FLIGHTPLAN FOR LIVER

K121200 · GE Healthcare · LLZ · Nov 2, 2012 · Radiology

Device Facts

• Record ID: K121200
• Device Name: FLIGHTPLAN FOR LIVER
• Applicant: GE Healthcare
• Product Code: LLZ · Radiology
• Decision Date: Nov 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K121200 · Nov 2, 2012	FLIGHTPLAN FOR LIVER	GE Healthcare	Retrospective database of hypervascular liver tumor clinical images	The retrospective study compared the device's automated output against a reference reading by two senior interventional oncologists to demonstrate the device's ability to aid in the evaluation of hepatic arterial anatomy.	Retrospective study; Clinical database; Hepatic embolization; Hypervascular liver tumors

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective study	Patients with hypervascular liver tumors treated by chemoembolization; Sample Size: 44 subjects (66 tumors)	Reference reading established by two senior interventional oncologists	Comparison of device output to reference reading for identification of arteries leading to hypervascular lesions

Indications for Use

FlightPlan for Liver is a post processing software package that helps the analysis of 3D X-ray images of the liver arterial tree. Its output is intended as an adjunct means to help identify arteries leading to the vicinity of hypervascular lesions in the liver. This adjunct information may be used by physicians to aid them in their evaluation of hepatic arterial anatomy during embolization procedures.

Device Story

FlightPlan for Liver is a post-processing software application for interventional fluoroscopy; it processes 3D rotational angiography images as input. The device operates on GE AW VolumeShare 4/5 platforms as an extension of the Volume Viewer application. It utilizes an algorithm to highlight potential vessels in the vicinity of a target lesion. The output is displayed to interventional oncologists/physicians to assist in evaluating hepatic arterial anatomy during chemoembolization procedures. It serves as an adjunct tool to aid clinical decision-making; it does not claim to improve clinical outcomes. The device is used in clinical settings by physicians.

Clinical Evidence

Retrospective study of 44 subjects (66 tumors) with hypervascular liver tumors treated by chemoembolization. Device output compared to reference reading by two senior interventional oncologists. Study demonstrated the device provides adjunct information for evaluating hepatic arterial anatomy. No claims of improved clinical outcomes.

Technological Characteristics

Post-processing software application; operates on AW VolumeShare 4/5 platforms. Complies with IEC 60601-1-4, IEC 62366, and IEC 62304. Utilizes 3D rotational angiography input. Includes vessel highlighting algorithm.

Indications for Use

Indicated for use by physicians to aid in the evaluation of hepatic arterial anatomy during embolization procedures by identifying arteries leading to the vicinity of hypervascular liver lesions using 3D X-ray 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 (K041521)

Submission Summary (Full Text)

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K12 1200

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NOV 2 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:

October 28, 2012 Date:

GE Healthcare, (GE Medical Systems SCS) Submitter: 283 rue de la MINIERE 78530 Buc, FRANCE

Primary Contact Person:

Ning WEN Regulatory Affairs Leader GE Healthcare, (GE Medical Systems SCS) Tel: [phone] Fax: [phone]

Secondary Contact Persons:

John Jaeckle Chief Regulatory Affairs Strategist GE Healthcare Tel: [phone]

Carol Alloian Regulatory Affairs Leader GE Healthcare Tel: [phone] Fax: [phone]

Device: Trade Name: Common/Usual Name: Classification Names: Product Code: FlightPlan for Liver Picture Archiving and Communications System 21CFR 892.2050, Class II

LLZ

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K041521, Volume Viewer Plus Predicate Device(s):

Device Description: FlightPlan for Liver is a post-processing software application for use with interventional fluoroscopy procedures, using 3D rotational angiography images as input. It operates on the AW VolumeShare 4 [K052995] and AW VolumeShare 5 [K110834] platform. It is an extension to the Volume Viewer application [K041521] utilizing the rich set of the 3D processing features of Volume Viewer.

> FlightPlan for Liver delivers post-processing features that will aid physicians in their analysis of 3D X-ray images of the liver

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K121200 Page 2 of 83

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## GE Healthcare 510(k) Premarket Notification Submission

### arterial tree.

Intended Use:

FlightPlan for Liver is a post processing software package that helps the analysis of 3D X-ray images of the liver arterial tree. Its output is intended as an adjunct means to help identify arteries leading to the vicinity of a hypervascular region of interest in the liver.

Indications for Use FlightPlan for Liver is a post processing software package that helps the analysis of 3D X-ray images of the liver arterial tree. Its output is intended as an adjunct means to help identify arteries leading to the vicinity of hypervascular lesions in the liver. This adjunct information may be used by physicians to aid them in their evaluation of hepatic arterial anatomy during embolization procedures.

FlightPlan for Liver employs the same fundamental scientific Technology: technology as its predicate device (Volume Viewer).

> When FlightPlan for Liver is active, all Volume Viewer functionalities are available at the same time.

> Additionally FlightPlan for Liver includes an algorithm to highlight the potential vessel(s) in the vicinity of a target.

Determination of Substantial Equivalence:

FlightPlan for Liver when used together with Volume Viewer delivers functionality of comparable type that is substantially equivalent to the predicate device listed above and complies with the same or equivalent standards and has the same Intended Use.

#### Summary of Non-Clinical Tests:

FlightPlan for Liver complies with voluntary standards IEC 60601-1-4, IEC 62304 and IEC 62366.

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

- Risk Analysis .
- Requirements Reviews �
- Design Reviews .
- and Safety testing (Verification). . Performance The Verification Tests of the FlightPlan for Liver were performed in accordance with device Design Verification Plan and with device Verification Procedure. The verification tests were performed to check whether the application works as required and whether the risk mitigations have been correctly implemented. Performance testing consists of computing time

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# GE Healthcare

#### 510(k) Premarket Notification Submission

of algorithm on several data. The Verification confirms that the Design Output meets the Design Input (Product Specifications) requirements.

Final acceptance testing (Validation). The Validation Tests of the FlightPlan for Liver were executed in accordance with device Design Validation Plan and with device Validation Procedure. The Validation tests consist of typical use case scenario described by the sequence of operator actions. The Design Validation confirms that the product fulfills the user needs and the intended use under simulated use conditions.

#### Summary of Clinical Tests:

This premarket submission included a clinical test to demonstrate the safety and effectiveness of FlightPlan for Liver.

In this retrospective study (44 subjects representing a total of 66 tumors) performed on a database of hypervascular liver tumors in patients subsequently treated by chemoembolization, the output of FlightPlan for Liver was compared to a reference reading established by two senior interventional oncologists.

The clinical data provided to support that FlightPlan for Liver provides adjunct information that may be used by physicians to aid them in their evaluation of hepatic arterial anatomy during embolization procedures was not designed nor intended to support a claim of an improvement in clinical outcomes of such procedures, and no such claim is being made.

Conclusion:

GE Healthcare considers the FlightPlan for Liver application to be as safe and as effective as its predicate device, and its performance is substantially equivalent to the predicate device.

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Public Health Service

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

GE Healthcare, GE Medical Systems SCS % Ms. Carol Alloian Regulatory Affairs Leader GE Healthcare 9900 W Innovation Drive WAUWATOSA WI 53226-4856

NOV 2 2012

Re: K121200

Trade/Device Name: FlightPlan for Liver Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 8, 2012 Received: October 15, 2012

#### Dear Ms. Alloian:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety 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,

Janine M. Morris

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): K121200

Device Name: FlightPlan for Liver

## Indications For Use:

FlightPlan for Liver is a post processing software package that helps the analysis of 3D X-ray images of the liver arterial tree. Its output is intended as an adjunct means to help identify arteries leading to the vicinity of hypervascular lesions in the liver. This adjunct information may be used by physicians to aid them in their evaluation of hepatic arterial anatomy during embolization procedures.

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)

Michael D'Ortenzio

Division Sion C

Division of Radiologic

Office of In Vitro

510(k) K121200

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