previously cleared in OEC Elite K171565) has been added so that user can draw lines on image display for planning or educational purposes. |
| | Auto/Manual Brightness and Contrast Control | Auto/Manual Brightness and Contrast Control | Zoom feature has improved with Live Zoom so it could be performed during a fluoro shot or Cine run. |
| | Negate | Negate | |
| | Swap and auto-swap | Swap and auto-swap | |
| | Save and auto-save | Save and auto-save | These changes did not raise any new safety and effectiveness concerns. |
| | Last image hold | Last image hold | |
| | Edge enhancement | Edge enhancement | |
| | Zoom & Roam | Zoom (Live Zoom) & Roam | |
| | Image rotation | Image rotation | |
| | Image flip/invert | Image flip/ invert | |
| | Manual/Auto Smart Metal | Manual/Auto Smart Metal | |
| | AutoTrak | AutoTrak | |
| | Patient Annotation | | |
| | Predicate Device | Subject Device | Discussion of differences |
| | OEC One (K182626) | OEC One ASD | |
| | Markers | Patient Annotation | |
| | Measurement Functions | Markers | |
| | Peak Opacification | Measurement Functions | |
| | Cine Recording/Playback | Peak Opacification | |
| | • Cine Automatic Image<br>Playback | Cine Recording/Playback | |
| | • Cine Frame-by-Frame<br>Review<br>• Fluorostore(up to 240<br>frames recording)…