(21 days)
Not Found
No
The summary describes image analysis software with mathematical and statistical analysis capabilities, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The performance studies focus on standard software verification and validation, not AI/ML model performance metrics.
No.
DynaCAD is an image analysis software used for diagnosis, reporting, and pre-planning, not for directly treating a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "DynaCAD is a MR image analysis software medical device used during clinical diagnosis, reporting, and interventional pre-planning" and is "intended to assist the physician through a series of sequential tasks" including "study review, lesion characterization, and additional mathematical and/or statistical analysis." It also mentions its use for "diagnostic and interventional procedure planning."
Yes
The device description explicitly states "DynaCAD is a MR image analysis software only medical device".
Based on the provided information, DynaCAD is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- DynaCAD's Function: DynaCAD analyzes MR images, which are generated in vivo (within the living body) using a medical imaging modality (Magnetic Resonance Imaging). It processes these images to assist in diagnosis, reporting, and planning, but it does not directly analyze biological specimens.
The description clearly states that DynaCAD is an "MR image analysis software medical device." Its function is to process and analyze images acquired from the patient's body, not to test samples taken from the body.
N/A
Intended Use / Indications for Use
DynaCAD is a MR image analysis software medical device used during clinical diagnosis, reporting, and interventional pre-planning and is intended to assist the physician through a series of sequential tasks. DynaCAD consists of: • MR Analysis Server post-processing software application facilitates the analysis of dynamic MR datasets to provide study review, lesion characterization, and additional mathematical and/or statistical analysis. · Viewer application facilitates the analysis and presentation of datasets generated by the MR Analysis Server. · Interventional Planning image-guidance application for diagnostic and interventional procedure planning for biopsy and/ or soft tissue ablation. DynaCAD is indicated for medical conditions that require interventional and/or diagnostic procedures of the prostate gland or breast tissue.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, LNH
Device Description
DynaCAD is a MR image analysis software only medical device used during clinical diagnosis, reporting, and interventional pre-planning and is intended to assist the physician through a series of sequential tasks. DynaCAD consists of: - . MR Analysis Server post-processing software application, which facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review, lesion characterization, and additional mathematical and/or statistical analysis. It includes the following software modules: DynaCAD Breast, DynaCAD Prostate, DynaLOC Breast, DynaLOC Prostate, and PK MRI Analysis. - . Viewer application, which facilitates the analysis and presentation of datasets generated by the MR Analysis Server. It includes 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. - Interventional Planning image-guidance application, i.e. Ablation Planning, which facilitates diagnostic and interventional procedure planning for biopsy and/or soft tissue ablation. It helps the user to prepare for ablation procedures by presenting the target regions along with critical structures identified in MR, and previously acquired biopsy data. It provides information about the ablation devices and applicators for automatic ablation plan computation, which the user can adjust as necessary. DynaCAD is used in both the radiology, i.e. DynaCAD Radiology, and urology domain, i.e. DynaCAD Urology.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR
Anatomical Site
prostate gland or breast tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / clinical diagnosis, reporting, and interventional pre-planning
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)
Non-clinical software verification testing has been performed to verify that all functional and nonfunctional requirements as well as the identified safety and security risk control measures for DynaCAD have been implemented. Results demonstrated that all executed verification test passed. Software validation testing has been performed to validate that DynaCAD conforms to its intended use, user needs, claims. The validation consisted of the following activities: - Usability validation was performed with user representatives that fulfil the intended user profile in a simulated use environment. DynaCAD was found to be safe and effective for the intended use, users and use environment. - In-house simulated use design validation was performed with user representatives that fulfil the intended user profile. The participants executed validation protocols that simulate the user need in the form of a typical DynaCAD clinical workflow. Results demonstrated that all executed validation protocols were passed. DynaCAD conforms to its intended use, claims, and user needs. All these tests were used to demonstrate that DynaCAD: - Complies with the aforementioned international and FDA-recognized consensus standards, and - Meets the acceptance criteria of the device requirements and is adequate for its intended use.
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
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
August 2, 2021
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Invivo Corporation % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114
Re: K212175
Trade/Device Name: DynaCAD Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ LNH Dated: July 10, 2021 Received: July 12, 2021
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)
Device Name DynaCAD
Indications for Use (Describe)
DynaCAD is a MR image analysis software medical device used during clinical diagnosis, reporting, and interventional pre-planning and is intended to assist the physician through a series of sequential tasks. DynaCAD consists of: • MR Analysis Server post-processing software application facilitates the analysis of dynamic MR datasets to provide study review, lesion characterization, and additional mathematical and/or statistical analysis.
· Viewer application facilitates the analysis and presentation of datasets generated by the MR Analysis Server.
· Interventional Planning image-guidance application for diagnostic and interventional procedure planning for biopsy and/ or soft tissue ablation.
DynaCAD is indicated for medical conditions that require interventional and/or diagnostic procedures of the prostate gland or breast tissue.
| 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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510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
Preparation date: May 18, 2021
Company identification
Invivo Corporation 3545 SW 47th Ave Gainesville, FL 32608 United States of America Establishment registration number: 1056069
Contact person
Name: Liselotte Kornmann (primary) Title: Senior Regulatory Affairs Specialist Philips Precision Diagnosis Solutions Telephone: +31611621238 Email: liselotte.kornmann@philips.com
Name: Monique Greijmans (secondary) Title: Head of Regulatory Affairs Philips Precision Diagnosis Solutions Telephone: +31621929674 Email: monique.greijmans@philips.com
Device
Device Trade Name: DynaCAD Device Class: Class II Product Code: LLZ Classification Regulation: 21 CFR, Part 892.2050 Classification Name: Medical image management and processing system Classification Panel: Radiology
Secondary Product Code: LNH Classification Regulation: 21 CFR, Part 892.1000 Classification Name: Magnetic resonance diagnostic device Classification Panel: Radiology
Predicate device
Device Trade Name: DynaCAD 510(k) Number: K192200
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Device description
DynaCAD is a MR image analysis software only medical device used during clinical diagnosis, reporting, and interventional pre-planning and is intended to assist the physician through a series of sequential tasks. DynaCAD consists of:
- . MR Analysis Server post-processing software application, which facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review, lesion characterization, and additional mathematical and/or statistical analysis. It includes the following software modules: DynaCAD Breast, DynaCAD Prostate, DynaLOC Breast, DynaLOC Prostate, and PK MRI Analysis.
- . Viewer application, which facilitates the analysis and presentation of datasets generated by the MR Analysis Server. It includes 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.
- Interventional Planning image-guidance application, i.e. Ablation Planning, which facilitates diagnostic and interventional procedure planning for biopsy and/or soft tissue ablation. It helps the user to prepare for ablation procedures by presenting the target regions along with critical structures identified in MR, and previously acquired biopsy data. It provides information about the ablation devices and applicators for automatic ablation plan computation, which the user can adjust as necessary.
DynaCAD is used in both the radiology, i.e. DynaCAD Radiology, and urology domain, i.e. DynaCAD Urology.
Intended use / Indications for use
DynaCAD has the following Indications for Use:
DynaCAD is a MR image analysis software medical device used during clinical diagnosis, reporting, and interventional pre-planning and is intended to assist the physician through a series of sequential tasks. DynaCAD consists of:
- MR Analysis Server post-processing software application facilitates the analysis of . dynamic and non-dynamic MR datasets to provide study review, lesion characterization, and additional mathematical and/or statistical analysis.
- . Viewer application facilitates the analysis and presentation of datasets generated by the MR Analysis Server.
- . Interventional Planning image-guidance application for diagnostic and interventional procedure planning for biopsy and/or soft tissue ablation.
DynaCAD is indicated for medical conditions that require interventional and/or diagnostic procedures of the prostate gland or breast tissue.
The Indications for Use statement of the subject device is similar compared to the currently marketed DynaCAD.
The addition of the Interventional Planning application together with the editorial changes in the Indications for Use statement do not raise any new safety and effectiveness questions. Both the
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subject and predicate device can be used for the same medical conditions that require interventional and/or diagnostic procedures of the prostate gland or breast tissue. Furthermore, the Indications for Use of the subject device falls within the intended use of the predicate device and, therefore, the two devices have the same intended use. Both the subject and predicate device are intended to assist the physician through a series of sequential tasks during clinical diagnosis, reporting, and interventional pre-planning.
Summary of technological characteristics
DynaCAD employs the same fundamental technology compared to the currently marketed predicate device. Both devices provide:
- MR Analysis Server post-processing software application, including the same software . modules: DynaCAD Breast, DynaCAD Prostate, DynaLOC Breast, DynaLOC Prostate, and PK MRI Analysis.
- . Viewer application, including the same functions that facilitates the analysis and presentation of datasets such as 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.
The technological differences for the subject device are as follows:
- DynaCAD offers (in addition to the currently cleared radiology workflow) a urology . workflow, i.e. DynaCAD Urology, which is customized to the needs of a clinical urologist for pre-planning and post review of biopsy and ablation procedures. It provides functionalities to
- review and edit (e.g. modify boundary/targets) the segmented MR results received from DynaCAD Prostate,
- create an ablation plan with Ablation Planning application (also optionally available o for DynaCAD Radiology),
- o view results from ablation procedures for post review purpose.
The differences between the subject and the predicate device do not raise any new questions regarding safety or effectiveness.
Summary of non-clinical performance data
Non-clinical performance testing has been performed on DynaCAD to demonstrate compliance with the following international and FDA-recognized consensus standards:
- IEC 62304 Medical device software Software life cycle processes (Edition 1.1 2015-06). . FDA/CDRH recognition number 13-79.
- . IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices (Edition 1.1 2020-06). FDA/CDRH recognition number 5-129.
- . ISO 14971 Medical devices – Application of risk management to medical devices (Third Edition 2019-12). FDA/CDRH recognition number 5-125,
- ISO 15223-1 Medical devices Symbols to be used with medical device labels, labelling . and information to be supplied - Part 1: General requirements (Third Edition 2016-11-01). FDA/CDRH recognition number 5-117,
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- NEMA PS 3.1-3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016). ● FDA/CDRH recognition number 12-300.
Non-clinical software verification testing has been performed to verify that all functional and nonfunctional requirements as well as the identified safety and security risk control measures for DynaCAD have been implemented. Results demonstrated that all executed verification test passed.
Software validation testing has been performed to validate that DynaCAD conforms to its intended use, user needs, claims. The validation consisted of the following activities:
- Usability validation was performed with user representatives that fulfil the intended user ● profile in a simulated use environment. DynaCAD was found to be safe and effective for the intended use, users and use environment.
- . In-house simulated use design validation was performed with user representatives that fulfil the intended user profile. The participants executed validation protocols that simulate the user need in the form of a typical DynaCAD clinical workflow. Results demonstrated that all executed validation protocols were passed. DynaCAD conforms to its intended use, claims, and user needs.
All these tests were used to demonstrate that DynaCAD:
- Complies with the aforementioned international and FDA-recognized consensus . standards, and
- . Meets the acceptance criteria of the device requirements and is adequate for its intended use.
Summary of clinical performance data
The subject DynaCAD did not require clinical performance data to demonstrate safe and effective use.
Conclusions
Non-clinical performance tests ensured that the modification is properly introduced, and the device conforms to its intended use, users and use environment. These tests were used to demonstrate that it is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.