Synapse Image Visualization Software MIP/MPR Obliquus enables the display of 3D (MIP/MPR) visualization of CT and MR studies. Typical users are radiologista, technologists and clinicians.

Device Description

Obliquus is an integrated Maximum Intensity Projection (MIP) and Multi-Planar Reformatting (MPR) software package intended to be used with Fuji Synapse Workstation Software Version 3.1.1 and higher. This software is designed to be used by radiologists, clinicians and referring physicians to acquire, process, review, store, print and distribute DICOM compliant image studies utilizing standard PC hardware. Obliquus offers similar user interface and image manipulation functionality as was cleared in Synapse Workstation software version 3.1.0.

The Obliquus software enables the user to display MPR visualization of CT or MRI studies in Synapse. Once opened in Synapse, the images can be presented in the following viewers:

MPR Viewer: Visualizes a study image of the selected series in the following four types of plane images:

(1) Original view is the original CT or MRI study image.

(2) Reformatted A view represents visualization of the original view orthogonal to the original study plane (i.e., if original image is axial, then Reformatted A will be of the coronal plane).

(3) Reformatted B view represents visualization of the original view orthogonal to the original study plane (i.e., if the original image is axial, then Reformatted B will be of the sagittal plane).

(4) Oblique view shows a plane image from any direction specified by the user.

Compare Viewer: Compare viewer consists of four windows and up to four series that can be displayed for visual comparison. The Compare viewer functions are as follows:

. Synchronously display images of each series
Make synchronous display setting which includes adjusting slice position and changing . synchro unit
. Switch among 3 orthogonal plane images
Set rendering mode and slab thickness .
Display patient study and image information .
. Toggle with the MPR viewer

Stereo Viewer: Presents images for stereopsis, particularly for Magnetic Resonance Angiography (MRA) MIP images. The Stereo viewer's functions include:

. Rotating and displaying plane images horizontally
. Setting image display format
. Setting rendering mode, slab thickness and projection angle interval
. Display patient, study and image information
. Toggle with the MPR viewer

Images can be saved either as bitmap files or to the Synapse server.

AI/ML Overview

The provided text is a 510(k) summary for the FUJIFILM Medical Systems U.S.A., Inc. Synapse 3D MIP/MPR Image Visualization Software OBLIQUUS. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically understood for performance metrics like accuracy, sensitivity, or specificity.

The document focuses on regulatory clearance based on substantial equivalence, rather than a detailed performance study with quantitative metrics. The "Testing" section broadly refers to "Functional testing" as part of the product development process, but provides no specifics on methodology, results, or acceptance criteria.

Therefore, for the requested information, many fields will be marked as "Not provided in the document."

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Not specified.	Not specified.	The document states "Functional testing is a part of the Product Development process" but does not detail specific acceptance criteria (e.g., accuracy, precision) or quantitative performance results for the device's image visualization capabilities.

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

Sample size for test set: Not provided in the document.
Data provenance: Not provided in the document. The document mentions "CT or MRI studies" as input for the software but does not specify the origin or nature of the data used for any testing.
Retrospective or Prospective: Not provided in the document.

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

Number of experts: Not provided in the document.
Qualifications of experts: Not provided in the document.

As there is no detailed performance study described for the device's visualization capabilities, the concept of "ground truth" and expert adjudication in the context of diagnostic accuracy, which these questions imply, is not applicable or detailed in this 510(k) summary. The summary focuses on functional equivalence to a predicate device for image display and manipulation.

4. Adjudication Method for the Test Set

Adjudication method: Not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers Improve with AI vs. Without AI Assistance

MRMC study done: No. This document describes an image visualization software, not an AI software intended to assist human readers in a diagnostic capacity or a comparative effectiveness study of its impact on reader performance.
Effect size of human reader improvement with AI vs. without AI assistance: Not applicable/Not provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

Standalone study done: Not explicitly described in the context of performance metrics for image visualization. The "Testing" section refers to "Functional testing" but doesn't detail a standalone performance study with specific outcomes. The device itself is an "Image Visualization Software," implying human interaction is integral to its intended use, rather than an autonomous algorithm making diagnoses.

7. The Type of Ground Truth Used

Type of ground truth: Not provided in the document. (Given the nature of the device as image visualization software, "ground truth" in the diagnostic sense is not the primary focus of this submission, which emphasizes functional equivalence).

8. The Sample Size for the Training Set

Sample size for training set: Not applicable/Not provided. This software is described as an image visualization tool, not a machine learning or AI-based diagnostic tool that would typically involve a "training set" for model development.

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

How ground truth for training set was established: Not applicable/Not provided. (See point 8).

Summary

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Kobl672

JUN 2 9 2006

510(k) Summary

Date Prepared

May 12, 2006

Submitter's Information

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

Telephone: (203) 602-3774 Facsimile: (203) 363-3813 Contact: Debra A. Peacock

Device Trade Name,

Synapse 3D MIP/MPR Image Visualization Software OBLIQUUS

Device Common Name:

Image processing, management and 3D (MIP/MPR) visualization system

Regulation Number:

892.2050

Device Classification: Class II

Device Classification Name: Picture Archiving Communication System (PACS)

Panel:

Radiology

Product Code:

90 LLZ

Date Received: TBD

Decision Date:

TBD

Decision:

TBD

Predicate Device

Sectra IDS5 Radiology Workstation with Sectra 3D and MPR packages 510(k) #: K040376, cleared by CDRH on 05/04/04

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Description of the Device

The Obliquus software enables the user to display MPR visualization of CT or MRI studies in Synapse. Once opened in Synapse, the images can be presented in the following viewers:

MPR Viewer: Visualizes a study image of the selected series in the following four types of plane images:

(1) Original view is the original CT or MRI study image.

(2) Reformatted A view represents visualization of the original view orthogonal to the original study plane (i.e., if original image is axial, then Reformatted A will be of the coronal plane).

(3) Reformatted B view represents visualization of the original view orthogonal to the original study plane (i.e., if the original image is axial, then Reformatted B will be of the sagittal plane).

(4) Oblique view shows a plane image from any direction specified by the user.

Compare Viewer: Compare viewer consists of four windows and up to four series that can be displayed for visual comparison. The Compare viewer functions are as follows:

. Synchronously display images of each series
Make synchronous display setting which includes adjusting slice position and changing . synchro unit
. Switch among 3 orthogonal plane images
Set rendering mode and slab thickness .
Display patient study and image information .
. Toggle with the MPR viewer

Stereo Viewer: Presents images for stereopsis, particularly for Magnetic Resonance Angiography (MRA) MIP images. The Stereo viewer's functions include:

. Rotating and displaying plane images horizontally
. Setting image display format
. Setting rendering mode, slab thickness and projection angle interval
. Display patient, study and image information
. Toggle with the MPR viewer

Images can be saved either as bitmap files or to the Synapse server.

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The maximum allowable number of slices for which images can be visualized depends on the memory capacity of the computer being used. With main memory of 1G bytes, approximately 600 slices of ordinary CT images can be processed.

Software Specifications

Obliquus is optional software for use with the medical network system SYNAPSE version 3.1.1 and higher. To allow Obliguus to run on a PC, it is essential that SYNAPSE is running on that same PC. Specifications for operating this Software are congruous with the SYNAPSE specifications. Below are notes specific to this Software:

(1) Supported operating systems

Windows 2000 and Windows XP.

(2) Measure of required memory capacity

1 to 2 Gbytes.

Intended Use

Obliquus:

Synapse Image Visualization Software MIP/MPR Obliquus enables the display of 3D (MIP/MPR) visualization of CT and MR studies. Typical users are radiologists, technologists and clinicians.

Predicate Device:

The Sectra IDS5 device is intended for the manipulation and displaying of x-ray images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.

Device options make possible mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3D and angiography, etc .; and teleconferencing.

Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

Technological Characteristics

The optional Synapse Image Visualization Software (MIP/MPR) OBLIQUUS is comparable and technically equivalent to the visualization software contained in the Sectra IDS5 device with Sectra 3D and MPR software package in that both are integrated into their PACS workstation and can view 2D images .

Safety Information

Synapse Image Visualization Software (MIP/MPR) Obliquus introduces no new safety or efficacy issues other than those already identified with the predicate device. The results of the Hazard Analysis combined with the appropriate preventive measures taken indicate that the device is of minor concern as per the May 11, 2005 issue of the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

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Testing

Obliquus is tested with reference to its Software Requirements Specifications, as documented in Section 16.3, Traceability Matrix Management included in this 510(k) filing. Functional testing is a part of the Product Development process, also included in Section 16 of this filing.

Conclusion

This 510(k) premarket notification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. We conclude the subject device to be as safe and effective as the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird-like symbol, depicted with three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN 2 9 2006

Fujifilm Medical Systems USA, Inc. % Mr. Casey Conry Project Engineer Underwriters Laboratory, Inc. 1285 Wait Whitman Rd. MELVILLE NY 11747

Re: K061672

Trade/Device Name: SYNAPSE 3D Visualization Software OBLIOUUS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 13, 2006 Received: June 14, 2006

Dear Mr. Conry:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/4/Picture/10 description: The image shows a circular logo with the letters "FDA" in the center. Above the letters, the years "1906 - 2006" are displayed. Below the letters, the word "Centennial" is written. The logo is surrounded by text, but the text is too blurry to read.

Protecting and Promoting Public Health

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Page 2 -

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 Part 801); 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.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):
Device Name:	Synapse 3D Visualization Software Obliquus
Indications for Use:

Synapse Image Visualization Software MIP/MPR Obliquus enables the display of 3D (MIP/MPR) visualization of CT and MR studies. Typical users are radiologista, technologists and clinicians.

Prescription Use (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 IS NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

()

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ K 1. 6. 1672

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).