FUSIONSYNC, CHIMAERA FUSIONSYNC

K132963 · Chimaera GmbH · LLZ · Dec 16, 2013 · Radiology

Device Facts

• Record ID: K132963
• Device Name: FUSIONSYNC, CHIMAERA FUSIONSYNC
• Applicant: Chimaera GmbH
• Product Code: LLZ · Radiology
• Decision Date: Dec 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The device FusionSync contains automatic registration algorithms that are intended for the spatial synchronization of different series. The automatic algorithm is not intended for the registration of series from modalities other than: CT, conventional MRI, PET or SPECT. In addition, the product contains a manual mode (non-automatic) that allows the registration via user interaction such that for example automatic registration results can be refined. The intended clinical use is to display different 3D series from the same patient in spatial synchronization as for example, but not limited to, followup examinations. The displayed series can be visualized as MPR views with arbitrary 3D orientation. It is possible to overlay a registered series onto an MPR view. The spatial synchronization and optional overlay, based on the registration result, is intended to help the clinician to obtain a better understanding of the joint information of two registered images. The clinician retains the responsibility for making the diagnosis based on their standard procedures where the separate unregistered images are compared visually. FusionSync complements these clinical standard procedures.

Device Story

FusionSync is a software plug-in for medical imaging workstations (e.g., OsiriX PRO) providing automatic and manual image registration. It accepts 3D volumetric data from CT, MRI, PET, and SPECT. The registration engine performs rigid body transformations (translation and rotation) to align image series spatially. Outputs include synchronized multiplanar reconstruction (MPR) views and overlaid images. Used by radiologists and nuclear medicine physicians in clinical settings to facilitate comparison of multi-modal or follow-up studies. By automating alignment, it eliminates manual viewing adjustments, allowing clinicians to visualize joint anatomical or functional information more efficiently. The clinician remains responsible for final diagnosis based on standard visual comparison procedures.

Clinical Evidence

No clinical data. Performance validation was based on bench testing, including software verification and validation per FDA guidance.

Technological Characteristics

Software-based registration engine; platform-independent plug-in architecture. Supports rigid body deformation (translation/rotation). Compatible with CT, MRI, PET, SPECT. Integrates with existing workstations (e.g., OsiriX PRO). Software level of concern: Moderate.

Indications for Use

Indicated for spatial synchronization of 3D image series (CT, MRI, PET, SPECT) for clinical visualization, including follow-up examinations. Intended for prescription use by clinicians to assist in understanding joint information of registered images; not for primary diagnosis.

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

• Fusion 7D (K020546)

Submission Summary (Full Text)

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K132963
Page 1 of 6

FusionSync

# 510(k) SUMMARY

DEC 1 6 2013 AERA

510(k) summary of safety and effectiveness (21 CFR 807.92):

| Date of summary:<br>807.92(a)(1) | 08/08/2013 |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Owner/Submitter's name:<br>807.92(a)(1) | Chimaera GmbH |
| Owner/Submitter's address:<br>807.92(a)(1) | Am Weichselgarten 7,<br>91058 Erlangen, Germany |
| Owner/Submitter's contact:<br>807.92(a)(1) | Marcus Pruemmer |
| Telephone number:<br>807.92(a)(1) | [phone] |
| Fax number:<br>807.92(a)(1) | [phone] |
| Device Proprietary Names:<br>807.92(a)(2) | FusionSync 1.0<br>Chimaera FusionSync 1.0 |
| Device Common Name(s):<br>807.92(a)(2) | Multi-modality Registration Software |
| Classification Name:<br>807.92(a)(2) | Class II: Picture Archiving and Communications System<br>(892.2050) Product Code: LLZ Image Processing System |

## 807.92(u)(3):

FusionSync is Substantially Equivalent to the following Legally Marketed device:

| 510(k) Number | Trade Name | Manufacturer |
|---------------|------------|---------------------|
| K020546 | Fusion 7D | Mirada Medical Ltd. |

# Definitions:

| Image Registration | |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The alignment of one or more images to a reference image. The alignment is computed based on a mathematical optimization problem that spatially correlates the images according functional activity or anatomical structures. The result of a registration is a transform that describes the spatial |

Chimaera GmbH

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## 510(k) SUMMARY FusionSync

## Traditional Premarket Notification 510(k)

| | correlation of 3D positions between the images. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Fusion | Visualize the content of different images (usually the same organ or<br>anatomical region) in the same image viewer window. A common technique<br>is to overlay the different images via semi-transparent rendering. |
| Synchronization/<br>Binding | Spatial linking of two different image views (no overlay), as for example<br>Multiplanar Reconstruction (MPR) views. The registration transform builds<br>the spatial link between two series such that the visualization setting (e.g.<br>spatial orientation and position) of one MPR view is transferred to a linked<br>MPR view such that both views show the same anatomical region during<br>navigation of one of the MPRs through the volumetric data. |

# 1 DEVICE DESCRIPTION (807.92(a)(4))

## Labeling Description Example:

Today, diagnosis based on follow-up image series and multi-modal acquisitions is often timeconsuming due to missing data alignment and the need for manual adaptions of viewing settings. FusionSync is a fast, automatic image-registration algorithm that is scamlessly integrated in the aycan workstation OsiriX PRO. FusionSync allows viewing of multi-modal and follow-up series together. Users can navigate easily through large data sets based on spatial synchronization. Timeconsuming adaptions of view settings are completely eliminated, as viewing properties are propagated to all linked series.

## Device Description:

FusionSync is a software program that provides a registration engine to align (register) pairs of images from same and different imaging modalities. The platform-independent registration engine is designed as a plug-in component that has the ability to extend the productivity of existing viewers like CAD workstations or PACS. The graphical user interface of FusionSync is designed as a plug-in component for avean workstation OsiriX PRO. It includes functionality to display the original volumetric data and the results of the registration operation. The graphical user interface allows to control the registration engine and fusion visualization.

## Registration Engine:

FusionSync supports the registration of anatomical images (MRI and CT) and functional images (SPECT and PET). The registration engine provides a) manual registration, where the user defines the registration transform and b) automatic registration, where the software computes without any user input the registration result. The transformation is limited to a rigid body deformation (i.e. translation and rotation). The registration engine allows to register any combination of CT, conventional MRI, PET and SPECT images. The advanced technology of our registration engine is designed to easily and rapidly integrate into existing medical imaging applications.

## 2 INTENDED USE (807.92(a)(5))

The device FusionSyne contains automatic registration algorithms that are intended for the spatial

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### FusionSync

synchronization of different series. The automatic algorithm is not intended for the registration of series from modalities other than: CT, conventional MRI, PET or SPECT. In addition, the product contains a manual mode (non-automatic) that allows the registration via user interaction such that for example automatic registration results can be refined. The intended clinical use is to display different 3D series from the same patient in spatial synchronization as for example, but not limited to, followup examinations. The displayed series can be visualized as MPR views with arbitrary 3D orientation. It is possible to overlay a registered series onto an MPR view. The spatial synchronization and optional overlay, based on the registration result, is intended to help the clinician to obtain a better understanding of the joint information of two registered images. The clinician retains the responsibility for making the diagnosis based on their standard procedures where the separate unregistered images are compared visually. FusionSync complements these clinical standard procedures.

# 3 TECHNOLOGICAL CHARACTERISTICS/FEATURE COMPARISON

#### 807.92(a)(6):

The following Table 1 provides technological characteristics and a feature comparison to the predicate device:

| Feature | Fusion7D | FusionSync | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|---------------------------------------------------|-----|
| Registration Engine | | | |
| Automatic Registration | YES | YES | |
| Manual Registration | YES | YES | |
| Semi-automatic<br>(matching of landmarks) | YES | . NO | |
| Rigid body deformation<br>i.e. translation and rotation | YES | YES | |
| Consecutive sequence of<br>fusion methods.<br>(An automatic fusion can be run on the<br>results of an initial step e.g. manual<br>registration) | YES | YES | |
| Fast Registration | 20-30s even for very large<br>imaging studies. | 3-10s even for very large<br>imaging studies. | |
| Spatial Precision<br>1. Precision depends on the accuracy of<br>the lowest resolution voxel in either the<br>source or target imaging study.<br>2. For high resolution CT or MRI the<br>fusion should achieve millimeter-level<br>accuracy<br>3. Lower resolution data sets for<br>functional imaging typically have a voxel<br>resolution of several millimeters (even<br>centimeters in the slicing direction) | | YES | YES |
| Deformable body deformation<br>i.e. non-rigid registration | | YES (Fusion7D Advanced)<br>NO (Fusion7D Standard) | NO |
| Supported data to compare<br>pairs of images: | | | |
| Anatomical to Anatomical | | | |
| Source | Target | | |
| MRI | MRI | YES | YES |
| MRI | CT | YES | YES |
| CT | CT | YES | YES |
| Anatomical to Functional | | | |
| Source | Target | | |
| MRI | PET | YES | YES |
| MRI | SPECT | YES | YES |
| CT | PET | YES | YES |
| CT | SPECT | YES | YES |
| Data/Image Browsing and Visualization | | | |
| Orthogonal and any-plane<br>slicing of the volumetric data | | YES | YES |
| Whole and region of interest<br>zooming | | YES | YES |
| Panning | | YES | YES |
| Window and level controls | | YES | YES |
| Image overlays for which the<br>transparency, threshold and<br>colormap is user controlled | | YES | YES |
| Bindings/Spatial<br>Synchronization<br>(using tools such as Zoom affect every<br>image window) | YES | YES | |
| Save/Load Transformation<br>(registration matrix) | YES | NO | |
| Live Updates<br>(shows on the screen the steps in the<br>registration process) | YES | NO | |
| Stand-Alone Workstation<br>Software | YES | NO | |
| Application Range | Radiology, Nuclear Medicine | Radiology, Nuclear Medicine | |
| Supports compressed image<br>formats | NO | NO | |
| Snapshot (capture any image) | YES | YES | |

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# 510(k) SUMMARY
FusionSync

# ______________________________________________________________________________________________________________________________________________________________________________

.

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## 510(k) SUMMARY Traditional Premarket Notification 510(k)

Tuble 2: Comparison of technological features

## 3.a SUMMARY

FusionSync

FusionSync does not provide landmark based registration. However, this feature requires the user to manually place software based landmarks in the rendered images. This is very time consuming and usually a feature that is rarely used in standard clinical routines. It is sufficient to provide a manual registration to allow a physician a refinement/correction of an automatic registration result. Furthermore, FusionSync does not feature a live update of the fused images during the registration process. This does not effect the effectiveness of the device since there is no diagnostic benefit from showing intermediate results of a registration that takes in average less than three seconds.

# 4 DISCUSSION OF NON-CLINICAL TESTS PERFORMED FOR

# DETERMINATION OF SUBSTANTIAL EQUIVALENCE

## 807.92(b)(1):

Performance testing included software validation, verification and testing per FDA's software validation guidance.

# 5 DISCUSSION OF CLINICAL TESTS PERFORMED

807.92(b)(2): N/A

# 6 SUMMARY AND CONCLUSIONS

## 807.92(b)(3):

The intended use, technological characteristics/features and performance characteristics for FusionSync are substantially equivalent to the legally marketed predicate device Fusion7D. The documentation supplied demonstrates that any difference in technological characteristics do not raise

Chimacra GmbH

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K132963
Page 6 of 6

## 510(k) SUMMARY FusionSync

# Traditional Premarket Notification 510(k)

any new question of safety or effectiveness.

The 510(k) Pre-Market Notification for FusionSync contains adequate information and data to enable FDA – CDRH to determine substantial equivalence to the predicate device. The submission contains the results of a hazard analysis and the "Level of Concern" for potential

hazards has been classified as "Moderate".

Chimaera GmbHi

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 16, 2013

Chimaera GmbH % Marcus Pruemmer, Dr .- Ing, CEO Am Weichselgarten 7 Erlangen, Bavaria, 91058 GERMANY

Re: K132963

Trade/Device Name: FusionSync, Chimaera FusionSync Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications software Regulatory Class: Class II Product Code: LLZ Dated: September 26, 2013 Received: September 27, 2013

Dear Dr. Pruemmer:

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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#### Page 2-Dr. Pruemmer

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcestorYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

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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### .............................................................................................................................................................................. Food and Drug Administration

## Indications for Use

510(k) Number (if known) K132963

# Device Name

FusionSync

### Indications for Use (Describe)

The device FusionSync contains automatic registration algorithms that are intended for the spatial synchronization of different series. The automatic algorithm is not intended for the registration of series from modalities other than: CT, conventional MRI, PET or SPECT. In addition, the product contains a manual mode (non-automatic) that allows the registration via user interaction such that for example automatic registration results can be refined. The intended clinical use is to display different 3D series from the same patial synchronization as for example, but not limited to, followup examinations. The displayed series can be visualized as MPR views with arbitrary 3D orientation. It is possible to overlay a registered series onto an MPR view. The spatial synchronization and optional overlay, based on the registration result, is intended to help the clinician to obtain a better understanding of the joint information of two registered images. The clinician retains the responsibility for making the diagnosis based on their standard procedures where the separate unregistered images are compared visually. FusionSync complements these clinical standard procedures.

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)
Page 1 of 2
PSC Publishing Services [phone]

FORM FDA 3881 (9/13)

Form Approved: OMB No. 0910-0120… Expiration Date: December 31, 2013 See PRA Slatement on last page.