ENDOSIZE

K141475 · Therenva Sas · LLZ · Jul 31, 2014 · Radiology

Device Facts

• Record ID: K141475
• Device Name: ENDOSIZE
• Applicant: Therenva Sas
• Product Code: LLZ · Radiology
• Decision Date: Jul 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

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 (EVAR, FEVAR, TEVAR, TAVI, Peripheral). It imports DICOM CT scan data from local files or PACS servers. The software provides tools for 3D reconstruction, segmentation of cardiovascular structures, and automatic/manual centerline detection. It enables visualization (MPR, volume rendering, stretched CMPR) and quantitative measurements (diameters, lengths, volumes, angles). The output is displayed to the clinician to assist in diagnosis, procedure planning, and postoperative evaluation. It does not control life-sustaining devices or contact the patient; all outputs are interpreted by the clinician.

Clinical Evidence

Bench testing only. No clinical data provided. Validation included testing of DICOM image importation, patient manager functionality, image display/processing, module-specific functioning (EVAR, TEVAR, FEVAR, TAVI, Peripheral), measurement accuracy, and report generation.

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, and measurement tools. Software lifecycle follows IEC 62304:2006. Risk management follows ISO 14971:2012.

Indications for Use

Indicated for visualization and measurement of heart and vessels for pre-operational planning, sizing for cardiovascular interventions/surgery, and postoperative evaluation. Intended for use by physicians and clinical specialists.

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

• 3mensio Workstation (K120367)

Submission Summary (Full Text)

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K141475
Page 1 of 4.

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# 10 (K) SUMMARY (20 OFR 807 82 (GN) 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

| Manufacturer Name: | Therenva SAS<br>Centre d'Innovation Technologique<br>Niv. O du CCP<br>2 rue Henri Le Guilloux<br>35000 Rennes<br>FRANCE |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cemil Göksu, CEO<br>Tel : [phone]<br>Fax : [phone]<br>E-mail : [e-mail] |
| Official Correspondant : | |
| Establishment Registration Number: | Awaiting acceptance of this 510k |
| Date prepared: | 12/19/2013 |
| Trade Name: | EndoSize |
| Regulation Class | Class II (21 CFR 892.2050, LLZ) |

Identification of Predicate Device:

| Device Classification Name | Picture Archiving<br>Communications System |
|----------------------------|--------------------------------------------|
| Regulation Number | 892.2050 |
| 510(k) Number | K120367 |
| Device Name | 3mensio Workstation |
| Product Code | LLZ |
| Decision | SUBSTANTIALLY<br>EQUIVALENT (SE) |

Picture Archiving Communications System

## Device Description:

Classification Name:

EndoSize is a stand-alone software application that runs on any standard Windows or Mac OSX based computer which meets the minimal requirements. 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.

EndoSize contains five modules dedicated to different types of endovascular interventions, EVAR, FEVAR, TEVAR, TAVI and 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 catalogue included in the software, of a generic module) do not modify neither the functioning nor the safety of the software.

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EndoSize enables assessment and measurement of different vascular structures such as vessels, valves, aneurysms, and other anomalies. It provides simple techniques 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 and plan interventional procedures. 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.

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:

2

- Tests of Importation of DICOM images �

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- Patient Manager tests .
- Tests of image display and processing .
- . Functioning tests of the different modules EVAR, TEVAR, FEVAR, TAVI and Peripheral
- Measurement tests t

·

- Reports creation and exportation tests .
## Predicate Device Comparison:

EndoSize has similar intended use and technical features of the predicate device listed above. The differences between the devices do not raise any questions with respect to the safety and effectiveness of the subject device.

| New Device | Predicate Device |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| EndoSize | 3mensio Workstation |
| Therenva | Pie Medical Imaging |
| | K120367 |
| Interface to image sources: | Interface to image sources: |
| DICOM image data | DICOM image data |
| Import of Patient Data: | Import of Patient Data: |
| Manual through keyboard/mouse | Manual through keyboard/mouse |
| Automatic import with image file | Automatic import with image file |
| Study List Creation | Study List Creation |
| Study list image functionality: | Study list image functionality: |
| Exporting | Exporting |
| Deleting | Deleting |
| Anonymizing | Anonymizing |
| Search | Search |
| 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<br>measurements | Linear (length and diameter), angular and ROI<br>measurements |
| Volume measurements | Volume measurements |
| C-Arm angulation calculation | C-Arm angulation calculation |
| Test annotations on snapshots | Text and arrow annotations |
| Calcium scoring for assessment of calcium in the<br>aortic root | Calcium scoring for assessment of calcium in<br>the aortic root |
| Image display: | Image display: |
| Orthogonal, oblique, double oblique, curved,<br>cross-curved, stretched MPR rendering | Orthogonal, oblique, double oblique, curved,<br>cross-curved, stretched MPR rendering |
| MIP volume rendering | MIP, AvelP, MinIP and color volume slabs |
| Color volume rendering | MIP volume rendering |

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| 2D slice review | Color volume rendering |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Endoscopic view | Greyscale volume rendering |
| Interactive VOI clipping | 2D slice review and stack comparison |
| Multi-tissue color and opacity control | 4D cine |
| Active presets | Interactive VOI clipping |
| User-defined presets | Multi-tissue color and opacity control |
| DICOM Support: | DICOM Support: |
| Compatible with all scanner vendor DICOM datasets | Compatible with all scanner vendor DICOM datasets |
| Storage SCP | Storage SCP |
| Import DICOM files | Import DICOM files |
| DICOM compliance for CT and enhanced CT | DICOM compliance for CT, enhanced CT, MRI, enhanced MRI, XA, Nuclear Medicine, CR, SC, and Ultrasound images |
| Import from DICOMDIR | Import from DICOMDIR |
| Storage SCU | Storage SCU |
| Query/retrieve SCU | Query/retrieve SCU |
| Storage of Results | Automatic grouping of images into volumes<br>Windows printing or send to PACS |
| Printout | Storage of Results |
| Session state | Printout |
| PDF format | Session state |
| MS Windows | PDF format<br>DICOM PDF report |
| Mac OSX | MS Windows |

## Conclusion

The EndoSize software is substantially equivalent to the predicate software in terms of intended use, indications for use and technical characteristics. The EndoSize software has successfully undergone every bench testing designed to simulate clinical use.

Based on the information supplied in this 510(k), THERENVA SAS concludes that EndoSize is substantially equivalent to the predicate device and is safe and effective.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 31, 2014

Therenva SAS % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K141475

Trade/Device Name: EndoSize Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications svstem Regulatory Class: II Product Code: LLZ Dated: July 1, 2014 Received: July 2, 2014

Dear Mr. Job:

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 docs 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 cither 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 complics 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-Mr. Job

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,

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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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

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

510(k) Number (if known)

K141475

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, Streiched CMPR

· Measurement and annotation tools

· Reporting tools

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="text-decoration: underline;">Over-The-Counter Use (21 CFR 807 Subpart C)</span> |
| [x] | [] |

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

| FORM FDA 3881 (6/13) | Page 1 of 2 | PSC Publishing Serman [phone] EF |
|------------------------------------------------------------------------------|------------------|-----------------------------------------|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | 182 22 | |
| | FOR FDA USE ONLY | |
| | | |