(67 days)
No
The summary describes a standard mobile fluoroscopy system with image processing capabilities, but there is no mention of AI, ML, or any features that would typically be associated with these technologies (e.g., automated detection, segmentation, or analysis based on learned patterns). The performance metrics and testing described are also standard for imaging devices and do not suggest the use of AI/ML.
No
The device is described as an imaging system used to visualize patient anatomy and interventional tools during diagnostic, interventional, and surgical procedures. It provides images and records, but does not directly provide therapy.
Yes
Explanation: The device is explicitly stated as being used during "diagnostic, interventional and surgical procedures" and helps physicians "visualize the patient's anatomy and interventional tools" to "localize clinical regions of interest and pathology." This indicates its role in identifying or characterizing conditions, which falls under diagnostic use.
No
The device is described as a "Mobile Fluoroscopic C-arm Imaging system" with two primary physical components: a "C-Arm" and a "Workstation". These components include hardware such as an X-ray tube, flat panel detector/image intensifier, high voltage generator, and a mobile platform. 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 tests performed 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 medical procedures. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it provides fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures. This is direct imaging of the patient.
Therefore, the OEC Elite mobile fluoroscopy system falls under the category of medical imaging devices, not In Vitro Diagnostics.
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 populations during diagnostic, interventional and surgical procedures.
Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, critical care and emergency procedures.
Product codes
OXO, OWB, JAA
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 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 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, critical care and emergency procedures.
The OEC Elite comes with four image receptor (detector) options: the choice of 21x21 cm or 31x31 cm (new) Thallium-doped Cesium Iodide Cs] solid state flat panel X-ray detector with Complementary Metal Oxide Semiconductor (CMOS) light imager; or the choice of a 9 inch or 12 inch of the same existing image intensifier as in the OEC 9900 Elite.
The most outwardly visible technology change for this new device compared to the predicate, OEC 9900 Elite, is the introduction of the new Cs1:T1 - CMOS detectors. However, the new flat panel detectors for the OEC Elite are substantially equivalent to those of the two reference devices.
Additionally, software and hardware design modifications have been made to the subject device, OEC Elite, which are intended to improve the overall performance and reliability of the system and to eliminate or reduce failure mechanisms that periodically occurred with the predicate device, specifically: loss of cine functionality, data loss/mix, system lockup, no live image, failure to boot, and uncommanded X-ray. These modifications include a redesigned computer architecture (hardware and software), elimination and redesign of interconnecting cables, and addition of continuous monitoring of power conditions and new Uninterrupted Power Supply (UPS), and new on-screen user messaging (e.g., battery life and charge indications).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-Ray, Digital Spot Images
Anatomical Site
patient anatomy
Indicated Patient Age Range
adult and pediatric 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 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 IEC60601-2-54 and 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. Additional engineering bench testing was performed including: the non-clinical testing identified in the guidance for submission of 510(k)s for Solid State X-Ray Imaging Devices (SSXI); 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. Test documentation provided demonstrates compliance of the OE Elite to "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices".
Clinical Testing:
Because OEC Elite's new flat panel detectors do not change the system's intended use and represent equivalent technological characteristics, clinical images are not required. Also, because the II configurations are identical to the predicate, clinical images are not included for them. Therefore, for all OEC Elite configurations, clinical images are not needed to demonstrate that the device is as safe and as effective as the predicate and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SSXI Metrics with performance compared to Predicate OEC 9900 Elite:
- DQE: Improved
- Dynamic Range: Improved
- Spatial Resolution (MTF, Limiting Resolution): Equivalent
- Temporal Resolution: Equivalent
- Contrast Resolution: Equivalent
- Beam Alignment: Equivalent
- Dose Rate: Equivalent
- Stability of the device characteristics over time: Equivalent
- brightness uniformity: Improved
- Fluoroscopy Frame Rate: Equivalent
- Reuse Rate: Equivalent
Predicate Device(s)
OEC 9900 Elite K122234
Reference Device(s)
Ziehm Vision RFD Digital Mobile Imaging System K132904, Ziehm Solo FD K161976
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.
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a symbolic graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The graphic element features a stylized representation of three human profiles, one behind the other, creating a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mav 19, 2017
OEC Medical Systems, Inc. % Ms. Helen Peng Senior Regulatory Affairs Manager 384 Wright Brothers Drive SALT LAKE CITY UT 84116
Re: K170752
Trade/Device Name: OEC Elite Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO, OWB, JAA Dated: March 10, 2017 Received: March 13, 2017
Dear Ms. Peng:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D. O'Hara For
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) K170752
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 populations during diagnostic, interventional and surgical procedures.
Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, 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, cursive font, enclosed within a blue circle. There are three teardrop-shaped elements surrounding the circle, positioned at the top, left, and right sides. The logo is simple and recognizable, representing the brand identity of General Electric.
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: | March 10th, 2017 |
|---|---|
| Submitter: | GE OEC Medical Systems, Inc (GE Healthcare) |
| 384 Wright Brothers Drive | |
| Salt Lake City, Utah 84116 | |
| Primary Contact: | Helen Peng |
| Senior Regulatory Affairs Manager | |
| GE Medical Systems, LLC | |
| Tel: 262-424-8222 | |
| e-mail: hong.peng@ge.com | |
| Secondary Contact: | 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 | |
| Predicate Device: |
Device Name: 510(k) number: Manufacturer: Regulation Name: OEC 9900 Elite K122234 GE OEC Medical Systems, Inc (same as proposed device) Image-intensified Fluoroscopic x-ray system
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Image /page/4/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. There are three white swirls around the outside of the circle. The logo is simple and recognizable, and it is associated with a well-known company.
| Regulation: | 21CFR 892.1650 |
|---|---|
| Classification: | Class II |
| Product Code: | OWB, JAA, OXC |
Reference Devices:
| Device Name: | Ziehm Vision RFD Digital Mobile Imaging System |
|---|---|
| 510(K) number: | K132904 |
| Manufacturer: | ZIEHM IMAGING GMBH |
| Regulation Name: | Image-intensified Fluoroscopic x-ray system |
| Regulation: | 21CFR 892.1650 |
| Classification: | Class II |
| Product Code: | JAA, OWB, OXO |
| Device Name: | Ziehm Solo FD |
| 510(K) number: | K161976 |
| Manufacturer: | ZIEHM IMAGING GMBH |
| Regulation Name: | Image-intensified Fluoroscopic x-ray system |
| Regulation: | 21CFR 892.1650 |
| Classification: | Class II |
| Product Code: | OWB, JAA, OXO |
Marketed Devices:
OEC Elite is a Mobile Fluoroscopic C-arm Imaging System built upon the existing technologies of the predicate device OEC 9900 Elite (K122234) and reference devices. It is of comparable type and substantially equivalent to its predicate device OEC 9900 Elite. The new flat panel detector for the OEC Elite provides similar imaging performance to those used in the two reference devices. Ziehm Vision FD and Ziehm Solo FD Digital Mobile C-arm. The intended use has not changed between the proposed device and the predicate device. The proposed device's indications for use have been revised to clearly identify current and historical patient populations and the system capabilities as substantiated in the testing and evaluations provided.
The system is labeled as the OEC Elite.
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
5
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 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 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, critical care and emergency procedures.
The OEC Elite comes with four image receptor (detector) options: the choice of 21x21 cm or 31x31 cm (new) Thallium-doped Cesium Iodide Cs] solid state flat panel X-ray detector with Complementary Metal Oxide Semiconductor (CMOS) light imager; or the choice of a 9 inch or 12 inch of the same existing image intensifier as in the OEC 9900 Elite.
The most outwardly visible technology change for this new device compared to the predicate, OEC 9900 Elite, is the introduction of the new Cs1:T1 - CMOS detectors. However, the new flat panel detectors for the OEC Elite are substantially equivalent to those of the two reference devices.
Additionally, software and hardware design modifications have been made to the subject device, OEC Elite, which are intended to improve the overall performance and reliability of the system and to eliminate or reduce failure mechanisms that periodically occurred with the predicate device, specifically: loss of cine functionality, data loss/mix, system lockup, no live image, failure to boot, and uncommanded X-ray. These modifications include a redesigned computer architecture (hardware and software), elimination and redesign of interconnecting cables, and addition of continuous monitoring of power conditions and new Uninterrupted Power Supply (UPS), and new on-screen user messaging (e.g., battery life and charge indications).
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:
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Image /page/6/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. There are three water droplet shapes surrounding the circle. The logo is simple and recognizable.
The OEC Elite mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, critical care and emergency procedures.
Technology:
The OEC Elite employs the same fundamental scientific technology as that of the predicate device OEC 9900 Elite (K122234) and the reference devices, Ziehm Vision FD Digital Mobile Imaging System (K132904) and Ziehm Solo FD (K161976).
OEC Elite introduces Thallium-doped Cesium Iodide Cs] solid state flat panel X- ray detectors with Complementary Metal Oxide Semiconductor (CMOS) photodiodes. However, the new flat panel detector for the OEC Elite provides similar imaging performance to those used in the two reference devices.
The X-Ray source and generator remain unchanged from that of the OEC 9900 Elite. On the workstation, the main hardware changes include an updated computer that offers more image storage, processing power and speed, and a single monitor. The workstation mechanical design is improved for usability, maneuverability, and positioning.
The changes described above do not change the control mechanism, operating principle, energy type, or intended use from the predicate and reference devices.
Determination of Substantial Equivalence:
The main change in the proposed device is the introduction of the Thallium-doped Cesium Iodide [Csl(TI)] solid state flat panel X- ray detector with Complementary Metal Oxide Semiconductor (CMOS) photodiodes. The table below summarizes the substantive feature/technological differences between the predicate device, the reference device and the proposed device:
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| Predicate Device | Reference Device | Reference Device | Proposed Device | |
|---|---|---|---|---|
| OEC 9900 Elite - K122234 | Ziehm Vision RFD - | |||
| K132904 | Ziehm Solo FD - K161976 | OEC Elite | ||
| KV Range | 40-120 kVp | 40-120 kVp | 40-120 kVp | 40-120 kVp |
| Max power output | 15 kW | 7.5kW | 2.0kW | 15 kW |
| Image Receptor | Image intensifier | aSi Flat Panel Detector | CMOS Flat Panel Detector | Image intensifier & CMOS Flat Panel |
| Detector | ||||
| Pixel Pitch | 9" II 215 µm 157 µm 119 µm 12" II 287 µm 201 µm 156 µm | FPD 20 X 20 cm: 194 µm FPD 30 x 30 cm: 194 µm | FPD 20 X 20 cm: 100 µm | Pixel Pitch: |
| 9" II 215 µm 157 µm 119 µm 12" II 287 µm 201 µm 156 µm FPD 21 x 21 cm: 135.3 µm | ||||
| FPD 31 x 31cm: 198 µm | ||||
| Pixel Matrix | 9" II: 1000x1000 total pixels 12" II: 1000x1000 total pixels | FPD 20x20cm: 1024 x 1024 total pixels FPD 30x30 cm: 1536 x 1536 total pixels | FPD 20x20cm: 2048x2048 total pixels | 9" II: 1000x1000 total pixels 12" II: 1000x1000 total pixels FPD 21x21 cm: 1536 x 1496 total pixels FPD 31x31 cm: 1548 x 1524 total pixels |
| Predicate Device | ||||
| OEC 9900 Elite - K122234 | Reference Device | |||
| Ziehm Vision RFD - K132904 | Reference Device | |||
| Ziehm Solo FD - K161976 | Proposed Device | |||
| OEC Elite | ||||
| Field of View | 9" II (diameter) | |||
| • 215mm | ||||
| • 157mm | ||||
| • 119mm |
12" II (diameter)
• 287mm
• 201mm
• 156mm | FPD 20 cm:
• 20 cm
• 15 cm
• 10 cm
FPD 30 cm:
• 30cm
• 20 cm
• 15 cm | FPD 20 cm:
• 20 cm
• 15 cm
• 10 cm | 9" II (diameter)
• 215mm
• 157mm
• 119mm
12" II (diameter)
• 287mm
• 201mm
• 156mm
FPD 21 cm:
• 21 cm
• 15 cm
• 11 cm
FPD 31 cm:
• 31cm
• 21 cm
• 15 cm |
| Imaging Modes | • Continuous – Fluoroscopy
• Pulsed Fluoroscopy
• Digital Spot | • Pulsed Fluoroscopy
• Digital Spot | • Pulsed Fluoroscopy
• Digital Spot | • Continuous – Fluoroscopy
• Pulsed Fluoroscopy
• Digital Spot |
| Dose Area Product (DAP) | Dose Area Product (DAP) Display | Dose Area Product (DAP) Display | Dose Area Product (DAP) Display | Dose Area Product (DAP) Display |
| Removable anti-scatter grid | No | Yes | Yes | Yes |
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Image /page/8/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. There are four white swirls around the letters, one in each quadrant of the circle. The logo is simple and recognizable, and it is often used to represent the company's brand.
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Image /page/9/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. There are also some white, water-drop-like shapes surrounding the circle. The logo is simple, clean, and recognizable.
GE Healthcare believes the OEC Elite is of comparable type and substantially equivalent to our currently marketed system OEC 9900 Elite.
The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.
Summary of Additional Testing
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.
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 IEC60601-2-54 and 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: the non-clinical testing identified in the guidance for submission of 510(k)s for Solid State X-Ray Imaging Devices (SSXI); 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:
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Image /page/10/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. There are four white water droplet shapes surrounding the circle, positioned at the top, bottom, left, and right. The logo is simple and recognizable, representing the company's brand identity.
X-ray Imaging Devices- Laboratory Image Quality and Dose Assessment, Tests and Standards' was performed with acceptable results.
With regards to the flat panel detector (SSXI), test documentation provided in this submission demonstrates compliance of the OE Elite to "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices". The evaluation includes but is not limited to the following performance metrics identified in the SSXI guidance, showing comparable or better performance of the OEC Elite compared to the predicate device OEC 9900 Elite:
| SSXI Metrics | OEC Elite Performance Compared to |
|---|---|
| Predicate OEC 9900 Elite | |
| DQE | Improved |
| Dynamic Range | Improved |
| Spatial Resolution (MTF, Limiting Resolution) | Equivalent |
| Temporal Resolution | Equivalent |
| Contrast Resolution | Equivalent |
| Beam Alignment | Equivalent |
| Dose Rate | Equivalent |
| Stability of the device characteristics over time | Equivalent |
| brightness uniformity | Improved |
| Fluoroscopy Frame Rate | Equivalent |
| Reuse Rate | Equivalent |
Clinical Testing
Because OEC Elite's new flat panel detectors do not change the system's intended use and represent equivalent technological characteristics, clinical images are not required. Also, because the II configurations are identical to the predicate, clinical images are not included for them. Therefore, for all OEC Elite configurations, clinical images are not needed to demonstrate that the device is as safe and as effective as the predicate and reference devices.
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 OEC Medical System's Quality Management System, we believe that the OEC Elite is of comparable type and substantially equivalent to the predicate device OEC 9900 Elite (K122234) with support from the reference devices, and therefore is safe and effective for its intended use.