The OEC 9800 Plus is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

Device Description

The OEC® 9800 Plus is a system used to assist trained Surgeons. The system is used to provide X-Ray images while the Surgeon performs a medical procedure. Images from the system help the Surgeon to visualize the patients' anatomy. This visualization helps to localize surgical regions of interest and pathology. The images provide real-time visualization and records of pre-surgical anatomy, in vivo-surgical activity and post surgical outcomes.

The proposed device will add an alternative supplier for the X-Ray Tube. The current tube and the proposed tube have the same specifications and will be interchangeable. Verification activities confirmed that the proposed tube meets the same specification as the current supplier's tube.

The proposed device will add an alternative supplier for the Radiological Imaging Unit (RIU) or Image Intensifier. The current RIU and the proposed RIU have the same specifications and will be interchangeable. Verification activities confirmed that the alternate RIU meets the same specification as the current supplier's RIU.

The proposed device will provide an optional wireless foot switch and hand switch. The new option is equivalent to the predicate in that functionality is identical. The wireless option provides placement flexibility and reduced cable clutter.

Two printed circuit board assemblies have been combined into a single board in the proposed device due to parts obsolescence. Both the proposed and predicate assemblies share common specifications as confirmed through verification testing.

The proposed device will include a LCD monitor which replaces the obsolete CRT monitor. Both the proposed and predicate assemblies share common specifications as confirmed through verification testing.

The proposed device includes an alternative solid state drive. This drive provides a faster write speed. Both drives meet their specifications.

The proposed device will include a different model of an OEM injector system. Both the proposed and predicate OEM injector systems share common specifications as confirmed through verification testing.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the OEC® 9800 Plus, structured according to your request:

Acceptance Criteria and Device Performance

This 510(k) summary primarily describes modifications to an existing fluoroscopic imaging system (OEC® 9800 Plus) rather than a novel device. The core acceptance criteria revolve around demonstrating that the modified components (X-Ray tube, RIU/Image Intensifier, wireless switches, PCBs, LCD monitor, solid state drive, OEM injector system) perform equivalently to the original components and that the overall system maintains its safety, effectiveness, and intended use as the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Component Equivalence	Proposed X-Ray tube has same specifications as current supplier's tube.	Verification activities confirmed the proposed tube meets the same specifications.
	Proposed RIU/Image Intensifier has same specifications as current supplier's RIU.	Verification activities confirmed the alternate RIU meets the same specifications.
	Wireless foot switch and hand switch provide identical functionality to predicate's wired versions.	The new option is equivalent to the predicate; functionality is identical.
	Combined printed circuit board assemblies maintain common specifications as predicate's separate boards.	Both proposed and predicate assemblies share common specifications as confirmed through verification testing.
	LCD monitor maintains common specifications/performance as obsolete CRT monitor.	Both proposed and predicate assemblies share common specifications as confirmed through verification testing.
	Alternative solid-state drive meets specifications and provides improved write speed.	Both drives meet their specifications. (Explicitly states faster write speed for the new drive).
	Different model of OEM injector system maintains common specifications as predicate's injector.	Both proposed and predicate OEM injector systems share common specifications as confirmed through verification testing.
System Functionality	Maintained X-ray acquisition, X-ray control and indication, patient data management, imaging modes (basic/advanced).	Functional testing performed, including these aspects.
Image Quality	Maintained image quality acquisition and assessment, image processing and presentation, screen measurements.	Performance testing included image quality. Proposed device used to produce images evaluated to confirm new monitor met user needs.
System Safety & Performance	Overall system mechanical, electrical, and subsystem mechanical tests, and overall system tests are met.	Functional testing performed.
User Needs & Intended Use	Device meets user needs and intended uses by simulating a use environment.	Product Simulated Use Testing performed by users with relevant clinical experience. Functional requirements of image storage and recall validated. Images from proposed device evaluated for new monitor.
Compliance with Standards	Complies with relevant national and international medical device and radiation safety standards (e.g., 21 CFR 1020.30-32, IEC 60601 series).	The OEC® 9800 Plus complies with the voluntary and mandatory standards listed in Table 1 (e.g., 21 CFR 1020.30-32, UL 60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, NFPA 99, DICOM).

Study Details:

Sample sizes used for the test set and the data provenance:
- The document does not specify numerical sample sizes for test sets (e.g., number of images, number of patients, number of devices tested).
- The testing described is primarily retrospective in the sense that the device is a modification to an already cleared product. The testing involved verification and validation of component changes and system performance against established specifications.
- Data provenance: Not explicitly stated as "country of origin for data" in the context of clinical data, as no clinical studies on human patients were performed. The testing seems to be internal to GE Healthcare Surgery, likely performed at their facilities or those of their component suppliers.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states "testing performed by users with relevant clinical experience" for the "Product Simulated Use Testing."
- It does not specify the number of experts, nor their specific qualifications (e.g., "Radiologist with 10 years of experience"). It's a general statement about "users with relevant clinical experience."
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No formal adjudication method (like 2+1 or 3+1 consensus for image interpretation) is mentioned. This is typical for a 510(k) submission for modifications where the focus is on engineering verification and validation rather than new clinical claims requiring extensive reader studies.
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 study was done. This submission is for modifications to an existing fluoroscopic imaging system, not an AI-powered diagnostic tool. The purpose was to demonstrate equivalence of new components and maintain overall system performance, not to evaluate human reader performance with or without AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is an image-intensified fluoroscopic X-ray system, a hardware and software system for image acquisition and display, not a standalone AI algorithm. The performance evaluated was the system's ability to produce images and function correctly.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For component-level changes, the "ground truth" was the specifications of the predicate device's components. The new components had to match or exceed these specifications.
- For system-level functionality and performance (like image quality, electrical/mechanical tests), the "ground truth" was established engineering design input requirements and established standards (e.g., IEC 60601 series, 21 CFR 1020.30-32).
- For "Product Simulated Use Testing," the "ground truth" for meeting user needs was likely based on the assessment/feedback of "users with relevant clinical experience" against the intended use and established functional requirements.
The sample size for the training set:
- Not applicable/Not mentioned. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not applicable as there is no training set for an AI algorithm.

Summary

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510(k) Summary

MAY 0 1 2014

K132027

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date: November 20, 2013

GE Healthcare Surgery Submitter: 384 Wright Brothers Drive Salt Lake City, UT 84116

Primary Contact Person: Karen Russell
	Regulatory Affairs Leader
	GE Healthcare Surgery
	Phone: (801) 536-4930 Fax: (801) 517-6566
Secondary Contact Person: Jeff Wagner
	Regulatory Affairs Manager
	GE Healthcare Surgery
	Phone: (801) 517-6415 Fax: (801) 517-6566

OEC® 9800 Plus Device: (Trade Name): Mobile Fluoroscopic Imaging System Common/Usual Name: 21 CFR 892.1650 Image-intensified fluoroscopic x-ray system Classification Names:

Product Code: 90OWB, 90OXO and 90JAA

K111551 OEC® 9800 Plus Predicate Device(s):

Device Description:

The OEC® 9800 Plus is a system used to assist trained The system is used to provide X-Ray images Surgeons. while the Surgeon performs a medical procedure. Images from the system help the Surgeon to visualize the patients' This visualization helps to localize surgical anatomy. regions of interest and pathology. The images provide realtime visualization and records of pre-surgical anatomy, in vivo-surgical activity and post surgical outcomes.

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Two printed circuit board assemblies have been combined into a single board in the proposed device due to parts obsolescence. Both the proposed and predicate assemblies common specifications as confirmed through share verification testing.

The proposed device includes an alternative solid state drive. This drive provides a faster write speed. Both drives meet their specifications.

The proposed device will include a different model of an OEM injector system. Both the proposed and predicate OEM iniector systems share common specifications as confirmed through verification testing.

Intended Use:

The Series OEC® 9800 Plus is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

The modified OEC® 9800 Plus device employs the same Technology: fundamental scientific technology as the predicate device.

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Determination of Substantial Equivalence:

Summary of Non-Clinical Tests

The following quality assurance measures were applied to the development of the proposed device: Risk Analysis, Requirements Reviews, Design Reviews and testing which included component, subsystem, and system.

Design verification methodology was hierarchal. When component development was completed, component level tests were executed. Upon completion of component testing, subsystem and system verification were also performed. The Design Verification of the OEC 9800 Plus confirms that design output meets design input requirements.

testing was performed which included Functional mechanical, electrical, and overall system tests. X-ray acquisition, X-ray control and indication, patient data management, imaging modes (basic and advanced), image quality acquisition and assessment, image processing and presentation, screen measurements, motorized system, and subsystem mechanical tests were performed. Performance testing included image quality, and subsystem performance.

Product Simulated Use Testing was used to evaluate whether the device meets user needs and intended uses by simulating a use environment, and having testing performed by users with relevant clinical experience. The functional requirements of image storage and recall capability were validated using the proposed device. The proposed device was also used to produce images that were evaluated to confirm the new monitor met user needs and intended use.

Safety testing was performed in laboratory settings by qualified technicians to confirm that the product met the requirements of the standards listed in Table 1 below.

The OEC® 9800 Plus complies with the voluntary and mandatory standards listed in Table 1 below.

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Summary of Clinical Tests

The OEC 9800 Plus is based on modifications to a cleared predicate device. There were no changes to the intended use. Clinical studies on living human patients were not necessary to support substantial equivalence.

The verification and validation testing described above Conclusion: demonstrates that the OEC® 9800 Plus is safe, effective, and performs, for its intended use, in an equivalent manner to the predicate device and in accordance with its labeling. OEC® 9800 Plus is substantially equivalent in performance to the predicate OEC® 9800 Plus (K111551).

StandardsNo.	StandardsOrganization	Standards Title	Version	Date
21 CFR1020.30-32	FDA	Federal Performance Standard forDiagnostic X-ray Systems	2012	2012
60601-1	UL	Medical Electrical Equipment, Part 1:General Requirements for Safety	1st edition	2003
60601-1	IEC	Medical Electrical Equipment, Part 1:General Requirements for Safety	A1 (1991)and A2(1995)	1988,1991,1995
60601-1-2	IEC	Collateral Std: ElectromagneticCompatibility	2.1 edition	2004
60601-1-3	IEC	Collateral Std: Radiation Protection inDiagnostic X-ray Equipment	1st edition	1994
60601-1-4	IEC	Collateral Std: Radiation Protection inDiagnostic X-ray Equipment	1.1 edition(+A1)	2000
60601-1-6	IEC	Collateral Std: General Requirementsfor Basic Safety and EssentialPerformance	2nd edition	2006
60601-2-7	IEC	Particular Std: Safety of H.V.Diagnostic X-ray Generators	2nd edition	1998
60601-2-28	IEC	Particular Std: Safety of X-ray Tubeand X-ray Source Assemblies	1st edition	1993
60601-2-32	IEC	Particular Std: Safety of AssociatedEquipment of X-ray Equipment	1st edition	1994
NEPA 99	NFPA	US National Electric Code HealthCare Facilities	2005	2005
DICOM	DICOM	US National Electric Code HealthCare Facilities	2008	2008

Table 1 Product Standards Compliance

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002

May 1. 2014

GE Healthcare Surgery Jeff Wagner Regulatory Affairs Manager 384 Wright Brothers Drive Salt Lake City, Utah 84116

K132027/S004 Re:

Trade/Device Name: OEC 9800 Plus Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II -Product Code: OWB, OXO, JAA Dated: February 27, 2014 Received: April 2, 2014

Dear Mr. Wagner:

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 cither 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.

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Page 2 - Mr. Wagner

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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132027

Device Name GE OEC® 9800 Plus

Indications for Use (Describe)

Indications for Use: The OEC 9800 Plus is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, margical and interventional procedures. Clinical application may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

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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 I he burden time for this collection of information is common to connections of the parties of complete time to review instruction. Send comments regarding this burden estimate or any other aspect afto te now the collection, including suggestions for reducing this burden, to:

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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.