(84 days)
No
The document describes a remote collaboration tool for controlling MR imaging devices and viewing images, focusing on real-time communication and remote control features. There is no mention of AI, ML, or any form of automated analysis or decision-making based on image data or scanning parameters. The device explicitly states it does not perform image acquisition or post-processing.
No
This device is a remote collaboration tool for controlling MR imaging devices and reviewing images, explicitly stating it's not for diagnostic use or patient safety-related management, and does not directly interface with patients or affect their treatment.
No
The device description explicitly states: "Images reviewed remotely are not for diagnostic use," and "Digital Expert Access with Remote Scanning is not intended for diagnostic use or patient safety-related management." Its purpose is remote assistance for MR image acquisition, not interpretation or diagnosis.
Yes
The device is described as a "remote scan assistance solution" that provides "real time communication mechanisms" and "remote control" of an MR Imaging Device. While it interacts with hardware (the MRI system), the device itself is presented as a software solution enabling these remote functionalities. The description focuses on the software capabilities and does not mention any specific hardware components included with the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "remote collaboration tool to view and review MR images, to remotely control MR Imaging Devices and to initiate MRI scans remotely." It explicitly states that "Images reviewed remotely are not for diagnostic use."
- Device Description: The description reinforces that the device is for "remote scan assistance" and "collaboration between an Onsite Technologist and Remote Expert." It also explicitly states, "Digital Expert Access with Remote Scanning is not intended for diagnostic use or patient safety-related management."
- No Biological Samples: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue). This device interacts with an MRI system and images, not biological samples.
- No Diagnostic Claims: The documentation repeatedly emphasizes that the device is not for diagnostic use.
Therefore, this device falls under the category of medical imaging equipment control and assistance, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
LNH, LLZ
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:
-
- Collaborative session between an Onsite Technologist and Remote Expert
-
- Real-time scanner screen share and live annotation
- Remote console access and control
-
- 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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologist, Expert Technologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
October 27, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
1
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
2
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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3
Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has a wavy, water-like design around the letters, giving it a dynamic and fluid appearance.
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 HealthCare |
| 500 W. Monroe Street | |
| Chicago, IL 60661 | |
| Primary Contact: | Allena Holzworth |
| Regulatory Affairs Leader | |
| GE HealthCare | |
| Phone: +1 (414) 208-5162 | |
| Email: Allena.Holzworth@ge.com | |
| Secondary Contact: | Christopher Paulik |
| Senior Manager Regulatory Affairs | |
| GE HealthCare | |
| Phone: +1 (262) 548-2010 | |
| Email: 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 Device |
| 21 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 |
4
Image /page/4/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized font, enclosed within a circular border. There are small, curved lines emanating from the circle, giving the impression of movement or energy. The logo is colored in a light blue hue.
| Regulation Number:
Product Code: | 21 CFR 892.2050 Medical image management and processing system
LLZ |
|-------------------------------------|-----------------------------------------------------------------------|
| 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 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:
-
- Collaborative session between an Onsite Technologist and Remote Expert
-
- Real-time scanner screen share and live annotation
- ന് Remote console access and control
-
- 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.
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
5
GE HealthCare 510(k) Premarket Notification Submission
Image /page/5/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are stylized and connected, and there are small white swirls around the edge of the circle. The logo is simple and recognizable, and it is often used to represent the company.
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.
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 Remote
Console (CRC)
K150193 | Predicate 3:
MAGNETOM Systems
with syngo Expert-i
option (K052433) | Proposed:
Digital Expert Access
with Remote Scanning |
|------------------------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User Interface
Functions | PC-based | PC-based | PC-based | Tablet-based/PC-based |
| Operator
Interface | Keyboard, mouse | Keyboard, mouse | Keyboard, mouse | Touch LCD, Keyboard,
touchpad |
| Remote Viewer
interactive
control | N/A | User profile
(preferences) is
associated with an
Administrator, User
with View role, or
User with Guidance
role. | The Expert-I status
dialog is used to
determine if
the remote user
should have Full
Access or View Only
access to the syngo
Workplace | The onsite user initiates
a request through DEA
which initiates an
acceptance screen on
the user interface. Once
the request is
acknowledged on the
scanner, the onsite user
must validate the
connection by entering
the session password
for the remote session. |
| Imaging System
Modality for
Remote
Scanning | N/A | N/A | MR | MR |
| Intended Users | Radiologist, Expert
Technologist | Radiologist, Expert
Technologist | Radiologist, Expert
Technologist | Radiologist, Expert
Technologist |
Table 5-1: Comparison Table for Digital Expert Access with Remote Scanning and its Predicate Devices
6
Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. There are three curved lines, resembling water droplets or stylized commas, surrounding the circle. The logo is simple, recognizable, and has been used by GE for many years.
GE HealthCare 510(k) Premarket Notification Submission
| Scan Initiation | Scan initiated by
onsite technologist | Scan initiated by
onsite technologist | Remote user can
initiate scan on MR
scanners remotely | Remote user can initiate
scan on MR scanners
remotely |
|--------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Patient/Scanner
Support during
Acquisition | Onsite technologist
oversees patient
support during
scanning acquisition | N/A – CRC is not
intended for scan
acquisition | Onsite technologist
oversees patient
support during
scanning acquisition | Onsite technologist
oversees patient
support during scanning
acquisition |
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
7
Image /page/7/Picture/0 description: The image shows the logo of General Electric (GE). The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the letters, giving it a classic and recognizable appearance.
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.