(87 days)
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.
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.
Here's an analysis of the acceptance criteria and study information for the FusionSync device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) summary, does not explicitly state quantitative acceptance criteria for FusionSync's performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (Fusion7D) by comparing technological characteristics and features. The comparison focuses on functionality and speed rather than specific performance metrics like accuracy or precision with defined thresholds.
However, based on the "Technological Characteristics/Feature Comparison" table, we can infer some performance aspects:
| Feature | Acceptance Criteria (Implied by Comparison to Predicate) | Reported FusionSync Performance |
|---|---|---|
| Automatic Registration | Must perform automatic registration. | YES (Performs automatic registration) |
| Manual Registration | Must perform manual registration. | YES (Performs manual registration) |
| Rigid Body Deformation | Must support rigid body deformation (translation, rotation). | YES (Supports translation and rotation) |
| Consecutive Fusion Methods | Must allow consecutive fusion methods (e.g., automatic refinement of manual). | YES (Supports consecutive fusion methods) |
| Fast Registration | Performance comparable to or better than predicate (20-30s for large studies). | 3-10s even for very large imaging studies. |
| Spatial Precision | Achieve millimeter-level accuracy for high-res CT/MRI; precision depends on lowest resolution voxel. | YES (Supports spatial precision criteria similar to predicate) |
| Deformable Body Deformation | Not required for FusionSync (predicate had standard and advanced versions). | NO |
| Supported Image Pairs | Must support various anatomical and functional image pair registrations as predicate. | YES (MRI-MRI, MRI-CT, CT-CT, MRI-PET, MRI-SPECT, CT-PET, CT-SPECT) |
| Image Browsing/Visualization | Must include standard viewing features as predicate. | YES (Orthogonal/any-plane slicing, zooming, panning, window/level, image overlays, spatial synchronization, snapshot) |
| Save/Load Transformation | Predicate had this feature. | NO (FusionSync does not have this) |
| Live Updates | Predicate had this feature. | NO (FusionSync does not have this) |
| Stand-Alone Workstation Software | Predicate had this feature. | NO (FusionSync is a plug-in component) |
Key takeaway: The submission argues that FusionSync's faster registration speed is a technological advancement, and the absence of features like landmark-based registration, live updates, or standalone software does not negatively impact effectiveness because they are either time-consuming, rarely used, or not diagnostically beneficial.
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention any specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a study to prove acceptance criteria.
The submission focuses entirely on non-clinical tests (software validation, verification, and testing per FDA guidance) to demonstrate substantial equivalence, rather than a clinical performance study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical test set or study is described, there is no information provided regarding experts, their number, or qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
As no test set or clinical study is described, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted or reported in this 510(k) summary. The document explicitly states "DISCUSSION OF CLINICAL TESTS PERFORMED: N/A". Therefore, no effect size for human readers improving with AI vs. without AI assistance is provided.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
The document states that "Performance testing included software validation, verification and testing per FDA's software validation guidance." This suggests that the algorithm's functionality and performance were tested in isolation as part of the software validation process. The "Automatic Registration" feature implies standalone algorithmic performance. However, no specific standalone performance study with reported metrics (e.g., accuracy against ground truth) is described. The comparison is feature-based against the predicate.
7. The Type of Ground Truth Used
Given that no clinical study is described, no specific type of ground truth (expert consensus, pathology, outcomes data, etc.) is mentioned as being used for performance evaluation of the device against clinical criteria. The "ground truth" implicitly referred to in software validation for a registration device would relate to the correctness of the spatial alignment based on mathematical or pre-defined transformations, rather than clinical diagnostic ground truth.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This 510(k) pertains to a software device, and while it uses "automatic registration algorithms," it does not specify if these algorithms are machine learning-based requiring a distinct training phase. If they are based on traditional image processing and optimization techniques, a separate "training set" in the machine learning sense might not be applicable or explicitly mentioned.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, no information on how its ground truth was established is provided.
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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:807.92(a)(1) | 08/08/2013 |
|---|---|
| Owner/Submitter's name:807.92(a)(1) | Chimaera GmbH |
| Owner/Submitter's address:807.92(a)(1) | Am Weichselgarten 7,91058 Erlangen, Germany |
| Owner/Submitter's contact:807.92(a)(1) | Marcus Pruemmer |
| Telephone number:807.92(a)(1) | +49 9131 691385 |
| Fax number:807.92(a)(1) | +49 9131 691386 |
| Device Proprietary Names:807.92(a)(2) | FusionSync 1.0Chimaera FusionSync 1.0 |
| Device Common Name(s):807.92(a)(2) | Multi-modality Registration Software |
| Classification Name:807.92(a)(2) | Class II: Picture Archiving and Communications System(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 oranatomical region) in the same image viewer window. A common techniqueis to overlay the different images via semi-transparent rendering. |
| Synchronization/Binding | Spatial linking of two different image views (no overlay), as for exampleMultiplanar Reconstruction (MPR) views. The registration transform buildsthe spatial link between two series such that the visualization setting (e.g.spatial orientation and position) of one MPR view is transferred to a linkedMPR view such that both views show the same anatomical region duringnavigation 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(matching of landmarks) | YES | . NO | |
| Rigid body deformationi.e. translation and rotation | YES | YES | |
| Consecutive sequence offusion methods.(An automatic fusion can be run on theresults of an initial step e.g. manualregistration) | YES | YES | |
| Fast Registration | 20-30s even for very largeimaging studies. | 3-10s even for very largeimaging studies. | |
| Spatial Precision1. Precision depends on the accuracy ofthe lowest resolution voxel in either thesource or target imaging study.2. For high resolution CT or MRI thefusion should achieve millimeter-levelaccuracy3. Lower resolution data sets forfunctional imaging typically have a voxelresolution of several millimeters (evencentimeters in the slicing direction) | YES | YES | |
| Deformable body deformationi.e. non-rigid registration | YES (Fusion7D Advanced)NO (Fusion7D Standard) | NO | |
| Supported data to comparepairs 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-planeslicing of the volumetric data | YES | YES | |
| Whole and region of interestzooming | YES | YES | |
| Panning | YES | YES | |
| Window and level controls | YES | YES | |
| Image overlays for which thetransparency, threshold andcolormap is user controlled | YES | YES | |
| Bindings/SpatialSynchronization(using tools such as Zoom affect everyimage window) | YES | YES | |
| Save/Load Transformation(registration matrix) | YES | NO | |
| Live Updates(shows on the screen the steps in theregistration process) | YES | NO | |
| Stand-Alone WorkstationSoftware | YES | NO | |
| Application Range | Radiology, Nuclear Medicine | Radiology, Nuclear Medicine | |
| Supports compressed imageformats | 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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 (301) 443-6740
FORM FDA 3881 (9/13)
Form Approved: OMB No. 0910-0120… Expiration Date: December 31, 2013 See PRA Slatement on last page.
N/A