(57 days)
No
The summary describes post-processing software using mathematical and statistical analysis, algorithms, and workflow guidance, but does not mention AI or ML.
No.
The device is primarily a post-processing software package for analyzing MR datasets, facilitating diagnosis and treatment planning, rather than directly providing therapy.
Yes
The software's intended use is to assist radiologists in analyzing MR datasets to arrive at a diagnosis, including lesion characterization and reporting, and to provide assistance in the interpretation of MR studies. Furthermore, it is explicitly stated that the device is intended for "diagnostic procedures" in the case of DynaLOC Prostate.
Yes
The device is described as a "software platform" and "software modules" for post-processing and analysis of MR datasets. While it interacts with MR imaging systems and interventional devices, the core functionality and the device being cleared is the software itself. The description focuses on software functions, algorithms, and workflow tools.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
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.
- Device Function: The DynaCAD software and its modules are designed for the post-processing, analysis, and visualization of medical images (specifically MR images). It assists physicians in interpreting these images and planning interventional procedures.
- Lack of Biological Sample Analysis: The device does not involve the analysis of any biological samples taken from the patient. Its input is image data, not biological specimens.
Therefore, while it is a medical device used in a clinical setting to aid in diagnosis and treatment planning, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The DynaCAD software consists of the MR Analysis Server software and the viewer workstation software.
The MR Analysis Server software, which includes the DynaCAD Prostate, and DynaCAD PK for other MR Analysis modules, is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic MR datasets to provide study review and additional mathematical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.
The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.
DynaCAD software serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates into the radiologist's existing departmental workflow and can be adapted to fit the needs of each user. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies.
DynaLOC Breast
The DynaLOC Breast Interventional Planning software module supports the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion, relative to the interventional device.
DynaLOC Prostate
DynaLOC Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and interventional devices.
The application provides the user with patient data processing, visualization and storage functions. It allows image analysis, display and recording of simulated images of a tracked insertion tool, such as a needle guide or sleeve, on a computer monitor or other display that shows images of the target organs and the current and/ or projected path of the interventional instrument.
The device is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional and/or diagnostic procedures of the prostate.
Product codes
LLZ
Device Description
DynaCAD is a software platform for post-processing of MR datasets to provide a reliable means for visualizing MR datasets. It is also designed to provide study review and mathematical and/or statistical analysis. DynaCAD serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. that runs software modules that use algorithms to evaluate MR images as a postprocessing module. The DynaCAD software platform consists of a viewer workstation and the MR Analysis Server. The MR Analysis Server consists of 5 software modules controlled by license keys:
- DynaCAD Breast
- DynaCAD Prostate ●
- PK MR Analysis
- DynaLoc Breast Intervention ●
- DynaLoc Prostate Intervention .
It is used to review, analyze, and generate reports for MRI studies, as well as post-processing of MR raw images directly from the scanner for viewing and analysis. The software facilitates the analysis of dynamic and non-dynamic MR Datasets to provide study review and additional mathematical and statistical analysis. The results can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.
The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (P01) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.
DynaCAD software serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that should be performed to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates smoothly into the radiologist's existing departmental workflow and can be adapted to fit the needs of each user, thereby streamlining diagnosis. In the hands of a trained physician, the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies.
DynaLOC Breast
The DynaLOC Breast Interventional Planning software module supports the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures.
DynaLOC Prostate
DynaLOC Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and the DynaTRIM Interventional device. The device is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional or diagnostic procedures of the prostate. The application provides the user with patient data processing, visualization, and storage functions.
PK MRI Analysis
The PK analysis software is designed to allow radiologists to visualize the presence and pattern of contrast induced enhancement for protocols other than Breast and Prostate MR datasets. The option uses the same core processing algorithm contained within All-Time Point pharmacokinetic analysis software, permitting the calculation of Ktrans and Ve values for all voxels within a region of interest in contrast-enhanced MRI studies. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) imaging systems
Anatomical Site
Breast, Prostate, target organs (specific examples not provided, but generally for clinical, interventional, and/or diagnostic procedures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in a clinical setting, Radiologist
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)
Nonclinical Testing and Performance Information:
This 510(k) premarket notification contains technical documentation which includes nonclinical verification and validation tests as well as image quality testing. Tests were performed on DynaCAD according to the following international and FDA-recognized consensus standards:
- IEC 62304: 2015 Ed 1.1
- ISO 14971:2007
The test results demonstrate that DynaCAD meets the acceptance criteria and is adequate for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
October 9, 2019
Invivo Corporation % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114
Re: K192200
Trade/Device Name: DynaCAD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: September 30, 2019 Received: October 2, 2019
Dear Prithul Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192200
Device Name DynaCAD
Indications for Use (Describe)
DynaCAD
The DynaCAD software consists of the MR Analysis Server software and the viewer workstation software.
The MR Analysis Server software, which includes the DynaCAD Prostate, and DynaCAD PK for other MR Analysis modules, is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic MR datasets to provide study review and additional mathematical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.
The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.
DynaCAD software serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates into the radiologist's existing departmental workflow and can be adapted to fit the needs of each user. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies.
DynaLOC Breast
The DynaLOC Breast Interventional Planning software module supports the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion, relative to the interventional device.
DynaLOC Prostate
DynaLOC Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and interventional devices.
The application provides the user with patient data processing, visualization and storage functions. It allows image analysis, display and recording of simulated images of a tracked insertion tool, such as a needle guide or sleeve, on a computer monitor or other display that shows images of the target organs and the current and/ or projected path of the interventional instrument.
The device is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional and/or diagnostic procedures of the prostate.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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5 510(k) Summary
510(k) Summary of Safety and Effectiveness
DynaCAD
This summary of safety and effectiveness information is submitted in accordance with 21CFR §807.92
-
- Submitter's name, address, telephone number, contact person. Invivo Corporation 3545 SW 47th Ave Gainesville, FL 32608
| Contact person: | Kym Rupp, Regulatory Affairs Manager |
|---|---|
| Email: | kym.rupp@philips.com |
| Tel: | 425-487-7127 |
| Secondary Contact: | Jennifer Conyac, Regulatory Affairs Specialist |
| Email: | jennifer.bonacci@philips.com |
June 7, 2019 Date prepared:
-
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
| Common name: | Picture Archiving and Communications System |
|---|---|
| Proprietarv name: |
These devices are classified as follows:
| Classification Description | 21 CFR
Section | Classification
Panel | Product
Code | Classification |
|--------------------------------------|-------------------|-------------------------|-----------------|----------------|
| Picture archiving and communications | 892.2050 | Radiology | LLZ | |
| system | | | | |
3. Substantially Equivalent Devices
DynaCAD Software is substantially equivalent to the following devices:
| Predicate Device | 510(k) |
|---|---|
| VersaVue Enterprise Suite | K121517 |
| Reference Devices | 510(k) |
| DynaCAD/Prostate Interventional | K133030 |
| iCAD Breast Interventional Planning Software | K090223 |
4. Device Description
DynaCAD is a software platform for post-processing of MR datasets to provide a reliable means for visualizing MR datasets. It is also designed to provide study review and mathematical and/or
DynaCAD Premarket Notification - Traditional 510(k) Page 38 of 93
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statistical analysis. DynaCAD serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. that runs software modules that use algorithms to evaluate MR images as a postprocessing module. The DynaCAD software platform consists of a viewer workstation and the MR Analysis Server. The MR Analysis Server consists of 5 software modules controlled by license keys:
- DynaCAD Breast
- DynaCAD Prostate ●
- PK MR Analysis
- DynaLoc Breast Intervention ●
- DynaLoc Prostate Intervention .
It is used to review, analyze, and generate reports for MRI studies, as well as post-processing of MR raw images directly from the scanner for viewing and analysis. The software facilitates the analysis of dynamic and non-dynamic MR Datasets to provide study review and additional mathematical and statistical analysis. The results can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.
The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (P01) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.
DynaCAD software serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that should be performed to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates smoothly into the radiologist's existing departmental workflow and can be adapted to fit the needs of each user, thereby streamlining diagnosis. In the hands of a trained physician, the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies.
DynaLOC Breast
The DynaLOC Breast Interventional Planning software module supports the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures.
DynaLOC Prostate
DynaLOC Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and the DynaTRIM Interventional device. The device is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional or diagnostic procedures of the prostate. The application provides the user with patient data processing, visualization, and storage functions.
PK MRI Analysis
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Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.
The PK analysis software is designed to allow radiologists to visualize the presence and pattern of contrast induced enhancement for protocols other than Breast and Prostate MR datasets. The option uses the same core processing algorithm contained within All-Time Point pharmacokinetic analysis software, permitting the calculation of Ktrans and Ve values for all voxels within a region of interest in contrast-enhanced MRI studies. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images.
5. Indications for Use
DynaCAD software consists of the MR Analysis Server software and the viewer workstation software.
The MR Analysis Server software, which includes the DynaCAD Breast, DynaCAD Prostate, and DynaCAD PK for other MR Analysis modules, is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.
The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.
DynaCAD software serves as a workflow roadman tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates into the radiologist's existing departmental workflow and can be adapted to fit the needs of each user. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and nondynamic MR studies.
DynaLOC Breast
The DynaLOC Breast Interventional Planning software module supports the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion, relative to the interventional device.
DynaLOC Prostate
DynaLOC Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and interventional devices.
The application provides the user with patient data processing, visualization and storage functions. It allows image analysis, display and recording of simulated images of a tracked insertion tool, such as a needle guide or sleeve, on a computer monitor or other display that
DynaCAD Premarket Notification - Traditional 510(k) Page 40 of 93
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shows images of the target organs and the current and/ or projected path of the interventional instrument.
The device is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional and/or diagnostic procedures of the prostate.
6. Technological Comparison to Predicate Devices
DynaCAD employs the same basic construction and fundamental scientific technology as the predicate VersaVue Enterprise Suite (K121517) and reference devices DynaCAD/Prostate Interventional (K133030) and iCAD Breast Interventional Planning Software (K090223), with regards to the functionality and technology. DynaCAD incorporates several software modules that have been cleared by the FDA separately. DynaCAD incorporates the following software modules, previously cleared by FDA in the following reference devices:
- DynaCAD Breast
- DynaCAD Prostate ●
- DynaLoc Breast Intervention
- DynaLoc Prostate Intervention ●
- PK Analysis ●
The outcome of this comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of DynaCAD when compared to the predicate VersaVue Enterprise Suite and reference devices DynaCAD/Prostate Interventional and iCAD Breast Interventional Planning Software.
Safety and Effectiveness
DynaCAD labeling contains instructions for use and necessary cautions, warnings and notes to provide for safe and effective use of the device. Risk Management is ensured via Invivo's Risk Management procedure, which is used to identify potential hazards. These potential hazards are controlled via the product development process, verification and validation testing.
Nonclinical Testing and Performance Information
This 510(k) premarket notification contains technical documentation which includes nonclinical verification and validation tests as well as image quality testing. Tests were performed on DynaCAD according to the following international and FDA-recognized consensus standards:
- IEC 62304: 2015 Ed 1.1
- ISO 14971:2007
The test results demonstrate that DynaCAD meets the acceptance criteria and is adequate for its intended use.
Based upon the same intended use, similar technology, software functionalities, same product configuration and administration, and similarity of materials. it can be concluded DynaCAD is substantially equivalent to the predicate device Versa Vue Enterprise Suite and reference devices DynaCAD/Prostate Interventional and iCAD Breast Interventional Planning Software, in terms of intended use, design characteristics, and safety and effectiveness.
Substantial Equivalence Conclusion:
DynaCAD Premarket Notification - Traditional 510(k) Page 41 of 93
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The comparison of technological characteristics, safety testing, and software validation, demonstrates that the device is as safe and effective as the predicate device. The new device, predicate, and reference devices are substantially equivalent in the areas of technological characteristics such as basic design, features, and method of operation, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.
Conclusion
The 510(k) Pre-Market Notification for DynaCAD contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. Invivo has determined that its device, the DynaCAD, is substantially equivalent to the identified predicate device listed above. A comparison with the legally marketed predicate device indicates that it is substantially equivalent to this device, and that it does not raise any new safety or efficacy concerns. Nonclinical tests demonstrate that the device is safe, effective, and is substantially equivalent to the predicate device.