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.

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.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. Instead, it is a 510(k) premarket notification summary from the FDA, asserting substantial equivalence to predicate devices rather than demonstrating performance against explicit acceptance criteria with clinical data.

Here's an analysis of the information available in the document, and where details are explicitly not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance testing against general standards, rather than specific acceptance criteria for performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document states that "clinical data is not required to demonstrate substantial equivalence" and that the device was evaluated using "engineering bench testing" and "non-clinical performance testing." Therefore, there is no discrete "test set" of patient data in the clinical sense mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. Since clinical data was not used for the performance evaluation for substantial equivalence, no expert ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set

This information is not provided. As no clinical test set with human assessments is described, no adjudication method is relevant or provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The new performance claims did not require clinical data in order to establish safety or efficacy." Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes non-clinical performance testing and engineering bench testing, which would broadly cover standalone algorithm performance in a technical sense (e.g., image quality metrics, reconstruction accuracy). However, it does not explicitly detail a "standalone performance study" in the context of clinical metrics like sensitivity, specificity, or reader performance. The focus is on demonstrating that the new 3D functionality is "substantially equivalent" to that of reference devices.

7. The Type of Ground Truth Used

The document does not describe the use of specific ground truth (expert consensus, pathology, outcomes data) in the context of clinical performance evaluation for substantial equivalence to the same extent as a traditional clinical study. The "ground truth" for the non-clinical performance testing would be derived from engineering specifications, phantom measurements, and compliance with standards (e.g., IEC 60601-1, NEMA XR-27). The 3D algorithm is stated to be "identical" to one of the reference devices (INNOVA IGS 5), implying its performance characteristics are assumed to be similar to that previously cleared device.

8. The Sample Size for the Training Set

This information is not provided. The document does not describe any machine learning or AI algorithm development that would involve a training set of data. The 3D algorithm is stated to be "identical" to one of the reference devices, suggesting it's an existing, proven algorithm rather than a newly trained one requiring a specific training set.

9. How the Ground Truth for the Training Set Was Established

This information is not provided, as no training set is mentioned.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

K203346

Device Name

OEC 3D

Indications for Use (Describe)

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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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 DriveSalt Lake City, Utah 84116
Primary Contact:	Rachel SchandelRegulatory Affairs LeaderTel: +1-385-237-7519e-mail: rachel.schandel@ge.com
Secondary Contacts:	Philip MalcaRegulatory Affairs DirectorGeneral Electric CompanyTel: +33 646-373-852e-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

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GE Healthcare

510(k) Premarket Notification Submission - OEC 3D

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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:

C-Arm functionality is managed by a digital flat tablet control panel mounted on the C-arm base. Motion is controlled by a joystick.

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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:

1. Composite isocentric C gantry
1. Dedicated 3D reconstruction computer
1. Live view camera embedded in the detector housing
1. 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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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	ClearanceDate	Comparable Properties
Predicate Device: OEC EliteGE OEC Medical Systems, IncProduct 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: CiosSpinSiemens 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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Device Name and Manufacturer	510(k)Number	ClearanceDate	Comparable Properties
Secondary Reference Device:INNOVA IGS 5	K181403	11/02/2018	- 3D Algorithm
GE Medical Systems SCS
283 Rue De La Miniere, 78530BUC, 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:

KeyDifferenceCategory	Subject Device:OEC 3D	Predicate Device:OEC Elite(K192819)	Reference Device:Cios Spin(K181550)	Comparison Results
X-ray TubeAssembly	X-ray tube assemblywith housing, tubeinsert, andrecirculating oilcooling unit.	X-ray tubeassembly withhousing and tubeinsert.	NA	Improved coolingrate and capacitydoes not raise anynew issues of safetyand effectiveness.
PowerRequirements	115-120V 20Apower for additionalcomputinghardware.	100-120V 15Apower.	NA	Change in powerconsumption doesnot raise any newissues of safety andeffectiveness.
C-armDimensions	Isocentric gantrydesign changesoverall dimensionsand weight.	Offset gantrydesign.	NA	C-arm dimensions donot raise any newissues of safety andeffectiveness.
C-armPositioning	Increased orbitalrange for 3Dscanning.	Orbital rangecommensuratewith 2D imaging.	NA	C-arm positioningdoes not raise anynew issues of safetyand effectiveness.
WorkstationDimensions	Workstation weightincreased due toadditional computerand supporthardware.	Base configurationworkstationweight.	NA	Workstation weightdoes not raise anynew issues of safetyand effectiveness.
ComputingHardwarePlatform	Two computers, onecomputer forimaging functionsand features andsecond computer for	One computer forimaging functionsand features.	NA	Additional computerdoes not raise anynew issues of safetyand effectiveness.

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KeyDifferenceCategory	Subject Device:OEC 3D	Predicate Device:OEC Elite(K192819)	Reference Device:Cios Spin(K181550)	Comparison Results
	3D feature.
AlignmentAid	Laser aimer andpreview camera.	Laser aimer.	NA	Addition of previewcamera does not raiseany new issues ofsafety andeffectiveness.
C-armDesign	Isocentric gantrycapable of rotating200 degrees.	NA	Isocentric gantrycapable of rotating196 degrees.	Gantry designchange does not raiseany new issues ofsafety andeffectiveness.
3D ImagingModes	Six modes with 200-400 images perscan.	NA	Four modes with100-400 imagesper scan.	Imaging modes aresimilar and do notraise any new issuesof safety andeffectiveness.
3D ImagingFeatures	Comprehensive setof adjustments andviewing options forvisualizing 3Dreconstructions, plusa maximumintensity projection(MIP) view.	NA	Comprehensive setof adjustments andviewing optionsfor visualizing 3Dreconstructions.	Imaging features aresimilar and do notraise any new issuesof safety andeffectiveness.

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.

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GE Healthcare

510(k) Premarket Notification Submission - OEC 3D

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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.

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.