CARDIAC VX

K121762 · Ge Medical Systems, LLC · LLZ · Jan 18, 2013 · Radiology

Device Facts

• Record ID: K121762
• Device Name: CARDIAC VX
• Applicant: Ge Medical Systems, LLC
• Product Code: LLZ · Radiology
• Decision Date: Jan 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The GE CardiacVX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. CardiacVX can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization. A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point, distance, area, and volume measurement tools such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements. Semi-automatic tools are available for left ventricular contour detection, valve plane detection, vessel contour detection for flow analysis, signal intensity analysis for myocardium and infarct sizing measurement, and T2 star analysis. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians. When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.

Device Story

CardiacVX is a post-processing software application for cardiac MR datasets; operates on GE Advantage Workstation (AW). Inputs: multi-slice, multi-phase MR images. Function: provides visualization (cine mode) and semi-automatic measurement tools for cardiac analysis. Outputs: quantitative metrics including ejection fraction, cardiac output, end-diastolic/systolic volumes, volume flow, myocardium signal intensity, infarct sizing, T2 star, and PFO analysis. Used in clinical settings by physicians to generate reports; results assist in clinical decision-making and diagnosis. Benefits: provides reproducible, reliable measurements to facilitate efficient clinical reporting.

Clinical Evidence

No clinical trials performed. Evidence consists of verification and validation testing using internal volunteer MR scans and multi-vendor anonymized MR contrast-enhanced images from a third-party clinical research study. Bench testing confirmed software performance and safety.

Technological Characteristics

Software-only application running on GE Advantage Workstation (AW). Complies with ISO 13485, ISO 14971, and IEC 62304. Features semi-automatic tools for contour detection, flow analysis, and signal intensity analysis.

Indications for Use

Indicated for use by trained physicians as an analytical software tool for the review, measurement, and reporting of cardiac MR imaging datasets to support clinical diagnosis.

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

• GE Delta Software Option for MRI (marketed as ReportCARD) (K031927)
• READY View (K110573)

Submission Summary (Full Text)

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# AN 1 8 2013

K121762

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GE Healthcare 510(k) Premarket Notification Submission .......

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## 510(k) Summary

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

Date: December 11, 2012

GE Medical Systems, LLC (doing business as GE Submitter: Healthcare) 3200 N. Grandview Blvd . Waukesha, WI 53188 FDA Registration Number: 2183553

Primary Contact Person:

Michelle Huettner Regulatory Affairs Leader, MR GE Medical Systems, LLC (doing business as GE Healthcare) Phone [phone] Fax [phone]

Secondary Contact Person:

Glen Sabin Regulatory Affairs Director, MR GE Medical Systems, LLC (doing business as GE Healthcare) Phone [phone] Fax [phone]

Device: Trade Name: Cardiac VX ... ...

Common/Usual Name:

System, image processing, radiological- Picture archiving and communications system.

lassification Names: 21CFR 892.2050

Product Code:

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#### K121762

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## GE Healthcare 510(k) Premarket Notification Submission

#### GE Delta Software Option for MRI (marketed as Predicate Device(s): ReportCARD) (K031927) manufactured by GE

Device Description: ::

Indications for Use:

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READY View (K110573) manufactured by GE

CardiacVX is a post-processing analytical software application, which provides tools for the review and reporting of cardiac MR datasets. Measurement tools on the report interface include: point, distance, area, and volume measurements (including ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements). Semi-automatic tools are available for left ventricular contour detection, valve plane detection, vessel contour detection for flow analysis, signal intensity analysis for myocardium and infarct sizing measurement, T2 Star analysis, and patent foramen ovale (PFO) analysis.

The GE CardiacVX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. Cardiac VX can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multiphase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization.

A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point, distance, area, and volume measurement tools such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements.

Semi-automatic tools are available for left ventricular contour detection, valve plane detection, vessel contour detection for flow analysis, signal intensity analysis for myocardium and infarct sizing measurement, and T2 Star analysis.

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Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters and the circle are in black, creating a strong contrast. The logo is a well-known symbol associated with the General Electric company.

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

The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.

When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.

#### Technology:

Determination of

Substantial Equivalence:

The proposed medical device, Cardiac VX, employs the same fundamental scientific technology as its predicate devices. The proposed device (CardiacVX) is substantially equivalent to the predicate devices because it is a post-processing software option for use on cardiac MR image datasets.

#### Summary of Non-Clinical Tests:

CardiacVX complies with voluntary standards, including the following process standards: ISO 13485, ISO 14971, and IEC 62304. Because CardiacVX is a software-only application which runs on the Advantage Workstation . (AW), there are no applicable mandatory performance standards.

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

- Risk Analysis .
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification),
- Performance testing (Verification)
- Safety testing (Verification)

Simulated use testing (Validation)

### Summary of Clinical Tests:

The MR acquired clinical images that were used for the completion of verification and validation testing for CardiacVX was obtained from the GE Healthcare facilities under the provisions of a non-significant risk investigation for internal volunteer scanning. In addition,

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K121762

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GE Healthcare

510(k) Premarket Notification Submission . . . .

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multi-vendor anonymized MR contrast-enhanced images were obtained from a third-party clinical research study.

Conclusion: GE Healthcare considers the CardiacVX application to be as safe, as effective, and performance is substantially equivalent to its predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol, with three curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

Food and Drug Administration 10903 New Hampshire A venue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

### January 18, 2013

GE Medical Systems, LLC % Michelle Huettner 3200 N. Grandview Blvd. WAUKESHA WI 53188

Re: K121762

Trade/Device Name: CardiacVX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 11, 2012 Received: December 12, 2012

Dear Ms. Huettner:

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. Trou may, therefore, maxisions of the Act include requirements for annual registration, listing of The general vonations practice, labeling, and prohibitions against misbranding and adulteration.

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 or any 1 outhall 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 Or K F at 607), lacemig (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 Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at [phone]. 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 Small Manufacturers, International 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,

Sean M. Boyd -S

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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# Indications for Use

510(k) Number (if known):

K121762

Cardiac VX Device Name:

Indications for Use:

The GE CardiacVX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. CardiacVX can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization.

A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point, distance, area, and volume measurement tools such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements.

Semi-automatic tools are available for left ventricular contour detection, valve plane detection, vessel contour detection for flow analysis, signal intensity analysis for myocardium and infarct sizing measurement, and T2 star analysis.

The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.

When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

# Sean M. Boyd -S

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K121762 510(k)

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