(218 days)
Not Found
No
The document describes standard medical image review and analysis tools, including manual or assisted image alignment and segmentation engines, but does not mention AI, ML, or related terms. The performance evaluation focuses on traditional software testing and literature review, not AI/ML specific validation methods.
No.
This device is a software medical device used for reviewing and analyzing medical images for diagnosis, and surgical and treatment planning, but it does not directly apply therapy to a patient.
Yes
The device is described as a "software medical device aimed at reviewing images," and its "toolsets which enable the reviewing physician to provide any selected relevant information for diagnosis." It also mentions "Clinical features ... is intended to be used for diagnosis purpose." These statements clearly indicate its use in aiding diagnosis based on medical images.
Yes
The device description explicitly states "Myrian® is a software medical device" and that it "can be run from any standard client platform (such as PC) that might be purchased independently by the end user," indicating it is a software-only product.
Based on the provided information, Myrian® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Myrian's Function: Myrian® is a software medical device that reviews and analyzes images produced by medical imaging devices (like CT and MRI). It works with images of the human body, not with specimens taken from the body.
- Intended Use: The intended use clearly states it's for reviewing images and includes features for communication, media interchange, and reporting related to these images.
- Device Description: The description reinforces that it's for reviewing and analyzing anatomy and pathology in multi-dimensional images.
Therefore, Myrian® falls under the category of medical imaging software or picture archiving and communication systems (PACS) with advanced visualization and analysis tools, rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
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: Imaging tools (Multi-Planar Reformatting views, Cross-sectional or Endoscopic Exploration Modes, "Filet Visualization Mode"), Manual or interactive Objects Of Interest (OOI) including Annotations of Interest (AOI), Paths, Regions of Interest (ROI), and Points of Interest (POI). Reporting tools generate reports from OOIs. It also includes manual or assisted image alignment tools and a Virtual ROI Cutting Surface tool. Longitudinal Follow-up tools are provided for oncology workflow, with features like a dedicated workflow, user interface for "Time Points," measurements through OOIs, linking OOIs as "Lesion of Interest," and Follow-up Response Evaluation Criteria (e.g., RECIST 1.1 or Cheson 2007). An automatic or semi-automatic response calculation based on these criteria is included, along with a validation mechanism for analyzed Time Points and specific reports. Multiple Longitudinal Follow-ups per Patient are allowed.
Myrian functionalities can be packaged as individual modules:
- XP Lung: Designed to study the human respiratory system for identifying and analyzing conditions like emphysema, using dedicated generic Protocols, a semi-automatic Lung ROI segmentation engine, and the CutSimulator tool.
- XP LungNodule: Enables volumetric analysis and follow-up of lung nodules with automatic segmentation, measurement, characterization, 3D visualization, matching and follow-up tools, Density Histogram, auto-adjusting display protocols, advanced Surfacic mode rendering, and a dedicated report template.
- XP Liver: For use on CT datasets with contrast enhancement for portal veins and slices below 2 millimetres, offering measurements and analysis of liver structures and 2D/3D hepatectomy simulation.
- XP Vessel: For visualization and analysis of medical image data from CT, MRI scans of selected human vessels (carotid arteries, peripheral arteries, aorta, brain arteries, opacified veins) to automate routine inspection for stenosis and dissection. It supports interactive segmentation and isolation of vessel parts.
- XL Onco: Designed around 3 methods for reviewing various types of lesions of interest, each with three stages (baseline, time point) and specific constraints based on guidelines (RECIST 1.0, RECIST1.1, CHESON). It includes an automatic segmentation engine, editing tools, viewport layout for time point comparison, and a follow-up dashboard with lesion graph and table.
Myrian System allows OEM customization of GUI and functionality without impacting performance or intended use. It is not indicated for mammography use; lossy compressed mammography images and digitized film screen images must not be used for primary interpretations, and mammographic images require an FDA approved monitor (at least 5 mega pixel resolution).
An identical version of the software can be installed on an Application Server in "Remote Execution Mode" (REM), allowing multiple users to access Myrian features remotely via LAN/WAN through a web browser or client application. Medical images are not transmitted; instead, a compressed stream of screen content is transmitted. Access to Myrian REM and the screen content stream are encrypted for security and confidentiality. For diagnostic purposes, users must ensure compliance with diagnostic requirements and regulations for compression scheme and client platform display device. Once accessed in REM, Myrian is intended to be used exactly like the standalone Myrian Medical Device.
Mentions image processing
System, Image Processing, Radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
images produced by all standard medical imaging devices, DICOM images, CT, MRI scans
Anatomical Site
human respiratory system, lung, liver, human vessels (carotid arteries, peripheral arteries, aorta, arteries of the brain, any opacified veins), anatomy and pathology in multi-d images
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals, including surgeons, radiologists, clinicians., radiologist, clinicians.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance and safety of Myrian is evaluated in pre-marketing phase during the through ventication and validation including the internal performance evaluations. Before release of the software the following tests are performed to check specifications and fulfill 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: to be performed by the Build Engineer: no warning or compilation error should appear and binaries should be silently produces.
Tests are performed by referring 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.
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.
K081985, K061624, K082228, K091001, K093621, K073194
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
§ 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).
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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 |
|---|---|
| Submitter | |
| Name | |
| Registration number | INTRASENSE |
| 3006546169 | |
| Address | |
| Tel Fax | 1231 Avenue du Mondial 98 34900 Montpellier FR |
| (+33) 467 130 130 / (+33) 467 130 132 | |
| Contact Persons | Mr Frédéric BANEGAS |
| Phone number : (+33) 467 130 130 | |
| Fax number : (+33) 467 130 132 | |
| Ms Colette MAURIN | |
| Phone number : (+33) 467 130 130 | |
| Fax number : (+33) 467 130 132 | |
| Device name | |
| Common Name | |
| Trade Name | |
| Model number | System, Image Processing |
| Myrian® | |
| N/A | |
| Device classification | |
| Classification name | |
| Code product | |
| Panel | |
| Regulation number | |
| Regulatory class | System, Image Processing, Radiological |
| LLZ | |
| 892 | |
| 892.2050 | |
| II | |
| 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
ರ
0
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).
i
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
5
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
6
Indications for Use Form
510(k) Number (if known): _K113620
Device Name: MYRIAN 1.11
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, 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.
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
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