The OEC One ASD mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatic patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, vascular, critical care, and emergency procedures.

Device Description

The OEC One ASD is a mobile C-arm X-ray system to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures. These images help the physician visualize the patient's anatomy and localize clinical regions of interest. The system consists of a mobile stand with an articulating arm attached to it to support an image display monitor (widescreen monitor) and a TechView tablet, and a "C" shaped apparatus that has a flat panel detector on the top of the C-arm and the X-ray Source assembly at the opposite end.

The OEC One ASD is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allows the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C- arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock.

The subject device is labelled as OEC One ASD.

AI/ML Overview

The provided document is a 510(k) Summary of Safety and Effectiveness for the GE Hualun Medical Systems Co. Ltd. OEC One ASD, a mobile C-arm X-ray system. The document focuses on demonstrating substantial equivalence to a predicate device, OEC One (K182626), rather than presenting a study with specific acceptance criteria and detailed device performance results for a new AI/CAD feature.

The submission is for a modification of an existing device, primarily introducing an amorphous silicon (a-Si) flat panel detector as the image receptor and updating some hardware and software components. The changes are stated to enhance device performance and are discussed in terms of their impact on safety and effectiveness, concluding that no new hazards or concerns were raised.

Therefore, the information required for a detailed description of acceptance criteria and a study proving device performance, especially for AI/CAD features, is largely not present in this document. The document centers on demonstrating that the modified device maintains safety and effectiveness and is substantially equivalent to the predicate, rather than detailing a study against specific acceptance criteria for a novel functionality.

However, I can extract the available relevant information and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in the context of a study demonstrating novel AI/CAD feature performance. Instead, it presents a comparison table of technical specifications between the proposed device (OEC One ASD) and the predicate device (OEC One K182626) to demonstrate substantial equivalence. The "Acceptance Criteria" here are implicitly derived from the predicate's performance and safety profiles.

Feature / Performance Metric	Predicate Device (OEC One K182626)	Subject Device (OEC One ASD)	Discussion of Differences / Equivalence
Image Receptor	Image Intensifier	21cm Amorphous Silicon (a-Si) Flat Panel Detector	Substantially Equivalent. Change to enhance device performance.
DQE	65%	70% (0 lp/mm)	Enhanced DQE, indicating improved image quality.
MTF	45%	46% (1.0 lp/mm)	Slightly enhanced MTF, indicating improved image quality.
Field of View	9 inch, 6 inch, 4.5 inch	21 cm, 15 cm, 11 cm	No new hazards or hazard situations. Performance testing indicated effectiveness.
Image Matrix Size	1000x1000	1520x1520	Substantially Equivalent. Driven by detector pixel matrix for higher resolution.
Image Shape	Circle	Squircle	Substantially Equivalent. Enhanced viewing area without typically unnecessary corner areas.
Anti-scatter Grid	Line Rate: 60 L/cm, Ratio: 10:1, Focal Distance: 100 cm	Line Rate: 74 L/cm, Ratio: 14:1, Focal Distance: 100 cm	Substantially Equivalent. Specification updated based on new image receptor.
X-ray Generator	Fluoroscopy: 0.1-4.0 mA	Fluoroscopy: 0.1-8.0 mA	Substantially Equivalent. mA range change for optimized image quality (ABS). No new safety/effectiveness concerns.
	Digital Spot: 0.2-10.0 mA (100-120V system)	Digital Spot: 2-10.0 mA (100-120V system)	Substantially Equivalent. mA range change for optimized image quality (increasing mA on thin anatomy). No new safety/effectiveness concerns.
Imaging Modes	Digital Spot: Normal Dose, Low Dose	Digital Spot: Normal Dose	Low Dose mode not provided for Digital Spot as high mA exposure ensures quality; similar functionality available via Fluoroscopy.
	Roadmap: Normal Dose, Low Dose	Removed	Roadmap mode removed based on marketing; similar functionality via peak opacify function on cine.
Imaging Features	Zoom & Roam	Zoom (Live Zoom) & Roam	Improved with Live Zoom during fluoro/cine.
	N/A	Digital Pen	Added for planning/educational purposes.
Monitor Display	Resolution: 1920x1080	Resolution: 3840 x 2160	Substantially Equivalent. Updated to higher resolution due to IT advancement.
	8bit image display	10bit image display	Substantially Equivalent. Better display technology.
Tech View Tablet	OS: Android 5.1	OS: Android 11.0	Substantially Equivalent. OS upgraded due to IT advancement.
C-Arm Physical Dimensions	Orbital Rotation: 120° (90° underscan /30° overscan)	Orbital Rotation: 150° (95° underscan /55° overscan)	Substantially Equivalent. Larger range for user convenience.
Image Storage	100,000 Images	150,000 Images	Substantially Equivalent. Driven by IT advancement (more storage).
Wireless Printing Module	N/A	Wireless Printing Module	Substantially Equivalent. Not for diagnostic use or device control. No new risks.
Video Distributor	DVI, BNC	DP, BNC	Substantially Equivalent. Driven by IT advancement.
Laser Aimer	Red Laser, Class IIIa/3R, 650 nm, ≤ 5.0 mW	Green Laser, Class 2, 510-530nm, 1mW	Substantially Equivalent. Updated for green laser and convenience (tube side). Both meet laser product requirements.
Image Processing	ADRO (based on CPU)	ADRO (based on GPU)	Substantially Equivalent. GPU for better calculation speed. All other listed image processing functions are the same.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission states, "comparative clinical images were evaluated to demonstrate substantial equivalence for the OEC One ASD compared to the cleared predicate," but no details on the sample size, data provenance (e.g., country of origin, retrospective/prospective nature), or specific evaluation methodology for these clinical images are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document states that "comparative clinical images were evaluated," but it does not specify the number or qualifications of experts involved in this evaluation or the establishment of ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. The method used to resolve discrepancies or establish a consensus for the evaluation of comparative clinical images is not described.

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

A multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not mentioned or described in this 510(k) submission. The document discusses device modifications and their impact on image quality and functionality, but not the comparative effectiveness of human readers utilizing AI.

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

This submission does not describe a standalone performance study for an AI algorithm. The device itself is an X-ray system, and while it has "Image Processing" features, these are not presented as standalone AI algorithms for diagnostic assistance but rather as integrated components affecting image generation and display characteristics. The update to ADRO from CPU to GPU based processing is noted for speed, but its standalone performance as an AI algorithm is not evaluated or presented.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document mentions "comparative clinical images were evaluated," but it does not specify the type of ground truth against which these images were assessed. Since the primary focus is on demonstrating substantial equivalence of technical image characteristics rather than validating a diagnostic AI output, a traditional "ground truth" (like pathology or outcomes a specific AI would predict) is not explicitly detailed. The implicit ground truth would be the expected imaging performance and diagnostic utility comparable to the predicate device.

8. The sample size for the training set

This information is not provided in the document. The document describes modifications to an existing X-ray system, including software updates. It states, "Its software is based on the architecture, design and code base of the predicate device OEC One (K182626)," and underwent a standard software development lifecycle. There is no mention of a separate "training set" in the context of an AI/CAD algorithm as typically understood for deep learning models.

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

Since no training set for an AI/CAD algorithm is mentioned (refer to point 8), the method for establishing its ground truth is not applicable/provided in this document.

Summary

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Image /page/0/Picture/0 description: The image shows the date December 27, 2024. The month is December, the day is the 27th, and the year is 2024. The date is written in a clear, sans-serif font. The text is black on a white background.

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GE Hualun Medical Systems Co. Ltd. % Michelle Huettner Director, Regulatory Affairs - IGT and Oncology No 1 Yong Chang North Road. Beijing Economic Technological Development Zone, Beijing CHINA 100176

Re: K240828

Trade/Device Name: OEC One ASD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OXO, JAA, OWB Dated: November 28, 2024 Received: November 29, 2024

Dear Michelle Huettner:

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.

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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 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-regulatory

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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,

Digitally signed Gabriela M. by Gabriela M. Rodal -S for Rodal -S

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) K240828

Device Name OEC One ASD

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) Number: K240828

510(k) Summary of Safety and Effectiveness

OEC One ASD

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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:	December 27, 2024
Submitter:	GE HUALUN MEDICAL SYSTEMS CO., LtdNo. 1 Yong Chang North Road,Beijing Economic Technological Development Zone, Beijing 100176China
Primary Contact:	Lifeng WangRegulatory Affairs Manager- IGTTel: +8613381164329e-mail: lifeng.wang@gehealthcare.com
Secondary Contacts:	Michelle HuettnerDirector, Regulatory Affairs - IGT and OncologyGE HealthCareTel: 901-558-8035e-mail: michelle.huettner@gehealthcare.com

PRODUCT IDENTIFICATION

Device Trade Name:	OEC One ASD
Regulation Name:	Image-intensified Fluoroscopic x-ray system
Classification Panel:	Radiology
Regulation:	21CFR 892.1650
Classification:	Class II
Product Code:	OXO
Subsequent Product Codes	JAA, OWB
Manufacturer:	GE HUALUN MEDICAL SYSTEMS CO., LtdNo. 1 Yong Chang North Road,Beijing Economic Technological Development ZoneBeijing 100176 China

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Predicate Device:

Device Name:	OEC One
510(k) number:	K182626
Manufacturer:	GE HUALUN MEDICAL SYSTEMS CO., LtdNo. 1 Yong Chang North Road,Beijing Economic Technological Development Zone,Beijing 100176 China
Regulation Name:	Image-intensified Fluoroscopic x-ray system
Regulation:	21CFR 892.1650
Classification:	Class II
Product Code:	OWB
Subsequent Product Code:	OXO, JAA

Device Description:

The subject device is labelled as OEC One ASD.

The purpose of this premarket notification is to demonstrate that the subject device, OEC One ASD, is a modification of and is substantially equivalent to the predicate device OEC One (K182626).

Proposed Device Modification:

The modified OEC One ASD employs the same fundamental scientific technology as that of the unmodified predicate device (K182626). The primary change for the subject device is to introduce an amorphous silicon (a-Si) flat panel detector as the image receptor. Roadmap functionality, which is optional in the predicate device (K182626), has been removed and a printer shelf has been integrated into the subject device to place the applicable printer on.

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Indications for Use:

The OEC One ASD mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.

The intended use and indications for use are unchanged from the predicate device.

Technology:

The indications for use are identical and the technology is similar to the predicate device.

The primary change on the subject device is to introduce an Amorphous Silicon (a-Si) solid state flat panel X-ray detector. A printer shelf is integrated into the subject device for the user to place the applicable printer on. The electrical boards have been re-laid out or redesigned to be more compact to make space for the printer shelf. The image shape changed from a circle to a squircle by introducing the flat panel detector and squircle secondary collimator. The X-Ray source monoblock remains unchanged from that of the predicate device OEC One (K182626). The hardware changes also include using an up-to-date computer, tablet and monitor that offers more image storage, processing speed, and higher resolution display, driven by IT technology advancement.

Its software is based on the architecture, design and code base of the predicate device OEC One (K182626). The software architecture framework was updated to a platform-based architecture with no significant changes in order to support different OEC C-Arm products. The modifications were also being made to support the flat panel detector, the necessary imaging and post-processing applications related to the flat panel detector, and device specific features/functionality. The design followed the same design control process and software development lifecycle process that is compliant to IEC 62304 used in the predicate OEC One.

The table below compares the main performance data of the proposed device with the predicate device.

	Predicate DeviceOEC One (K182626)	Subject DeviceOEC One ASD	Discussion of differences
ImageReceptor	Image IntensifierDetective QuantumEfficiency (DQE): 65%Modulation TransferFunction (MTF): 45%	21cm Amorphous Silicon(a-Si) Flat Panel DetectorDQE: 70% (0 lp/mm)MTF: 46% (1.0 lp/mm)	Substantially Equivalent.The change of the image receptor isto enhance the device performance.
	Predicate DeviceOEC One (K182626)	Subject DeviceOEC One ASD	Discussion of differences
	Field of View:• 9 inch• 6 inch• 4.5 inch	Field of View:• 21 cm• 15 cm• 11 cm	No new hazards or hazard situations were raised due to this change.The performance testing indicated that the subject device is still effective.This change did not raise any new safety and effectiveness concerns.
Image Matrix Size	$1000\times1000$	$1520\times1520$	Substantially Equivalent.This change is driven by the detector pixel matrix to get higher resolution.This change did not raise any new safety and effectiveness concerns.
Image Shape	Circle	Squircle	Substantially Equivalent.The squircle shape provides an enhanced viewing area without exposing the areas at the corners, which are not typically clinically needed.The squircle design can maintain the identical size and shape even when the image is rotated.This change did not raise any new safety and effectiveness concerns.
Anti-scatter Grid	Line Rate: 60 L/cmRatio: 10:1Focal Distance: 100 cm	Line Rate: 74 L/cmRatio: 14:1Focal Distance: 100 cm	Substantially Equivalent.The grid's specification is defined based on the image receptor's pixel size, which has been updated because of the introduction of flat panel detector.This change did not raise any new safety and effectiveness concerns.
	Predicate Device	Subject Device	Discussion of differences
	OEC One (K182626)	OEC One ASD
Monoblock	Type: Stationary Anode	Type: Stationary Anode	Identical.
	Focal Spot: 0.6 x 1.4 & 1.4(IEC60336)	Focal Spot: 0.6 x 1.4 & 1.4(IEC60336)
	Anode Heat Capacity:76,000 H.U.	Anode Heat Capacity:76,000 H.U.
	Anode Cooling Rate:37,000 H.U/min	Anode Cooling Rate:37,000 H.U/min
	Housing Heat Capacity:900,000 H.U	Housing Heat Capacity:900,000 H.U
	Housing Cooling Rate:12,500 H.U./min	Housing Cooling Rate:12,500 H.U./min
X-rayGenerator	40 kHz High Frequency	40 kHz High Frequency	Substantially Equivalent.mA range changing in Fluoroscopymode is caused by different imageprocessing parameters of AutoBrightness Stable (ABS) to getoptimized image quality.mA range changing in Digital Spotmode is to get optimized imagequality by increasing tube current(mA) especially on thin anatomysuch as hands.This change did not raise any newsafety and effectiveness concerns.
	Max Power 2.5 kW	Max Power 2.5 kW
	Peak Tube Potential: 40-110 kVp	Peak Tube Potential: 40-110 kVp
	Fluoroscopy: 0.1-4.0 mA	Fluoroscopy: 0.1-8.0 mA
	High Level Fluoro: 0.2-25.0 mA	High Level Fluoro: 0.2-25.0 mA
	Pulsed Fluoro: 1, 2, 4, 8, 12 pulses/sec	Pulsed Fluoro: 1, 2, 4, 8, 12 pulses/sec
	Digital Spot: 0.2-10.0 mA(for 100-120V system)	Digital Spot: 2-10.0 mA(for 100-120V system)
Collimator	Iris, Tungsten Dual LeafShutter	Iris, Tungsten Dual LeafShutter	Substantially Equivalent.Secondary collimator has beenmodified to achieve the squirclefield of view.This change did not raise any newsafety and effectiveness concerns.
	Collimator Iris Preview	Collimator Iris Preview
	Collimator ShutterPreview	Collimator ShutterPreview
	Circle shape secondarycollimator	Squircle shape secondarycollimator
X-ray ControlModes	Auto ModeManual Mode(Normal Fluoro, Low Dose Fluoro, High Level Fluoro)	Auto ModeManual Mode(Normal Fluoro, Low Dose Fluoro, High Level Fluoro)	Identical.
	Predicate DeviceOEC One (K182626)	Subject DeviceOEC One ASD	Discussion of differences
ImagingModes	Continuous – Fluoroscopy Normal Dose High Level Dose Low Dose	Continuous – Fluoroscopy Normal Dose High Level Dose Low Dose	Substantially Equivalent.
	Pulsed Fluoroscopy Normal Dose High Level Dose Low Dose	Pulsed Fluoroscopy Normal Dose High Level Dose Low Dose	Digital Spot Low Dose mode will not be provided as Digital Spot mode creates a short-duration, high mA exposure to produce a single high quality image. Therefore, the low dose mode is not necessary for Digital Spot mode. The user can still get similar functionality by using Fluoroscopy.
	Digital Spot Normal Dose Low Dose	Digital Spot Normal Dose	Roadmap mode will not be provided based on marketing positioning, however, user can still get the similar functionality by applying the peak opacify function on contrast-agent-flowed cine.
	Roadmap Normal Dose Low Dose	Subtraction Normal Dose Low Dose
	Subtraction Normal Dose Low Dose		This change did not raise any new safety and effectiveness concerns.
ImagingFeatures	Auto X-Ray technique control	Auto X-Ray technique control	Substantially Equivalent.
	Noise and motion reduction (TNR)	Noise and motion reduction (TNR)	Digital Pen (previously cleared in OEC Elite K171565) has been added so that user can draw lines on image display for planning or educational purposes.
	Auto/Manual Brightness and Contrast Control	Auto/Manual Brightness and Contrast Control	Zoom feature has improved with Live Zoom so it could be performed during a fluoro shot or Cine run.
	Negate	Negate
	Swap and auto-swap	Swap and auto-swap
	Save and auto-save	Save and auto-save	These changes did not raise any new safety and effectiveness concerns.
	Last image hold	Last image hold
	Edge enhancement	Edge enhancement
	Zoom & Roam	Zoom (Live Zoom) & Roam
	Image rotation	Image rotation
	Image flip/invert	Image flip/ invert
	Manual/Auto Smart Metal	Manual/Auto Smart Metal
	AutoTrak	AutoTrak
	Patient Annotation
	Predicate Device	Subject Device	Discussion of differences
	OEC One (K182626)	OEC One ASD
	Markers	Patient Annotation
	Measurement Functions	Markers
	Peak Opacification	Measurement Functions
	Cine Recording/Playback	Peak Opacification
	• Cine Automatic ImagePlayback	Cine Recording/Playback
	• Cine Frame-by-FrameReview• Fluorostore(up to 240frames recording)	• Cine Automatic ImagePlayback• Cine Frame-by-FrameReview• Fluorostore(up to 240frames recording)
	Re-Registration	Re-Registration
	Variable Landmarking	Variable Landmarking
	Mask save/Recall	Mask save/Recall
	Reference Image Hold	Reference Image Hold
		Digital Pen
MonitorDisplay	Colored 27" monitor	Colored 27" monitor	Substantially Equivalent.
	Resolution: 1920x1080	Resolution: 3840 x 2160	The monitor was updated to a
	Brightness: 600 cd/m2	Brightness: 600 cd/m2	higher resolution one. This change
	Touch screen	Touch screen	was driven by IT technology
	8bit image display onmonitor	10bit image display onmonitor	advancement by using a more stateof the art display technology whichachieves the same or betterfunctionality.This change did not raise any newsafety and effectiveness concerns.
DisplayArticulation	180 degree swivel	180 degree swivel	Identical
	5 degrees tilt up	5 degrees tilt up
	25 degrees tilt down	25 degrees tilt down
	Monitor viewable from all4 sides	Monitor viewable from all4 sides
	Horizontal and Verticalviewing angle 178 degrees	Horizontal and Verticalviewing angle 178 degrees
	20cm up vertical travel	20cm up vertical travel
	Predicate Device	Subject Device	Discussion of differences
	OEC One (K182626)	OEC One ASD
	20cm down vertical travel	20cm down vertical travel
	Extension arm rotation 210 degrees	Extension arm rotation 210 degrees
	Spring arm rotation 180 degrees	Spring arm rotation 180 degrees
	Position monitor above C-arm by folding articulation arm within system footprint	Position monitor above C-arm by folding articulation arm within system footprint
Tech ViewTablet	Size: 10.1 inchResolution: 1280 × 800OS: Android 5.1	Size: 10.1 inchResolution: 1280 × 800OS: Android 11.0	Substantially EquivalentAndroid OS has been upgraded to Android 11.0. This change was driven by IT technology advancement by using a more state of the art display technology which achieves the same functionality.This change did not raise any new safety and effectiveness concerns.
C-ArmPhysicalDimensions	Depth of Arc: 26.0" (66 cm)	Depth of Arc: 26.0" (66 cm)	Substantially Equivalent.The orbital rotation was changed to a larger range to make the user easily use the system.
	Source Image Distance:39.4" (100 cm)	Source Image Distance:39.4" (100 cm)
	Lateral Rotation: 410°(+205° / -205°)	Lateral Rotation: 410°(+205° / -205°)	This change did not raise any new safety and effectiveness concerns.
	Wig/Wag: 25° (+12.5°/-12.5°)	Wig/Wag: 25° (+12.5°/-12.5°)
	Orbital Rotation: 120° (90° underscan /30° overscan)	Orbital Rotation: 150° (95° underscan /55° overscan)
	Horizontal Movement:7.9" (20cm)	Horizontal Movement:7.9" (20cm)
	Vertical Travel: 17.5" (44 cm)	Vertical Travel: 17.5" (44 cm)
	Predicate Device	Subject Device	Discussion of differences
	OEC One (K182626)	OEC One ASD
Image Storage	100,000 Images	150,000 Images	Substantially Equivalent.This change was driven by ITtechnology advancement by using amore state of the art computingtechnology which achieves thesame or better functionality.This change did not raise any newsafety and effectiveness concerns.
WirelessPrintingModule andPrinters	N/A	Wireless Printing ModulePrinters	Substantially EquivalentThe printer is used to createreference image that is not fordiagnostic purpose.The wireless printing module is notused to control the deviceoperations nor X-ray activation.The changes from wired printer towireless printer does notsignificantly affect the use of thedevice. No new risks raised orexisting risks was changed due tothis change.This change did not raise any newsafety and effectiveness concerns.
VideoDistributor	DVI, BNC	DP, BNC	Substantially Equivalent.This change was driven by ITtechnology advancement by using amore state of the art computingtechnology which achieves thesame or better functionality.This change did not raise any newsafety and effectiveness concerns.
Laser Aimer	Red Laser	Green Laser	Substantially Equivalent.Laser has been updated forintroducing green laser as well as
	Predicate Device	Subject Device	Discussion of differences
	OEC One (K182626)	OEC One ASD
	Image intensifier side laserAimer:	Flat panel detector sidelaser aimer and Tube sidelaser aimer:	introducing tube side laser aimerfor users' convenience.
	CLASS IIIa/3R laserproduct	CLASS 2 laser product	Both lasers meet the IEC 60825-1:2014 and 21CFR 1040.10 laserproducts requirement.
	Wavelength: 650 nm	Wavelength: 510nm-530nm	This change did not raise any newsafety and effectiveness concerns.
	Optical output power: $≤$ 5.0mW	Optical output power:1mW
ImageProcessing	Noise and motion artifactreduction, Autotrak, ABS,Smart window, smartmetal, ADRO (AdaptiveDynamic RangeOptimization)(based on CPU)Note: ADRO is tooptimize the postprocessing algorithm toachieve optimizeddynamic range andimproved contrast forvisualization of moreanatomical details.	Noise and motion artifactreduction, Autotrak, ABS(based on CPU)Smart window, smartmetal, ADRO (AdaptiveDynamic RangeOptimization)(based on GPU)	Substantially EquivalentThe noise and motion artifactreduction, AutoTrak and ABS, aresame with OEC One (K182626)while Smart window, smart metalpost processing modules are basedon GPU calculation which isbecause GPU has a bettercalculation speed which can moresuitable to detectors.ADRO is an available feature onOEC One (K182626) that ischanged to base on GPU for bettercalculation speed.This change did not raise any newsafety and effectiveness concerns.

Comparison between the Subject Device and Predicate Device

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Image /page/9/Picture/1 description: The image contains 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 text are both in a purple color.

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Image /page/10/Picture/1 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem with intertwined letters on the left, followed by the text "GE HealthCare" in a simple, sans-serif font. The color of both the emblem and the text is a shade of purple.

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Image /page/11/Picture/1 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 inside a circular border. The text "GE HealthCare" is also purple and is written in a sans-serif font.

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Image /page/12/Picture/1 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 inside a circular border. The text "GE HealthCare" is also purple and is written in a sans-serif font.

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Image /page/13/Picture/1 description: The image contains the logo for GE HealthCare. The logo consists of a circular emblem with intertwined letters 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.

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Image /page/14/Picture/1 description: The image shows the GE Healthcare logo. The logo consists of a purple circle with the letters "GE" inside, followed by the words "GE HealthCare" in purple. The text is simple and clean, and the logo is easily recognizable.

The system continues to meet all applicable IEC 60601-1 series of standards, NEMA XR-27, and applicable parts of 21CFR Subchapter J.

The changes described above do not change the control mechanism, operating principle, energy type, or the scientific technology of the predicate devices.

Determination of Substantial Equivalence:

GE HealthCare believes the OEC One ASD is of comparable type and substantially equivalent to the cleared predicate OEC One.

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Non-Clinical Performance Testing

The verification and validation testing has been successfully completed as required by design control procedures under GE HealthCare's quality system has been tested and is compliant with the following FDA-recognized consensus standards and FDA guidance documents:

FDA-recognized consensus standards

· ANSI AAMI ES60601-1:2005/(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 - FDA recognition number 19-46.
· IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. FDA recognition number 19-36.
· IEC 60601-1-3 Edition 2.2 2021-01 Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment. FDA recognition number 12-336.
IEC 60601-1-6 Edition 3.2 2020-07 Medical electrical equipment Part 1-6: General . requirements for basic safety and essential performance - Collateral standard: Usability. FDA recognition number 5-132.
· IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis. FDA recognition number 12-309.
· IEC 60601-2-54 Edition 1.2 2018-06 Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. FDA recognition number 12-317.
· IEC 60601-2-43 Edition 2.2 2019-10 Medical electrical equipment Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures. FDA recognition number 12-329.
· IEC 62304 Edition 1.1 2015-06 Medical device software Software life cycle processes. FDA recognition number 13-79.
· IEC 62366-1 Edition 1.1 2020-06 Medical devices Part 1: Application of usability engineering to medical devices. FDA recognition number 5-129.

FDA guidance

· Pediatric information for X-ray imaging device premarket notifications, Nov 28, 2017
· Content of Premarket Submissions for Device Software Functions, June 14, 2023
· Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, September 27, 2023

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Image /page/16/Picture/1 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with stylized letters inside, followed by the text "GE HealthCare" in a matching purple font. The text is positioned to the right of the emblem.

· Radio frequency wireless technology in medical devices- Guidance for Industry and Food and Drug Administration Staff, Aug 14, 2013
· Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and Food and Drug Administration Staff, Sep 01, 2016

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 One ASD system was developed under the GE HealthCare 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 a basic software documentation level.

Clinical Testing

OEC One ASD is substantially equivalent to the cleared predicate OEC One. The indication for use is identical and has equivalent/identical technological characteristics. This type of premarket notification supports using scientific, established, engineering-based performance testing. The system has been fully tested/evaluated by using engineering bench testing. In addition, comparative clinical images were evaluated to demonstrate substantial equivalence for the OEC One ASD compared to the cleared predicate.

Substantial Equivalence Conclusion

OEC One ASD follows the same design control process and software development lifecycle processes as the predicate OEC One (K182626).

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 performance bench testing, conformance to standards, and development under the GE HealthCare Quality Management System, we believe that OEC One ASD is substantially equivalent to the cleared predicate device OEC One (K182626) 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.