(125 days)
No
The summary describes a software application for visualizing and comparing medical images and modeling ablation zones. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on image display, annotation, volume rendering, and measurement accuracy.
No.
The Emprint™ Visualization Application is a software tool used to display and process medical images for visualization and comparison, which aids in planning and evaluating ablation procedures. It does not directly provide therapy or interact with the patient's body to treat a condition.
No
The "Intended Use / Indications for Use" section explicitly states, "The software is not intended for diagnosis."
Yes
The device description explicitly states it is a "software product that achieves its medical purpose without being part of the hardware of a medical device (SaMD)" and is a "Windows™ desktop program".
Based on the provided information, the Emprint™ Visualization Application 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.
- Emprint™ Visualization Application's Function: The Emprint™ Visualization Application works with imaging data (CT and MRI), which are obtained from outside the body. It processes and displays these images to aid in ablation procedures, not to analyze biological samples.
- Intended Use: The intended use explicitly states that the software "allows physicians to visualize and compare CT and MRI imaging data" and "aids in ablation procedures." It also explicitly states, "The software is not intended for diagnosis." This further reinforces that it's not performing diagnostic tests on biological samples.
Therefore, the Emprint™ Visualization Application falls under the category of a medical device that processes and displays medical images, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Emprint™ Visualization Application is a stand-alone software product that allows physicians to visualize and compare CT and MRI imaging data. The display, annotation, and volume rendering of medical images aids in ablation procedures conducted using Emprint™ ablation systems. The software is not intended for diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The Emprint™ Visualization Application is a software product that achieves its medical purpose without being part of the hardware of a medical device (SaMD). The Emprint™ Visualization Application is used to support Emprint ™-system ablation procedures by displaying patient CT and MRI images with modeled ablation zones / volumes. The application is a Windows™ desktop program that is installed on a hospital computer with local storage and a network connection. The software receives CT and MRI images by supporting DICOM connections with CT/MRI scanners and hospital PACS. The software's DICOM image viewer does not in any way alter the medical images. The device is designed to meet the procedure planning and evaluation needs of physicians conducting soft tissue ablation procedures using Emprint ™-branded systems only.
Using the visualization application, clinicians can perform the following activities:
- Import standard DICOM images and view them in 3-dimensions .
- . Select and view specific anatomical features (e.g., soft-tissue lesions, anatomical landmarks)
- . Measure and mark critical anatomical features / areas of interest
- Overlay and position virtual images of the Emprint™ ablation antenna and the . anticipated thermal ablation zone onto the medical image
- . Add textual annotations to images
- . Export annotated plans for the patient's medical record or for use in a radiology or operating suite
- . View and compare any 2 of the imported images, simultaneously.
Using these features, the physician can prepare for an Emprint™-system ablation procedure by viewing and annotating patient-specific anatomy. Additionally, images taken before, during, or after an ablation procedure can be compared for a specific patient, and images can be compared across patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians / hospital computer, CT suite
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)
Extensive software verification testing was conducted for the SaMD product and included both software subsystem and system-level verification. Subsystem testing included unit and integration testing, while system-level verification was conducted to fully evaluate the performance of the application's user interface. Additionally, system-level testing was conducted to verify the application's measurement accuracy (+/- 2 voxels).
During the product's development, Covidien followed a human-factors engineering (HFE) process and conducted simulated-use, validation testing to confirm that the visualization application met user needs and expectations.
Performance testing demonstrated the Emprint™ Visualization's compliance with the following international standards.
1 IEC 62304:2006, Medical Device Software – Software Life Cycle Processes
2 NEMA PS 3.1-3.20:2016, Digital Imaging and Communications in Medicine (DICOM)
The performance and safety of the Emprint™ Ablation Visualization Application was characterized using laboratory (bench) verification and simulated-use validation testing. Animal studies and clinical studies in human subjects were not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
measurement accuracy (+/- 2 voxels)
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The text reads "U.S. FOOD & DRUG ADMINISTRATION".
December 2, 2019
Covidien LLC % Tim Thomas, RAC VP Regulatory Affairs Medtronic 6135 Gunbarrel Avenue BOULDER CO 80301
Re: K192038
Trade/Device Name: Emprint™ Visualization Application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: November 6, 2019 Received: November 7, 2019
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. 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
1
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 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 (OS) 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,
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
2
Indications for Use
510(k) Number (if known) K192038
Device Name
Emprint™ Visualization Application
Indications for Use (Describe)
The Emprint™ Visualization Application is a stand-alone software product that allows physicians to visualize and compare CT and MRI imaging data. The display, annotation, and volume rendering of medical images aids in ablation procedures conducted using Emprint™ ablation systems. The software is not intended for diagnosis.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary - K192038
510(k) Submitter/Holder
Covidien IIc 15 Hampshire Street Mansfield, MA 02048
Contact
Tim Thomas RAC
VP, Regulatory Affairs Phone: 770.480.2911 Email: tim.n.thomas@medtronic.com
Date of Summary Preparation
September 27, 2019
Name of Device
| Device Trade Name: | Emprint TM Visualization Application |
|---|---|
| Device Common Name: | DICOM Viewer |
| Classification Name: | Picture Archiving and Communications System / Class II |
| Regulation: | 21 CFR 892.2050 |
| Regulatory Class: | II |
| Product Code: | LLZ |
| Special Controls: | Compliance with Voluntary Standards: |
(1) Digital Imaging and Communications in Medicine (DICOM)
Standard
(2) Joint Photographic Experts Group (JPEG) Standard, Society of
Motion Picture and Television Engineers; (SMPTE) Test Pattern
Note: The JPEG Standard does not apply, as the subject device
does not include motion imaging.
Predicate Device
The Emprint™ Visualization is substantially equivalent to the following, commercially available predicate device:
| Device Trade Name: | Emprint™ Ablation Visualization Application |
|---|---|
| Device Common Name: | DICOM Viewer |
| 510(k) Numbers: | K180192 |
| Manufacturer: | Covidien IIc |
De vice Description
The Emprint™ Visualization Application is a software product that achieves its medical purpose without being part of the hardware of a medical device (SaMD).
4
The Emprint™ Visualization Application is used to support Emprint ™-system ablation procedures by displaying patient CT and MRI images with modeled ablation zones / volumes. The application is a Windows™ desktop program that is installed on a hospital computer with local storage and a network connection. The software receives CT and MRI images by supporting DICOM connections with CT/MRI scanners and hospital PACS. The software's DICOM image viewer does not in any way alter the medical images. The device is designed to meet the procedure planning and evaluation needs of physicians conducting soft tissue ablation procedures using Emprint ™-branded systems only.
Using the visualization application, clinicians can perform the following activities:
- Import standard DICOM images and view them in 3-dimensions .
- . Select and view specific anatomical features (e.g., soft-tissue lesions, anatomical landmarks)
- . Measure and mark critical anatomical features / areas of interest
- Overlay and position virtual images of the Emprint™ ablation antenna and the . anticipated thermal ablation zone onto the medical image
- . Add textual annotations to images
- . Export annotated plans for the patient's medical record or for use in a radiology or operating suite
- . View and compare any 2 of the imported images, simultaneously.
Using these features, the physician can prepare for an Emprint™-system ablation procedure by viewing and annotating patient-specific anatomy. Additionally, images taken before, during, or after an ablation procedure can be compared for a specific patient, and images can be compared across patients.
Indications for Use
The Emprint™ Visualization Application is a stand-alone software product that allows physicians to visualize and compare CT and MRI imaging data. The display, annotation, and volume rendering of medical images aids in ablation procedures conducted using Emprint™ ablation systems.
The software is not intended for diagnosis.
Technological Characteristics
The visualization application is a DICOM (Digital Imaging and Communications in Medicine) image viewer. It relies on the same principle of operation and fundamental technology and has the same performance characteristics as the predicate device / previous version of software.
5
Performance Testing
Extensive software verification testing was conducted for the SaMD product and included both software subsystem and system-level verification. Subsystem testing included unit and integration testing, while system-level verification was conducted to fully evaluate the performance of the application's user interface. Additionally, system-level testing was conducted to verify the application's measurement accuracy (+/- 2 voxels).
During the product's development, Covidien followed a human-factors engineering (HFE) process and conducted simulated-use, validation testing to confirm that the visualization application met user needs and expectations.
Performance testing demonstrated the Emprint™ Visualization's compliance with the following international standards.
| International Standard | |
|---|---|
| 1 | IEC 62304:2006, Medical Device Software – Software Life Cycle Processes |
| 2 | NEMA PS 3.1-3.20:2016, Digital Imaging and Communications in Medicine (DICOM) |
Animal and Clinical Testing
The performance and safety of the Emprint™ Ablation Visualization Application was characterized using laboratory (bench) verification and simulated-use validation testing. Animal studies and clinical studies in human subjects were not required.
Comparison to Predicate Device
Key differences between the subject and predicate devices include the following:
- . The subject device was designed using a new, more efficient architecture.
- . Workflow/procedural steps were optimized/organized for ease of use and to remove redundancy from the application. The predicate device (Emprint ™ Ablation Visualization Application, Version 1.4), provides the user with the same functionality as the subject device, but requires the physician to use four different workflows. A separate workflow is required for each tissue type (liver ablation, kidney ablation, and lung ablation) and, also, for the application's 'Compare Images' feature. In the subject device (Emprint ™ Ablation Application. Version 2.0), a single workflow is used for all tissue types and to implement the "Compare Images" feature. In addition to improving the software's usability, this change significantly reduces the amount of disk storage space required by the application.
- . The user interface was optimized to reflect the application's use in the CT suite, where images are acquired during the procedure to confirm the antenna's position and trajectory, immediately prior to ablation. The application's workflow reflects its intraprocedural use and better supports clinical decisions for ablations performed in the CT suite.
- . The subject device may be used with both MRI and CT images, as opposed to CT images only (predicate device).
6
The Emprint™ Visualization Application relies on the same principles of operation and fundamental technology and has essentially the same performance characteristics and intended use as its predicate. The subject device uses the same operating mechanism as the predicate device to size and display predicted ablation zones onto an image series. Like the predicate device, the Emprint™ Visualization references zone charts (look-up tables) that characterize the performance of the 510(k)-cleared Emprint™ Ablation System (K133821) and Emprint™ SX Ablation Platform (K171358).
Conclusion
The Emprint™ Visualization Application is used to plan and evaluate soft-tissue ablation procedures conducted with Emprint™-branded ablation systems in the same way as the predicate device / previous software version. The subject and predicate devices are both DICOM image viewers and comply with the associated NEMA DICOM Standard. Differences between the subject and predicate devices include architecture design and usability enhancements - none of which impact the SaMD product's intended use, measurement accuracy, underlying technology, principle of operation, or raise new questions of safety and effectiveness. The Emprint™ Visualization (subject device) and Emprint™ Ablation Visualization Application (predicate device) are substantially equivalent.