Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes image processing and measurement tools but does not mention AI, ML, or related terms like deep learning or neural networks. The validation focuses on bench testing of functionalities and measurements, not performance metrics typically associated with AI/ML models.

Therapeutic

No
The device is a software solution for reading and interpreting DICOM CT scan images, visualizing and measuring anatomical structures for preoperative planning and postoperative evaluation. It does not provide any treatment or therapy.

Diagnostic

Yes

The device assists physicians in reading and interpreting DICOM CT scan images and enables visualization, measurement, and assessment of vascular structures and anomalies, which are functions typical of a diagnostic device. It also mentions "easier to diagnose anomalies".

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as a "stand-alone software application" that runs on standard computers and processes DICOM CT scan images. There is no mention of accompanying hardware components that are part of the medical device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
EndoSize's Function: EndoSize processes and analyzes images (DICOM CT scans) of the human body. It does not interact with or analyze biological specimens.
Intended Use: The intended use clearly states that EndoSize is for assisting physicians in reading and interpreting images for preoperational planning, sizing, and postoperative evaluation. This is image analysis and visualization, not in vitro testing of biological samples.

Therefore, while EndoSize is a medical device, it falls under the category of image processing and analysis software, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

LLZ

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.

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT scan images, DICOM CT scan data

Anatomical Site

heart and vessels

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physicians and Clinical Specialists

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K141475

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).

Summary

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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.

1

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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)
(K160376) to provide a notification submission for
proposed software changes in the already 510(k)
cleared EndoSize software (K141475) |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer Name: | Therenva SAS
4 rue Jean Jaurès
35000 Rennes
FRANCE |
| Contact Person : | Cemil Göksu, CEO
Tel : +33 9 72 52 29 18
Fax : +33 9 72 52 54 16
E-mail : cemil.goksu@therenva.com |
| 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
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.

4

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
measurements, key points placement and health care provider's
responsibility	Improved performance and user
experience
PATIENT MANAGER COMPONENT
Patient Manager new minor functionalities: choose default
database, reset sizing data	Improved user experience
SHARED FUNCTIONS (ALL MODULES)
MPR view new minor functionalities: new shortcuts, full screen
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
volume in a region of interest (ROI). The user chooses the ROI
and the Hounsfield Unit (HU) thresholds for the measure. The
function is based on the volume measurement technology already
existing in the predicate device.	Improved performance
C-arm angle tool: The user can move the 3D view and visualize
and record the corresponding C-arm angles (LAO/RAO and
cranial/caudal). In the previous version of EndoSize (predicate) the
C-arm angle values were already displayed in the 3D view, but this
tool is now considered as a "custom measure" that can be
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
device components, polymer volume estimation, and health care
provider's responsibility	Improved performance and user
experience
Custom IFU: the user can access pdf versions of specific IFUs
dedicated to Intelix AFX, Intelix AFX2 and Intelix NELLIX modules,
in addition to the General User Manual	Improved performance and user
experience
Custom measurements step: Additional key measurements
proposed in the "measurements panel" for better sizing of AFX /
AFX2 / NELLIX endografts.	Improved user experience
Custom planning strategy and sizing sheet:	Improved user experience
- Modified sizing sheet with additional key measurements
for INTELIX modules

AFX / AFX2 / NELLIX endograft catalogs only | |
| Custom sizing report: | Improved user experience |
| - AFX / AFX2 / NELLIX logo
Modified sizing sheet
3D view snapshot of the aneurysm added to the report by
default | |
| The user can create and manage assemblies of components and
visualize a 3D view of selected devices | Improved user experience |
| The user can send emails with the pdf sizing report attached from
the software through its email client | Improved user experience |

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Predicate Device Comparison:

7

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
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 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.	EndoSize enables the user to visualize and
measure (diameters, lengths, volumes, angles)
structures of the heart and vessels.
Indications for Use:	Indications for Use:
EndoSize enables visualization and measurement
of structures of the heart and vessels for pre-
operational planning and sizing for cardiovascular
interventions and surgery, and for postoperative
evaluation.	EndoSize enables visualization and
measurement of structures 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:	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	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
Interface to image sources:
DICOM image data	Interface to image sources:
DICOM image data
Import of Patient Data:
Manual through keyboard/mouse
Automatic import with image file
Study List Creation
Study list image functionality:
Exporting
Deleting
Anonymizing
Search	Import of Patient Data:
Manual through keyboard/mouse
Automatic import with image file
Study List Creation
Study list image functionality:
Exporting
Deleting
Anonymizing
Search
Choose a default database
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.