(53 days)
The OEC One™ 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 OEC One™ 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, vascular, neurologic, 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 an image intensifier on the top of the C-arm and the X-ray Source assembly at the opposite end.
The OEC One™ is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allow 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.
The provided text is a 510(k) Premarket Notification Submission for the OEC One with vascular option. This document primarily focuses on establishing substantial equivalence to a predicate device (OEC One, K172700) rather than presenting a detailed study with acceptance criteria for device performance in the context of an AI/algorithm-driven device.
The "device" in this context is an X-ray imaging system (OEC One™ mobile C-arm system), and the changes described are hardware and software modifications to enhance vascular imaging features. It is not an AI or algorithm-only device with specific performance metrics like sensitivity, specificity, or AUC.
Therefore, most of the requested information regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable or cannot be extracted from this document.
However, I can extract information related to the device's technical specifications and the testing performed to demonstrate its safety and effectiveness.
Here is a summary of the information that can be extracted, addressing the closest relevant points:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of numerical acceptance criteria (e.g., sensitivity, specificity) for the device's imaging performance in relation to clinical outcomes. Instead, the acceptance criteria are generally implied by conformance to existing standards and successful completion of various engineering and verification tests. The "reported device performance" refers to the device meeting these design inputs and user needs.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with medical electrical equipment standards | Certified compliant with IEC 60601-1 Ed. 3 series, including IEC60601-2-54:2009 and IEC 60601-2-43:2010. |
| Compliance with radiation performance standards | All applicable 21 CFR Subchapter J performance standards were met. |
| Design inputs and user needs met | Verification and validation executed; results demonstrate the OEC One™ system met the design inputs and user needs. |
| Image quality and dose assessment for fluoroscopy | All image quality/performance testing identified for fluoroscopy in FDA's "Information for Industry: X-ray Imaging Devices- Laboratory Image Quality and Dose Assessment. Tests and Standards" was performed with acceptable results. This included testing using anthropomorphic phantoms. |
| Software documentation requirements for moderate level of concern | Substantial equivalence based on software documentation for a "Moderate" level of concern device. |
| Functional operation of new vascular features | The primary change was to implement vascular features (Subtraction, Roadmap, Peak Opacification, Cine Recording/Playback, Re-registration, Variable Landmarking, Mask Save/Recall, Reference Image Hold) to perform vascular procedures with "easiest workflow and least intervention by the user" and "further enhance the vascular workflows." (Bench testing demonstrated user requirements were met.) |
| Safety and effectiveness | The changes do not introduce any adverse effects nor raise new questions of safety and effectiveness. |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated in terms of patient data. The testing involved "anthropomorphic phantoms" for image performance and various engineering/bench testing for functional validation. These are not "test sets" in the typical sense of a dataset for an AI algorithm.
- Data Provenance: Not applicable as it's not patient data for AI evaluation. The testing was conducted internally at GE Hualun Medical Systems Co., Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth from experts is not mentioned for this type of device evaluation.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There was no expert adjudication process described for the testing performed.
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. This document describes a C-arm X-ray system, not an AI-assisted diagnostic tool that would typically undergo such a study.
- Effect Size of Human Readers: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is an imaging system; its "performance" is inherently tied to image acquisition and display, which are used by a human operator/physician. The "vascular features" are software enhancements to the imaging workflow, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For image quality, the ground truth was based on physical phantom characteristics and established technical standards (e.g., image resolution, contrast, noise, dose measurements). For functional aspects, it was based on meeting design inputs and user requirements validated through engineering tests. No expert consensus, pathology, or outcomes data were used as "ground truth" for this device's substantial equivalence declaration.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This document does not describe an AI model that requires a training set. The software updates are feature additions and modifications, not learned from a large dataset in the way a deep learning model would be.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable, as there is no mention of an AI model with a training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
November 16, 2018
GE Hualun Medical Systems Co., Ltd. c/o Lifeng Wang Regulatory Affairs Manager No.1 YongChang North Road, Beijing Economic Technological Development Zone 100176 Beijing CHINA
Re: K182626
Trade/Device Name: OEC One Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OXO, JAA, OWB Dated: September 21, 2018 Received: September 24, 2018
Dear Lifeng Wang:
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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hse 2. Nils
for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182626
Device Name OEC One™
Indications for Use (Describe)
The OEC One 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, endosic, neurologic, vascular, critical care, and emergency 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) |
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Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a circular shape. The circle is surrounded by swirling, cloud-like elements, giving the logo a dynamic and recognizable appearance. The color of the logo is a light blue.
510(k) Premarket Notification Submission- OEC One with Vascular Option
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of 21 CFR 807.92 the following summary of information is provided:
| Date: | Sep 21, 2018 |
|---|---|
| Submitter: | GE HUALUN MEDICAL SYSTEMS CO. Ltd.No.1 Yong Chang North Road, Beijing EconomicTechnological Development ZoneBeijing 100176, China |
| Manufacturer/Manufacturing Location | GE HUALUN MEDICAL SYSTEMS CO. Ltd.No.1 Yong Chang North Road, Beijing EconomicTechnological Development ZoneBeijing 100176, China |
| Primary Contact Person: | Lifeng WangRegulatory Affairs ManagerGE Healthcare+86 10 57083145Lifeng. Wang@ge.com |
| Secondary ContactPerson: | Philip MalcaRegulatory Affairs DirectorGE Healthcare+33 646373852Philip.Malca@ge.com |
| Device Trade Name: | OEC One™ |
| Classification Names: | Image-intensified fluoroscopic x-ray system |
| Device Class | Class II |
| Regulation Number: | 21CFR 892.1650 |
| Primary Product Code: | OXO |
| Secondary Product Code: | JAA, OWB |
| Predicate Device(s): | Device Trade Name: OEC One™510(k) Clearance: K172700Classification Name: Image-intensified fluoroscopic x-ray systemRegulation number: 21CFR 892.1650Primary Product Code: OXOSecondary Product Code: JAA, OWB |
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510(k) Premarket Notification Submission- OEC One with Vascular Option
| Device Description: | The OEC One™ is a mobile C-arm x-ray system to provide fluoroscopic images ofthe patient during diagnostic, interventional, and surgical procedures such asorthopedic, gastrointestinal, endoscopic, urologic, vascular, neurologic, criticalcare, and emergency procedures. These images help the physician visualize thepatient's anatomy and localize clinical regions of interest. The system consists of amobile stand with an articulating arm attached to it to support an image displaymonitor (widescreen monitor) and a TechView tablet, and a "C" shaped apparatusthat has an image intensifier on the top of the C-arm and the X-ray Source assemblyat the opposite end. |
|---|---|
| The OEC One™ is capable of performing linear motions (vertical, horizontal) androtational motions (orbital, lateral, wig-wag) that allow the user to position the X-ray image chain at various angles and distances with respect to the patient anatomyto be imaged. The C- arm is mechanically balanced allowing for ease of movementand capable of being "locked" in place using a manually activated lock. | |
| The subject device is labelled as OEC One. | |
| Intended Use: | The OEC One™ mobile C-arm system is intended to provide fluoroscopic anddigital spot images of the patient anatomy, interventional tools/devices, and/orcontrast agents during diagnostic, interventional, and surgical procedures. |
| Indications for Use | The OEC One™ mobile C-arm system is designed to provide fluoroscopic anddigital spot images of adult and pediatric patient populations during diagnostic,interventional, and surgical procedures. Examples of a clinical application mayinclude: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular,critical care, and emergency procedures. |
Technology:
The modified OEC One™ employs the same fundamental scientific technology as that of the unmodified predicate device(K172700).
The primary change was to implement the vascular features such as Subtraction and Roadmap to help perform vascular procedures with the easiest workflow and least intervention by the user. A suite of supporting features such as Peak Opacification, Cine Recording/Playback, Re-registration, Variable Landmarking, Mask Save/Recall, and Reference Image Hold were added to further enhance the vascular workflows.
Other incremental changes are summarized below:
Film mode was withdrawn considering the state of the art and therefore the optional cassette holder which was withdrawn as well from the accessories of OEC One with the vascular option.
Generator specification was changed by updating software.
An optional off-the-shelf wireless foot switch was introduced to provide placement flexibility and reduces cable clutter. A new anti-scatter grid was introduced to improve system performance. The anti-scatter grid was used on OEC Brivo 865 (K123603)
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510(k) Premarket Notification Submission- OEC One with Vascular Option
Other minor modifications have also been made in the software for Alternating Current (AC) recovery and tube heat management, as well as supporting GESAK (GE Service Access Key) to improve the access control.
The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device:
| Predicate Device (K172700) | Proposed Device | |
|---|---|---|
| OEC One | OEC One | |
| X-ray Generator | > 40 kHz High Frequency | > 40 kHz High Frequency |
| > Max Power 2.2 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: 0.1-4.0 mA | |
| > High Level Fluoro: 0.2-12.0 mA | > High Level Fluoro: 0.2-25.0 mA | |
| > Pulsed Fluoro: 1, 2, 4, 8 pulses/sec | > Pulsed Fluoro: 1, 2, 4, 8, 12 pulses/sec | |
| > Digital Spot:0.2-10mA | > Digital Spot:0.2-10mA | |
| (for 100-120V system) | (for 100-120V system) | |
| > Film:1mAs-40mAs and constant10mA | ||
| (for 100-120V system) | ||
| Imaging Modes | > Continuous – Fluoroscopy | > Continuous – Fluoroscopy |
| o Normal Dose | o Normal Dose | |
| o High Level Dose (aka HighLevel Control) | o High Level Dose (aka High LevelControl) | |
| o Low Dose | o Low Dose | |
| > Pulsed Fluoroscopy | > Pulsed Fluoroscopy | |
| o Normal Dose | o Normal Dose | |
| o High Level Dose (aka HighLevel Control) | o High Level Dose (aka High LevelControl) | |
| o Low Dose | o Low Dose | |
| > Digital Spot | > Digital Spot | |
| > Film | > Roadmap | |
| o Normal Dose | ||
| o Low Dose | ||
| > Subtraction | ||
| Predicate Device (K172700) | Proposed Device | |
| OEC One | OEC One | |
| o Normal Dose | ||
| o Low Dose | ||
| Imaging Features | > Auto X-Ray technique control | > Auto X-Ray technique control |
| > Noise and motion reduction (TNR) | > Noise and motion reduction (TNR) | |
| > Auto/Manual Brightness and ContrastControl | > Auto/Manual Brightness and ContrastControl | |
| > Negate | > Negate | |
| > Swap and auto-swap | > Swap and auto-swap | |
| > Save and auto-save | > Save and auto-save | |
| > Last image hold | > Last image hold | |
| > Edge enhancement | > Edge enhancement | |
| > Zoom & Roam | > Zoom & Roam | |
| > Image rotation | > Image rotation | |
| > Image flip/ invert | > Image flip/ invert | |
| > Manual/Auto Smart Metal | > Manual/Auto Smart Metal | |
| > AutoTrak | > AutoTrak | |
| > Patient Annotation | > Patient Annotation | |
| > Markers | > Markers | |
| > Measurement Functions | > Measurement Functions | |
| > Peak Opacification | ||
| > Cine Recording/Playback | ||
| o Cine Automatic ImagePlayback | ||
| o Cine Frame-by-Frame Review | ||
| > Re-Registration | ||
| > Variable Landmarking | ||
| > Mask Save/Recall | ||
| > Reference Image Hold |
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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a blue circle with the letters "GE" in a stylized font in the center. There are two curved lines on either side of the circle, giving the impression of movement or energy. The logo is simple and recognizable, and it is associated with a well-known and established company.
510(k) Premarket Notification Submission- OEC One with Vascular Option
The changes described above do not change the control mechanism, operating principle, or intended use in nature from the predicate device.
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510(k) Premarket Notification Submission- OEC One with Vascular Option
Determination of Substantial Equivalence:
Summary of Non-Clinical Testing:
Verification and validation including risk mitigations have been executed with results demonstrating the OEC One™ system met the design inputs and user needs.
The system has been tested by an NRTL and certified compliant with the IEC 60601-1 Ed. 3 series, including IEC60601-2-54:2009 and IEC 60601-2-43:2010. All applicable 21CFR Subchapter J performance standards were met.
The OEC One™ system was developed under the GE Healthcare's Quality Management System, including design controls, risk management and software development life cycle processes. The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Required Reviews
- · Design Reviews
- · Unit Testing (Sub System verification)
- · Integration testing (System verification)
- · Performance testing (Verification)
- · Safety testing (Verification)
- · Simulated use testing (Validation)
Additional engineering bench testing on image performance using anthropomorphic phantoms was also performed. All the image quality/performance testing identified for fluoroscopy found in FDA's "Information for Industry: Xray Imaging Devices- Laboratory Image Quality and Dose Assessment. Tests and Standards' was performed with acceptable results.
The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.
Clinical Testing:
OEC One's modification, based on the predicate device, does not change the system's intended use in nature and keeps the same well-established technology as its predicate. This type of change is supported by scientific, established/standardized, engineering/physics-basic performance testing. The bench testing performed on this change has demonstrated that the user requirements were met. Therefore, for OEC One with vascular option configurations, clinical images are not required to demonstrate the substantial equivalence to the predicate device.
Conclusion:
The differences discussed in this section do not introduce any adverse effects nor raise new questions of safety and effectiveness. Based on the successful verification and validation testing, additional engineering bench testing, conformance to standards, and development under GE Healthcare's Quality Management System, we believe that the OEC One with vascular option is of comparable type and substantially equivalent to the predicate device OEC One (K172700).
§ 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.