(85 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard imaging system components and image processing, not AI/ML capabilities.
No
The device is described as an imaging system used to visualize anatomy and guide procedures, not to directly treat a condition.
Yes
The "Intended Use / Indications for Use" states that the system is designed to provide images "during diagnostic, interventional, and surgical procedures" and gives "diagnostic" as an example of a clinical application. The "Device Description" also mentions it is "used to provide fluoroscopic X-Ray images during diagnostic, interventional, and surgical procedures."
No
The device description explicitly states it is a "Mobile Fluoroscopic C-arm Imaging system" composed of two primary physical components: a "C-Arm" and a "Workstation." These components include hardware like an X-ray tube, Flat Panel Detector or Image Intensifier, high voltage generator, and a display monitor. While it includes software for image processing and control, it is fundamentally a hardware-based imaging system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The OEC Elite mobile fluoroscopy system is an imaging device that uses X-rays to visualize the internal anatomy of a patient in vivo (within the living body) during procedures. It does not perform tests on samples taken from the body.
- Intended Use: The intended use clearly states it provides images of patients during diagnostic, interventional, and surgical procedures.
- Device Description: The description details the physical components and how they are used to generate and display X-ray images of the patient.
The device is a medical imaging system used for visualization and guidance during procedures, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The OEC Elite mobile fluoroscopy 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, vasular, cardiac, critical care, and emergency procedures.
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA, OXO
Device Description
The OEC Elite is a Mobile Fluoroscopic C-arm Imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic X-Ray images during diagnostic, interventional, and surgical procedures. These images help the physician visualize the patient's anatomy and interventional tools. This visualization helps to localize clinical regions of interest and pathology. The images provide real-time visualization and records of pre-procedure anatomy, in vivo-clinical activity and post-procedure outcomes. The system is composed of two primary physical components. The first is referred to as the "C - Arm" because of its "C" shaped image gantry; the second is referred to as the "Workstation", which is the primary interface for the user to interact with the system.
The C-arm is a stable mobile platform 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 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 C-Arm is comprised of the high voltage generator, software, X-ray control, and a "C" shaped image gantry, which supports an X-ray tube and a Flat Panel Detector or Image Intensifier, depending on the choice of detector configuration desired.
The workstation is a stable mobile platform with an articulating arm supporting a color image, high resolution, LCD display monitor. It also includes image processing equipment/software, recording devices, data input/output devices and power control systems.
The primary purpose of the mobile fluoroscopy system is to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, cardiac, critical care and emergency procedures.
Mentions image processing
Yes
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
trained surgeons and other qualified physicians
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Verification and validation, including hazard mitigation, were executed. The system was tested and found compliant with IEC 60601-1 Ed. 3 series, including IEC 60601-2-43. All applicable 21CFR Subchapter J performance standards were met. Quality assurance measures included Risk Analysis, Required Reviews, Design Reviews, Testing on unit level (Sub System verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), and Simulated use testing (Validation). Additional engineering bench testing was performed, including a demonstration of system performance and an imaging performance evaluation using anthropomorphic phantoms. 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. The OEC Elite with Cardiac option was also evaluated for performance per the FDA "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' (SSXI), and it was determined that the modified system continues to comply. The evaluation included performance metrics identified in the SSXI guidance, showing identical performance of the subject device to the predicate device OEC Elite for: DOE, Dynamic Range, Spatial Resolution (MTF, Limiting Resolution), Temporal Resolution, Contrast Resolution, Beam Alignment, Dose Rate, Stability of the device characteristics over time, brightness uniformity, and Fluoroscopy Frame Rate.
Clinical Testing:
Not required as the device did not change intended use and had equivalent technological characteristics, supporting the use of scientific, established/standardized, engineering/physics-based performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
November 16, 2017
Image /page/0/Picture/1 description: The image contains the logos of the U.S. Food and Drug Administration (FDA) and the Department of Health & Human Services. The FDA logo features the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. To the left of the FDA logo is the symbol of the Department of Health & Human Services, which consists of a stylized human figure.
GE OEC Medical Systems, Inc. % Ms. Rachel Schandel Regulatory Affairs Leader 384 Wright Brothers Drive SALT LAKE CITY UT 84116
Re: K172550
Trade/Device Name: OEC Elite Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA, OXO Dated: October 20, 2017 Received: October 23, 2017
Dear Ms. Schandel:
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 medical devices and radiation-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 Oals
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172550
Device Name OEC Elite
Indications for Use (Describe)
The OEC Elite mobile fluoroscopy 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, vasular, cardiac, 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 logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by four stylized water droplets, one at each cardinal direction. The logo is simple and recognizable, and it is associated with a well-known and established company.
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).
| Date: | August 22, 2017 |
|---|---|
| Submitter: | GE OEC Medical Systems, Inc (GE Healthcare) |
| 384 Wright Brothers Drive | |
| Salt Lake City, Utah 84116 | |
| Primary Contact: | Rachel Schandel |
| Regulatory Affairs Leader | |
| Tel: 385-237-7519 | |
| Rachel.schandel@ge.com | |
| Secondary Contact: | Helen Peng |
| Regulatory Affairs Director | |
| GE Medical Systems, LLC | |
| Tel: 262-424-8222 | |
| e-mail: hong.peng@ge.com |
John Jaeckle
Chief Regulatory Affairs Strategist
GE Medical Systems, LLC
Tel: 262-424-9547
e-mail: john.jaeckle@ge.com |
PRODUCT IDENTIFICATION
| Device Trade Name: | OEC Elite |
|---|---|
| Regulation Name: | Image-intensified Fluoroscopic x-ray system |
| Regulation: | 21CFR 892.1650 |
| Classification: | Class II |
| Product Code: | OWB, JAA, OXO |
| Manufacturer / Design Location: | GE OEC Medical Systems, Inc (GE Healthcare) |
| 384 Wright Brothers Drive. | |
| Salt Lake City, Utah 84116 | |
| Manufacturing Location(s): | GE OEC Medical Systems, Inc (GE Healthcare) |
| 384 Wright Brothers Drive. | |
| Salt Lake City, Utah 84116 |
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Image /page/4/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 blue circle. There are three water droplet shapes surrounding the circle.
Predicate Device:
| Device Name: | OEC Elite |
|---|---|
| 510(k) number: | K171565 |
| Manufacturer: | GE OEC Medical Systems, Inc (same as proposed device) |
| Regulation Name: | Image-intensified Fluoroscopic x-ray system |
| Regulation: | 21CFR 892.1650 |
| Classification: | Class II |
| Product Code: | OWB, JAA, OXO |
Marketed Device:
OEC Elite with Cardiac option is a Mobile Fluoroscopic C-arm Imaging System with modification to the predicate device OEC Elite (K171565) to offer the users the cardiac features. It is of comparable type and substantially equivalent to the predicate device OEC Elite. This 510(k)submission for the OEC Elite system with cardiac option includes the same intended use and substantially equivalent indications for use as its predicate device. The existing indications for use of OEC Elite are expanded to include the cardiac capability which is one of the current clinical uses of mobile c-arm systems that are well established in the medical community.
The subject device is labeled OEC Elite (name unchanged from the predicate device).
Device Description:
The OEC Elite is a Mobile Fluoroscopic C-arm Imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic X-Ray images during diagnostic, interventional, and surgical procedures. These images help the physician visualize the patient's anatomy and interventional tools. This visualization helps to localize clinical regions of interest and pathology. The images provide real-time visualization and records of pre-procedure anatomy, in vivo-clinical activity and post-procedure outcomes. The system is composed of two primary physical components. The first is referred to as the "C - Arm" because of its "C" shaped image gantry; the second is referred to as the "Workstation", which is the primary interface for the user to interact with the system.
The C-arm is a stable mobile platform 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 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 C-Arm is comprised of the high voltage generator, software, X-ray control, and a "C" shaped image gantry, which supports an X-ray tube and a Flat Panel Detector or Image Intensifier, depending on the choice of detector configuration desired.
The workstation is a stable mobile platform with an articulating arm supporting a color image, high resolution, LCD display monitor. It also includes image processing equipment/software, recording devices, data input/output devices and power control systems.
The primary purpose of the mobile fluoroscopy system is to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, cardiac, critical care and emergency procedures.
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Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. There are decorative flourishes resembling water droplets or stylized leaves surrounding the circle. The logo is simple and iconic, representing the brand identity of General Electric.
The primary technology change for the subject device compared to the unmodified predicate, OEC Elite, is the introduction of the cardiac capabilities.
Intended Use
The OEC Elite Mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
Indications for Use:
The OEC Elite mobile fluoroscopy 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, cardiac, critical care, and emergency procedures.
Technology:
The OEC Elite with Cardiac option employs the same fundamental scientific technology as that of the predicate device OEC Elite (K171565).
The image chain including the X-Ray source and generator remain unchanged from that of the predicate OEC Elite. The primary change was in the software to implement the cardiac features. It re-uses the existing standard fluoroscopy modes as well as the vascular modes for cardiac imaging procedures. In order to optimize cardiac imaging, a Cardiac profile was added to the system. The Cardiac profile reduces blooming artifacts and enhances the visibility of moving features and vessels filled with a contrast agent when compared to not using the profile. The moving features are interventional devices such as guidewires, catheters, and stents that are inserted into vessels and manually manipulated through vessels to the surgical location in the heart. This is the most notable change for this submission. Additionally, a three pedal footswitch is also added which provides a dedicated pedal for Digital Cine pulse on OEC Elite systems with the cardiac option to assist the most typical cardiac workflow.
The modifications however, were built upon the existing robust and extensible software architecture, following the same design control process and software development lifecycle process that is compliant to IEC62304. The changes described above do not change the control mechanism, operating principle, energy type, or intended use from the predicate device.
Determination of Substantial Equivalence:
In addition to the verification and validation testing successfully completed as required by GE OEC Medical System's Quality Management System, additional engineering (non-Clinical) testing was performed to provide the requisite data to substantiate performance claims, the revised indications, and ultimately substantial equivalence.
The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.
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Non-Clinical Testing
Verification and validation, including hazard mitigation has been executed with results demonstrating the OEC Elite mobile fluoroscopy system met design input and user needs.
The system has been tested and is compliant with the IEC 60601-1 Ed. 3 series, including IEC 60601-2-43. All applicable 21CFR Subchapter J performance standards are met. The OEC Elite system was developed under the GE OEC Medical Systems 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
- Testing on unit level (Sub System verification)
- · Integration testing (System verification)
- · Performance testing (Verification)
- · Safety testing (Verification)
- · Simulated use testing (Validation)
Additional engineering bench testing was performed including demonstration of system performance; and an imaging performance evaluation using anthropomorphic phantoms. 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 OEC Elite with Cardiac option was also evaluated for its performance per the FDA "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' (SSXI). It was determined the modified system continues to comply to this guidance. The evaluation includes but not limited to the following performance metrics identified in the SSXI guidance, showing identical performance of the subject device to the predicate device OEC Elite:
- DOE ●
- Dynamic Range ●
- Spatial Resolution (MTF, Limiting Resolution) ●
- Temporal Resolution
- Contrast Resolution ●
- Beam Alignment
- Dose Rate
- Stability of the device characteristics over time
- brightness uniformity ●
- Fluoroscopy Frame Rate
- . Reuse Rate
The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.
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Image /page/7/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 circle. The circle is adorned with water droplet-like shapes around its perimeter, giving it a dynamic and fluid appearance. The color scheme is primarily blue, with the 'GE' letters and the surrounding circle in a lighter shade of blue.
Clinical Testing
Because OEC Elite with the cardiac option does not change the system's intended use and represents equivalent technological characteristics, this type of change supports using scientific, established/standardized, engineering/physics-based performance testing, without inclusion of clinical images. Therefore, for OEC Elite with Cardiac option configurations, clinical images are not required to demonstrate the substantial equivalence to the predicate device.
Substantial Equivalence Conclusion:
The differences discussed in this submission 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 OEC Medical System's Quality Management System, we believe that the OEC Elite with the cardiac option is of comparable type and substantially equivalent to the predicate device OEC Elite (K171565), and therefore is safe and effective for its intended use.