(35 days)
Myrian is a multi modality medical diagnostic device. It is aimed at reviewing and analysing anatomy and pathology. 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. It provides user a set of tools meant to create and modify 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. 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.
Myrian® system is a software suite providing the following services : Import of DICOM images from any DICOM modality, workstation or PACS Visualization of DICOM images in thin MPR, thick MPR and full 3D volume rendering Creation of VOI (Volume Of Interest) with dedicated tools Calculation of volumes, surface and of average, minimum and maximum densities of VOI Follow-up of patient examination Generation of medical reports Export of DICOM images to any format, DICOM entity or media
Here's an analysis of the provided text regarding the Intrasense MYRIAN device:
Analysis of Intrasense MYRIAN Device Performance and Study
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria and corresponding reported device performance metrics are not explicitly stated. The submission focuses on demonstrating substantial equivalence to predicate devices and adherence to general software safety guidelines.
| Acceptance Criteria Category | Acceptance Criteria (As stated or inferred) | Reported Device Performance (As stated or inferred) |
|---|---|---|
| General Compliance | Requirements of FDA "Guidance of the Content of Pre Market Submissions for Software Contained in Medical Devices" | MYRIAN meets the required specifications. |
| Adverse Effects | No adverse effects detected. | No adverse effects have been detected. |
| Feature Functionality | All described functionalities (Image import, Visualization, VOI creation, Calculation, Follow-up, Reporting, Export) operate as intended. | User Site Testing and Benchmarking demonstrate MYRIAN meets required specifications. Implied successful operation of features. |
| Safety and Effectiveness | Substantially equivalent to predicate devices in terms of safety and effectiveness. | The technological characteristics, features, specifications, materials, mode of operation, and intended use of MYRIAN device are equivalent to those of the predicate devices. Differences do not raise new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "User Site Testing, Benchmarking and clinical data analysis" for performance verification. However, no specific sample sizes for the test set or details about data provenance (e.g., country of origin, retrospective/prospective nature) are provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications. It states that "Typical users of Myrian® with its Modules are trained medical professionals, including but not limited to radiologists, technologists and clinicians," and that images, "When interpreted by a trained physician, filmed or displayed images on the Myrian® and its Modules may be used as a basis for diagnosis." This implies that medical professionals would be involved in evaluating the device, but no details on ground truth establishment are given.
4. Adjudication Method
The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for the test set.
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 with and without AI assistance or any effect size of improvement. The device description and performance data focus on its standalone functionality and equivalence to predicate devices.
6. Standalone (Algorithm Only) Performance Study
The document implies that the device's performance was evaluated in various settings, stating "User Site Testing, Benchmarking and clinical data analysis demonstrate that MYRIAN meet the required specifications." This suggests that the algorithm and its features were tested for their intended functionality, which aligns with standalone performance evaluation. However, specific metrics of "algorithm-only" performance (like sensitivity, specificity, accuracy for a particular task) are not provided. The focus is on the software suite's general functionality for image processing, visualization, and measurement.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). While it mentions that images interpreted by a trained physician may be used for diagnosis, it doesn't describe how ground truth was established for the purpose of validating the device's performance.
8. Sample Size for the Training Set
The document does not specify the sample size used for any training set. Given the submission date (2007) and the description of the device (a software suite for general image processing and visualization), it's highly likely that this device does not utilize deep learning or other machine learning algorithms that require explicit "training sets" in the modern sense. It appears to be a rule-based or conventional image processing software.
9. How Ground Truth for the Training Set Was Established
As there's no mention of a training set, the document does not describe how ground truth for a training set was established.
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Intrasense PREMARKET NOTIFICATION 510(K) SUBMISSION
MYRIAN
060830
.
| 5. 510(K) SUMMARY | |||
|---|---|---|---|
| [As Required by 21 CFR 807.92]Summary of Safety and Effectiveness | MAY 14 2007 | ||
| Preparation date | April 6th, 2007 | ||
| Submitter | |||
| Name | INTRASENSE | ||
| Registration number | TBD | ||
| Address | CAP OMEGA, Rond Point Benjamin Franklin CS 39521 34960 Montpellier FR | ||
| Tel Fax | (+33) 467 130 130 / (+33) 467 130 132 | ||
| Contact Person | Mr Stéphane CHEMOUNYPhone number : (+33) 467 130 130Fax number : (+33) 467 130 132 | ||
| Device name | |||
| Common Name | System, Image Processing | ||
| Trade Name | MYRIAN | ||
| Model number | N/A | ||
| Device classification | |||
| Classification name | System, Image Processing, Radiological | ||
| Code product | LLZ | ||
| Panel | 892 | ||
| Regulation number | 892.=2050 | ||
| Regulatory class | II | ||
| Predicate devices | [K052995] Cleared [November 8, 2005] [General Electric Medical Systems][Advantage Workstation Version 4.3], manufactured by [General Electric MedicalSystems][K061624] Cleared [June 27, 2006] [Vital Images, Inc.] [Vitrea2 Version 3.9],manufactured by [Vital Images, Inc.] | ||
| Description | Myrian® system is a software suite providing the following services :Import of DICOM images from any DICOM modality, workstation or PACSVisualization of DICOM images in thin MPR, thick MPR and full 3D volume renderingCreation of VOI (Volume Of Interest) with dedicated toolsCalculation of volumes, surface and of average, minimum and maximum densities ofVOIFollow-up of patient examinationGeneration of medical reportsExport of DICOM images to any format, DICOM entity or media | ||
| Explanation of how the device operates | Myrian® with its modules is designed to run on standard PC hardware. The hardwareis all "off-the-shelf' standard computer components and may be purchasedindependently by the end user. | ||
| Intended use | Myrian® with its modules is a software application that is used for reviewing medicalimages. Myrian® with its modules is designed to run on standard PC hardware. Thehardware is all "off-the-shelf' standard computer components and may be purchasedindependently by the end user. Myrian with its modules receives digital images anddata from various sources (including but not limited to CT, MR, US, RF modalities,computed and direct radiographic devices, secondary capture devices, scanners,imaging gateways or imaging sources like PACS).Myrian® and its Modules can be used to communicate, to process, print and displaymedical images. Users have access to various image processing, Volume of Interestediting and measurement tools to assist them in viewing and quantifying images.Myrian® and its Modules can be integrated with an institution's existing HIS or RIS fora fully integrated electronic patient record. | ||
| Typical users of Myrian® with its Modules are trained medical professionals, includingbut not limited to radiologists, technologists and clinicians. | |||
| When interpreted by a trained physician, filmed or displayed images on the Myrian®and its Modules may be used as a basis for diagnosis, except in the case ofmammography images.Myrian® with its Modules does not support the display of mammography images fordiagnosis. | |||
| Performance data | Performance data were verified versus the requirements of the FDA "Guidance of theContent of Pre Market Submissions for Software Contained in Medical Devices" | ||
| User Site Testing, Benchmarking and clinical data analysis demonstrate that MYRIANmeet the required specifications. No adverse affects have been detected. | |||
| Substantial equivalence summary | The technological characteristics, features, specifications, materials, mode ofoperation, and intended use of MYRIAN device are equivalent to those of thepredicate devices quoted above. | ||
| MYRIAN is the same as the predicate devices in K061624 and K052995 | |||
| The differences that exist between the devices do not raise new issues of safety oreffectiveness regarding MYRIAN Device. | |||
| It is substantially equivalent in terms of safety and effectiveness to the predicatedevices. |
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Intrasense PREMARKET NOTIFICATION 510(K) SUBMISSION 060830
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
INTRASENSE % Mr. Nicolas Clary Project Leader CEISO "Les Portes d'Espagne" - Bât. B - 99, route d'Espagne 31100 Toulouse 31100 FRANCE
MAY 1 4 2007
Re: K071000
Trade/Device Name: Myrian Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 6, 2007 Received: April 13, 2007
Dear Mr. Clary:
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 (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 1906-2006. The logo features the letters "FDA" in a stylized font, with the word "Centennial" written below. The logo is surrounded by a circular border with text and stars.
moting Public J
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I toase or acressed a determination that your device complies with other requirements of the Act that I Dederal statutes and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) Premarket notification. The FDA finding of substantial equivalence of your device to a legally premainer nedicated 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 Part 801), please 11 you use office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under (21 CFF at 80 ! 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon 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 MYRIAN Intrasense 060830
| 4. INDICATIONS FOR USE | |
|---|---|
| 510(k) Number (if known): | K07/000 |
| Device Name: | Myrian |
| Indications for Use: | Myrian is a multi modality medical diagnostic device. It is aimed at reviewing and analysing anatomy and pathology. 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. It provides user a set of tools meant to create and modify 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. 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. | |
| Prescription Use (Part 21 CFR 801 Subpart D) | 1.1 AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
.
.
Nancy C Hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 071000 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 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).