(63 days)
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific algorithms typically associated with AI/ML in medical imaging. The performance studies focus on traditional verification, validation, and compliance testing.
No.
The device is used to provide imaging for diagnostic, interventional, and surgical procedures, helping physicians visualize anatomy and localize regions of interest, rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed to provide fluoroscopic and digital spot/film images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures." The "Device Description" also notes that the images help the physician "visualize the patient's anatomy and localize clinical regions of interest," which is a key part of diagnosis.
No
The device description explicitly states it is a "mobile C-arm x-ray system" and describes hardware components like a mobile stand, articulating arm, image display monitor, TechView tablet, and a "C" shaped structure. The performance studies also mention testing of the "OEC One™ system" which includes hardware.
Based on the provided information, the OEC One™ mobile C-arm system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing fluoroscopic and digital images of patients during diagnostic, interventional, and surgical procedures. This involves imaging the patient's anatomy directly.
- Device Description: The description reinforces that it's an x-ray system used to visualize the patient's anatomy and localize regions of interest.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The OEC One™ does not perform any such tests on biological samples.
The OEC One™ is a medical imaging device used for visualizing internal structures of the body using X-rays. This falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The OEC One mobile C-arm system is designed to provide fluoroscopic and digital spot/film images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, critical care, and emergency procedures.
Product codes
OWB, OXO, JAA
Device Description
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, 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 Page 1 of 3
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patient populations
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Summary of Non-Clinical Testing:
Verification and validation including hazard mitigation has been executed with results demonstrating the OEC One™ system met design input 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 and IEC 60601-2-43. All applicable 21CFR Subchapter J performance standards are 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: X-ray 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:
Because OEC One's modification based on the predicate device does not change the system's intended use and represent equivalent technological characteristics, clinical studies are not required to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K123603 OEC Brivo, 892.1650, OXO
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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November 9, 2017
GE Hualun Medical Systems Co., Ltd. Lifeng Wang Regulatory Affairs Manager No 1 Yong Chang North Road Beijing Economic Technological Development Zone Beijing, 100176, China
Re: K172700
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: OWB. OXO. JAA Dated: September 7, 2017 Received: September 7, 2017
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Robert Oolo
Robert 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)
Device Name OEC One™
Indications for Use (Describe)
The OEC One mobile C-arm system is designed to provide fluoroscopic and digital spot/film images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, 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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GE Healthcare
510(k) Premarket Notification Submission- OEC One™
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 7, 2017 |
|---|---|
| Submitter: | GE HUALUN MEDICAL SYSTEMS CO. Ltd. |
| No.1 Yong Chang North Road, Beijing Economic | |
| Technological Development Zone | |
| Beijing 100176, China | |
| Manufacturer/ | |
| Manufacturing Location | GE HUALUN MEDICAL SYSTEMS CO. Ltd. |
| No.1 Yong Chang North Road, Beijing Economic | |
| Technological Development Zone | |
| Beijing 100176, China | |
| Primary Contact Person: | Lifeng Wang |
| Regulatory Affairs Manager | |
| GE Healthcare | |
| +86 10 57083145 | |
| Lifeng.Wang@ge.com | |
| Secondary Contact Person: | Helen Peng |
| Regulatory Affairs Director | |
| GE Healthcare | |
| +1 262 424-8222 | |
| Hong.Peng@ge.com | |
| Device Trade Name: | OEC One™ |
| Classification Names: | Image-intensified fluoroscopic x-ray system |
| Device Class | Class II |
| Classification regulation: | 21CFR 892.1650 |
| Primary Product Code: | OXO |
| Secondary Product Code: | JAA, OWB |
| Predicate Device(s): | K123603 OEC Brivo, 892.1650, OXO |
| Device Description: | 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, 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 | |
| Page 1 of 3 | |
| Intended Use: | The OEC One™ mobile C-arm system is intended to provide fluoroscopic and digital spot/film images of the patient anatomy, interventional tools/devices, and/or contrast agents during diagnostic, interventional, and surgical procedures. |
| Indications for Use | The OEC One™ mobile C-arm system is designed to provide fluoroscopic and digital spot/film 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, critical care, and emergency procedures. |
| Technology: | The modified OEC One™ employs the same fundamental scientific technology as that of the unmodified predicate device(K123603). The primary change for the subject device was to integrate the separate mainframe and workstation of the predicate device into a compact configuration to save the space of the operation room with smaller foot print and to offer better workflow, ergonomics and usability. |
Additionally, a separate articulating arm attached to the mobile stand was added to support the single widescreen image display monitor and a TechView tablet and to offer more degrees of freedom for easier positioning and maneuverability.
The software was updated primarily to support changing to a single image display monitor, adding a new TechView tablet, consolidation of user interface, and modifying existing features for Adaptive Dynamic Range Optimization(ARDO) and motion artifact reduction. Additionally, the software was also modified to add an Alternating Current (AC) recovery feature and to comply to NEMA XR-27(User Quality Mode) requirement. |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Testing:
Verification and validation including hazard mitigation has been
executed with results demonstrating the OEC One™ system met
design input 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 and
IEC 60601-2-43. All applicable 21CFR Subchapter J
performance standards are 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 AnalysisRequired ReviewsDesign ReviewsUnit 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: X-ray 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:
Because OEC One's modification based on the predicate device
does not change the system's intended use and represent
equivalent technological characteristics, clinical studies are not
required to support substantial equivalence. |
| 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 is of
comparable type and substantially equivalent to the predicate
device OEC Brivo Series (K123603). |
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GE Healthcare
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510(k) Premarket Notification Submission- OEC One™
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GE Healthcare
510(k) Premarket Notification Submission- OEC One™