(197 days)
No
The summary describes image processing and an algorithm to highlight vessels, but does not mention AI, ML, or related terms, nor does it describe training or test sets in a way that suggests an ML model.
No
The device is a software package that provides adjunct information to aid physicians in their evaluation of hepatic arterial anatomy; it does not directly treat or prevent a disease or condition.
Yes
The device aids in identifying arteries leading to lesions and evaluating hepatic arterial anatomy for embolization procedures, which are diagnostic functions.
Yes
The device description explicitly states it is a "post-processing software application" that operates on existing hardware platforms (AW VolumeShare 4 and 5) and is an extension to another software application (Volume Viewer). There is no mention of any accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: FlightPlan for Liver is a software package that processes imaging data (3D X-ray images) of the liver arterial tree. It does not examine biological specimens (blood, tissue, etc.) derived from the human body.
- Intended Use: Its intended use is to help analyze imaging data to identify arteries and provide adjunct information to physicians during embolization procedures. This is a diagnostic aid based on imaging, not an in vitro test.
Therefore, FlightPlan for Liver falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 a hypervascular region of interest in the liver.
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.
Product codes
LLZ
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 arterial tree.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D rotational angiography images, 3D X-ray images
Anatomical Site
Liver, hepatic arterial anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041521, Volume Viewer Plus
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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K12 1200
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The logo is black and white, with the letters and the circle outline in black and the background in white.
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: (+33)-1-3070-5668 Fax: (+33) 1-3070-4670
Secondary Contact Persons:
John Jaeckle Chief Regulatory Affairs Strategist GE Healthcare Tel: 262-424-9547
Carol Alloian Regulatory Affairs Leader GE Healthcare Tel: (224) 280-1008 Fax: (847) 589-8524
Device: Trade Name: Common/Usual Name: Classification Names: Product Code: FlightPlan for Liver Picture Archiving and Communications System 21CFR 892.2050, Class II
LLZ
1
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
Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters are stylized and connected, with the "G" and "E" forming a single, continuous shape. The logo is black and white.
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
2
Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are in white, set against a black background.
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.
3
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 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 text is in all caps and is in a sans-serif font.
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
4
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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
5
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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