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

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.

AI/ML Overview

The provided document does not detail specific acceptance criteria or a comprehensive study demonstrating that the device meets these criteria in a quantitative manner. Instead, it is a 510(k) summary for a software update (EndoSize version 3.1, K160376), asserting substantial equivalence to a previously cleared device (EndoSize version 3.0, K141475).

The document focuses on:

Product description and intended use: EndoSize is software for visualizing and measuring heart and vessel structures from CT scans for pre-operational planning, sizing, and post-operative evaluation in cardiovascular interventions and surgery.
Changes from predicate device: Primarily updates to catalogs, minor UI/UX improvements, and new tools like calcium estimation, C-arm angle recording, and NASCET value calculation, which are based on existing functionalities.
Performance Data (Conformance): The device is stated to conform to DICOM standards, ISO 14971 (risk management), and IEC 62304 (software life-cycle).
Bench Testing: It states that every specification is validated by bench tests, including importation, patient management, display, processing, module functioning, measurement, and report creation/exportation. Any modifications undergo the same bench testing and regression testing.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not present in this regulatory submission document. This type of 510(k) relies on the argument of substantial equivalence, where the new features are described as based on existing, cleared technology, and the changes do not raise new questions of safety or effectiveness. The "performance data" section focuses on software development life cycle processes and internal validation via bench testing, rather than a formal clinical performance study with defined acceptance criteria and human readers.

Here's a breakdown of what can be inferred or is explicitly stated from the document regarding your questions:

1. A table of acceptance criteria and the reported device performance

Not explicitly provided. The document states:

"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..., Measurement tests, Reports creation and exportation tests."
"Every modification to the EndoSize software is validated by the same bench testing as described above."

This implies that acceptance criteria are defined for these bench tests, but the specific numerical or qualitative criteria and the results (e.g., "99% of images imported successfully," "measurements were within X% of ground truth") are not publicly disclosed in this summary. The "reported device performance" is essentially that it "successfully undergone bench testing" and "performs as well or better than the predicate device."

2. Sample sizes used for the test set and the data provenance

Not specified. The document mentions "bench testing" which usually refers to internal laboratory testing on a set of pre-defined test cases, not necessarily a large patient image dataset for clinical validation. The provenance of any data used for these internal bench tests (e.g., country of origin, retrospective/prospective) is not disclosed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified. Given the nature of a software update (special 510(k)) and the focus on "bench testing" of software functionalities, it's highly probable that ground truth for internal validation was established by software engineers and potentially clinical experts employed by the manufacturer, but no details on their number or qualifications are provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not specified. This level of detail on ground truth establishment is not present.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC study was not detailed or performed for this submission. The device is not presented as an AI-assistant for human interpretation in the sense of a diagnostic aid that changes reader performance. It's an image processing and measurement tool. The primary purpose of this 510(k) (a 'Special 510(k)') is to demonstrate substantial equivalence of updated software, not to prove clinical utility with a new type of performance study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not explicitly detailed as a formal study for this submission. The document describes the software's capabilities (segmentation, centerline detection, measurements, etc.) and states these were validated via "bench testing." This implies internal, automated, or semi-automated tests of the algorithms' outputs, which aligns with "standalone" performance, but not in the context of a rigorous, independently assessed clinical study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not specified. For internal bench tests on image processing and measurement software, ground truth likely involves:

Known input data: Using CT scans with pre-defined anatomical structures or simulated data where "true" measurements are known.
Manual measurements: Highly precise, manually performed measurements by trained personnel (possibly clinical experts) on images to serve as a reference for comparison with software's automated measurements.

8. The sample size for the training set

Not specified. This document focuses on the software update and its validation (bench testing), not the development of a machine learning model, so a "training set" in that context is not discussed. If any machine learning components were present, the original K141475 submission might have briefly touched upon it, but this document contains no information.

9. How the ground truth for the training set was established

Not applicable/Not specified. As there's no mention of a machine learning training set for this specific submission, this information is not provided.

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.

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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 (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)

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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 forproposed software changes in the already 510(k)cleared EndoSize software (K141475)
Manufacturer Name:	Therenva SAS4 rue Jean Jaurès35000 RennesFRANCE
Contact Person :	Cemil Göksu, CEOTel : +33 9 72 52 29 18Fax : +33 9 72 52 54 16E-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	SUBSTANTIALLYEQUIVALENT (SE)

Device Description:

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Intended Use:

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 ofmeasurements, key points placement and health care provider'sresponsibility	Improved performance and userexperience
PATIENT MANAGER COMPONENT
Patient Manager new minor functionalities: choose defaultdatabase, reset sizing data	Improved user experience
SHARED FUNCTIONS (ALL MODULES)
MPR view new minor functionalities: new shortcuts, full screenview, 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 calcificationvolume in a region of interest (ROI). The user chooses the ROIand the Hounsfield Unit (HU) thresholds for the measure. Thefunction is based on the volume measurement technology alreadyexisting in the predicate device.	Improved performance
C-arm angle tool: The user can move the 3D view and visualizeand record the corresponding C-arm angles (LAO/RAO andcranial/caudal). In the previous version of EndoSize (predicate) theC-arm angle values were already displayed in the 3D view, but thistool is now considered as a "custom measure" that can berecorded 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 ofdevice components, polymer volume estimation, and health careprovider's responsibility	Improved performance and userexperience
Custom IFU: the user can access pdf versions of specific IFUsdedicated to Intelix AFX, Intelix AFX2 and Intelix NELLIX modules,in addition to the General User Manual	Improved performance and userexperience
Custom measurements step: Additional key measurementsproposed 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 measurementsfor 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 bydefault
The user can create and manage assemblies of components andvisualize a 3D view of selected devices	Improved user experience
The user can send emails with the pdf sizing report attached fromthe 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 toprovide Physicians and Clinical Specialists withadditional information to assist them in readingand interpreting DICOM CT scan images ofstructures of the heart and vessels.	EndoSize is a software solution that is intendedto provide Physicians and Clinical Specialistswith additional information to assist them inreading and interpreting DICOM CT scanimages of structures of the heart and vessels.
EndoSize enables the user to visualize andmeasure (diameters, lengths, volumes, angles)structures of the heart and vessels.	EndoSize enables the user to visualize andmeasure (diameters, lengths, volumes, angles)structures of the heart and vessels.
Indications for Use:	Indications for Use:
EndoSize enables visualization and measurementof structures of the heart and vessels for pre-operational planning and sizing for cardiovascularinterventions and surgery, and for postoperativeevaluation.	EndoSize enables visualization andmeasurement of structures of the heart andvessels for pre-operational planning and sizingfor 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 everyplanes, 2D review, 3D reconstruction,Volume Rendering, MPR, StretchedCMPR Measurement and annotation tools Reporting tools	Segmentation of cardiovascularstructures Automatic and manual centerlinedetection Visualization of CT scan images inevery planes, 2D review, 3Dreconstruction, 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/mouseAutomatic import with image fileStudy List CreationStudy list image functionality:ExportingDeletingAnonymizingSearch	Import of Patient Data:Manual through keyboard/mouseAutomatic import with image fileStudy List CreationStudy list image functionality:ExportingDeletingAnonymizingSearchChoose a default databaseReset 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.

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).