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.

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.

AI/ML Overview

This document describes the OEC Elite, a mobile fluoroscopy system. It does not contain information on human performance studies or the establishment of ground truth by expert consensus for evaluating clinical tasks. Instead, it focuses on non-clinical engineering and imaging performance testing against defined metrics.

Here is an analysis based on the provided text, focusing on the acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document outlines acceptance criteria based on performance metrics for Solid State X-ray Imaging Devices (SSXI) and compares the OEC Elite to its predicate device, OEC 9900 Elite.

SSXI Metrics	OEC Elite Performance Compared to Predicate OEC 9900 Elite
DQE (Detective Quantum Efficiency)	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

2. Sample size used for the test set and the data provenance:

The document refers to "additional engineering bench testing" and "imaging performance evaluation using anthropomorphic phantoms." It does not specify a distinct "test set" in terms of clinical images or patient data, nor does it provide a sample size for such a set. It appears the performance evaluations were conducted on the device itself and phantoms.

The data provenance is through non-clinical testing using anthropomorphic phantoms in a laboratory setting at GE OEC Medical Systems, Inc. (GE Healthcare).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the evaluation was based on non-clinical engineering and imaging performance metrics, primarily using anthropomorphic phantoms and objective measurements. There was no mention of human experts establishing ground truth for a clinical test set in this context.

4. Adjudication method for the test set:

This information is not applicable as there was no clinical test set requiring human adjudication to establish ground truth. The evaluation focused on technical performance metrics against a predicate device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. The device described (OEC Elite) is a mobile fluoroscopy system, a medical imaging hardware device, not an AI-powered diagnostic tool that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable in the context of an x-ray imaging system. The OEC Elite is a hardware device that produces images, not an algorithm, and the performance criteria relate to image quality and system functionality, not algorithmic output without human intervention.

7. The type of ground truth used:

The "ground truth" for the non-clinical testing was established by objective measurements of physical performance metrics (e.g., DQE, spatial resolution) on the OEC Elite and compared to the established performance of the predicate device (OEC 9900 Elite) and reference devices. Additionally, compliance with recognized standards (e.g., IEC 60601-1 Ed. 3 series, 21CFR Subchapter J) served as a form of "ground truth" for safety and efficacy.

8. The sample size for the training set:

This information is not applicable. The OEC Elite is a medical imaging hardware system, not a machine learning or AI algorithm that requires a "training set."

9. How the ground truth for the training set was established:

This information is not applicable as there was no training set.

Summary

{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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 DriveSalt Lake City, Utah 84116
Primary Contact:	Helen PengSenior Regulatory Affairs ManagerGE Medical Systems, LLCTel: 262-424-8222e-mail: hong.peng@ge.com
Secondary Contact:	John JaeckleChief Regulatory Affairs StrategistGE Medical Systems, LLCTel: 262-424-9547e-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

{4}------------------------------------------------

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:

{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 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:

{6}------------------------------------------------

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.

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:

{7}------------------------------------------------

	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 PanelDetector
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 µmFPD 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 DeviceOEC 9900 Elite - K122234	Reference DeviceZiehm Vision RFD - K132904	Reference DeviceZiehm Solo FD - K161976	Proposed DeviceOEC Elite
Field of View	9" II (diameter)• 215mm• 157mm• 119mm12" II (diameter)• 287mm• 201mm• 156mm	FPD 20 cm:• 20 cm• 15 cm• 10 cmFPD 30 cm:• 30cm• 20 cm• 15 cm	FPD 20 cm:• 20 cm• 15 cm• 10 cm	9" II (diameter)• 215mm• 157mm• 119mm12" II (diameter)• 287mm• 201mm• 156mmFPD 21 cm:• 21 cm• 15 cm• 11 cmFPD 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

{8}------------------------------------------------

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.

{9}------------------------------------------------

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:

{10}------------------------------------------------

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.

Regulation Number and Section

§ 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.