Synapse PACS

K160108 · Fujifilm Medical Systems U.S.A, Inc. · LLZ · Feb 3, 2016 · Radiology

Device Facts

• Record ID: K160108
• Device Name: Synapse PACS
• Applicant: Fujifilm Medical Systems U.S.A, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Feb 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

FUJIFILM Synapse PACS Software (client) is intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server). The FUJIFILM Synapse PACS Software is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The Synapse PACS Software can process medical images from the following modality types: plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine and images from other DICOM compliant modalities. The FUJIFILM Synapse PACS Software enables the display, comparison of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists and clinicians. These functions (MIPMPR/Fusion) are not intended for Mammography use. The FUJIFILM Synapse PACS Software may be used to process FUJIFILM's DICOM MG "For Processing" images and also for the display, manipulation, and interpretation of lossless compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible displays for mammography.

Device Story

Synapse PACS is a web-based client/server software system for medical image management; integrates capabilities of previous Synapse Workstation and MPR/Fusion software. Inputs: DICOM-compliant medical images (X-ray, CT, MRI, ultrasound, nuclear medicine, PET, SPECT). Processing: Server-side image processing; web-based UI for display, manipulation, and 3D reconstruction (MIP/MPR/Fusion). Outputs: Visualized medical images on standard off-the-shelf PCs. Used in clinical environments by radiologists and clinicians for diagnostic interpretation. Enables comparison of current/prior studies, measurement, and annotation. Benefits: Centralized, platform-independent access to multi-modal imaging data; facilitates clinical decision-making through advanced visualization and efficient workflow.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level functionality, component, integration, usability, and installation testing. Benchmark performance testing was conducted using actual clinical images to demonstrate accuracy. All tests passed based on predefined requirements.

Technological Characteristics

Web-based client/server architecture; server-side image processing. Client platform: Windows 7/8.1, browser-based (IE 10/11, Chrome). Server platform: Windows Server 2008 R2/2012 R2. Database: Oracle. Connectivity: Networked DICOM-compliant. Programming: Javascript (TypeScript), HTML5, CSS. Security: Windows Authentication. Software class: Moderate concern per FDA guidance.

Indications for Use

Indicated for radiologists and clinicians to process, display, and compare medical images from DICOM-compliant modalities including X-ray, CT, MRI, ultrasound, nuclear medicine, PET, and SPECT. Includes 3D visualization (MIP/MPR) and fusion capabilities. Supports processing and interpretation of mammography images (For Processing/For Presentation). Not intended for mammography use with MIP/MPR/Fusion functions.

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

• FUJIFILM Synapse Workstation Software (K112439)
• Synapse MPR Fusion (K113244)

Submission Summary (Full Text)

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

February 3, 2016

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

Re: K160108 Trade/Device Name: Synapse PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 15, 2016 Received: January 19, 2016

Dear Jyh-Shyan 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 comply with all 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 device-related adverse events) (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 Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ochs

Robert Ochs. Ph.D. 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) K160108

Device Name Synapse PACS

#### Indications for Use (Describe)

FUJIFILM Synapse PACS Software (client) is intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server). The FUJIFILM Synapse PACS Software is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The Synapse PACS Software can process medical images from the following modality types: plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine and images from other DICOM compliant modalities.

The FUJIFILM Synapse PACS Software enables the display. comparison of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists and clinicians. These functions (MIPMPR/Fusion) are not intended for Mammography use.

The FUJIFILM Synapse PACS Software may be used to process FUJIFILM's DICOM MG "For Processing" images and also for the display, manipulation, and interpretation of lossless compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible displays for mammography.

| Type of Use (Select one or both, as applicable) | | | |
|-----------------------------------------------------------------------------------------------|---------------------------------------------|--|--|
| <div><span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | Over-The-Counter Use (21 CFR 801 Subpart C) | | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED | | | |

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## FUJ}FILM MEDICAL SYSTEMS U.S.A., Inc.

Synapse PACS

#### 510(k) Summary

## 510(k) Number: K160108

## Date Prepared:

February 1, 2016

#### Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, Connecticut 06902 Telephone: [phone] Fax: [phone] Contact: Jyh-Shyan Lin

## Device Trade Name:

Synapse PACS

## Device Common Names:

Picture Archiving and Communications System (PACS)

## Device Classification Name:

System, Image Processing, Radiological

#### Product Code:

LLZ

Regulation Number: 21 CFR 892.2050

## Device Class:

Class II

## Panel:

Radiology

## Predicate Devices:

- . FUJIFILM Synapse Workstation Software (K112439)
- Synapse MPR Fusion (K113244) .

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Synapse PACS

## 1. Description of the Device

The proposed Synapse PACS Software is an implementation that combines capabilities of Synapse Workstation software (K112439) and Synapse MPR/Fusion software (K113244) in a single system, using the current Internet standards for Web clients and servers. The Synapse PACS Software and the predicate devices, i.e., Synapse Workstation Software (K112439) and Synapse MPR Fusion Software (K113244), are picture archiving and communication systems (as defined by 21 CFR 892.2050). Synapse PACS Software is the web based (client/server) application and implementation of the Synapse Workstation Software and the Synapse MPR Fusion Software. The Synapse PACS Software (client) is intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with Synapse PACS Software (server). The Synapse PACS Software is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The Synapse PACS Software can process medical images from the following modality types: plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine and images from other DICOM compliant modalities. Synapse PACS Software enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies (K113244).

In summary, this 510(k) submission introduces the Synapse PACS with the web based (client/server) application and the ability to the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies.

## 2. Indication for Use

FUJIFILM Synapse PACS Software (client) is intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server). The FUJIFILM Synapse PACS Software is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The Synapse PACS Software can process medical images from the following modality types: plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine and images from other DICOM compliant modalities.

The FUJIFILM Synapse PACS Software enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists and clinicians. These functions (MIP/MPR/Fusion) are not intended for Mammography use.

The FUJIFILM Synapse PACS Software may be used to process FUJIFILM's DICOM MG "For Processing" images and also for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible displays for mammography.

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# FUJIYFILM MEDICAL SYSTEMS U.S.A., Inc.

Synapse PACS

#### 3. Substantial Equivalence Comparison

#### 3.1 Device features and technological characteristics comparison

## Table 1. Synapse PACS 5.1.0 vs. Synapse Workstation 3.3.0 (K112439)

| Features | Synapse PACS 5.1.0<br>(This submission) | Synapse Workstation 3.3.0<br>(K112439) |
|----------------------------------------------------------------------------|---------------------------------------------------------|----------------------------------------|
| Product availability | Provided as Software only | Provided as Software only |
| Operating Systems | Windows 7/8.1 | Windows 2000/XP |
| Web Browser | Internet Explorer Version: 10 or 11<br>or Google Chrome | Internet Explorer |
| Database and file access method | Web based (http(s)) | Web based (http(s)) |
| Display of Digital Mammography Images | Yes | Yes |
| Process of Digital Mammography (Non-<br>Processed or For Process) Images | Yes | Yes |
| On-demand access to database and images | Yes | Yes |
| Viewing study lists | Yes | Yes |
| Decompression for compressed images before<br>display | Yes | Yes |
| Display images | Yes | Yes |
| Viewing Reports | Yes | Yes |
| Hanging Protocol | Yes | Yes |
| Spine Labeling | Yes | Yes |
| Reference line display | Yes | Yes |
| Key images identification | Yes | Yes |
| Link multiple series | Yes | Yes |
| Measurement Tools | Yes | Yes |
| Annotation Tools | Yes | Yes |
| Standard Image Manipulation Tools (Window<br>width/level, Zoom, Pan, etc.) | Yes | Yes |
| FCR IPSS for Fuji-CR images | Yes | Yes |
| CT IPSS for CT images | Yes | Yes |

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Synapse PACS

| Features | Synapse PACS 5.1.0<br>(This submission) | Synapse MPR Fusion 2.5<br>(K113244) |
|--------------------------------------------------------------------------------|---------------------------------------------------------|-------------------------------------|
| Product availability | Provided as Software only | Provided as Software only |
| Operating Systems | Windows XP/Vista/Windows 7 | Windows 7, Windows 8.1 64bit |
| Web Browser | Internet Explorer Version: 10 or 11 or Google<br>Chrome | Internet Explorer |
| Database and file access method | Web based (http(s)) | Web based (http(s)) |
| Orthogonal and Oblique Multi Planar<br>Reconstruction (MPR) | Yes | Yes |
| Maximum, Average, and Minimum Intensity<br>Projection (MIP, MPVR, MinIP) | Yes | Yes |
| Curved Multi Planar Reconstruction (CPR) | No | Yes |
| Independent Window/Level of upper and lower<br>images in Fusion Study | Yes | Yes |
| Save Preferences by User Profile | No | Yes |
| Save Window/Level Preferences | Yes | Yes |
| Multi-Modal Fusion to include MR/PET/NM/and<br>CT | Yes | Yes |
| Compare Current Study to previous study in<br>Fusion View | Yes | Yes |
| Compare Current Study to Prior Study in<br>Compare Mode | Yes | Yes |
| Manual Fusion Correction with Rigid<br>Registration in Blend and overlay modes | No | Yes |
| Save series to Synapse PACS | Yes | Yes |

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## FUJIFILM MEDICAL SYSTEMS U.S.A., Inc.

Synapse PACS

#### 3.2 Technology Similarities and Differences

| Technology | Synapse PACS 5.1.0<br>(This Submission) | Synapse Workstation 3.3.0<br>(K112439) |
|------------------------------------------|-----------------------------------------|----------------------------------------|
| Image and Data Processing | Server Side | Client Side |
| Technology Platform (Synapse Client) | Platform Independent (Browser based UI) | Windows Active-X |
| Technology Platform (Synapse Server) | Windows Server | Windows Server |
| System Security | Windows Authentication | Windows Authentication |
| Programming Language(s) (Synapse Client) | Javascript (TypeScript), HTML5, CSS | C++, Active-X |

## Table 3. Synapse PACS 5.1.0 vs. Synapse Workstation 3.3.0 (K112439)

## Table 4. Synapse PACS 5.1.0 vs. Synapse MPR Fusion 2.5 (K113244)

| Technology | Synapse PACS 5.1.0<br>(This Submission) | Synapse MPR Fusion 2.5<br>(K113244) |
|------------------------------------------|-----------------------------------------|-------------------------------------|
| Image and Data Processing | Server Side | Client Side |
| Technology Platform (Synapse Client) | Platform Independent (Browser based UI) | Windows Native Application |
| Technology Platform (Synapse Server) | Windows Server | Windows Server |
| System Security | Windows Authentication | Windows Authentication |
| Programming Language(s) (Synapse Client) | Javascript (TypeScript), HTML5, CSS | C++ |

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## FUJ}{F||LM|MEDICAL SYSTEMS U.S.A., Inc.

Synapse PACS

#### 3.3 Device Specifications Comparison

| Specifications | Synapse PACS 5.1.0<br>(This Submission) | Synapse Workstation 3.3.0<br>(K112439) |
|----------------|---------------------------------------------------|----------------------------------------|
| Client O/S | Windows 7/8.1 | Windows 2000/XP |
| Browser | Internet Explorer Version: 10/11 or Google Chrome | Internet Explorer |
| Server O/S | Windows 2008 R2, or 2012 R2 Server OS | Windows 2003, or 2008 Server OS |
| Database | Oracle | Oracle |

## Table 5. Synapse PACS 5.1.0 vs. Synapse Workstation 3.3.0 (K112439)

## Table 6. Synapse PACS 5.1.0 vs. Synapse MPR Fusion 2.5 (K113244)

| Specifications | Synapse PACS 5.1.0<br>(This Submission) | Synapse MPR Fusion 2.5<br>(K113244) |
|----------------|------------------------------------------------------|-------------------------------------|
| Client O/S | Windows 7/8.1 | Windows 2000/XP |
| Browser | Internet Explorer Version: 10 or 11 or Google Chrome | Internet Explorer |
| Server O/S | Windows 2008 R2, or 2012 Server R2 OS | Windows 2003, or 2008 Server OS |
| Database | Oracle | N/A |

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## FUJIFILM MEDICAL SYSTEMS U.S.A., Inc.

Synapse PACS

## 4. Safety Information

Synapse PACS introduces no new safety or efficacy issues other than those already indentified with the predicate device. The Risk Management and the results of the Hazard Analysis combined with the appropriate preventive measures taken indicate 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." The Synapse PACS labeling contains instructions for use and necessary cautions, warnings and notes to provide the safe and effective use of the device.

## 5. Testing and Performance Information

Synapse PACS is tested successfully with reference to its product requirements, 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 PACS software, which is found to be safe and effective and substantially equivalent to the predicate devices.

Testing involved system level functionality test, component testing, verification testing, integration testing, usability testing, installation/upgrade testing, labeling testing, as well as the testing for risk mitigations associated with the risk management process. In addition, we conducted benchmark performance testing using actual clinical images to help demonstrate that the proposed device achieved the expected accuracy performance.

Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests successfully passed.

## 6. 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 device.