Customer Remote Console (CRC)

K150193 · Ge Medical Systems, LLC · LLZ · Mar 24, 2015 · Radiology

Device Facts

• Record ID: K150193
• Device Name: Customer Remote Console (CRC)
• Applicant: Ge Medical Systems, LLC
• Product Code: LLZ · Radiology
• Decision Date: Mar 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications 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 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 Story

Customer Remote Console (CRC) is a software application enabling remote access to GE Healthcare medical imaging devices within a hospital network. It allows remote users (e.g., trainers, experts) to view images and provide real-time guidance to on-site technologists regarding scanning parameters and procedure assessment. The system requires the on-site technologist to grant and maintain control of the session; only one remote session is permitted at a time. Access is secured via user authentication. The device facilitates knowledge sharing and expertise distribution across a facility without diagnostic intent. It operates via a client-server architecture where a CRC server manages connections between imaging devices and remote client PCs/laptops. The technologist retains the ability to revoke access or terminate the session at any time.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including risk analysis, requirements reviews, design reviews, performance/safety verification, and clinical scenario validation.

Technological Characteristics

Software-only application; operates within hospital LAN/VPN. Client-server architecture. Features include remote image viewing, real-time guidance, user authentication, and session control. Adheres to 21 CFR 820 quality system regulations.

Indications for Use

Indicated for remote viewing/review of images and real-time guidance for technologists operating GE Healthcare medical imaging devices. Intended for training, procedure assessment, and scanning parameter management. Not for diagnostic use.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• MAGNETOM Systems with syngo Expert-i option (K052423)
• SYNGO EXPERT-I (K061449)
• AW Server (K081985)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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)

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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)<br>Establishment Registration Number - 2126677<br>3000 N Grandview Blvd.,<br>Waukesha, WI - 53188 |
| Primary Contact Person: | Elizabeth Mathew<br>Regulatory Affairs Manager<br>GE Healthcare<br>9900 Innovation Drive,<br>Wauwatosa, WI - 53226<br>Mail Stop: RP-2124<br>Phone: [phone]<br>Email: [e-mail] |
| Secondary Contact Person: | John Jaeckle<br>Chief Regulatory Affairs Strategist<br>GE Healthcare, (GE Medical Systems, LLC)<br>3000 N Grandview Blvd.,<br>Waukesha, WI - 53188<br>Phone: [phone]<br>Email: [e-mail] |
| Device:<br>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)<br>SYNGO EXPERT-I (K061449)<br>AW Server (K081985) |

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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.

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 on<br>Health: | Potential hazards are identified in risk management including<br>hazard 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.