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 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

Device Description

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.

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.

AI/ML Overview

The provided text describes the EndoSize software, its intended use, and its equivalence to a predicate device but does not contain detailed acceptance criteria or a specific study proving the device meets quantitative performance metrics. Instead, it refers to "bench tests" for validation.

Here's an attempt to answer your questions based only on the provided text, highlighting what is missing:

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

The document states: "Every specification of the EndoSize software is validated by a bench test before release."
It then lists the types of tests conducted:

Tests of Importation of DICOM images
Patient Manager tests
Tests of image display and processing
Functioning tests of the different modules EVAR, TEVAR, FEVAR, TAVI and Peripheral
Measurement tests
Reports creation and exportation tests

However, specific quantitative acceptance criteria (e.g., accuracy thresholds for measurements, speed requirements, specific segmentation performance metrics) and the numerical results of these tests (the "reported device performance") are NOT provided in this document. The document only states that the software "successfully undergone every bench testing designed to simulate clinical use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. It only mentions "bench tests" but does not detail the nature, size, or provenance of any testing datasets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The document makes no mention of expert involvement in establishing ground truth for any test set. It does state that "The information and measurements displayed, exported or printed are validated and interpreted by Physicians," but this refers to end-user interpretation, not ground truth establishment for software validation.

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

This information is not provided.

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

This information is not provided. The document does not describe any MRMC studies or human reader performance evaluations.

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

The document refers to "bench tests" that validate "every specification of the EndoSize software." This implies a standalone performance evaluation of the software's functionalities. However, no specific quantitative results or methodology for such a standalone performance study are detailed. The listed tests (image importation, display, processing, module functioning, measurements, reports) suggest a system-level functional test, but not a rigorous clinical performance study.

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

This information is not provided. Given that the listed tests are functional ("importation," "display," "processing," "measurement," "reporting"), the ground truth for these might be internal reference standards or expected outputs rather than clinical data ground truth.

8. The sample size for the training set

This information is not provided. The document focuses on validation/testing and does not describe the development or training of any machine learning components, although features like "Automatic segmentation" and "Automatic centerline" suggest some underlying algorithms.

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

This information is not provided.

Summary

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K141475
Page 1 of 4.

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 SASCentre d'Innovation TechnologiqueNiv. O du CCP2 rue Henri Le Guilloux35000 RennesFRANCE
Contact Person:	Cemil Göksu, CEOTel : +33 2 99 28 37 51Fax : +33 2 99 28 95 88E-mail : cemil.goksu@therenva.com
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 ArchivingCommunications System
Regulation Number	892.2050
510(k) Number	K120367
Device Name	3mensio Workstation
Product Code	LLZ
Decision	SUBSTANTIALLYEQUIVALENT (SE)

Picture Archiving Communications System

Device Description:

Classification Name:

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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.

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 �

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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 angularmeasurements	Linear (length and diameter), angular and ROImeasurements
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 theaortic root	Calcium scoring for assessment of calcium inthe aortic root
Image display:	Image display:
Orthogonal, oblique, double oblique, curved,cross-curved, stretched MPR rendering	Orthogonal, oblique, double oblique, curved,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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Page 4 of 4

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 volumesWindows printing or send to PACS
Printout	Storage of Results
Session state	Printout
PDF format	Session state
MS Windows	PDF formatDICOM 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 (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,

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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 807 Subpart C)
[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 (101) 443-6740 EF
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)	182 22
	FOR FDA USE ONLY

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).