Myrian is a multi modality medical diagnostic device for the review and analysis of anatomy and pathology in multi-dimensional digital images acquired from a variety of imaging devices. It also includes DICOM communication capabilities and media interchange features (printing, CD burning, storing). It runs on any standard PC including laptops that might be purchased independently by the end user. Typical end users are trained medical professionals. Myrian includes tools which enable the reviewing physician to provide any selected relevant information for diagnosis, surgery and treatment planning to the referring physician. 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® with its modules is designed to run on standard PC hardware, through the installed operating system. The hardware is all "off-the-shelf" standard computer components and may be purchased independently by the end user. Myrian is a multi modality medical diagnostic device for the review and analysis of anatomy and pathology in multi-dimensional digital images acquired from a variety of imaging devices. It also includes DICOM communication capabilities and media interchange features (printing, CD burning, storing). It runs on any standard PC including laptops that might be purchased independently by the end user. Typical end users are trained medical professionals. Myrian includes tools which enable the reviewing physician to provide any selected relevant information for diagnosis, surgery and treatment planning to the referring physician. These toolsets are categorised as follow: Enhanced imaging tools such as: Multi-Planar Reformation (MPR) views in any plane (orthogonal, oblique or curved), 3D views in any rendering mode (MIP, MiniP, Average, Volume Rendering). Cross-sectional or Endoscope Exploration Modes along a centerline (e.g. of a vessel, a colon ... etc.). Filet Visualization Mode, to visualize as a flat surface any tubular hollow organ (such as a colon). Manual or interactive Objects Of Interest such as : Annotations of Interest, for information or measurement purposes. Paths (considered as Annotations of Interest). Regions of Interest, for anatomical and pathological structure isolation (such as liver, spleen, lungs, colon ... etc.) through which any measurement can be performed. Points of Interest, for marking areas such as lesions, tumors ... etc. Reporting tools : Objects of Interest generates reports which may be viewed and sent to standard film or paper printers or sent electronically to an intranet web server or any other DICOM device. Manual or assisted image alignment tools : for multiphasic or time-based image comparisons. Cutting Surface Tool based on ROI for preoperative evaluation of surgery strategies (such as for the liver). All Myrian functionalities can be packaged, licensed and marketed as individual modules. The Myrian System allows the OEM customization of both the graphical user interface and the available functionalities, while implying no impact on the system performance or system intended use.

AI/ML Overview

The provided text is a 510(k) Summary for the MYRIAN 1.4 image processing system. It describes the device's intended use and general operations but does not contain any specific acceptance criteria or details of a study proving the device meets acceptance criteria.

The document states:

"Performance data were verified versus the requirements of the FDA 'Guidance of the Content of Pre Market Submissions for Software Contained in Medical Devices'"
"User Site Testing and Benchmarking demonstrate that MYRIAN meet the required specifications. No adverse affects have been detected."

However, it does not provide any actual performance data, specific acceptance criteria, or details of the mentioned "User Site Testing and Benchmarking" study. Therefore, I cannot extract the requested information.

To answer your request, the input text would need to include a section detailing:

Specific numerical acceptance criteria (e.g., accuracy, precision, processing speed thresholds).
The measured performance of the device against those criteria.
Details about the study design, sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, and whether it was a standalone or comparative effectiveness study.

Summary

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PREMARKET NOTIFICATION 510(K) SUBMISSION

MYRIAN 1.4

Image /page/0/Figure/3 description: This document is a 510(K) summary for a medical device. The preparation date is April 2nd, 2009, and the submitter is INTRASENSE with registration number 3006546169. The device name is System, Image Processing, trade name MYRIAN, and model number N/A. The classification name is System, Image Processing, Radiological, with code product LLZ, panel 892, regulation number 892.-2050, and regulatory class II.

Follow-up of patient examination

Generation of medical reports

Export of DICOM images to any format, towards any DICOM entity or recognized media.

Virtual Cutting surface tool for preoperative evaluation of surgery strategies.

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PREMARKET NOTIFICATION 510(K) SUBMISSION

MYRIAN 1.4

Explanation of how the device operates

Intended use

Mvrian is a multi modality medical diagnostic device for the review and analysis of anatomy and pathology in multi-dimensional digital images acquired from a variety of imaging devices. It also includes DICOM communication capabilities and media interchange features (printing, CD burning, storing). It runs on any standard PC including laptops that might be purchased independently by the end user. Typical end users are trained medical professionals ..

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

These toolsets are categorised as follow:

Enhanced imaging tools such as:

Multi-Planar Reformation (MPR) views in any plane (orthogonal, oblique or curved), 3D views in any rendering mode (MIP, MiniP, Average, Volume Rendering)
· Cross-sectional or Endoscope Exploration Modes along a centerline (e.g. of a vessel, a colon ... etc.)
· Filet Visualization Mode, to visualize as a flat surface any tubular hollow organ (such as a colon)
Manual or interactive Objects Of Interest such as :
- · Annotations of Interest, for information or measurement purposes
- · Paths (considered as Annotations of Interest);
- · Regions of Interest, for anatomical and pathological structure isolation (such as liver, spleen, lungs, colon ... etc.) through which any measurement can be performed
- · Points of Interest, for marking areas such as lesions, tumors ... etc.
Reporting tools :

Objects of Interest generates reports which may be viewed and sent to standard film or paper printers or sent electronically to an intranet web server or any other DICOM device.

Manual or assisted image alignment tools :
- · for multiphasic or time-based image comparisons
- · Cutting Surface Tool based on ROI for preoperative evaluation of surgery strategies (such as for the liver).

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.

All Myrian functionalities can be packaged, licensed and marketed as individual modules. The Myrian System allows the OEM customization of both the graphical user interface and the available functionalities, while implying no impact on the system performance or system intended use.

Performance data

Performance data were verified versus the requirements of the FDA "Guidance of the Content of Pre Market Submissions for Software Contained in Medical Devices'

User Site Testing and Benchmarking demonstrate that MYRIAN meet the required specifications. No adverse affects have been detected.

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PREMARKET NOTIFICATION 510(K) SUBMISSION

Substantial equivalence summary

The technological characteristics, features, specifications, materials, mode of operation, and intended use of MYRIAN device are equivalent to those of the predicate devices quoted above.

MYRIAN is the same as the predicate devices in K061624, K052995, K071000 and K082228

The differences that exist between the devices do not raise new issues of safety or effectiveness regarding MYRIAN Device.

It is substantially equivalent in terms of safety and effectiveness to the predicate devices.

The "Substantial Equivalence Decision Making Process" provided by the FDA has been followed, see dedicated section in this document.

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Image /page/3/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 2 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frederic Banegas Chief Technical Officer Intrasense CAP OMEGA. Rond Point Benjamin Franklin CS 39521 Montpellier, 34960 FRANCE

Re: K091001

Trade/Device Name; Myrian Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 10, 2009 Received: June 16, 2009

Dear Mr. Banegas:

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.

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 of medical

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PREMARKET NOTIFICATION 510(K) SUBMISSION

A . . . . . . . . . . . INDICATIONS FOR USE .

510{k) Number (if known) :

K04100

Device Name:

Myrian

Indications for Use (no change):

Myrian is a multi modality medical diagnostic device. It is aimed at reviewing and matorny and pathology. It also includes DICOM communication capabilities and media interchange features (printing, storing). It runs on any standard PC including laptops that might be purchased independently by the end user a set of tools meant to create and modify objects of interest : points of interest, annotations of interest and volumes of interest.

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. Mamnographic 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.

Prescription Use
(Part 21 CFR 801 Subpart D)

510/k) Number

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

A MULA WASHING BANGURA CASA BASANA A POWER

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hula Reum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev

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).