This product is intended to generate digital radiographic images of the skull, spinal column, 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. This device is not intended for mammographic applications.

Device Description

The Definium Pace Select is a Digital Radiographic System designed as a modular system with components that includes fixed table with tube-stand, wallstand, cleared wireless digital detector, X-ray tube, collimator, high kV generator and acquisition workstation in control room. The system generates diagnostic radiographic images which can be sent through a DICOM network for applications including printing, viewing, and storage. The components may be grouped into different configurations to meet specific customer needs.

AI/ML Overview

The FDA 510(k) summary for the Definium Pace Select, a Digital Radiographic System, indicates that clinical studies were not required to support substantial equivalence for this device. Therefore, a study proving the device meets specific acceptance criteria in terms of clinical performance (like sensitivity, specificity, or reader improvement with AI assistance) or a detailed clinical acceptance criteria table for such measures is not provided in this document.

The submission focuses primarily on demonstrating substantial equivalence to its predicate device (Discovery XR656 HD) based on non-clinical tests, technological characteristics, and safety/effectiveness data. The device's safety and effectiveness were confirmed through design verification and validation testing.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since clinical studies were not deemed necessary for this 510(k) submission, there isn't a table presenting clinical acceptance criteria (e.g., sensitivity, specificity) and corresponding device performance metrics in the document. The acceptance criteria focused on compliance with voluntary standards and successful completion of verification and validation testing.

Acceptance Criteria Category	Reported Device Performance / Compliance
Voluntary Standards (Non-Clinical)	Device complies with listed standards:

ES 60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012
IEC 60601-1-2:2014[Including AMD 1:2021]
IEC 60601-1-3: 2021
IEC 60601-1-6: 2020
IEC 60601-2-54: 2018
IEC 62366: 2015 + AMD1:2020
ISO 10993-1: 2018
ISO 10993-5: 2009/(R)2014
ISO 10993-10: 2010/(R)2014
ISO 10993-18 Second edition 2020-01
PS 3.1 - 3.20: 2022d (DICOM set) |
| Quality Assurance Measures | Applied: Risk Analysis, Requirements Reviews, Design Reviews, Unit level testing (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), Simulated use testing (Validation). |
| Risk Mitigation | Risks for new floor mounted positioners and image chain were evaluated, mitigated with design controls and labeling. Mitigations were verified and validated with acceptable results. |
| Design Verification & Validation | Performed to confirm safety and effectiveness; test plans and results were executed with acceptable results. |

2. Sample Size for Test Set and Data Provenance:

No distinct "test set" in the context of clinical performance evaluation (e.g., images for diagnostic accuracy assessment) is mentioned because clinical studies were not required. The "testing" referred to in the document pertains to design verification and validation, which would involve hardware and software testing, rather than a clinical image dataset.

3. Number of Experts for Ground Truth and Qualifications:

Not applicable, as no clinical study requiring expert ground truth establishment for diagnostic accuracy was conducted for this submission.

4. Adjudication Method:

Not applicable, as no clinical study requiring adjudication of expert interpretations was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was conducted. The device is a digital radiographic system, and the submission emphasizes its substantial equivalence based on technological characteristics and safety, not on AI assistance to human readers.

6. Standalone (Algorithm Only) Performance:

Not explicitly detailed in terms of a standalone diagnostic performance study, as the device itself is an imaging system, not a standalone diagnostic algorithm. The "image processing with same algorithm" as the predicate device suggests the algorithms are part of the overall system functionality, not a separate AI diagnostic tool.

7. Type of Ground Truth Used:

For the non-clinical tests and design verification/validation, the "ground truth" would be established through engineering specifications, regulatory compliance standards, and functional requirements. For example, for radiation output, the ground truth would be the expected range defined by standards and the device's design. There is no mention of clinical ground truth (e.g., pathology, outcomes data) being used for this 510(k) submission.

8. Sample Size for Training Set:

Not applicable, as this device submission is for a digital radiographic system, not an AI/ML algorithm that typically requires a training set of data for development. The reference to "same algorithm" for image processing as the predicate implies existing, validated algorithms rather than newly trained ones.

9. How Ground Truth for Training Set Was Established:

Not applicable, as this device is not presented as an AI/ML system requiring a training set with established ground truth.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 12, 2023

GE Hualun Medical Systems Co. Ltd. % Miny Liu Regulatory Affairs Leader No. 1 Yong Chang North Road, Beijing Economic Technological Development Zone Beijing, Beijing 100176 CHINA

Re: K231892

Trade/Device Name: Definium Pace Select Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MOB Dated: June 5, 2023 Received: June 29, 2023

Dear Miny Liu:

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/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.

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

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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 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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K231892

Device Name Definium Pace Select

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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GE HealthCare

510(k) Premarket Notification Submission

Image /page/3/Picture/3 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem with a stylized "GE" monogram on the left, and the text "GE HealthCare" on the right. The emblem and text are both in a purple color. The logo is simple and modern, and it is likely used to represent the company's brand.

510(k) Summary

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

Date:	Jun. 26, 2023
Submitter:	GE Hualun Medical Systems Co., Ltd.No.1, Yong Chang North Road, Beijing Economic TechnologicalDevelopment Zone, 100176 Beijing P.R. China
Primary Contact Person:	Miny LiuRegulatory Affairs LeaderGE Hualun Medical Systems Co., Ltd.Contact Phone Number: +86 (173) 10313927Email: liuminy@ge.com
Secondary Contact Person:	Christopher PaulikSenior Regulatory Affairs ManagerGE HealthCare (GE Medical Systems, LLC)Contact Phone Number: +1 (262) 8945415Email: christopher.a.paulik@ge.com
Device Trade Name:	Definium Pace Select
Common/Usual Name:	Digital Radiographic System
Regulation, Classification Names:Product Code:	Regulation: 21CFR 892.1680Classification: Class IIRegulation Name: Stationary X-Ray SystemProduct Codes: KPR, MQB

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Image /page/4/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of the GE monogram on the left and the words "GE HealthCare" on the right. The monogram and the words are both in purple.

Predicate Device(s):	Discovery XR656 HD clearance (K172869).
Regulation:	21CFR 892.1680
Classification:	Class II
Regulation Name:	Stationary X-Ray System
Product Codes:	KPR, MQB
Legal Manufacturer Name:	GE Hualun Medical Systems Co., Ltd.
Device Description:	The Definium Pace Select is a Digital Radiographic System designed as a modular system with components that includes fixed table with tube-stand, wallstand, cleared wireless digital detector, X-ray tube, collimator, high kV generator and acquisition workstation in control room. The system generates diagnostic radiographic images which can be sent through a DICOM network for applications including printing, viewing, and storage. The components may be grouped into different configurations to meet specific customer needs.
Intended Use:	General Purpose Digital Radiographic Imaging System
Indication for Use:	This product 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.This device is not intended for mammographic applications.

Technology:	The Definium Pace Select employs the same fundamentalscientific technology as its predicate device Discovery XR656 HD.By leveraging platform components/design, it delivers a floormounted DR system with incremental changes. Technically,Definium Pace Select is similar as Discovery XR656 HD from useroperation, i.e., patient worklist access, image acquisition, imageprocessing with same algorithm and image management withDICOM compliance. New image chain components areintroduced, including a cleared wireless detector, tube andcollimator. Traditional floor mounted positioner is used, thatincludes fixed table with tube Stand and wallstand. DefiniumPace Select has equivalent feature from risk and safety level bycomparation with Discovery XR656HD but removing advanced
Determination ofSubstantial Equivalence:	application Image pasting. These change from XR656 HD involves:A cleared detector Mars1717X Wireless Digital Flat Panel Detector (cleared in K210314) is used. It has the same detector size 17"X17", pixel size 100um and same 802.11 wireless technology as the predicate The tube support is changed. It uses traditional floor mounted tube support instead of Overhead Suspend tube support. The tube support and positioning is equivalent to the predicate. The patient table is changed. The Definium Pace Select uses a traditional fixed non-elevating table. The patient support function is equivalent to the predicate. A new X-ray tube is used. It has equivalent functionality with same kV range and slight differences in target angle and focal spot and HU capability A new manual collimator is used. It has equivalent functionality with the predicate collimator. Wall stand is changed. The manual Wall Stand function it provides is equivalent to the predicate. The indication for use is the equivalent with its predicate product. The only difference is the removal of the “image pasting option” (removing an optional feature). No functionalities are added, and the intended use and patient population remains unchanged. Summary of Non-Clinical Tests:The Definium Pace Select and its applications comply with voluntary standards.ES 60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2014[Including AMD 1:2021], Edition 4.1
	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances -Requirements and tests
●	IEC 60601-1-3: 2021, Edition 2.2
	Medical Electrical Equipment - Part 1-3: GeneralRequirements for Basic Safety and Essential Performance -Collateral Standard: Radiation Protection in Diagnostic X-Ray Equipment
●	IEC 60601-1-6: 2020, Edition 3.2
	Medical electrical equipment - Part 1-6: Generalrequirements for safety - Collateral Standard: Usability
●	IEC 60601-2-54: 2018, Edition 1.2
	Medical Electrical Equipment - Part 2-54: ParticularRequirements for The Basic Safety and EssentialPerformance of X-Ray Equipment for Radiography andRadioscopy
●	IEC 62366: 2015 + AMD1:2020
	Medical devices Part 1: Application of usability engineeringto medical devices, including Amendment 1
●	ISO 10993-1: 2018
	Biological evaluation of medical devices - Part 1: Evaluationand testing within a risk management process
●	ISO 10993-5: 2009/(R)2014
	Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity
●	ISO 10993-10: 2010/(R)2014
	Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization
●	ISO 10993-18 Second edition 2020-01
Biological evaluation of medical devices - Part 18: Chemicalcharacterization of medical device materials within a riskmanagement process
• PS 3.1 - 3.20: 2022d
Digital Imaging and Communications in Medicine (DICOM)set
The following quality assurance measures were applied to thedevelopment of the system:
Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation)
The risks were evaluated for the newly introduced floormounted positioners and image chain. These risks werereviewed and mitigated with design controls and labeling. Themitigations were verified and validated as a part of the designverification and validation testing that has been executed withacceptable results. The testing/ documentation we provided forthe Definium Pace Select were according to the following FDAguidance documents:
Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices Content of Premarket Submissions for Management ofCybersecurity in Medical Devices Pediatric Information for X-ray Imaging PremarketNotifications
Summary of Clinical Tests:
The subject of this premarket submission, Definium Pace Select,does not require clinical studies to support substantialequivalence for the introduction of the floor mountedpositioners and updates to the image chain.
Design verification and validation testing was performed toconfirm the safety and effectiveness of the device. The testplans and results have been executed with acceptable results.
Conclusion:	The Definium Pace Select use traditional floor mountedpositioners and equivalent or same image chain componentsbased on the predicate. This introduction of the Definium PaceSelect system does not result in any new potential safety risks, ithas the similar technological characteristics, and perform as wellas the devices currently on the market.After analyzing design verification and validation testing on thebench it is the conclusion of GE HealthCare that the DefiniumPace Select to be as safe, as effective, and performance issubstantially equivalent to the predicate device.

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Image /page/6/Picture/1 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem with a stylized "GE" inside, followed by the text "GE HealthCare". The emblem and text are both in a purple color.

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Image /page/7/Picture/1 description: The image contains the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" inside, followed by the text "GE HealthCare" in purple. The text is written in a clean, sans-serif font and is aligned horizontally with the emblem.

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Image /page/8/Picture/1 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" inside. To the right of the emblem is the text "GE HealthCare" in purple. The text is in a sans-serif font and is aligned horizontally with the emblem.

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.