(93 days)
Not Found
No
The summary describes standard image processing, visualization, and quantification tools without mentioning AI or ML algorithms.
No
This device is for viewing and analyzing medical images and provides quantification facilities; it does not directly treat or diagnose conditions.
Yes
The "Intended Use / Indications for Use" states that the device is used for "viewing and analyzing cardiovascular magnetic resonance images" and that "Only DICOM images will be used for presentation, display and diagnosis." The "Device Description" further elaborates on its functionalities, such as calculating volume and mass indices for ventricles and T2* for iron loading, which are diagnostic parameters.
Yes
The device is explicitly described as a "software device" and a "software package" that runs on a "standard PC without dedicated hardware." Its function is the viewing and analysis of existing medical images.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- CMRtools Function: CMRtools is a software device that analyzes medical images acquired from a cardiovascular magnetic resonance scanner. It processes and quantifies information from these images (specifically of the heart, liver, and vascular system).
- No Sample Analysis: The software does not interact with or analyze biological samples taken from the patient. Its input is image data, not biological material.
Therefore, while CMRtools is a medical device used in the diagnostic process, it falls under the category of medical image analysis software rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CMRtools™ and plug-ins VentricularTools™ & ThalassaemiaTools™ is a software device used for viewing and analyzing cardiovascular magnetic resonance images. It allows high performance image manipulation, 3D visualization, and advanced image processing on a standard PC without dedicated hardware. All software plug-ins have comprehensive quantification facilities with full analysis session recording for providing comprehensive audit trails. It contains an image viewer for importing DICOM images, browsing through patient datasets, viewing cine images and performing region-of-interest analysis. Plug-ins are used for specialist cardiac assessment including VentricularTools for left ventricular assessment and ThalassaemiaTools for T2* image quantification. It is important that CMRtools is only used to view and analyze human cardiac and or liver images acquired with a cardiovascular magnetic resonance scanner. CMRtools must not be used to view or analyze images acquired with any other type of imaging device. The software must not be used to view or analyze images of any part of the body except the heart and or liver or the vascular system. Furthermore, the software must not be used to view or analyze images acquired from animals. Only DICOM images will be used for presentation, display and diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
CMRtools™ is a software package for the visualization and analysis of cardiovascular magnetic resonance images (CMR). CMRtools™ is comprised of an image loader, an image viewer and a set of optional plug-ins for specialist cardiac analysis, including VentricularTools and ThalassaemiaTools.
- VentricularTools provides dedicated functionality for calculating volume and mass indices of the . ventricles of the heart from magnetic resonance images.
- ThalassaemiaTools allows the calculation of a property called T2* that characterizes iron loading . in the heart and liver.
CMRtools™ allows high performance image manipulation, 3D visualization, and advanced image processing on a standard PC without dedicated hardware. All software plug-ins have comprehensive quantification facilities with full analysis session record for providing comprehensive audit trails.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cardiovascular magnetic resonance images (CMR)
Anatomical Site
heart and or liver or the vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
A physician providing ample opportunity for competent human intervention interprets images and information being displayed and/or printed.
The images will typically be transferred via a CD, network drive or though a PACS transfer from the scanner onto the clinician's local machine.
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)
CMRtools and plug-ins have been tested according to the specifications that are documented in a Software Test Plan. Testing is an integral part Cardiovascular Imaging Solutions Ltd. software development process as described in the company's Product Development Process.
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.
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).
0
Ko 73194
10/2
510(k) Summary of Safety and Effectiveness
Date Prepared
November 10, 2007
Submitter's Information
Professor Guang-Zhong Yang, Director Cardiovascular Imaging Solutions Ltd. 53 Cavendish Road, London SW12 OBL, UK Tel: 011 44(0)7771 888 886
Contact Person
Mr. Robert Merrifield Cardiovascular Imaging Solutions Ltd. 53 Cavendish Road, London SW12 OBL, UK Tel: 011 44(0)7771 888 886
Device Name
| Common/Usual Name: | Picture Archiving Communications System |
|---|---|
| Proprietary Name: | CMRtools and plug-ins VentricularTools & ThalassaemiaTools |
| Classification Names: | System, image processing, radiological 892.2050 90-LLZ |
Substantially Equivalent to both:
| 510(k) Number | K060941 | K994283 |
|---|---|---|
| Device Classification Name | system, image processing, | |
| radiological | system, nuclear magnetic resonance | |
| imaging | ||
| Device Name | CAAS MRV VERSION 3.0 | MRI- MAGNETIC RESONANCE |
| ANALYTICAL SOFTWARE SYSTEM | ||
| Applicant | PIE MEDICAL IMAGING B.V. | |
| 7450 Flying Cloud Dr. | ||
| Eden Prairie, MN 55344 | MEDIS MEDICAL IMAGING | |
| SYSTEMS, B.V. | ||
| Poortgebouw Rijnsburgerweg 10 | ||
| Leiden, NL 2333 AA | ||
| Regulation Number | 892.2050 | 892.1000 |
| Classification Product Code | LLZ | LNH |
| Decision Date | 04/19/2006 | 08/30/2000 |
| Decision | substantially equivalent (SE) | substantially equivalent (SE) |
| Classification Advisory | ||
| Committee | Radiology | Radiology |
Device Description
CMRtools™ is a software package for the visualization and analysis of cardiovascular magnetic resonance images (CMR). CMRtools™ is comprised of an image loader, an image viewer and a set of optional plug-ins for specialist cardiac analysis, including VentricularTools and ThalassaemiaTools.
- VentricularTools provides dedicated functionality for calculating volume and mass indices of the . ventricles of the heart from magnetic resonance images.
- ThalassaemiaTools allows the calculation of a property called T2* that characterizes iron loading . in the heart and liver.
1
Kó 73/94
20f2
510(k) Summary of Safety and Effectiveness
CMRtools™ allows high performance image manipulation, 3D visualization, and advanced image processing on a standard PC without dedicated hardware. All software plug-ins have comprehensive quantification facilities with full analysis session record for providing comprehensive audit trails.
Indications for Use
CMRtools™ and plug-ins VentricularTools™ & ThalassaemiaTools™ is a software device used for viewing and analyzing cardiovascular magnetic resonance images. It allows high performance image manipulation, 3D visualization, and advanced image processing on a standard PC without dedicated hardware. All software plug-ins have comprehensive quantification facilities with full analysis session recording for providing comprehensive audit trails. It contains an image viewer for importing DICOM images, browsing through patient datasets, viewing cine images and performing region-of-interest analysis. Plug-ins are used for specialist cardiac assessment including VentricularTools for left ventricular assessment and ThalassaemiaTools for T2* image quantification. It is important that CMRtools is only used to view and analyze human cardiac and or liver images acquired with a cardiovascular magnetic resonance scanner. CMRtools must not be used to view or analyze images acquired with any other type of imaging device. The software must not be used to view or analyze images of any part of the body except the heart and or liver or the vascular system. Furthermore, the software must not be used to view or analyze images acquired from animals. Only DICOM images will be used for presentation, display and diagnosis.
Technological Characteristics
CMRtools and plug-ins is a stand-alone software package which can be used on more than one hardware platform, as long as minimum hardware requirements are met. The device does not contact the patient, nor does it control any life-sustaining devices. A physician providing ample opportunity for competent human intervention interprets images and information being displayed and/or printed.
CMRtools and its plug-ins require a PC or a laptop with a mouse, keyboard and display running Microsoft Windows XP/Vista with a 1GHz processor, 512MB RAM, 128MB graphics card and 2GB of free hard disk space. The user interacts with CMRtools and its plug-ins using a desktop or laptop computer with a keyboard, mouse and display. The Software utilizes the standard point-and-click approach to user interface design that is ubiquitous on modern windowing operating systems.
CMRtools provides a user interface with individual items for selecting images, changing the brightness/contrast and accessing the different aspects of functionality. The plug-ins for CMRtools make use of a workflow orientated graphical user interface that guides the User through the analysis process by presenting a set of simple tasks. Each aspect of the software is clearly documented with context-sensitive Interactive Help. CMRtools and its plug-ins are designed to be used after the scanning of the patient is complete. The images will typically be transferred via a CD, network drive or though a PACS transfer from the scanner onto the clinician's local machine. Image viewing and analysis can then be performed without connection to the internet or a network.
Testing
CMRtools and plug-ins have been tested according to the specifications that are documented in a Software Test Plan. Testing is an integral part Cardiovascular Imaging Solutions Ltd. software development process as described in the company's Product Development Process.
Conclusion
The 510(k) pre-market notification for the CMRtools and plug-ins VentricularTools & ThalassaemiaTools contains adequate information and data to enable FDA-CDRH to determine substantial equivalence to the predicate device.
- The device has been and will continue to be manufactured according to the voluntary standards 1. list in the Voluntary Standards section of the submission.
- The submission contains the results of a hazard analysis and the "Level of Concern for potential 2. hazards has been classified as "Minor".
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its back, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
2000 ।
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardiovascular Imaging Solutions Ltd. c/o Mr. Carl Thomas, Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76210
K073194 Re:
Trade/Device Name: CMRtools" and plug-ins VentricularTools & Thalassaemia Tools Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: LLZ
Dated: November 12, 2007 Received: November 13, 2007
Dear Mr. Thomas:
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 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.
3
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 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 marketed predicate 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
TAB2
510(k) Number:
Device Name:
CMRtools™ and plug-ins VentricularTools™ & ThalassaemiaTools™
Indications for Use:
CMRtools™ and plug-ins VentricularTools™ & ThalassaemiaTools™ is a software device used for viewing and analyzing cardiovascular magnetic resonance images. It allows high performance image manipulation, 3D visualization, and advanced image processing on a standard PC without dedicated hardware. All software plugins have comprehensive quantification facilities with full analysis session recording for providing comprehensive audit trails. It contains an image viewer for importing DICOM images, browsing through patient datasets, viewing cine images and performing region-of-interest analysis.
Plug-ins are used for specialist cardiac assessment including VentricularTools for left ventricular assessment and ThalassaemiaTools for T2* image quantification. It is important that CMRtools is only used to view and analyze human cardiac and or liver images acquired with a cardiovascular magnetic resonance scanner. CMRtools must not be used to view or analyze images acquired with any other type of imaging device.
The software must not be used to view or analyze images of any part of the body except the heart and or liver or the vascular system. Furthermore, the software must not be used to view or analyze images acquired from animals.
Only DICOM images will be used for presentation, display and diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
hogu Whha
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number Ko73194