The Definium Pace Select ET is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This device is not intended for mammographic applications.

Device Description

The Definium Pace Select ET Radiography X-ray System is designed as a modular system with components that include a 2-axis motorized tube stand with tube and auto collimator assembled on an elevating table, a motorized wall stand, a cabinet with X-ray high voltage generator, a wireless access point, wireless detectors, an acquisition workstation including a monitor and control box with hand-switch. The system generates diagnostic radiographic images which can be reviewed or managed locally and sent through a DICOM network for reviewing, storage and printing.

By leveraging platform components / design, Definium Pace Select ET is similar to the predicate Definium Pace Select (K231892) and the reference Discovery XR656 HD (K191699) with regards to the user interface layout, patient worklist refresh and selection, protocol selection, image acquisition, and image processing based on the raw image. This product introduces motorized tube stand (vertical and tube angulation) instead of manual tube stand of the predicate. The high voltage generator is new and is backwards compatible to the predicates high voltage generator. This product also introduced Image Pasting on Table and Wall Stand Mode, Auto tracking for Wall Stand, Auto Angulation, Camera Workflow, DAP software calculation, Siemens LED collimator and LCD touch screen console. The other minor changes include updates to components due to obsolescence.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Definium Pace Select ET." It describes the device, its intended use, and compares its technological characteristics to a predicate device ("Definium Pace Select") and a reference device ("Discovery XR656 HD").

However, this document does not contain any performance data or details of a clinical study that proves the device meets specific acceptance criteria based on AI or human reading performance.

The "PERFORMANCE DATA" section explicitly states: "The Definium Pace Select ET does not contain clinical testing data." Instead, it lists non-clinical tests performed, such as Risk Analysis, Requirements Reviews, Design Reviews, and various levels of verification testing (unit, integration, performance, safety, simulated use). These non-clinical tests are aimed at confirming the safety and effectiveness of the device as it relates to changes from the predicate, rather than evaluating specific clinical diagnostic performance metrics with a test set, ground truth, and human readers.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided input does not contain this information.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.

October 1, 2024

GE Hualun Medical Systems Co., Ltd % Kenny Ma Manager, Regulatory Affairs - WHXR No.1, Yong Chang North Road, Beijing Economic Technological Development Zone Beijing, 100176 CHINA

Re: K242678

Trade/Device Name: Definium Pace Select ET Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: September 3, 2024 Received: September 6, 2024

Dear Kenny Ma:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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.

{1}------------------------------------------------

Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-regulatory

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

assistance/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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

Submission Number (if known)

K242678

Device Name

Definium Pace Select ET

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)

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."

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

Image /page/4/Picture/2 description: The image contains the GE HealthCare logo. The logo consists of the GE monogram enclosed in a circular design on the left, followed by the text "GE HealthCare" on the right. The text is in a simple, sans-serif font and is colored in the same shade of purple as the monogram.

510K Summary Definium Pace Select ET

{5}------------------------------------------------

Image /page/5/Picture/2 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" inside, followed by the text "GE HealthCare" in a matching purple color. The text is simple and modern.

510(k) Summary:

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

Date:	September 6, 2024
Owner/Submitter:21 CFR 807.92(a)(1)	GE Hualun Medical Systems Co., Ltd.No.1, Yong Chang North Road, Beijing Economic Technological Development Zone, 100176 Beijing P.R. China
Primary ContactPerson:	Kenny MaManager, Regulatory Affairs, WHXRGE Hualun Medical Systems Co., Ltd.Email: Kenny.Ma@gehealthcare.comContact Phone Number: +86 (181) 01130591
Secondary ContactPerson:	Christopher PaulikSenior Regulatory Affairs ManagerGE HealthCare (GE Medical Systems, LLC)Email: Christopher.A.Paulik@gehealthcare.comContact Phone Number: +1 (262) 8945415
Device Trade Name:21 CFR 801.92(a)(2)	Definium Pace Select ET
Common/UsualName:	Digital Radiographic System
Regulation Name:	Stationary X-Ray System
Regulation:	21 CFR 892.1680
Classification:	Class II
Product Code:	KPR
Subsequent ProductCode(s):	MQB
Predicate Device:21 CFR 807.92(a)(3)	Definium Pace Select (K231892)21CFR 892.1680 (KPR, MQB)Class 2
Predicate DeviceManufacturer	GE Hualun Medical Systems Co., Ltd.No.1, Yong Chang North Road, Beijing Economic Technological Development Zone,100176 Beijing P.R. China
Reference Device:	Discovery XR656 HD with VolumeRad (K191699)21CFR 892.1680 (KPR, MQB)Class 2
Reference DeviceManufacturer:	GE Hualun Medical Systems Co., Ltd.No.1, Yong Chang North Road, Beijing Economic Technological Development Zone,100176 Beijing P.R. China
Device Description:21 CFR 807.92(a)(4)	The Definium Pace Select ET Radiography X-ray System is designed as a modularsystem with components that include a 2-axis motorized tube stand with tube andauto collimator assembled on an elevating table, a motorized wall stand, a cabinetwith X-ray high voltage generator, a wireless access point, wireless detectors, anacquisition workstation including a monitor and control box with hand-switch. Thesystem generates diagnostic radiographic images which can be reviewed ormanaged locally and sent through a DICOM network for reviewing, storage andprinting.By leveraging platform components / design, Definium Pace Select ET is similar tothe predicate Definium Pace Select (K231892) and the reference Discovery XR656HD (K191699) with regards to the user interface layout, patient worklist refresh andselection, protocol selection, image acquisition, and image processing based on theraw image. This product introduces motorized tube stand (vertical and tubeangulation) instead of manual tube stand of the predicate. The high voltagegenerator is new and is backwards compatible to the predicates high voltagegenerator. This product also introduced Image Pasting on Table and Wall StandMode, Auto tracking for Wall Stand, Auto Angulation, Camera Workflow, DAPsoftware calculation, Siemens LED collimator and LCD touch screen console. Theother minor changes include updates to components due to obsolescence.
Indications for Use:21 CFR 807.92(a)(5)	The Definium Pace Select ET is intended to generate digital radiographic imagesof the skull, spinal column, chest, abdomen, extremities, and other body parts inpatients of all ages. Applications can be performed with the patient sitting,standing, or lying in the prone or supine position and the system is intended foruse in all routine radiography exams. Optional image pasting function enables theoperator to stitch sequentially acquired radiographs into a single image.

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

Image /page/6/Picture/2 description: The image shows the GE HealthCare logo. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is purple and features a stylized "GE" monogram. The text "GE HealthCare" is also purple and is written in a clean, sans-serif font.

are

This device is not intended for mammographic applications.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE: 21CFR807.92(a)(6)

A comparison of the indications for use and technological features of the subject and predicate device is provided in Table 1 below.

Specification	Predicate DeviceDefinium Pace Select	Subject DeviceDefinium Pace Select ET	Discussion ofDifferences
Intended Use	General Purpose DigitalRadiographic Imaging System	General Purpose DigitalRadiographic Imaging System	Identical
Indications forUse	The Definium Pace Select isintended to generate digitalradiographic images of theskull, spinal column, chest,abdomen, extremities, andother body parts in patients ofall ages. Applications can be	The Definium Pace Select ET isintended to generate digitalradiographic images of theskull, spinal column, chest,abdomen, extremities, andother body parts in patients ofall ages. Applications can be	EquivalentThe optional imagepasting function hasbeen cleared in thereference productDiscovery XR656 HDunder K191699.
Specification	Predicate DeviceDefinium Pace Select	Subject DeviceDefinium Pace Select ET	Discussion ofDifferences
	performed with the patientsitting, standing, or lying in theprone or supine position andthe system is intended for usein all routine radiographyexams.The device is not intended formammographic applications.	performed with the patientsitting, standing, or lying in theprone or supine position andthe system is intended for usein all routine radiographyexams. Optional image pastingfunction enables the operatorto stitch sequentially acquiredradiographs into a singleimage.The device is not intended formammographic applications.
Contraindications	None .	None .	Identical
User group	Professional Use Only	Professional Use Only	Identical
PatientPopulation	All ages	All ages	Identical
System SoftwareArchitecture	Distributed softwarearchitecture (Atlas)	Distributed softwarearchitecture (Atlas)	Identical
Operator I/F	One-LCD monitor, Keyboard,Mouse, Barcode reader	One-LCD monitor, Keyboard,Mouse, Barcode reader	Identical
X-Ray Tube	Kailong 300kHU Tube: KLH1080Y	Kailong 300kHU Tube: KLH1080Y	Identical
Tube headconsole	LED screen display	LCD touch screen console	ChangedBesides the previousangle display. Thisconsole providesmore positionerinformation andexposure parameterdisplay andadjustment approachfrom the exam room.
Collimator andAuto FOV	Manual collimatorManual FOV change and lighton/off	Siemens AL01CIIeL LED lampManual and automatic FOVchange and light on/off	ChangedThe device nowprovides additionalautomaticcollimation (AutoFOV).
DAP	Physical DAP meter	DAP software calculationbased on FOV and SIDmeasured by Encoder afterDose calibration	ChangedThe system nowautomaticallycalculates the DAPinstead of providing aphysicalmeasurement.
Specification	Predicate DeviceDefinium Pace Select	Subject DeviceDefinium Pace Select ET	Discussion ofDifferences
Camera Workflow	None	The depth camera providesworkflow improvement:1. Live video on main UI2. Patient size suggestionbased on camera depthmeasurement;3. Detector and ion chamberoutline on video;4. FOV adjustable from video	NewThis new featureprovides additionalobservation forpatient positioning.
High VoltageGenerator	- Jedi 80 RD 1T- 50KW or 65KW or 80kW	- PSG-HR80S5- 50KW or 65KW or 80kW	EquivalentSame function,different supplier
DICOM	DICOM 3.0	DICOM 3.0	Identical
OS	Linux OS - SUSE	Linux OS - SUSE	Identical
Detector	IRAY17x17 detector US (K210314)	IRAY17x17 detector US (K210314)	Identical
Detector WirelessConnectivity	YES – 802.11 wireless (PersonalArea Network)	YES – 802.11 wireless (PersonalArea Network)	Identical
Detector size/resolution	One detector Size supported at100 um resolutions:17 x 17 inch	One detector Size supported at100 um resolutions:17 x 17 inch	Identical
Detector loading	300kg (distributed loading)150kg (point loading)	300kg (distributed loading)150kg (point loading)	Identical
Patient Table	Fixed table height 66cm220 kg static non-elevatingtableLongitudinal travel 900mmTransversal travel 220mm	Elevating range 59 – 90 cmMaximum Loading 305kg(672lbs)Elevation speed< 18 secondswith loading 135kg(397lbs)Longitudinal travel 1110mmTransversal travel 220mm	ChangedThe table nowprovides motorizedelevation withadditional tabletoptransverse andlongitudinal travelrange
Tube Support	Floor-mount tube support withlongitudinal vertical andangulation manual motion	Floor-mount tube support withlongitudinal vertical andangulation manual motion.Additional motorization ofvertical and angulation areprovided	ChangedThe vertical andangulation motionsare now motorized
Tube to TableTray Alignment	Alignment between tube standand table tray is implementedby mechanical connection	Alignment between tube standand table tray is implementedby automatic electrical control(also called auto alignment)	EquivalentSame function in tubeand table trayalignment.
Wall stand	Minimum height from floor tocenter of panel: 50cmMaximum height from floor tocenter of panel 176cm	Minimum height from floor tocenter of panel: 28.5 cmMaximum height from floor tocenter of panel 180.5 cm	ChangedMotorized verticaltravel with a minor
Specification	Predicate DeviceDefinium Pace Select	Subject DeviceDefinium Pace Select ET	Discussion ofDifferences
	Vertical travel 126cmNo motorization	Vertical travel: 152 cm.Vertical motorization isprovided	change in travelranges.
Image Pasting onTable and WallStand Mode	None	Image pasting can beperformed at Wall stand modeand Table mode	NewThe image pastingfunction has beencleared in thereference productDiscovery XR656 HDunder K191699.
Auto Grid Option	YesVirtual grid function in Table,WS and DC mode	YesVirtual grid function in Table,WS and DC mode	Identical
Auto tracking forWall Stand	None	Auto-tracking between Wallstand and tube stand vertically	NewThis feature is new toPredicate. But it isequivalent to theauto-tracking in thereference DiscoveryXR656 HD.
Auto Angulation	None	YesTube can be automaticallyangulated according to theinput on tube head console UI.	NewThe tube angulationis now motioncontrolled.

Table 1: High-level Comparison of Subject Device to Predicate

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

Image /page/7/Picture/2 description: The image shows the GE HealthCare logo. The logo consists of the GE monogram in a circle on the left, followed by the words "GE HealthCare" in a sans-serif font. The logo is purple in color.

Page 4 of 7

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

Image /page/8/Picture/2 description: The image contains the logo for GE HealthCare. The logo consists of the GE monogram enclosed in a circular design on the left, followed by the text "GE HealthCare" in a sans-serif font. The color of the logo and text is a shade of purple.

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

Image /page/9/Picture/2 description: The image contains the GE HealthCare logo. The logo consists of the GE monogram enclosed in a circular frame on the left, followed by the text "GE HealthCare" on the right. The color of the logo and text is a shade of purple.

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

Image /page/10/Picture/2 description: The image shows the GE Healthcare logo. The logo consists of a purple circular emblem with intertwined letters on the left, followed by the text "GE HealthCare" in purple. The text is written in a clean, sans-serif font.

PERFORMANCE DATA: Determination of Substantial Equivalence 21 CFR807(b)(1)

Summary of Non-Clinical Tests:

The following quality assurance measures were applied to the development of Definium Pace Select ET system:

1. Risk Analysis
1. Requirements Reviews
1. Design Reviews
1. Testing on unit level (Module verification)
1. Integration testing (System verification)
1. Performance testing (Verification)
1. Safety testing (Verification)
1. Simulated use testing (Validation)

Definium Pace Select ET verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results.

Summary of Clinical testing: 21 CFR 807.92(b)(2)

The Definium Pace Select ET does not contain clinical testing data.

CONCLUSION:

The results of the testing described above demonstrate that the Definium Pace Select ET is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.