(112 days)
No
The document mentions image processing and 3D reconstruction, but there is no explicit mention of AI, ML, or related terms like deep learning or neural networks. The description focuses on standard imaging and reconstruction techniques.
No.
The device is an imaging system designed to provide fluoroscopic and digital spot images to assist physicians visualize anatomy and interventional tools during diagnostic, interventional, and surgical procedures. It does not provide any direct therapeutic benefit.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is designed to provide images "during diagnostic, interventional, and surgical procedures." The "Device Description" also reiterates its use during "diagnostic, interventional, and surgical procedures" and mentions that the images help "visualize the patient's anatomy and interventional tools" and "localize clinical regions of interest and pathology."
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," both containing significant hardware components like an X-ray tube, flat panel detector, generator, and computer hardware. While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The OEC 3D mobile fluoroscopy system is an imaging device that uses X-rays to visualize the patient's anatomy directly within the body (in vivo) during procedures. It does not analyze samples taken from the patient.
- Intended Use: The intended use clearly states it provides images during diagnostic, interventional, and surgical procedures to help physicians visualize anatomy and tools. This is a direct imaging function, not an in vitro test.
The device is a medical imaging system, not an IVD.
N/A
Intended Use / Indications for Use
The OEC 3D mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediativ populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, neurologic, vascular, cardiac, citical care and emergency procedures.
Product codes (comma separated list FDA assigned to the subject device)
OXO, OWB, JAA
Device Description
The OEC 3D 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 and volumetric reconstructions 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", and this is the primary user interface for the user to interact with the system. The C-arm has an interface tablet allowing a technician 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) 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 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,
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.
On the C-Arm, the generator remains unchanged from the OEC Elite. This is also true for the 31 cm x 31 cm image receptor, consisting of a Thallium-doped Cesium Iodide [Cs] (TI)] solid state flat panel X-ray detector with Complementary Metal Oxide Semiconductor (CMOS) light imager. The X-ray tube housing and insert remains the same as on the predicate OEC Elite (K192819).
C-Arm functionality is managed by a digital flat tablet control panel mounted on the C-arm base. Motion is controlled by a joystick.
On the workstation, the main hardware includes a computer with integrated wireless capability and a dedicated computer for 3D reconstruction located within the storage bay. The OEC 3D employs the same software architecture and platform design that fully supports the flat panel detector as the OEC Elite and complies with IEC 60601-1. The OEC 3D includes the existing 2D imaging functionalities available on the OEC Elite including imaging and post processing applications.
Mentions image processing
Yes, "It also includes image processing equipment/software, recording devices, data input/output devices and power control systems."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric populations
Intended User / Care Setting
trained surgeons and other qualified physicians; during diagnostic, interventional, and surgical procedures, critical care and emergency procedures.
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)
The OEC 3D device has successfully completed verification testing per GE Healthcare quality system as well engineering bench testing in support of this submission. The system has been tested and is compliant with the IEC 60601-1, including IEC 60601-1-3, 60601-1-3, 60601-2-43, and 60601-2-54.
All applicable 21CFR Subchapter J performance standards are met., 1020.30 Diagnostic X-Ray Systems and their major components, 1020.32 Fluoroscopic equipment, 1040.10 Laser products.
The OEC 3D 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
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.
The system can be fully tested/evaluated using engineering bench testing and clinical data is not required to demonstrate substantial equivalence. Results of all conducted testing assessments were found acceptable and do not raise any new issues of safety or effectiveness.
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.
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
March 5, 2021
Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE OEC Medical Systems, Inc. % Rachel Schandel Regulatory Affairs Leader 384 N Wright Brothers Drive SALT LAKE CITY UT 84116
Re: K203346
Trade/Device Name: OEC 3D Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OXO, OWB, JAA Dated: February 5, 2021 Received: February 8, 2021
Dear Rachel 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. 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/cfpmp/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.
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
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
OEC 3D
Indications for Use (Describe)
The OEC 3D mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediativ populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, neurologic, vascular, cardiac, citical 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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3
Image /page/3/Picture/2 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 decorative white swirls around the outer edge of the circle, adding a touch of elegance to the design. The logo is simple, recognizable, and has been used by GE for many years.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) Summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | February XX , 2020 |
|---|---|
| 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: +1-385-237-7519 | |
| e-mail: rachel.schandel@ge.com | |
| Secondary Contacts: | Philip Malca |
| Regulatory Affairs Director | |
| General Electric Company | |
| Tel: +33 646-373-852 | |
| e-mail: philip.malca@ge.com | |
| PRODUCT IDENTIFICATION | |
| Device Trade Name: | OEC 3D |
| Regulation Name: | Image-intensified Fluoroscopic x-ray system |
| Classification Panel: | Radiology |
| Regulation: | 21CFR 892.1650 |
| Classification: | Class II |
| Product Codes: | OXO, OWB, JAA |
| Manufacturer: | GE OEC Medical Systems, Inc (GE Healthcare) |
| 384 Wright Brothers Drive. | |
| Salt Lake City, Utah 84116 | |
| Manufacturing Location: | GE OEC Medical Systems, Inc (GE Healthcare) |
| 384 Wright Brothers Drive. |
Predicate Device:
Device Name: 510(k) number: Manufacturer: Regulation Name: Regulation: Classification: Product Code:
OEC Elite K192819 GE OEC Medical Systems, Inc Image-intensified Fluoroscopic x-ray system 21CFR 892.1650 Class II OWB, OXO, JAA
4
GE Healthcare
510(k) Premarket Notification Submission - OEC 3D
Image /page/4/Picture/2 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. The circle is surrounded by four decorative, swirling shapes, one at each cardinal direction (top, bottom, left, and right).
Primary Reference Device:
| Device Name: | Cios Spin (VA30) |
|---|---|
| 510(k) number: | K181550 |
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| Regulation Name: | Image-intensified Fluoroscopic x-ray system |
| Regulation: | 21CFR 892.1650 |
| Classification: | Class II |
| Product Code: | OWB, OXO, JAA |
Secondary Reference Device:
| Device Name: | INNOVA IGS 5 |
|---|---|
| 510(k) number: | K181403 |
| Manufacturer: | GE Medical Systems SCS |
| Regulation Name: | Image-intensified Fluoroscopic x-ray system |
| Regulation: | 21CFR 892.1650 |
| Classification: | Class II |
| Product Code: | OWB, JAA, IZI and OXO |
Device Description:
The OEC 3D 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 and volumetric reconstructions 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", and this is the primary user interface for the user to interact with the system. The C-arm has an interface tablet allowing a technician 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) 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 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,
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.
On the C-Arm, the generator remains unchanged from the OEC Elite. This is also true for the 31 cm x 31 cm image receptor, consisting of a Thallium-doped Cesium Iodide [Cs] (TI)] solid state flat panel X-ray detector with Complementary Metal Oxide Semiconductor (CMOS) light imager. The X-ray tube housing and insert remains the same as on the predicate OEC Elite (K192819).
C-Arm functionality is managed by a digital flat tablet control panel mounted on the C-arm base. Motion is controlled by a joystick.
5
Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. There are decorative swirls around the letters, adding to the logo's distinctive design. The logo is simple, yet recognizable.
On the workstation, the main hardware includes a computer with integrated wireless capability and a dedicated computer for 3D reconstruction located within the storage bay. The OEC 3D employs the same software architecture and platform design that fully supports the flat panel detector as the OEC Elite and complies with IEC 60601-1. The OEC 3D includes the existing 2D imaging functionalities available on the OEC Elite including imaging and post processing applications.
The change that triggered this submission for the subject device compared to the predicate, OEC Elite, is the introduction of the new 3D functionality. However, the new 3D function is substantially equivalent to the Siemens Inc. Cios Spin (K181550) and the 3D algorithm is identical to the Medical Systems INNOVA IGS 5 (K181403). Additionally, software and hardware are comparable to the OEC Elite (K192819).
This premarket notification is being submitted as a Traditional 510(k) to request clearance for the Subject Device the OEC 3D device. The subject device OEC 3D is substantially equivalent to the GE Healthcare predicate device OEC Elite (K192819) and the reference devices: Cios Spin (K181550) as well as INNOVA IGS 5(K181403), they are within the same classification and regulation with these devices.
Proposed Device Modification:
The proposed OEC 3D device is a modification of GE's own predicate OEC Elite system (K192819). Its built upon the existing technologies of the predicate device "OEC Elite" (K192819).
The primary modifications for the OEC 3D as compared to OEC Elite are summarized below:
-
- Composite isocentric C gantry
-
- Dedicated 3D reconstruction computer
-
- Live view camera embedded in the detector housing
-
- Recirculating oil cooler on the X-ray tube
The wheels and wheel brakes, cable wraps, working surface, ergonomic handles, aesthetic open frame, LCD monitor, articulating arm and latch system remain unchanged from the OEC Elite.
Indications for Use:
The OEC 3D 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, neurologic, vascular, cardiac, critical care and emergency procedures.
Technology:
The indications for use are identical and technology is similar to the predicate device. X-ray generation and control used with the subject device OEC 3D is identical to the technology used with the predicate device OEC Elite. The subject OEC 3D device employs the same fundamental technology as that of the predicate device. The image chain including the X-ray tube, high voltage generator, collimator, X-ray filters, and detectors, remains unchanged from the predicate, OEC Elite. The 3D functionality is similar to the reference device Cios Spin and INNOVA IGS 5. Table 1 provides predicate and reference device comparison.
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Image /page/6/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 four white teardrop shapes symmetrically placed around the circle, adding a decorative element to the design.
The system continues to meet all applicable IEC 60601-1 series of standards, NEMA XR-27, and applicable parts of 21CFR Subchapter J. The new performance claims did not require clinical data in order to establish safety or efficacy.
The OEC 3D device was built upon the existing modular and extensible software architecture, following the same design control process and software development lifecycle process that is compliant to IEC62304 used in the predicate OEC Elite.
The changes described above do not change the control mechanism, operating principle, energy type, or the scientific technology of the predicate devices.
| Device Name and Manufacturer | 510(k)
Number | Clearance
Date | Comparable Properties |
|------------------------------------------------------------------------------------------------------------------|------------------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device: OEC Elite
GE OEC Medical Systems, Inc
Product Codes: OWB, OXO, JAA | K192819 | 11/08/2019 | - Indications for Use
- X-ray tube assembly
- X-ray generator
- Collimator
- Image receptor
- X-ray control modes
- X-ray initiation and termination
- Imaging modes
- Dose area product
- Imaging features
- Image noise reduction
- Power requirements
- C-arm dimensions
- C-arm positioning
- Motorization
- Workstation dimensions
- Display articulation
- Primary monitor
- Control panel
- Software platform
- Computing hardware platform
- Image management
- Image storage
- Data transfer
- Alignment Aid
- Standards compliance |
| Primary Reference Device: Cios
Spin
Siemens Medical Solutions USA,
Inc.
Product Codes: OWB, OXO, JAA | K181550 | 10/30/2018 | - Isocentric C-arm design - 3D imaging modes
- 3D imaging features
- Navigation interface |
Table 1: Predicate and Reference Device Comparison
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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, cursive font, enclosed within a blue circle. The circle has decorative flourishes or wave-like designs emanating from it, giving it a dynamic and recognizable appearance.
| Device Name and Manufacturer | 510(k)
Number | Clearance
Date | Comparable Properties |
|---------------------------------------------|------------------|-------------------|-----------------------|
| Secondary Reference Device:
INNOVA IGS 5 | K181403 | 11/02/2018 | - 3D Algorithm |
| GE Medical Systems SCS | | | |
| 283 Rue De La Miniere, 78530
BUC, France | | | |
| Product Codes: JAA, IZI and OXO | | | |
Determination of Substantial Equivalence:
The main change in the proposed device is the introduction of the 3D functionality.
The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device:
| Key
Difference
Category | Subject Device:
OEC 3D | Predicate Device:
OEC Elite
(K192819) | Reference Device:
Cios Spin
(K181550) | Comparison Results |
|-----------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| X-ray Tube
Assembly | X-ray tube assembly
with housing, tube
insert, and
recirculating oil
cooling unit. | X-ray tube
assembly with
housing and tube
insert. | NA | Improved cooling
rate and capacity
does not raise any
new issues of safety
and effectiveness. |
| Power
Requirements | 115-120V 20A
power for additional
computing
hardware. | 100-120V 15A
power. | NA | Change in power
consumption does
not raise any new
issues of safety and
effectiveness. |
| C-arm
Dimensions | Isocentric gantry
design changes
overall dimensions
and weight. | Offset gantry
design. | NA | C-arm dimensions do
not raise any new
issues of safety and
effectiveness. |
| C-arm
Positioning | Increased orbital
range for 3D
scanning. | Orbital range
commensurate
with 2D imaging. | NA | C-arm positioning
does not raise any
new issues of safety
and effectiveness. |
| Workstation
Dimensions | Workstation weight
increased due to
additional computer
and support
hardware. | Base configuration
workstation
weight. | NA | Workstation weight
does not raise any
new issues of safety
and effectiveness. |
| Computing
Hardware
Platform | Two computers, one
computer for
imaging functions
and features and
second computer for | One computer for
imaging functions
and features. | NA | Additional computer
does not raise any
new issues of safety
and effectiveness. |
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Image /page/8/Picture/2 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. The circle is surrounded by decorative, swirling lines, also in blue, which give the logo a classic and recognizable appearance.
| Key
Difference
Category | Subject Device:
OEC 3D | Predicate Device:
OEC Elite
(K192819) | Reference Device:
Cios Spin
(K181550) | Comparison Results |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| | 3D feature. | | | |
| Alignment
Aid | Laser aimer and
preview camera. | Laser aimer. | NA | Addition of preview
camera does not raise
any new issues of
safety and
effectiveness. |
| C-arm
Design | Isocentric gantry
capable of rotating
200 degrees. | NA | Isocentric gantry
capable of rotating
196 degrees. | Gantry design
change does not raise
any new issues of
safety and
effectiveness. |
| 3D Imaging
Modes | Six modes with 200-
400 images per
scan. | NA | Four modes with
100-400 images
per scan. | Imaging modes are
similar and do not
raise any new issues
of safety and
effectiveness. |
| 3D Imaging
Features | Comprehensive set
of adjustments and
viewing options for
visualizing 3D
reconstructions, plus
a maximum
intensity projection
(MIP) view. | NA | Comprehensive set
of adjustments and
viewing options
for visualizing 3D
reconstructions. | Imaging features are
similar and do not
raise any new issues
of safety and
effectiveness. |
Non-Clinical Performance Testing
The OEC 3D device has successfully completed verification testing per GE Healthcare quality system as well engineering bench testing in support of this submission. The system has been tested and is compliant with the IEC 60601-1, including IEC 60601-1-3, 60601-1-3, 60601-2-43, and 60601-2-54.
All applicable 21CFR Subchapter J performance standards are met., 1020.30 Diagnostic X-Ray Systems and their major components, 1020.32 Fluoroscopic equipment, 1040.10 Laser products.
The OEC 3D 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
- · Integration testing (System verification)
- · Performance testing (Verification)
- · Safety testing (Verification)
- · Simulated use testing (Validation)
The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.
9
GE Healthcare
510(k) Premarket Notification Submission - OEC 3D
Image /page/9/Picture/2 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 a decorative border. The logo is simple and recognizable, and it is often used to represent the company's brand.
Clinical Testing
The subject OEC 3D device is substantially equivalent to the predicate and reference devices. The indication for use is identical and has equivalent/identical technological characteristics. This type of notification supports using scientific, established, engineering-based performance testing. The system can be fully tested/evaluated using engineering bench testing and clinical data is not required to demonstrate substantial equivalence.
Summary:
OEC 3D uses identical imaging, identical Indications for Use, and has equivalent/identical technological characteristics to the predicates. This type of device supports using scientific, established, engineeringbased performance testing. The system can be fully tested/evaluated using engineering bench testing and clinical data is not required to demonstrate substantial equivalence. Results of all conducted testing assessments were found acceptable and do not raise any new issues of safety or effectiveness.
Substantial Equivalence Conclusion:
The OEC 3D device was built upon the existing modular and extensible predicate OEC Elite device (K192819), following the same design control process and software development lifecycle processes.
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 subject OEC 3D device is of comparable type and substantially equivalent to the predicate device OEC Elite (K192819) with support from the reference devices Siemens Cios Spin device (K181550) and INNOVA IGS 5 (K181403), and therefore is safe and effective for its intended use.