Synapse 3D Lung and Abdomen Analysis is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Lung and Abdomen Analysis accepts DICOM compliant medical images acquired from CT.

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Addition to Synapse 3D Base Tools, Synapse 3D Lung and Abdomen Analysis is intended to;

use non-contrast and contrast enhanced computed tomographic images of the lung, provide custom workflows and UI, and reporting for lung analysis including boundary detection and volume calculation for pulmonary nodules in the lung based on the location specified by the user, segmentation of bronchial tubes in the lung, approximation of air supply region by the user specified bronchial tube, identifying, displaying and processing low absorption regions in the lung.
use non-contrasted CT images and calculate subcutaneous fat and visceral fat areas in 2D and both volumes in 3D.

Device Description

Synapse 3D Lung and Abdomen Analysis (V3.0) is the updated version of previously-cleared Synapse 3D Lung and Abdomen Analysis software (cleared by CDRH via K103720 on 03/16/2011).

Synapse 3D Lung and Abdomen Analysis is used in addition to Synapse 3D Base Tools (K120361, cleared on April 6, 2012) to analyze the images acquired from CT. Synapse 3D Lung and Abdomen Analysis is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning of DICOM compliant medical images. This product is not intended for use with or for the primary diagnostic interpretation of mammography images.

Synapse 3D Lung and Abdomen Analysis (V3.0) is an application that performs the CT Jung analysis/airway and abdomen 2D and 3D fat analysis.

Lung analysis/Airway .
Lung analysis/Airway is an application using non-contrast and contrast enhanced computed tomographic images of the lung which provides custom workflows and UI, and reporting functions including boundary detection and volume calculation for pulmonary nodules in the lung based on the location specified by the user, segmentation of bronchial tubes in the lung, approximation of air supply region by the user specified bronchial tube, identifying, displaying and processing low absorption regions in the lung,
2D Fat Analysis (Unchanged from the cleared version K103720) . 2D Fat Analysis is an application which can use single slice (2-dimensional) noncontrasted CT images to calculate subcutaneous fat and visceral fat areas.
3D Fat Analysis (Unchanged from the cleared version K103720) . 3D Fat Analysis is an application which can use volume (3-dimensional) non-contrasted CT images to calculate subcutaneous fat and visceral fat areas and volumes.

The following common image processing functions are available to support the analysis of the lung and abdomen CT images. These functions belong to and are provided by Synapse 3D Base Tools (K120361) that is used with Synapse 3D Lung and Abdomen Analysis (V3.0).

Window width and window level. .
Zooming, panning, flip, rotate. .
Measurement of lengths, areas, etc. .
Adding annotations on an image. .
Extraction and Deletion of 3D objects: Editing of mask areas using the smart out feature. .
3D clipping: The display area can be specified for 3D display. .
Creation of video files: Video files with 2D or 3D display can be created. .

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for the Synapse 3D Lung and Abdomen Analysis (V3.0) device, specifically for its new lung volume analysis feature (approximation of air supply region).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Simulated Test: Measured results are within ±5% of known air supply volumes.	Passed. (It has been confirmed that the values obtained in the lung volume analysis have expected accuracy and can be used clinically.)
Real Human Body CT Image Test: Measured air supply region approximation values are within ±10% of reference volumes (for pulmonary lobes).	Passed. (It has been confirmed that the values obtained in the lung volume analysis have expected accuracy and can be used clinically.)

2. Sample Size Used for the Test Set and Data Provenance

Simulated Test: "a simulated image data set for air supply region approximation with known air supply volume for each bronchus." (Specific number of cases or volumes not given, but implies a designed set.)
Real Human Body CT Image Test: "five lung CT image data sets of real human body."
Data Provenance: Not explicitly stated for either test in terms of country of origin or whether it was retrospective or prospective. The term "real human body" suggests clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Simulated Test: Ground truth was established by "known air supply volume for each bronchus," implying a computational or theoretical basis rather than expert consensus on images. Experts were not used to establish this ground truth.
Real Human Body CT Image Test: The ground truth for the "reference volumes of five pulmonary lobes for each test data set" was established manually "using the validated segmentation tools." The number of experts is not specified, nor are their particular qualifications (e.g., radiologist with X years of experience). The phrasing "manually using the validated segmentation tools" suggests a skilled user performing the segmentation, rather than a multidisciplinary expert panel.

4. Adjudication Method for the Test Set

The document implies that the "validated segmentation tools" were used to establish the reference volumes for the real human body CT images. No formal adjudication method like "2+1" or "3+1" is described. The simulated test had "known values," so no adjudication was needed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned for the new lung volume analysis feature. The testing described focuses on the accuracy of the algorithm's measurements against defined ground truths.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies described are essentially standalone performance evaluations of the algorithm for the new lung volume analysis feature. In the "Test using lung CT image data sets of real human body," the device's output (air supply region approximation) is compared against "reference volumes" established prior to or independently of the device's main function being tested. The user's role is primarily to specify the root of each bronchus, which is an input for the algorithm, but the calculation and approximation itself are done by the device.

7. Type of Ground Truth Used

Simulated Test: "Known air supply volume" (presumably computationally derived or theoretically defined).
Real Human Body CT Image Test: Expert consensus via "manual... segmentation and volume calculation using validated segmentation tools" for pulmonary lobes. This serves as a reference standard for comparison with the device's approximation of air supply regions.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set for the lung volume analysis feature. The studies described are verification/validation tests, not details of model training.

9. How the Ground Truth for the Training Set Was Established

Since the document does not provide information on the training set, it also does not describe how its ground truth was established.

Summary

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K120648

5. 510(k) Summary

Date Prepared:

February 28, 2012

Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, Connecticut 06902

Telephone:	(301) 251-1092
Fax:	(203) 602-3785
Contact:	Jvh-Shyan Lin

Device Trade Name:

Synapse 3D Lung and Abdomen Analysis

Device Common Name:

Medical Image Processing and Analysis Software

Regulation Number:

21 CFR 892.2050

Device Classification:

Class II

Device Classification Name :

Picture Archiving and Communications System (PACS)

Panel:

· Radiology

Product Code:

LLZ

Date Received:

TBD

Decision Date:

TBD

Decision:

TBD

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Predicate Device:

· Synapse 3D Lung and Abdomen Analysis (K103720), FUJIFILM Medical Systems U.S.A., Inc.
· Pulmonary Workstation 2 (K083227), VIDA Diagnostics, Inc.

Description of the Device

Synapse 3D Lung and Abdomen Analysis (V3.0) is the updated version of previously-cleared Synapse 3D Lung and Abdomen Analysis software (cleared by CDRH via K103720 on 03/16/2011).

Synapse 3D Lung and Abdomen Analysis (V3.0) is an application that performs the CT Jung analysis/airway and abdomen 2D and 3D fat analysis.

Lung analysis/Airway .
Lung analysis/Airway is an application using non-contrast and contrast enhanced computed tomographic images of the lung which provides custom workflows and UI, and reporting functions including boundary detection and volume calculation for pulmonary nodules in the lung based on the location specified by the user, segmentation of bronchial tubes in the lung, approximation of air supply region by the user specified bronchial tube, identifying, displaying and processing low absorption regions in the lung,
2D Fat Analysis (Unchanged from the cleared version K103720) . 2D Fat Analysis is an application which can use single slice (2-dimensional) noncontrasted CT images to calculate subcutaneous fat and visceral fat areas.
3D Fat Analysis (Unchanged from the cleared version K103720) . 3D Fat Analysis is an application which can use volume (3-dimensional) non-contrasted CT images to calculate subcutaneous fat and visceral fat areas and volumes.

Window width and window level. .
Zooming, panning, flip, rotate. .
Measurement of lengths, areas, etc. .
Adding annotations on an image. .
Extraction and Deletion of 3D objects: Editing of mask areas using the smart out feature. .
3D clipping: The display area can be specified for 3D display. .
Creation of video files: Video files with 2D or 3D display can be created. .

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Indication for Use

Synapse 3D Lung and Abdomen Analysis is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning, Synapse 3D Lung and Abdomen Analysis accepts DICOM compliant medical images acquired from CT.

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Addition to Synapse 3D Base Tools, Synapse 3D Lung and Abdomen Analysis is intended to:

use non-contrast and contrast enhanced computed tomographic images of the lung. provide custom workflows and UI, and reporting functions for lung analysis including boundary detection and volume calculation for pulmonary nodules in the lung based on the location specified by the user, segmentation of bronchial tubes in the lung, approximation of air supply region by the user specified bronchial tube, identifying, displaying and processing low absorption regions in the lung.
use non-contrasted CT images and calculate subcutaneous fat and visceral fat areas in 2D and both volumes in 3D.

Technological Characteristics

Synapse 3D Lung and Abdomen Analysis introduces no new safety or efficacy issues other than those already indentified with the predicate devices. The results of the Hazard Analysis combined with the appropriate preventive measures that the device is of moderate concern as per the May 11, 2005 issue of the "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices."

Testing

Synapse 3D Lung and Abdomen Analysis is tested successfully with reference to its Software Requirements Specification, as well as design verification and validation documents and Traceability Matrix document. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the Synapse 3D Lung and Abdomen Analysis software, which is found to be safe and effective and substantially equivalent to the currently-cleared predicate device. Testing involved system level functionality test, segmentation accuracy test, measurement accuracy test, interfacing test, usability test, serviceability test, labeling test, as well as the test for risk mitigation method and implemented in the risk management process, in the same manner as our previously-cleared predicate device.

New to this submission is lung volume analysis (approximation of air supply region). To establish that our device is as safe and effective as the predicate device, Fujifilm performed the following two nonclinical tests for the proposed device:

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(a) Simulated test

Test protocol summary

Prepared a simulated image data set for air supply region approximation with known air supply volume for each bronchus. Then performed air supply region approximation and compared the measured results with known volumes.

Acceptance criteria

Pass if the measured results are within ±5% of known values.

(b) Test using lung CT image data sets of real human body

Test protocol summary

Prepared five lung CT image data sets of real human body. Performed five pulmonary lobes segmentation and volume calculation manually using the validated segmentation tools in order to obtain the reference volumes of five pulmonary lobes for each test data set. Then performed air supply region approximation of each lung lobe by specifying the root of each bronchus and compared the measured results with the reference volumes.

Acceptance criteria

Pass if the measured values are within ±10% of reference values.

Test Results: The planned test cases have passed. It has been confirmed that the values obtained in the lung volume analysis have expected accuracy and can be used clinically.

Conclusion

This 510(k) premarket notification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Druq and Cosmetic Act. Our device has similar indications for use, technology, labeling and testing as the predicate device. Therefore, we conclude that our device is as safe and effective as the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Mr. Jyh-Shyan Lin Senior Manager, Regulatory, Quality and Clinical Affairs FUJIFILM Medical Systems, U.S.A., Inc. 419 West Avenue STAMFORD CT 06902

JUN 1 4 2012

Re: K120648

Trade/Device Name: Synapse 3D Lung and Abdomen Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 26, 2012 Received: April 27, 2012

Dear Mr. Lin:

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 mourements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as be form as keting your device as described in your Section 510(k) premarket wification. The FDA finding of substantial equivalence of your device to a legally marketed notificate 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 s 1507 Tion, (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

Acting 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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Indications for Use

510(k) Number (if known):

Device Name: Synapse 3D Lung and Abdomen Analysis

Indications for Use:

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Addition to Synapse 3D Base Tools, Synapse 3D Lung and Abdomen Analysis is intended to;

use non-contrast and contrast enhanced computed tomographic images of the lung, provide custom workflows and UI, and reporting for lung analysis including boundary detection and volume calculation for pulmonary nodules in the lung based on the location specified by the user, segmentation of bronchial tubes in the lung, approximation of air supply region by the user specified bronchial tube, identifying, displaying and processing low absorption regions in the lung.

use non-contrasted CT images and calculate subcutaneous fat and visceral fat areas in 2D and both volumes in 3D.

Prescription Use × AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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 Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices

Office of In

510K

Page 1 of __

Regulation Number and Section

§ 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).