The Customer Remote Console Software Option allows remote access for viewing/review of images as well as the ability to remotely provide real time guidance to the technologist operating GE Healthcare medical imaging devices. This access must be granted by the technologist operating the system. The remote access is only available for systems supporting GE remote connectivity capability. Images reviewed remotely are not for diagnostic use.

Device Description

Customer Remote Console (CRC) is a customer facing software application that is fully contained within a hospital provider network. It provides remote access for viewing/review of images as well as the ability to remotely provide real time quidance to the technologist operating the GE Healthcare medical imaging devices in the context of training. procedure assessment, and scanning parameter management. Remote users will be able to log into a GEHC imaging medical device from a device (Laptop/Desktop) which meets minimum required specifications anywhere within the provider network. This allows users to spread imaging knowledge and expertise without limitation of time or distance. This access must be aranted by the technologist operating the system and it can also be revoked at any time by the technologist. While a remote session is taking place, the technologist operating the system will have complete control of the session at all times. Also, each remote session will be controlled via a secure credential that is managed by the technologist operating the system. Connections to a medical device are limited to one remote session at a time to maintain strict control over who is remotely interacting with the system. Images reviewed remotely are not for diagnostic use.

AI/ML Overview

This document is a 510(k) summary for the GE Medical Systems, LLC Customer Remote Console (CRC). It outlines the device description, intended use, indications for use, and a comparison to predicate devices, but it does not contain the detailed information needed to answer many of the questions about acceptance criteria and specific study designs.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or provide a table of reported device performance in the way typically expected for clinical accuracy or efficacy studies. It focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and assurances of quality control.

From the text, implicit "acceptance criteria" related to functionality and safety are:

Acceptance Criteria (Implicit)	Reported Device Performance
Remote access for viewing/review of images	Provides remote access for viewing/review of images.
Remotely provide real-time guidance to technologist	Allows the ability to remotely provide real-time guidance to the technologist operating GE Healthcare medical imaging devices (for training, procedure assessment, scanning parameter management).
Access granted by technologist	Access must be granted by the technologist operating the system and can be revoked at any time.
Technologist has complete control during remote session	While a remote session is taking place, the technologist operating the system will have complete control of the session at all times.
Secure credential control	Each remote session will be controlled via a secure credential managed by the technologist.
Limited to one remote session at a time	Connections to a medical device are limited to one remote session at a time.
Remote access only for systems supporting GE remote connectivity capability	The remote access is only available for systems supporting GE remote connectivity capability.
Images reviewed remotely are not for diagnostic use	Images reviewed remotely are not for diagnostic use.
Authentication required for remote users	CRC User has to be authenticated before the user can connect to the imaging device.
Capability for customer to select display quality during a remote session	CRC provides the capability for the customer to select the display quality during a remote session.
Restriction of remote user access to certain icons on the console of the imaging medical device	A remote user does not have access to certain icons on the console of the imaging medical device.
Technologist and remote users both have capability to terminate remote session	Both the technologist operating the scanner and the remote users both have the capability to terminate the remote session.
Design and manufacturing under Quality System Regulations	The device is designed and manufactured under the Quality System Regulations of 21 CFR 820. Quality assurance measures applied include Risk Analysis, Requirements Reviews, Design Reviews, Performance/Safety testing (Verification), and Clinical Scenarios testing (Validation).

2. Sample sized 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, "The subject of this premarket submission, CRC, does not require clinical studies to support substantial equivalence." Therefore, there would not be a specific "test set" in the context of clinical performance evaluation.

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 applicable as no clinical studies requiring ground truth establishment were conducted or reported for this 510(k) submission.

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

This information is not applicable as no clinical studies requiring adjudication were conducted or reported.

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

This information is not applicable. The CRC device is a remote access and guidance tool, not an AI-assisted diagnostic or interpretation device that would typically undergo an MRMC study.

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

This information is not applicable. The CRC is inherently a "human-in-the-loop" system, designed to facilitate interaction and guidance between a remote user and a local technologist. It is not an automated algorithm performing a task independently.

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

This information is not applicable as no clinical studies requiring ground truth establishment were conducted or reported.

8. The sample size for the training set

This information is not provided and is likely not relevant in the context of this device's type. Software development involves testing and validation, but not typically "training sets" in the machine learning sense for a device of this nature.

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

This information is not applicable as there is no mention of a training set or ground truth establishment for such a set in this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 24, 2015

GE Medical Systems, LLC % Ms. Elizabeth Mathew Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive WAUWATOSA WI 53226

Re: K150193

Trade/Device Name: Customer Remote Console (CRC) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 28, 2015 Received: January 30, 2015

Dear Ms. Mathew:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K150193

Device Name Customer Remote Console (CRC)

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 5: 510(k) Summary

Customer Remote Console (CRC)

Traditional 510(k)

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510(k) Summary

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

Date:	March 20 , 2015
Submitter:	GE Healthcare (GE Medical Systems, LLC)Establishment Registration Number - 21266773000 N Grandview Blvd.,Waukesha, WI - 53188
Primary Contact Person:	Elizabeth MathewRegulatory Affairs ManagerGE Healthcare9900 Innovation Drive,Wauwatosa, WI - 53226Mail Stop: RP-2124Phone: (262) 521-6658Email: Elizabeth.Mathew@ge.com
Secondary Contact Person:	John JaeckleChief Regulatory Affairs StrategistGE Healthcare, (GE Medical Systems, LLC)3000 N Grandview Blvd.,Waukesha, WI - 53188Phone: 262-424-9547Email: John.Jaeckle@ge.com
Device:Trade Name:	Customer Remote Console
Common/Usual Name:	CRC
Classification Names:	21 CFR 892.2050 Picture archiving and communication system
Product Code:	90 LLZ
Predicate Device:	MAGNETOM Systems with syngo Expert-i option (K052423)SYNGO EXPERT-I (K061449)AW Server (K081985)

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Device Description:

Customer Remote Console Software Option provides remote access Intended Use: for viewing/review of images as well as the ability to remotely provide real time quidance to the technologist operating the scanner. This quidance includes training, procedure assessment, and scanning parameter management.

Indication for Use: The Customer Remote Console Software Option allows remote access for viewing/review of images as well as the ability to remotely provide real time quidance to the technologist operating GE Healthcare medical imaging devices. This access must be granted by the technologist operating the system. The remote access is only available for systems supporting GE remote connectivity capability. Images reviewed remotely are not for diagnostic use.

Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:

The proposed device. Customer Remote Console (CRC) employs the same fundamental scientific technology as its predicate devices: MAGNETOM Systems with syngo Expert-i option (K052423), SYNGO EXPERT-I (K061449), AW Server (K081985).

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The Customer Remote Console (CRC) is a software solution that allows remote access for viewing/review of images as well as the ability to remotely provide real time quidance to the technologist operating the GE Healthcare medical imaging devices. Access to imaging devices is controlled through the CRC Server, which controls the connections between imaging devices and CRC Clients. CRC is intended to allow remote users to support technologists for training purposes or for assistance with acquiring images which is the same principle as the MAGNETOM Systems with syngo Expert-i option (K052423) and SYNGO EXPERT-I (K061449). CRC clients can be either inside the customer's local area network (LAN) or outside their LAN, connected to their virtual private network (VPN). The predicates, MAGNETOM Systems with syngo Expert-i option (K052423) and SYNGO EXPERT-I (K061449), also allow remote access to a customer workplace from a PC in the same local area network (LAN). CRC User has to be authenticated before the user can connect to the imaging device. The predicate devices, MAGNETOM Systems with syngo Expert-i option (K052423), SYNGO EXPERT-I (K061449) and AW Server (K081985) also require User Authentication. MAGNETOM Systems with syngo Expert-i option (K052423), SYNGO EXPERT-I (K061449) and the proposed device CRC provides the capability for the customer to select the display quality during a remote session. CRC allows only one remote session with an imaging medical device at a qiven time which is the same principle as the MAGNETOM Systems with syngo Expert-i option (K052423) and SYNGO EXPERT-I (K061449). In the predicate devices (MAGNETOM Systems with syngo Expert-i option (K052423), SYNGO EXPERT-I (K061449)) and proposed device CRC, a remote user does not have access to certain icons on the console of the imaging medical device. In both the predicate devices (MAGNETOM Systems with syngo Expert-i option (K052423) . SYNGO EXPERT-I (K061449)) and proposed device CRC. the technologist operating the scanner and the remote users both have the capability to terminate the remote session.

Potential Adverse Effects onHealth:	Potential hazards are identified in risk management includinghazard analysis and controlled by:
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System verification and validation to ensure performance to . specifications and user requirements.
. Adherence to software development lifecycle procedures ISDLCI
Instruction for Use provided for the safe and effective use by . users.

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The device is designed and manufactured under the Quality System Regulations of 21 CFR 820.

Summary of Non-Clinical Tests: Determination of Substantial Equivalence: The following quality assurance measures were applied to the development of CRC:

Risk Analysis
. Requirements Reviews
Design Reviews
Performance/Safety testing (Verification) .
. Clinical Scenarios testing (Validation)

Summary of Clinical Tests:

The subject of this premarket submission, CRC, does not require clinical studies to support substantial equivalence.

GE Healthcare considers CRC to be as safe, as effective, and Conclusion: substantially equivalent to the predicate devices.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).