Myrian® is a software medical device aimed at reviewing images produced by all standard medical imaging devices. It also includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. Myrian® can be run from any standard client platform (such as PC) that might be purchased independently by the end user.

Common Users are trained medical professionals, including surgeons, radiologist clinicians and technicians.

This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

Device Description

Myrian® is a multi modality medical device for the review and analysis of anatomy and pathology in multi-dimensional images acquired from a variety of imaging devices. Myrian provides users with several visualization modes and includes DICOM communication, media interchange (printing, CD burning, storing).

Myrian includes toolsets which enable the reviewing physician to provide any selected relevant information for diagnosis, surgery and treatment planning to the referring physician. These toolsets are categorized as follow: Imaging tools, Manual or interactive Objects Of Interest (OOI), Reporting tools, Manual or assisted image alignment tools for multiphase or time-based image comparison, Virtual ROI Cutting Surface tool for preoperative evaluation of surgery strategies, Longitudinal Follow-up tools for oncology workflow.

Myrian® functionalities can be packaged, licensed and marketed as individual modules: XP Lung, XP Lungnodule, XP Liver, XP Vessel, XL Onco.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study methodologies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics for diagnostic accuracy or clinical effectiveness. The submission focuses on internal verification and validation, as well as substantiating equivalence to predicate devices based on functional and technological characteristics.

Instead of a table of numerical acceptance criteria, the document describes a series of internal tests and a literature review to ensure the software fulfills its intended aim with complete safety for the patient and demonstrates Myrian's capability to be used in a clinical environment as intended by the manufacturer. The "Performance data" section outlines the types of internal testing performed.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a "test set" in the context of a clinical performance study. The stated testing refers to internal software validation.

Test Set (Clinical): Not applicable, as detailed clinical performance testing with a 'test set' of patient data for diagnostic accuracy is not described.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for a clinical test set. The information provided discusses internal software testing, not external validation against expert-derived ground truth.

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for establishing ground truth, as no clinical test set with corresponding ground truth establishment is detailed.

Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. There is no mention of comparing human readers' performance with and without AI assistance, nor any effect size reported.

MRMC Study Performed: No.
Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not specify a standalone performance study where the algorithm's performance is measured without human intervention for diagnostic tasks. The "Performance data" section refers to software testing and internal evaluations, not a standalone clinical performance study.

Standalone Study Performed: Not explicitly detailed as a clinical performance study.

7. Type of Ground Truth Used

Based on the provided information, the primary "ground truth" used for evaluating the device's performance is its adherence to specified software requirements and functionalities through various internal testing phases (pre-integration, functional, integration, regression, build testing). For "clinical features" (e.g., segmentation engines), the document states that a "statistical analysis to apply is defined" and "sample size and relevant inclusion criteria are specified to select the appropriate exams," but it does not explicitly describe the type of clinical ground truth used for these internal evaluations (e.g., pathology, expert consensus, outcomes data).

Ground Truth Type: Primarily software specification adherence. For certain "clinical features," it refers to "appropriate exams" and "statistical analysis" but lacks specifics on the nature of the clinical ground truth.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. The software mentioned is a medical image review and aided diagnosis software, but the document does not describe it as a machine learning or AI algorithm that would typically require a distinct training set. The descriptions of modules like XP LungNodule mention "Automatic segmentation engine" and "Automatic measurement and characterization," which could imply machine learning, but the document doesn't detail their development or training.

Training Set Sample Size: Not provided.

9. How the Ground Truth for the Training Set Was Established

Since no training set is described, the method for establishing its ground truth is not mentioned.

Ground Truth Establishment for Training Set: Not provided.

Summary

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JUL 12 2012

5. 510(K) SUMMARY

[As Required by 21 CFR 807.92] Summary of Safety and Effectiveness

Preparation date	July 13th, 2012
SubmitterNameRegistration number	INTRASENSE3006546169
AddressTel Fax	1231 Avenue du Mondial 98 34900 Montpellier FR(+33) 467 130 130 / (+33) 467 130 132
Contact Persons	Mr Frédéric BANEGASPhone number : (+33) 467 130 130Fax number : (+33) 467 130 132Ms Colette MAURINPhone number : (+33) 467 130 130Fax number : (+33) 467 130 132
Device name
Common NameTrade NameModel number	System, Image ProcessingMyrian®N/A
Device classification
Classification nameCode productPanelRegulation numberRegulatory class	System, Image Processing, RadiologicalLLZ892892.2050II
Predicate Devices

[K081985] Cleared [September 25, 2008] [Advantage Workstation Server], manufactured by [General Electric Healthcare]; [K061624] Cleared [June 27, 2006] [Vital Images, Inc.] [Vitrea2 Version 3.9], manufactured by [Vital Images, Inc.]; [K082228] Cleared [July 31, 2008] [Planisight Linasys] [LSPS], manufactured by [Pathfinder Therapeutics Inc.], [K091001] Cleared [June 29, 2009] [intrasense] [Myrian v1.4], manufactured by [intrasense] [K093621] Cleared [February 23, 2010] [syngo.PET&CT Oncology], manufactured by [Siemens Medical Solutions USA, Incl (K073194) Cleared (November 10, 2007) (CMRtools and plug-ins VentricularTools), manufactured by (Cardiovascular Imaging Solutions, Ltd]

Explanation of how the device operates

Myrian with its modules is designed to run on standare, through the installed operating system. The hardware is all 'off-the-shelf standard computer components and may be purchased independently by the end user.

The exact same version of the Myrian® application Server Platform and executed in "Remote Execution Mode" (REM). In REM mode, multiple Users can remotely access all Myrian® features from any Client Platform (off the shelf computers, including laptops), through a LAN or WAN network. This access is granted through a Web browser (via a standard URL) or a specific Client Application installed on the Client Platform

IFU (Indications For Use)

Myrian" is a software medical device aimed at reviewing images produced by all standard medical imaging devices. It also includes DICOM communication, media interchange (printing, storing) and reporting features. Myrian " can be run from any standard client platform (such as PC) that might be purchased independently by the end user.

Common Users are trained medical professionals, including surgeons, radiologists, clinicians.

This device is not indicaled for mammography use. Lossy compressed mammography images must not be used for primary mage interpretations. Mammographic images may only be interpreted using an least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

Intended Use

Myrian® is a medical inage review and aided diagnosis software Medical Device as delined by the 93/42/EEC Directive. It provides Users with the following features:

Import and export of DICOM files from/to any DICOM-compliant modality, workstation or PACS.

Visualization of DICOM images in various standard visualization modes (e.g. MPR, 3D ... etc.) with optional image-alignment feature;

Creation of Objects Of Interest ("OOI") for analysis and measurement purposes;

Generation of medical reports;

Virtual Cutting surface tool for preoperative evaluation of surgery strategies;

Longitudinal Follow-up of patient, designed to support the oncological worklow by helping the user to confirm the absence of lesions, including evaluation, quantification, follow-up and documentation of such lesions.

Common Users are trained medical professionals, including surgeons, radiologists, clinicians.

Myrian® is designed to be run:

On standard Standalone Plaform, through the installed operating system. The hardware of such platform onsists in "off-the-shell standard PC computer components and may be purchased independently by the end user.

Remotely, through a nework connecting a Client Platform (standard desktop or laptop PC, Apple® Mac, etc.) to the Sever Plation on which Myrian® is installed. This mode of the Myrian® application is called "Remote Execution Mode".

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Device Description

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Myrian includes toolsets which enable the reviewing physician to provide any selected relevant information for diagnosis, surgery and treatment planning to the referring physician.

These toolsets are categorized as follow:

Imaging tools:

Multi-Planar Reformatting views (MPR) in orthogonal, oblique or curved planes as well as 3D Views in various rendening 0 modes including MIP, MiniP, Average and Volume Rendering
- Cross-sectional or Endoscopic Exploration Modes along a Centerline, e.g. of a vessel, a colon, etc.
0 "Filet Visualization Mode", to visualize any tubular, hollow organ, such as a colon, as a flat, unfolded surface

Manual or interactive Objects Of Interest (OOI):

Annotations of Interest (AOI), for information or measurement purposes 0
Paths (considered as Annotations of Interest) 0
Regions of Interest (ROI), for anatomical and pathological structure isolation (such as liver, spleen, lungs, colon ... etc.) 0 through which any measurement can be performed
- Points of Interest (POI), for marking areas such as lesions, etc.

Reporting tools:

Objects of Interest (OOI) generate Reports which may be viewed and exported to standard film and paper printers or sent 0 electronically to intranet web servers and any DICOM device.
Manual or assisted image alignment tools for multiphase or time-based image comparison. Virtual ROI Cutting Surface tool for preoperative evaluation of surgery strategies, e.g. for a liver

Longitudinal Follow-up tools for oncology workflow:

A dedicated workflow and user interface, including a way to organize images in "Time Points", every Time Point being a O subset of Studies selected by the User:
0 A set of measurements collected by the User in each Time Point through the abovementioned Objects of Interest
0 A mechanism to link together these Objects of Interest through the Time Point, called "Lesion of Interest"
Some Follow-up Response Evaluation Criteria (one per Longitudinal Follow-up, e.g. RECIST 1.1 or Cheson 2007) attached 0 to the Lesions of Interest:
An Automatic or Semi-automatic Response Calculation using the attached Follow-up Response Evaluation Criteria, used to 0 quantify the analysis. This Calculation is based on the strict implementation of the related reference publications (e.g. http://www.eorc.be/recist/documents/RECIST Guidelines.pdf for RECIST 1.1), and can be controlled and overridden by the User:
A validation mechanism to sign and lock every analyzed Time Point used in the Longitudinal Follow-up; 0
o Specific Reports based on the chosen Follow-up Response Evaluation Criteria.
Multiple Longitudinal Follow-ups per Patient. O

All Myrian® functionalities can be packaged, licensed and marketed as individual modules:

XP Lung:

Myrian XP Lung is designed to study the human respiratory system to help clinicians identify and analyse such as emphysema

The XP-Lung Module Engine makes use of a set of dedicated tools such as:

Dedicated generic Protocols to predefine the workspace and available tools
A semi-automatic Lung ROI segmentation engine
The CutSimulator tool to simulate surgical action

Used in conjunction with other tools in the density histogram, it is possible to visualise, analyse and quantify healty, and pathological lung tissues rapidly with precision as well as to plan and simulate excision or lobectory

XPLungnodule:

Myrian® XP LungNodule enables volumetric analysis and follow-up of lung nodules making use of such functionalilies as:

. Automatic segmentation and volumetric analysis of solitary solid lung nodules
Automatic measurement and characterization as well as 3D visualisation of the nodules in their context -
Matching and follow-up tools
Density Histogram -
Auto-adjusting display protocols, optimising the workspace and available tools -
. Advanced Surfacic mode rendering
Dedicated report template

XP Liver:

Myrian XP Liver is designed for use on CT datasets with contrast enhancement for portal veins and slices below 2 millimetres in thickness. The available dedicated tools and features include the measurements and analysis of liver stuctures as well as 2d/3d hepatectory simulation enabling to plan single phase and multiphase Liver surgery.

XP Vessel:

Myrian XP Vessel is designed for the visualisation and analysis of medical image data derived from CT, MRI scans of selected human vessels, including but not limited to the carcid artenes, the peripheral atteries, the aota, arteries of the brain, and any opacified veins.

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The aim is to help automate rouline inspection of human vessels to detect stenosis, and dissection in the vessel. It also supports the interactive segmentation of any vessel and enable the isolation of highlighting or hiding of che data set from display for critical evaluation of selected part(s) of vessel. It is intended for use by radiologists, clinicians to acquire, process, render, measure, evaluate, archive, print and distribute DICOM compliant vessel image studies.

XL Onco:

Myrian® XL-Onco is designed around 3 methods and review of various types of lesions of interest. Each method comprises three stages (baseline, time point and has its specific constraints according to the coresponding guidelines (RECIST 1.0, RECIST1.1 and CHESON).

The use of the following enhanced features allows you to detect, assess and ensure volumeric longitudinal follow-up of the lesions:

Automatic segmentation engine -
-Editing tools
Viewport layout enabling to compare one time point to the other .
Follow-up dashboard including lesion graph and table.

The Myrian" System allows OEM customization of both the Graphical User Interface (GU) and the without implying any impact on system performance or system intended use.

This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

An identical version of this software can be installed on an Application Server in "Remote Execution Mode" (REM). In REM mode, multiple Users can remotely access all Myrian® features from any Client Platform (off-the shell computers including laptops), through a LAN or WAN network. This access is granted through a Web browser (via a standard URL) or through a specific Client Application installed on the Client Platform.

Medical Images themselves are not transmitted. Interaction, a stream of screen content which is compressed using either a lossless or lossy compression scheme, is transmitted from the Application Server to the Client Platform.

Access to Myrian® REM and the stream of screen content are both encrypted to ensure security and confidentiality,

For diagnosic purposes, the User must that the compression scheme and the Client Platform display device used for reading the images both comply with state-of-the-art diagnosic requirements and all current legislation, rules and regulations in force.

Once accessed in REM mode, Myrian® is intended to be used exactly as the Myrian® Medical Device.

Performance data

The performance and safety of Myran" is evaluated in pre-marketing phase during the through ventication and validation including the internal performance evaluations.

Before release of the software following testing are performed to checined specifications and fullifis its intended use:

-Pre-integration testing assures that all modules aimed at being integrated into the system behave integration to the system
-Functional Testing ensures that each element of the application meets of the business as outlined in the System Requirement Specification (SRS) and in the System Functional Sheet
Integration Testing proves that all areas of the system interface with each other correctly and that there are no gaps in the data flow. -Final Integration Test proves that system works as integrated unit when all the fixes are complete.
-Regression Testing ensures that there is no impact on previously released software. The regression testing is automated using ISVCR Automated Testing Tool.
Build Testing is to be performed by the Build Engineer: no warning or compilation error should appear and binaries should be silently produces.

Tests are performed by refering to a Test Plan which contains all test procedures created to guaranty that all the functional and operational aspects of the software are under control. The tests runs were successfully completed in the Software.

Internal performance evaluations are performed to check that the software fulfills its intended aim particularly with complete safety for the patient.

Clinical features refer to functionality which:

is closely related to patient risk

and/or - is intended to be used for diagnosis purpose

Typically it refers to segmentation engines.

According to the intended use of the feature the statistical analysis to apply is defined. Sample size and relevant inclusion criteria are specified in order to select the appropriate exams.

The performance and safety of Myrian" is also evaluated in post-marketing review. This review is performed for every considered paper evaluated as suitable the performances and/or safely of Myrian®. Every such document is analyzed to ensure that all identified risks are already covered and no new risk is identified. The literature review demonstrates Myrian's capability to be used in clinical environment as intended by the manufacturer.

Based on this evidence Myrian achieves its intended performance during normal conditions of use. Known and foreseeable risks and any adverse events are minimized and acceptable when weighed against the benefits of the intended performance.

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Technological characteristics

Myrian" is a multi modality medical diae for the review and analysis of anatomy and pathology in multi-dimages acquired from a variety of imaging devices. Myrian provides users with several visualization modes and includes DICOM communication, media interchange (printing, CD burning, stoning). This intended use is substantially equivalent to the one of the predicate devices Advantage Workstation Server® (K081985) and Vitrea2® (K061624).

Myrian orovides user with annotations, measurement, quantification and reporting tools. These features are substantially equivalent to hose of the predicate device Vitrea2 (K061624).Myian® contains an Endoscopic exploration mode to visualize any tubular hollow organ such as colon. This feature is substantially equivalent to the one of the predicate device Vitrea2® (K061624).

Myrian" includes tolsets which enable the review to provide any selected thismation for the destrement of the ment of the ment

Myrian provides users with longitudinal follow-up tools for oncology workflow. These features are substantially equivalent to those of the predicate device syngo.PET&CT Oncology (K093621).

The Iron Load Calculator available in Myrian® is substantial equivalent to the Thalassaematools included in the predicate device CMRtools (K073194), and which allows the calculation of a property called T2 that characterizes iron loading in the liver.

Myrian can be installed on an Application Server Platform and execution Mode". This mode of operation is substantialy equivalent to the one of the predicate device Advantage Workstation Server® (K081985).

Conclusion

The 510(k) Pre-market Notification for Myrian adequate information and data to enable FDA-CDRH to determine substanial equivalence to the predicate devices listed above.

Myrian® has the same intication for use and rew type of safety and effectiveness questions. Performance data provided demonstrate that the device is safe, effective, and is substantially equivalent to the predicate devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Frederic Banegas CTO Intrasense 1231 Avenue du Mondail 98 MONPELLIER 34000 FRANCE

Re: K113620

Trade/Device Name: MYRIAN 1.11 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 2, 2012 Received: July 10, 2012

Dear Mr. Banegas:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosure) to regars) to regard of the Medical Device Amendments, or to commerce pror to Pricy 20, 2017 11:12 in accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, merelere, maines of the Act include requirements for annual registration, listing of general controlo profitetvring practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is thassified (200 as regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 I reast of advised that I Dr o recament at your device complies with other requirements of the Act that I Dri has made a actor regulations administered by other Federal agencies. You must of ally it catales and regarations and regulations, but not limited to: registration and listing (21 Comply with an the 110. or studies and 809); medical device reporting (reporting of

JUL 12 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice mourements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket whitication. The FDA finding of substantial equivalence of your device to a legally marketed nouricate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you decire openits and office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket s 150. Fired the more 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 Tou inay of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): _K113620

Device Name: MYRIAN 1.11

Indications for Use:

Common Users are trained medical professionals, including surgeons, radiologist clinicians and technicians.

ctinformic and coomisor of mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

Over-The-Counter Use Prescription Use ਮ Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

WAH D OK
Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113620

Page 1 of 1

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).