Digital Expert Access with Remote Scanning is intended as a remote collaboration tool to view and review MR images, to remotely control MR Imaging Devices and to initiate MRI scans remotely.

Digital Expert Access with Remote Scanning is a remote scan assistance solution which allows remote control of an MR Imaging Device including the ability to initiate a scan remotely. This access provides real time communication mechanisms between the remote and onsite users to facilitate the acquisition occurring on the device. Access must be granted by the onsite user operating the system. Images reviewed remotely are not for diagnostic use.

Device Description

Digital Expert Access is a variation of the Customer Remote Console cleared under K150193. It is a remote scan assistance solution designed to address the skill variability in technologists and their need for ondemand support by allowing them to interact directly with a remote expert connected to the hospital network. By enabling the collaboration between an Onsite Technologist and Remote Expert, Digital Expert Access helps the onsite technologist to seek guidance and real time support on scanning related queries including but not limited to training, procedure assessment, and scanning parameter management.

Digital Expert Access with Remote Scanning introduces a feature that enables the Remote Expert to initiate a scan and make changes in real time during the scanning session. This remote scan feature is only available when Digital Expert Access is connected to a compatible GE HealthCare MRI system.

Digital Expert Access with Remote Scanning enables the following capabilities for the Onsite Technologist and the Remote Expert:

1. Collaborative session between an Onsite Technologist and Remote Expert
1. Real-time scanner screen share and live annotation
ന് Remote console access and control
1. Remote Scan Initiation

Digital Expert Access with Remote Scanning is not intended for diagnostic use or patient safety-related management. This solution is not intended to be used by individuals who are not properly trained in the operation of GE HealthCare Medical Imaging systems. Digital Expert Access with Remote Scanning does not directly interface with any patients and requires the Onsite Technologist to be continuously present throughout the scanning procedure. Digital Expert Access with Remote Scanning does not acquire any MRI images, nor does it do any post image processing. All image acquisition and image processing is conducted by the GE HealthCare MRI system.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a device called "Digital Expert Access with Remote Scanning." This document outlines the device's purpose, intended use, and substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or an analytical study proving the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The document emphasizes that the device did not require clinical studies to support substantial equivalence. Instead, the focus was on non-clinical tests, primarily design verification and validation testing, to ensure proper implementation of design requirements and that no new safety or effectiveness issues were introduced.

Therefore, many of the requested details about acceptance criteria for performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this document because the submission strategy relied on substantial equivalence based on technological similarity and non-clinical testing rather than performance studies against defined quantitative acceptance criteria.

However, based on the information provided, here's what can be extracted and inferred regarding the "acceptance criteria" and "study":

Acceptance Criteria (Inferred from Non-Clinical Testing and Device Functionality):

Since no performance metrics are given, the acceptance criteria are implicitly related to the successful functionality and safety of the remote scanning feature. These would likely be qualitative or functional:

Acceptance Criterion (Inferred)	Reported Device Performance (Summary)
1. Successful Remote Control of MR Imaging Device	Demonstrated through non-clinical verification and validation testing on a subset of GE HealthCare MRI systems.
2. Successful Remote Scan Initiation	Demonstrated through non-clinical verification and validation testing on a subset of GE HealthCare MRI systems.
3. Real-time Communication Mechanisms (Onsite & Remote Users)	Device described as providing real-time communication mechanisms; functionality tested during design verification.
4. Access Granting Mechanism by Onsite User	Functionality described and tested: "Access must be granted by the onsite user circulating the system."
5. No New Potential Safety Risks Introduced	Concluded based on design verification and validation testing; no unexpected test results or safety issues observed.
6. Proper Implementation of Design Requirements	Verified through design control testing per GE HealthCare's quality system (e.g., Requirement Definition, Risk Analysis, Technical Design Reviews).
7. Maintenance of Safety & Effectiveness	Confirmed by design verification and validation testing, concluding it has not been affected.

Study Information (Based on Non-Clinical Testing):

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of "cases" or "patients" in a clinical study. The testing was conducted on a "subset of GE HealthCare MRI systems" on the bench. This implies a sample of hardware configurations rather than patient data.
- Data Provenance: Not applicable as it was non-clinical "bench" testing, not involving patient data or a specific country of origin for such data. It was performed internally by GE HealthCare.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. As this was non-clinical, functional testing, there was no "ground truth" in the clinical diagnostic sense established by experts. Testing would have involved engineers and quality assurance personnel verifying the system's intended functionality.
Adjudication Method for the Test Set:
- Not applicable for functional verification testing. Adjudication methods are typically used when comparing human interpretations or algorithmic outputs against a gold standard in diagnostic or clinical performance 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, an MRMC comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, Digital Expert Access with Remote Scanning did not require clinical studies to support substantial equivalence..." The device is a remote control and collaboration tool, not an AI-assisted diagnostic device meant to improve human reader performance.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable in the context of performance. The device is inherently a "human-in-the-loop" collaboration tool. While its technical components were likely tested in isolation (standalone components), the overall device's "performance" is tied to its functional remote control and communication capabilities, not an algorithmic diagnostic output.
The Type of Ground Truth Used:
- For the non-clinical testing, the "ground truth" was the pre-defined design requirements and expected functional behavior of the device. This is typical for engineering verification and validation testing, where the "truth" is whether the system performs as designed and specified (e.g., does the remote expert successfully initiate a scan?).
The Sample Size for the Training Set:
- Not applicable. The document does not describe the device as employing machine learning or AI that would require a "training set" of data in the sense of a deep learning model. It is a control and communication software system.
How the Ground Truth for the Training Set Was Established:
- Not applicable. As no training set for a machine learning model is mentioned, ground truth establishment for such a set is irrelevant to this submission.

In summary, the FDA 510(k) clearance for this device was based on a demonstration of "substantial equivalence" to existing predicate devices through non-clinical design verification and validation testing, focusing on ensuring the new remote scanning feature did not introduce new safety or effectiveness issues, rather than requiring quantitative performance studies with clinical acceptance criteria.

Summary

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October 27, 2023

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GE Healthcare % Allena Holzworth Regulatory Affairs Leader 500 W. Monroe Street Chicago, Illinois 60661

Re: K232346

Trade/Device Name: Digital Expert Access with Remote Scanning Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LLZ Dated: August 4, 2023 Received: August 4, 2023

Dear Allena Holzworth:

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.

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).

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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.

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-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,

Samul for

Daniel Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)

K232346

Device Name Digital Expert Access with Remote Scanning

Indications for Use (Describe)

Digital Expert Access with Remote Scan assistance solution which allows remote control of an MR Imaging Device including the ability to initiate a scan remotely. This access provides real time communication mechanisms between the remote and onsite users to facilitate the acquisition occurring on the device. Access must be granted by the system. Images reviewed remotely are not for diagnostic use.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.92:

Date:	August 4, 2023
Submitter:	GE HealthCare500 W. Monroe StreetChicago, IL 60661
Primary Contact:	Allena HolzworthRegulatory Affairs LeaderGE HealthCarePhone: +1 (414) 208-5162Email: Allena.Holzworth@ge.com
Secondary Contact:	Christopher PaulikSenior Manager Regulatory AffairsGE HealthCarePhone: +1 (262) 548-2010Email: Christopher.A.Paulik@ge.com
Subject Device Name:	Digital Expert Access with Remote Scanning
Device Classification:	Class II
Regulation Number:	21 CFR 892.1000 Magnetic Resonance Diagnostic Device21 CFR 892.2050 Medical image management and processing system
Product Code:	LNH, LLZ

Predicate Device Information

Predicate Device 1
Device Name:	SIGNA Hero
Manufacturer:	GE Medical Systems, LLC
510(k) Number:	K213668
Regulation Number:	21 CFR 892.1000 Magnetic Resonance Diagnostic Device
Product Code:	LNH

Predicate Device 2
Device Name:	Customer Remote Console (CRC)
Manufacturer:	GE Medical Systems, LLC
510(k) Number:	K150193

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Regulation Number:Product Code:	21 CFR 892.2050 Medical image management and processing systemLLZ
Predicate Device 3
Device Name:	MAGNETOM Systems with syngo Expert-i option
Manufacturer:	Siemens Medical Solutions, INC.
510(k) Number:	K052423
Regulation Number:	21 CFR 892.1000 Magnetic Resonance Diagnostic Device
Product Code:	LNH

Device Description

Digital Expert Access with Remote Scanning enables the following capabilities for the Onsite Technologist and the Remote Expert:

1. Collaborative session between an Onsite Technologist and Remote Expert
1. Real-time scanner screen share and live annotation
ന് Remote console access and control
1. Remote Scan Initiation

Intended Use

Digital Expert Access with Remote Scanning is intended as a remote collaboration tool to view and review MR images, to remotely control MR Imaging Devices and to initiate MRI scans remotely.

Indications for Use

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GE HealthCare 510(k) Premarket Notification Submission

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Technology

The proposed device, Digital Expert Access with Remote Scanning, employs similar fundamental scientific technology as its predicate devices.

Comparisons

Digital Expert Access with Remote scanning is substantially equivalent to the predicate devices, SIGNA Hero (K213668), Customer Remote Console (CRC) (K150193) and MAGNETOM Systems with syngo Experti option (K052423). The proposed device is intended to be a remote scan assistance solution, allowing the onsite technologist to connect to a remote expert to view/review images, provide real time guidance and initiate an MRI scan remotely. The table below summarizes the substantive feature/technological similarities and differences between the predicate devices and the proposed device:

Items	Predicate 1:SIGNA Hero(K213668)	Predicate 2:Customer RemoteConsole (CRC)K150193	Predicate 3:MAGNETOM Systemswith syngo Expert-ioption (K052433)	Proposed:Digital Expert Accesswith Remote Scanning
User InterfaceFunctions	PC-based	PC-based	PC-based	Tablet-based/PC-based
OperatorInterface	Keyboard, mouse	Keyboard, mouse	Keyboard, mouse	Touch LCD, Keyboard,touchpad
Remote Viewerinteractivecontrol	N/A	User profile(preferences) isassociated with anAdministrator, Userwith View role, orUser with Guidancerole.	The Expert-I statusdialog is used todetermine ifthe remote usershould have FullAccess or View Onlyaccess to the syngoWorkplace	The onsite user initiatesa request through DEAwhich initiates anacceptance screen onthe user interface. Oncethe request isacknowledged on thescanner, the onsite usermust validate theconnection by enteringthe session passwordfor the remote session.
Imaging SystemModality forRemoteScanning	N/A	N/A	MR	MR
Intended Users	Radiologist, ExpertTechnologist	Radiologist, ExpertTechnologist	Radiologist, ExpertTechnologist	Radiologist, ExpertTechnologist

Table 5-1: Comparison Table for Digital Expert Access with Remote Scanning and its Predicate Devices

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GE HealthCare 510(k) Premarket Notification Submission

Scan Initiation	Scan initiated byonsite technologist	Scan initiated byonsite technologist	Remote user caninitiate scan on MRscanners remotely	Remote user can initiatescan on MR scannersremotely
Patient/ScannerSupport duringAcquisition	Onsite technologistoversees patientsupport duringscanning acquisition	N/A – CRC is notintended for scanacquisition	Onsite technologistoversees patientsupport duringscanning acquisition	Onsite technologistoversees patientsupport during scanningacquisition

Clinical and Non-Clinical Tests

Summary of Non-Clinical Tests

Digital Expert Access with Remote Scanning has successfully completed the design control testing per GE HealthCare's quality system. It was designed under the Quality System Regulations of 21CFR 820 and ISO 13485. No new questions of safety and effectiveness and no unexpected test results were observed.

The following quality assurance measures have been applied to the development of the system:

. Requirement Definition
Risk Analysis and Control
Technical Design Reviews
Formal Design Reviews
Software Development Lifecycle
Safety Testing (Verification) ●
Performance Testing (Verification, Validation)
Software Release

Digital Expert Access with Remote Scanning verification was conducted to demonstrate proper implementation of its design requirements. The testing and results did not raise any new issues of safety and effectiveness.

In addition, verification and validation testing was conducted on the bench by integrating Digital Expert Access with Remote Scanning on a subset of GE HealthCare MRI systems to ensure a Remote Expert was able to perform remote scanning on GE HealthCare MRI systems.

Design verification and validation testing confirmed 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

The subject of this premarket submission, Digital Expert Access with Remote Scanning did not require clinical studies to support substantial equivalence to enable the remote scanning feature on GE HealthCare MRI systems.

Substantial Equivalence Conclusion

The introduction of Digital Expert Access with Remote Scanning does not result in any new potential safety risks and uses the same technology as the predicate devices, including the initiation of an MRI scan remotely. After analyzing design verification and validation testing on the bench it is the conclusion of GE

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GE HealthCare

510(k) Premarket Notification Submission

HealthCare that Digital Expert Access with Remote Scanning to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.