MR VESSELLQ XPRESS

K122164 · GE Medical Systems SCS · LLZ · Sep 7, 2012 · Radiology

Device Facts

• Record ID: K122164
• Device Name: MR VESSELLQ XPRESS
• Applicant: GE Medical Systems SCS
• Product Code: LLZ · Radiology
• Decision Date: Sep 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MR VessellQ Xpress is intended to provide an optimized non-invasive application to facilitate vascular anatomy and pathology analysis from a set of DICOM 3.0 compliant 3D contrast-enhanced Magnetic Resonance Angiographic (MRA) images. MR VessellQ Xpress is a post processing application which can be used in the analysis of MRA data for the purpose of vascular disease assessment. This software is designed to assist radiologists and other clinicians in the evaluation and assessment of vascular anatomy and disease with the capability to provide a set of tools for visualizing directional vessel tortuosity, for sizing the vessel and for measuring areas of abnormalities within a vessel.

Device Story

MR VessellQ Xpress is a post-processing software application for Advantage Workstation (AW) and AW Server platforms; inputs DICOM 3.0 compliant 3D contrast-enhanced MRA images. Software provides tools for clinicians (radiologists, cardiologists) to visualize directional vessel tortuosity, size vessels, and measure abnormalities. Operates as an additional tool for 2D/3D analysis of user-selected vessels. Output assists clinicians in evaluating vascular anatomy and assessing vascular disease. Benefits include non-invasive analysis of vascular pathology.

Clinical Evidence

No clinical data; bench testing only. Verification and validation included requirements reviews, design reviews, unit-level testing, integration testing, and final acceptance testing.

Technological Characteristics

Software-based post-processing application; DICOM 3.0 compliant; operates on GE Advantage Workstation (AW) and AW Server platforms. Complies with NEMA PS 3.1-3.18 (DICOM), ISO 13485, ISO 14971, IEC 62304, and IEC 62366.

Indications for Use

Indicated for use by radiologists and clinicians to facilitate vascular anatomy and pathology analysis and vascular disease assessment using 3D contrast-enhanced MRA images.

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

• Volume Viewer Plus by GE Medical Systems (K041521)
• MRA-CMS by Medis Medical Imaging Systems (K040746)

Submission Summary (Full Text)

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K122164
p. 1 of 3

SEP 7 2012

GE Healthcare 510(k) Premarket Notification Submission

#### 510(k) Summary

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

July 19th, 2012 Date:

Submitter: GE Medical Systems SCS 283, Rue de la Minière 78530 Buc. France Helen Peng, RAC Primary Contact Person: Regulatory Affairs Leader GE Healthcare 3000 North Grandview Blvd. W1140 Waukesha, WI 53188, USA Tel: [phone] Fax: [phone] Email: [e-mail]

Secondary Contact Person:

Stephen Slavens , RAC Regulatory Affairs Director GE Healthcare 3000 North Grandview Blvd, W1140 Waukesha, WI 53188, USA Tel: [phone]

Fax: [phone]

MR VessellQ Xpress

Email: [e-mail]

Class II per 21 CFR 892.2050

Ali

Advanced Vessel Analysis MR (AVA MR)

Picture, Archiving and Communication System

Device: Trade Name: Common/Usual Name: Classification Names:

Product Code:

LLZ

Predicate Device(s):

K041521 Volume Viewer Plus by GE Medical Systems

K040746 MRA-CMS by Medis Medical Imaging Systems

Device Description:

MR VessellQ Xpress is a post processing analysis software application designed to assist Radiologists, Cardiologists, and other clinicians in the evaluation and assessment of vascular anatomy.

MR VessellQ Xpress is a software package for the Advantage Workstation (AW) platform and AW Server platform. The MR VessellQ Xpress is an additional tool for the 2D and 3D analysis


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K122164
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## GE Healthcare 510(k) Premarket Notification Submission

of DICOM compliant MR angiographic images/data , providing a number of display, measurements and batch filming/archive features to study user-selected vessels which include but are not limited to stenosis analysis and directional vessel tortuosity visualization.

MR VessellQ Xpress is intended to provide an optimized non-Intended Use: invasive application to facilitate vascular anatomy and pathology analysis and vascular disease assessment from a set of DICOM 3.0 compliant Magnetic Resonance Angiographic (MRA) images.

MR VessellQ Xpress is intended to provide an optimized non-Indication for Use invasive application to facilitate vascular anatomy and pathology analysis from a set of DICOM 3.0 compliant 3D contrast-enhanced Magnetic Resonance Angiographic (MRA) images.

> MR VessellQ Xpress is a post processing application which can be used in the analysis of MRA data for the purpose of vascular disease assessment.

> This software is designed to assist radiologists and other clinicians in the evaluation and assessment of vascular anatomy and disease with the capability to provide a set of tools for visualizing directional vessel tortuosity, for sizing the vessel and for measuring areas of abnormalities within a vessel.

The MR VesselIQ Xpress employs the same fundamental Technology: scientific technology as its predicate devices.

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K122164
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# GE Healthcare

510(k) Premarket Notification Submission

Determination of Substantial Equivalence:

The MR VessellQ Xpress and its components comply with the following voluntary standards :

> NEMA PS 3.1 - 3.18(2008) Digital Imaging and Communications in Medicine (DICOM) Set.

MR VessellQ Xpress was designed in compliance with the following Process Standards:

- ISO 13485 Quality Systems-Model for Quality . assurance in design, development, production, installation and servicing of medical device
- ISO 14971 Medical devices-Application of Risk . management to medical devices
- IEC 62304 Medical device software Software life . cycle processes
- IEC 62366. -Medical devices Application of usability . engineering to medical devices
- .

The following quality assurance measures were applied to the development of the device:

- . Risk Analysis
Summary of Non-Clinical Tests:

- Requirements Reviews .
- Design Reviews .
- . Unit level testing (Module Verification)
- Integration testing (System verification) �
- Final acceptance testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification)

### Summary of Clinical Tests:

The subject of this premarket submission, MR VessellQ Xpress did not require clinical studies to support substantial equivalence.

MR Vessell() Xpress does not result in any new potential safety Conclusion: risks and performs as well as the predicate devices currently on the market. GE Medical Systems SCS considers the MR VessellQ Xpress to be as safe, as effective as, and is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 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 an abstract symbol resembling a stylized caduceus or a representation of human figures.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

GE Medical Systems SCS % Ms. Helen Peng Regulatory Affairs Leader GE Medical Systems, LLC dba GE Healthcare 3000 N. Grandview, W1140 WAUKESHA WI 53188

SEP 7 2012

Re: K122164

Trade/Device Name: MR VesselIQ Xpress Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ and LNH Dated: July 19, 2012 Received: July 20, 2012

Dear Ms. Peng:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your becamined the device is substantially equivalent (for the indications and for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars annual date of the Medical Device American Continuents, or to commerce provision in May 20, 1976, the encordance with the provisions of the Federal Food. Drug, uevices that have been recuire approval of a premarket approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket You may, therefore, market the device, subject to the general controls provisions of the Act. The Act. The Y ou may, therefore, market the devices, ediferents for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such II your device is Classified (see above) into enas ffecting your device can be found in Title 21, additional controls. Existing mayor regards a 895. In addition, FDA may publish further Ode of Pederal concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuation with the router with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA lias made a determination and regulations administered by other Federal station and light or ally Federal statutes and regulations and limited to: registration and listing (21 Compy with all the Act 3 requirements, arrants 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-lefated adverse events) (21 CFR Pat 3-60 ), and 820). This letter requirents as set form in the quality Systems (QS) reged in your Section 510(k) prematket will allow you to ocgin marketing your actively walence of your device to a legally marketed notification. The I DFI imaing of successification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and II you desire specific advice for your device of the career Evaluation and Safety at (301) 796-607), please contact 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 under the MDK regulation (27 ℃FR Part 005), producem/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 Tou may other other general meeting and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circle. There are small swirls or flourishes around the letters and the outer edge of the circle, giving it a classic and recognizable design.

# GE Healthcare 510(k) Premarket Notification Submission

K122164 510(k) Number :

MR VessellQ Xpress Device Name:

Indications for Use:

MR VessellQ Xpress is intended to provide an optimized non-invasive application to facilitate vascular anatomy and pathology analysis from a set of DICOM 3.0 compliant 3D contrastenhanced Magnetic Resonance Angiographic (MRA) images.

MR VessellQ Xpress is a post processing application which can be used in the analysis of MRA data for the purpose of vascular disease assessment. ·

This software is designed to assist radiologists and other clinicians in the evaluation and assessment of vascular anatomy and disease with the capability to provide a set of tools for visualizing directional vessel tortuosity, for sizing the vessel and for measuring areas of abnormalities within a vessel.

Prescription Use_X (Part 21 CFR 801 Subpart D) AND/OR

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

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K122164