EndoSize

K160376 · Therenva Sas · LLZ · Apr 12, 2016 · Radiology

Device Facts

• Record ID: K160376
• Device Name: EndoSize
• Applicant: Therenva Sas
• Product Code: LLZ · Radiology
• Decision Date: Apr 12, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

EndoSize is a software solution that is intended to provide Physicians and Clinical Specialists with additional information to assist them in reading and interpreting DICOM CT scan images of structures of the heart and vessels. EndoSize enables the user to visualize and measure (diameters, lengths, volumes, angles) structures of the heart and vessels.

Device Story

EndoSize is a standalone software application for Windows/Mac OSX used by physicians and clinical specialists for preoperative planning of endovascular surgery. It ingests DICOM CT scan data from local files or PACS servers. The software performs image processing, including segmentation of cardiovascular structures, automatic/manual centerline detection, 3D reconstruction, volume rendering, and multi-planar reformation (MPR). It provides measurement tools for diameters, lengths, volumes, and angles, and includes modules for specific interventions (EVAR, FEVAR, TEVAR, TAVI, Peripheral). Outputs include annotated images, 3D models, and sizing reports. The device acts as a clinical decision support system; healthcare providers interpret the output to assist in surgical planning and sizing. It does not contact the patient or control life-sustaining equipment.

Clinical Evidence

Bench testing only. Validation included testing of DICOM importation, patient manager functions, image display/processing, module-specific functionality (EVAR, FEVAR, TAVI, Peripheral, Intelix), measurement accuracy, and report generation. Regression testing was performed following software modifications.

Technological Characteristics

Software-only device; runs on standard Windows/Mac OSX hardware. Complies with DICOM (ACR/NEMA) standards. Features include segmentation, centerline detection, 3D reconstruction, volume rendering, and measurement tools. Connectivity via local file import or PACS server. Software life-cycle processes conform to IEC 62304:2006; risk management conforms to ISO 14971:2012.

Indications for Use

Indicated for visualization and measurement of heart and vessel structures for pre-operational planning and sizing for cardiovascular interventions and surgery, and for postoperative evaluation.

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

• EndoSize (K141475)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

April 12, 2016

Therenva SAS % Mr. Cemil Göksu CEO 4 rue Jean Jaurès Rennes 35000 FRANCE

Re: K160376

Trade/Device Name: EndoSize Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 26, 2016 Received: March 14, 2016

Dear Mr. Göksu:

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.

Michael D. O'Hara

For

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) K160376

Device Name EndoSize

Indications for Use (Describe)

EndoSize enables visualization and measurement of the heart and vessels for pre-operational planning and sizing for

cardiovascular interventions and surgery, and for postoperative evaluation.

General functionalities are provided such as:

- Segmentation of cardiovascular structures
- · Automatic and manual centerline detection

· Visualization of CT scan images in every planes, 2D review, 3D reconstruction, Volume Rendering, MPR, Stretched CMPR

- Measurement and annotation tools
- Reporting tools

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)

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# SPECIAL 510(K) SUMMARY

This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.92(c)

| Purpose: | Therenva SAS hereby submits this special 510(k)<br>(K160376) to provide a notification submission for<br>proposed software changes in the already 510(k)<br>cleared EndoSize software (K141475) |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer Name: | Therenva SAS<br>4 rue Jean Jaurès<br>35000 Rennes<br>FRANCE |
| Contact Person : | Cemil Göksu, CEO<br>Tel : [phone]<br>Fax : [phone]<br>E-mail : [e-mail] |
| Establishment Registration Number: | 3011240766 |
| Date prepared: | 01/11/2016 |
| Device Trade Name: | EndoSize |
| Other Device Trade Names: | Intelix |
| Device Common Name: | Image processing software |
| Regulation Class | Class II (21 CFR 892.2050, LLZ) |
| Classification Name: | Picture Archiving Communications System |

Identification of Predicate Device:

| Device Classification Name | Picture Archiving Communications System |
|----------------------------|-----------------------------------------|
| Regulation Number | 892.2050 |
| 510(k) Number | K141475 |
| Device Name | EndoSize |
| Product Code | LLZ |
| Decision | SUBSTANTIALLY<br>EQUIVALENT (SE) |

# Device Description:

EndoSize is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables Physicians and Clinical Specialists to select patient CT scan studies from various data sources, view them, and process the images thanks to a comprehensive set of tools. EndoSize is intended to provide a clinical decision support system during the preoperative planning of endovascular surgery.

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EndoSize contains five modules dedicated to different types of endovascular interventions, EndoSize EVAR, EndoSize FEVAR, EndoSize TEVAR, EndoSize TAVI and EndoSize Peripheral. These modules can be marketed in combination or as separate solutions. It is also possible to market custom versions of EndoSize to Stent manufacturers, based on the modules listed above. The differences between EndoSize and a custom version of EndoSize (user interface, manufacturer logo, manufacturer stent catalogue in the software, optional features of a generic module), do not modify neither the functioning nor the safety of the software.

One custom version of EndoSize is marketed under the trademark "Intelix". This version includes the modules Intelix AFX and/or Intelix AFX2 and/or Intelix NELLIX which are customized versions of EndoSize EVAR module for specific endografts.

EndoSize enables assessment and measurement of different vascular structures such as vessels, valves, aneurysms, and other anomalies. It provides simple to assess the feasibility of endovascular procedures. EndoSize can combine 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. The software accurately represents different types of tissue, making it easier to diagnose anomalies in scans. It works with DICOM CT scan images and can access multiple DICOM data files and PACS server.

### Intended Use:

EndoSize is a software solution that is intended to provide Physicians and Clinical Specialists with additional information to assist them in reading and interpreting DICOM CT scan images of structures of the heart and vessels.

EndoSize enables the user to visualize and measure (diameters, lengths, volumes, angles) structures of the heart and vessels.

#### Indications for Use:

EndoSize enables visualization and measurement of the heart and vessels for preoperational planning and sizing for cardiovascular interventions and surgery, and for postoperative evaluation.

General functionalities are provided such as:

- Segmentation of cardiovascular structures
- Automatic and manual centerline detection
- . Visualization of CT scan images in every planes, 2D review, 3D reconstruction, Volume Rendering, MPR, Stretched CMPR
- . Measurement and annotation tools
- . Reporting tools

#### Technological Characteristics:

EndoSize is a software-only device that runs on a standard computer that meets the minimum requirements. It can use local DICOM files or distant PACS server. The device does not contact the patient, nor does it control any life sustaining devices. The information and measurements displayed, exported or printed are validated and interpreted by Physicians.

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EndoSize complies with the DICOM voluntary standards (ACR/NEMA Digital Imaging and Communication in Medicine).

# Performance Data:

The subject device is designed in conformance with:

- . ACR/NEMA Digital Imaging Communication in Medicine (DICOM) Version 3.1
- ISO 14971:2012 Medical devices Application of risk management to medical devices ●
- IEC 62304:2006 Medical device software Software life-cycle processes ●

Every specification of the EndoSize software is validated by a bench test before release. Bench testing includes:

- Tests of Importation of DICOM images
- Patient Manager tests
- . Tests of image display and processing
- Functioning tests of the different modules EVAR, FEVAR, TAVI, Peripheral, Intelix AFX, Intelix AFX2 and Intelix NELLIX
- . Measurement tests
- Reports creation and exportation tests .

Every modification to the EndoSize software is validated by the same bench testing as described above.

After modification to the EndoSize software, a regression testing of the testing of all specifications of the software as described above, is performed.

#### Design changes

THERENVA is updating some components and adding new features based on the existing software technology, to enhance performance and user experience of EndoSize. The fundamental scientific technology of the modified device has not changed, nor have the indications for use.

| Device Modifications | Rationale for Changes |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Catalogue update: inclusion of the latest endograft references | Improved existing functionality |
| New warnings and disclaimers related to user validation of<br>measurements, key points placement and health care provider's<br>responsibility | Improved performance and user<br>experience |
| PATIENT MANAGER COMPONENT | |
| Patient Manager new minor functionalities: choose default<br>database, reset sizing data | Improved user experience |
| SHARED FUNCTIONS (ALL MODULES) | |
| MPR view new minor functionalities: new shortcuts, full screen<br>view, synchronized zoom, new toolbar | Improved user experience |
| MIP rendering on MPR view | Improved performance and user experience |
| | experience |
| The user can import external images to the sizing report | Improved user experience |
| The user can organize snapshots in the sizing report | Improved user experience |
| Calcium estimation tool: The user can measure calcification<br>volume in a region of interest (ROI). The user chooses the ROI<br>and the Hounsfield Unit (HU) thresholds for the measure. The<br>function is based on the volume measurement technology already<br>existing in the predicate device. | Improved performance |
| C-arm angle tool: The user can move the 3D view and visualize<br>and record the corresponding C-arm angles (LAO/RAO and<br>cranial/caudal). In the previous version of EndoSize (predicate) the<br>C-arm angle values were already displayed in the 3D view, but this<br>tool is now considered as a "custom measure" that can be<br>recorded in the measurement panel and in the sizing report. | Improved performance |
| PERIPHERAL MODULE | |
| NASCET value calculation | Improved performance |
| INTELIX MODULES (AFX, AFX2 and NELLIX MODULES) | |
| New warnings and disclaimers related to virtual rendering of<br>device components, polymer volume estimation, and health care<br>provider's responsibility | Improved performance and user<br>experience |
| Custom IFU: the user can access pdf versions of specific IFUs<br>dedicated to Intelix AFX, Intelix AFX2 and Intelix NELLIX modules,<br>in addition to the General User Manual | Improved performance and user<br>experience |
| Custom measurements step: Additional key measurements<br>proposed in the "measurements panel" for better sizing of AFX /<br>AFX2 / NELLIX endografts. | Improved user experience |
| Custom planning strategy and sizing sheet: | Improved user experience |
| - Modified sizing sheet with additional key measurements<br>for INTELIX modules<br>- AFX / AFX2 / NELLIX endograft catalogs only | |
| Custom sizing report: | Improved user experience |
| - AFX / AFX2 / NELLIX logo<br>- Modified sizing sheet<br>- 3D view snapshot of the aneurysm added to the report by<br>default | |
| The user can create and manage assemblies of components and<br>visualize a 3D view of selected devices | Improved user experience |
| The user can send emails with the pdf sizing report attached from<br>the software through its email client | Improved user experience |

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# Predicate Device Comparison:

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EndoSize has same intended use and fundamental scientific technology of the legally marketed device. The differences between the devices do not raise any questions with respect to the safety and effectiveness of the subject device.

| Legally Marketed Device | Modified Subject Device |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EndoSize version 3.0 | EndoSize version 3.1 |
| Therenva | Therenva |
| K141475 | K160376 |
| (Predicate Device) | |
| EndoSize is a software solution that is intended to<br>provide Physicians and Clinical Specialists with<br>additional information to assist them in reading<br>and interpreting DICOM CT scan images of<br>structures of the heart and vessels. | EndoSize is a software solution that is intended<br>to provide Physicians and Clinical Specialists<br>with additional information to assist them in<br>reading and interpreting DICOM CT scan<br>images of structures of the heart and vessels. |
| EndoSize enables the user to visualize and<br>measure (diameters, lengths, volumes, angles)<br>structures of the heart and vessels. | EndoSize enables the user to visualize and<br>measure (diameters, lengths, volumes, angles)<br>structures of the heart and vessels. |
| Indications for Use: | Indications for Use: |
| EndoSize enables visualization and measurement<br>of structures of the heart and vessels for pre-<br>operational planning and sizing for cardiovascular<br>interventions and surgery, and for postoperative<br>evaluation. | EndoSize enables visualization and<br>measurement of structures of the heart and<br>vessels for pre-operational planning and sizing<br>for cardiovascular interventions and surgery,<br>and for postoperative evaluation. |
| General functionalities are provided such as: | General functionalities are provided such as: |
| Segmentation of cardiovascular structures Automatic and manual centerline detection Visualization of CT scan images in every<br>planes, 2D review, 3D reconstruction,<br>Volume Rendering, MPR, Stretched<br>CMPR Measurement and annotation tools Reporting tools | Segmentation of cardiovascular<br>structures Automatic and manual centerline<br>detection Visualization of CT scan images in<br>every planes, 2D review, 3D<br>reconstruction, Volume Rendering,<br>MPR, Stretched CMPR Measurement and annotation tools Reporting tools |
| Interface to image sources:<br>DICOM image data | Interface to image sources:<br>DICOM image data |
| Import of Patient Data:<br>Manual through keyboard/mouse<br>Automatic import with image file<br>Study List Creation<br>Study list image functionality:<br>Exporting<br>Deleting<br>Anonymizing<br>Search | Import of Patient Data:<br>Manual through keyboard/mouse<br>Automatic import with image file<br>Study List Creation<br>Study list image functionality:<br>Exporting<br>Deleting<br>Anonymizing<br>Search<br>Choose a default database<br>Reset sizing |
| Image Processing: | Image Processing: |
| Realign orthogonal MPRs | Realign orthogonal MPRs |
| Segmentation toolset: | Segmentation toolset: |
| Automatic segmentation | Automatic segmentation |
| Automatic centerline | Automatic centerline |
| Manual centerline | Manual centerline |
| Centerline editing | Centerline editing |
| Undo/redo operations | Undo/redo operations |
| Volume sculpting | Volume sculpting |
| Image assessment: | Image assessment: |
| Linear (length and diameter) and angular | Linear (length and diameter) and angular |
| measurements | measurements |
| Volume measurements | Volume measurements |
| C-Arm angulation calculation | C-Arm angulation calculation and record in the |
| | sizing report |
| Test annotations on snapshots | Test annotations on snapshots |
| Calcium scoring for assessment of calcium in the | Calcium scoring for assessment of calcium in |
| aortic root | the aortic root |
| | Calcium volume measurement |
| | NASCET calculation in Peripheral module |
| Image display: | Image display: |
| Orthogonal, oblique, double oblique, curved, | Orthogonal, oblique, double oblique, curved, |
| cross-curved MPR rendering | cross-curved MPR rendering (with new |
| | shortcuts and full screen view available) |
| MIP volume rendering | MIP volume rendering (available in MPR view |
| | for every module) |
| Color volume rendering | Color volume rendering |
| 2D slice review | 2D slice review |
| Endoscopic view | Endoscopic view |
| Interactive VOI clipping | Interactive VOI clipping |
| Multi-tissue color and opacity control | Multi-tissue color and opacity control |
| Active presets | Active presets |
| User-defined presets | User-defined presets |
| | 3D view of assemblies of devices |
| DICOM Support: | DICOM Support: |
| Compatible with all scanner vendor DICOM | Compatible with all scanner vendor DICOM |
| datasets | datasets |
| Storage SCP | Storage SCP |
| Import DICOM files | Import DICOM files |
| DICOM compliance for CT and enhanced CT | DICOM compliance for CT and enhanced CT |
| Import from DICOMDIR | Import from DICOMDIR |
| Storage SCU | Storage SCU |
| Query/retrieve SCU | Query/retrieve SCU |
| | |
| Storage of Results | Storage of Results |
| Printout | Printout |
| Session state | Session state |
| PDF format | PDF format |
| | Send report by email |
| | Import external image to the sizing report |
| | Up-to-date catalogues |
| MS Windows | MS Windows |
| Mac OSX | Mac OSX |

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# Conclusion

The modified EndoSize software is substantially equivalent to the legally marketed device (predicate device) in terms of intended use, indications for use and technical characteristics. The modified EndoSize software has successfully undergone bench testing.

Based on the information supplied in this special 510(k), THERENVA SAS concludes that the new version of EndoSize is substantially equivalent to the predicate device, is safe and effective and performs as well or better than the predicate device.