(106 days)
Not Found
No
The document describes image processing and analysis techniques but does not mention AI, ML, or related terms. The description of the functionality focuses on semi-automatic methods and standard image processing techniques.
No
The device is a software product that visualizes and evaluates blood flow to support clinical decision-making, but it does not directly treat or cure any condition. Its output is explicitly stated as "not to be regarded as the sole, irrefutable basis for clinical decision making."
Yes
The device is described as supporting "clinical decision making" and explicitly states it is used "to support diagnoses," which are key functions of a diagnostic device.
Yes
The device is explicitly described as a "software product" and a "stand-alone software package to run on a PC with a Windows operating system." It processes existing MR images and does not include any hardware components for image acquisition or patient interaction beyond the standard PC hardware it runs on.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device analyzes MR images of the human body.
- The intended use is to visualize and evaluate blood flow based on imaging data. This is a function of medical imaging analysis, not laboratory testing of biological samples.
- The device description focuses on image processing, segmentation, visualization, and quantification of flow within the body. These are all activities related to interpreting medical images.
Therefore, CAAS MR 4D Flow is a medical device that performs image analysis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CAAS MR 4D Flow is a software product intended to be used by or under supervision of a cardiologist in order to visualize and evaluate blood flow in cardiovascular structures based on multi-slice, multi-phase and velocity encoded MR images to support clinical decision making.
CAAS MR 4D Flow enables the analysis of blood flow in the heart and large vessels based on multi-slice, multi-phase and velocity encoded MR images by providing the following functionality:
- Segmentation of cardiovascular structures;
- Visualization of blood flow velocity and directions;
- Calculation of quantitative cardiovascular results.
When the results provided by CAAS MR 4D Flow are used in a clinical setting to support diagnoses, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.
Product codes
LLZ
Device Description
CAAS MR 4D Flow offers functionality to import images; to analyze the behavior of blood flow in vessels and through heart valves in phase-contrast MR (Flow) images semi-automaticative flow analysis on the images, and to present the analysis results in different formats.
The CAAS MR 4D Flow software is designed as a stand-alone software package to run on a PC with a Windows operating system. It can read DICOM MR Images from an accessible file system (CD) and CAAS MR 4D Flow provides the functionality to scan the contents of a specific directory and to organize the found DICOM MR images into patients, studies and logical imagesets.
A phase-contrast MR imageset is necessary for performing 4D Flow analysis. Depending on the specific analysis goals, one or more MR imagesets may be added for reference purposes (phase contrast or cine imagesets).
After the MR images are read, the CAAS MR 4D Flow software provides functionality to perform the following measurements:
- . Extraction (and, if wanted, manual editing) of a 3D mesh of the vessel lumen, based on user input points.
- Visualization of color-coded 3D blood motion vectors originating from one or more user-defined planes in the ● cardiovascular structure.
- Visualization of color-coded (fixed) streamlines and (animated) pathlines indicating blood movement pattern originating from one or more user-defined planes in the cardiovascular structure.
- Visualization and quantification of blood flow through a pre-defined plane.
Methods to automatically correct for image artifacts or user errors like aliasing, eddy-currents, movement offset, or incorrect velocity direction indication, are available.
The results of the analysis will be generated as visual snapshots or animation of 3D blood motion (see above) or quantifications, for example:
- Flow through a plane over time (forward, backward, total)
- Min, max, mean, average, sdev velocity through a plane over time
- Pulse wave velocity over a segment of the vessel
Results can be displayed in numerical format or (if applicable) as graphs. An analysis can be saved to hard disk to enable re-analysis of the data. Visual results can be exported as animation or bitmap images. A graphic report can be exported in DICOM or PDF format, containing both numerical and also be printed. Numerical results can be exported as text files.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR images (multi-slice, multi-phase and velocity encoded)
Anatomical Site
cardiovascular structures, heart and large vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiologist (or under supervision of a cardiologist) in a clinical setting
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)
Verification and validation of the CAAS MR 4D Flow functionality showed that the system requirements – derived from the intended use and indications for use – as well as risk control measures were implemented correctly and that the device meets its specifications including conformance to the following standards:
- ISO 14971:2007, Medical devices Application of risk management to medical devices
- NEMA PS 3.1 3.20 (2011), Digital Imaging and Communication in Medicine (DICOM)
- IEC 62304 First edition 2006-05, Medical device software Software life cycle processes
- IEC 62336:2007, Medical devices Application of usability engineering to medical devices
The verification and validation results demonstrate the safety and effectiveness of CAAS MR 4D Flow in relation to its intended use and therefore CAAS MR 4D Flow can be considered as safe and effective as its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 8, 2016
Pie Medical Imaging B.V. % Ms. Annemiek Bouts Regulatory Affairs Coordinator Philipsweg 1 Maastricht, Limburg 6227 AJ THE NETHERLAND
Re: K162376
Trade/Device Name: CAAS MR 4D Flow Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 3, 2016 Received: November 9, 2016
Dear Ms. Bouts:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (reporting of medical 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name CAAS MR 4D Flow
CAAS MR 4D Flow enables the analysis of blood flow in the heart and large vessels based on multi-slice, multi-phase and velocity encoded MR images by providing the following functionality:
· Segmentation of cardiovascular structures;
· Visualization of blood flow velocity and directions;
· Calculation of quantitative cardiovascular results.
When the results provided by CAAS MR 4D Flow are used in a clinical setting to support diagnoses, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
CAAS MR 4D Flow
510(k) Summary
| Submitter/Owner Name | Pie Medical Imaging BV |
|---|---|
| Address | Philipsweg 1, 6227 AJ Maastricht, The Netherlands |
| Phone Number | +31 43 32 81 328 |
| Fax Number | +31 43 32 81 329 |
| Contact Person | Annemiek Bouts, Regulatory Affairs Coordinator |
| Email Address | annemiek.bouts@pie.nl |
| Preparation Date | 02-Nov-2016 |
| Trade Name | CAAS MR 4D Flow |
| Common Name | CAAS MR 4D Flow |
| Classification | Classification Name: Image Processing System |
| Regulation Class: Class II | |
| Regulation number: 21 CFR 892.2050 | |
| Classification Product Code: LLZ |
Predicate Device Morpheus HeartScan (K133937, Image Processing System, 21 CFR 892.2050, LLZ)
Device Description
CAAS MR 4D Flow offers functionality to import images; to analyze the behavior of blood flow in vessels and through heart valves in phase-contrast MR (Flow) images semi-automaticative flow analysis on the images, and to present the analysis results in different formats.
The CAAS MR 4D Flow software is designed as a stand-alone software package to run on a PC with a Windows operating system. It can read DICOM MR Images from an accessible file system (CD) and CAAS MR 4D Flow provides the functionality to scan the contents of a specific directory and to organize the found DICOM MR images into patients, studies and logical imagesets.
A phase-contrast MR imageset is necessary for performing 4D Flow analysis. Depending on the specific analysis goals, one or more MR imagesets may be added for reference purposes (phase contrast or cine imagesets).
After the MR images are read, the CAAS MR 4D Flow software provides functionality to perform the following measurements:
- . Extraction (and, if wanted, manual editing) of a 3D mesh of the vessel lumen, based on user input points.
- Visualization of color-coded 3D blood motion vectors originating from one or more user-defined planes in the ● cardiovascular structure.
- Visualization of color-coded (fixed) streamlines and (animated) pathlines indicating blood movement pattern originating from one or more user-defined planes in the cardiovascular structure.
- Visualization and quantification of blood flow through a pre-defined plane.
Methods to automatically correct for image artifacts or user errors like aliasing, eddy-currents, movement offset, or incorrect velocity direction indication, are available.
The results of the analysis will be generated as visual snapshots or animation of 3D blood motion (see above) or quantifications, for example:
- Flow through a plane over time (forward, backward, total)
- Min, max, mean, average, sdev velocity through a plane over time
- Pulse wave velocity over a segment of the vessel
Results can be displayed in numerical format or (if applicable) as graphs. An analysis can be saved to hard disk to enable re-analysis of the data. Visual results can be exported as animation or bitmap images. A graphic report can be exported in DICOM or PDF format, containing both numerical and also be printed. Numerical results can be exported as text files.
4
Intended Use
CAAS MR 4D Flow is a software product intended to be used by or under supervision of a cardiologist in order to visualize and evaluate blood flow in cardiovascular structures based on multi-slice, multi-phase and velocity encoded MR images to support clinical decision making.
Indications for Use
CAAS MR 4D Flow enables the analysis of blood flow in the heart and large vessels based on multi-slice, multi-phase and velocity encoded MR images by providing the following functionality:
- Segmentation of cardiovascular structures; •
- Visualization of blood flow velocity and directions;
- Calculation of quantitative cardiovascular results.
When the results provided by CAAS MR 4D Flow are used in a clinical setting to support diagnoses, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.
Substantial equivalence
A comparison of the technological characteristics of the predicate and subject device is given the table below.
| New Device | Predicate Device | |
|---|---|---|
| Device name | CAAS MR 4D Flow | HeartScan |
| Manufacturer | Pie Medical Imaging | Morpheus |
| 510(k) number | K162376 | K133937 |
| Intended Use and Indications for Use | ||
| Intended use | CAAS MR 4D Flow is a software product intended to be used | |
| by or under supervision of a cardiologist or radiologist in | ||
| order to visualize and evaluate blood flow in cardiovascular | ||
| structures based on multi-slice, multi-phase and velocity | ||
| encoded MR images to support clinical decision making. | HeartScan consists of software that analyzes DICOM-compliant | |
| cardiovascular images acquired from magnetic resonance (MR) | ||
| scanners. HeartScan specifically analyzes the blood flow to the | ||
| heart and its major vessels using multi-slice, multi-phase and | ||
| velocity encoded MR images. It provides clinically relevant and | ||
| reproducible, quantitative data and has been tested and | ||
| validated on MR images acquired from both 1.5T and 3:0 T MR | ||
| Scanners. The data produced by HeartScan is intended to be | ||
| used to support qualified cardiologist, radiologist or other | ||
| licensed professional healthcare practitioners for clinical | ||
| decision making. It is a support tool that provides relevant | ||
| clinical data as a resource to the clinician and is not intended to | ||
| be a source of medical advice or to determine or recommend a | ||
| course of action or treatment for a patient. | ||
| Indications | ||
| for Use | CAAS MR 4D Flow enables the analysis of blood flow in the | |
| heart and large vessels based on multi-slice, multi-phase | ||
| and velocity encoded MR images by providing the following | ||
| functionality: | ||
| Segmentation of cardiovascular structures; Visualization of blood flow velocity and directions; Calculation of quantitative cardiovascular results. When the results provided by CAAS MR 4D Flow are used in | ||
| a clinical setting to support diagnoses, the results are | ||
| explicitly not to be regarded as the sole, irrefutable basis for | ||
| clinical decision making. | HeartScan consists of software that analyzes DICOM-compliant | |
| cardiovascular images acquired from magnetic resonance (MR) | ||
| scanners. HeartScan specifically analyzes the blood flow to the | ||
| heart and its major vessels using multi-slice, multi-phase and | ||
| velocity encoded MR images. It provides clinically relevant and | ||
| reproducible, quantitative data and has been tested and | ||
| validated on MR images acquired from both 1.5T and 3:0 T MR | ||
| Scanners. The data produced by HeartScan is intended to be | ||
| used to support qualified cardiologist, radiologist or other | ||
| licensed professional healthcare practitioners for clinical | ||
| decision making. It is a support tool that provides relevant | ||
| clinical data as a resource to the clinician and is not intended to | ||
| be a source of medical advice or to determine or recommend a | ||
| course of action or treatment for a patient. | ||
| Technological Characteristics | ||
| Images | ||
| supported | Vendor-independent DICOM, 1.5T and 3.0T. | |
| Supports DICOM 3.0 ; Enhanced DICOM; | ||
| Cardiovascular images: multi-phase. multi-slice and velocity | ||
| encoded images acquired from MRI scanners | Vendor-independent DICOM, 1.5T and 3.0T. | |
| Supports DICOM 3.0; | ||
| Cardiovascular images: multi-phase. multi-slice and velocity | ||
| encoded images acquired from MRI scanners | ||
| Image | ||
| assessment | Automatic vessel segmentation Automatic contour detection with user input; can be changed manually Blood flow visualization Streamlines Vector fields | Automatic vessel segmentation Automatic contour detection with user input; can be changed manually Blood flow visualization Streamlines Vector fields |
5
| New Device | Predicate Device | |
|---|---|---|
| Device name | CAAS MR 4D Flow | HeartScan |
| Manufacturer | Pie Medical Imaging | Morpheus |
| 510(k) number | K162376 | K133937 |
| Blood flow parameters Net blood flow rate Net blood flow volume Regurgitation fraction | Pathlines Blood flow parameters Net blood flow rate Net blood flow volume | |
| Image display | ||
| and | ||
| manipulation | Pan/zoom; magnify; maximize and minimize, scroll through slice stack; adjust window level, contrast, brightness; single image ROI placement; automated 2D ROI; propagate/copy/edit functions; 2D velocity color map | Pan/zoom; magnify; maximize and minimize, scroll through slice stack; adjust window level, contrast, brightness; single image ROI placement; automated 2D ROI; copy/edit functions; 2D velocity color map |
| Correction | ||
| types | Phase aliasing Eddy current correction (ECC) | Eddy current correction (ECC) |
| Storage of | ||
| results | Text files (CSV) DICOM SC report PDF report Print report Image snapshot bitmaps Animation (streamlines) Session state (reanalysis) | Export to clinical report containing graphic information (images, animation, charts) as PDF or DICOM |
| Operating | ||
| system | Windows | Windows |
The basic features and technology of CAAS MR 4D Flow are the same in terms of intended use and indications for use and have the same technological characteristics as the predicate device Morpheus HeartScan (K133937). Both software applications use the same types of images as input, and produce the same kind of results.
Performance Data
Verification and validation of the CAAS MR 4D Flow functionality showed that the system requirements – derived from the intended use and indications for use – as well as risk control measures were implemented correctly and that the device meets its specifications including conformance to the following standards:
- · ISO 14971:2007, Medical devices Application of risk management to medical devices
- NEMA PS 3.1 3.20 (2011), Digital Imaging and Communication in Medicine (DICOM)
- · IEC 62304 First edition 2006-05, Medical device software Software life cycle processes
- IEC 62336:2007, Medical devices Application of usability engineering to medical devices
The verification and validation results demonstrate the safety and effectiveness of CAAS MR 4D Flow in relation to its intended use and therefore CAAS MR 4D Flow can be considered as safe and effective as its predicate device.
Conclusion
Based on the application of risk management and performance testing inherent to PMI's QA system (compliant with recognized standards as stated above) we conclude that CAAS MR 4D Flow is as safe and effective as its predicate device in terms of intended use, indications for use, technological characteristics, measurements and operating environment and does not raise any new issues related to safety and effectiveness compared to the predicate device.