Emprint Ablation Visualization Application
Device Facts
| Record ID | K180192 |
|---|---|
| Device Name | Emprint Ablation Visualization Application |
| Applicant | Covidien, LLC |
| Product Code | LLZ · Radiology |
| Decision Date | Mar 21, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
The Emprint™ Ablation Visualization Application is a stand-alone software product that allows physicians to visualize and compare CT 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.
Device Story
Software-as-a-Medical-Device (SaMD) DICOM viewer; enables visualization, annotation, and volume rendering of pre-, intra-, and post-procedure CT images. Used by surgeons and interventionists in clinical settings to plan and evaluate soft-tissue ablation procedures performed with Emprint™ Ablation System or Emprint™ SX Ablation Platform. Physicians import DICOM datasets; select anatomical features; measure/mark areas of interest; overlay virtual antenna models and anticipated thermal ablation zones; and compare image sets. Device does not perform automated calculations; uses look-up tables (zone charts) to display predicted ablation zones. Output assists in procedure planning and post-procedure evaluation. Decoupled from dedicated hardware, allowing installation on standard Windows™-based computers.
Clinical Evidence
Bench testing only. Verification included software subsystem and system-level testing, including measurement accuracy (+/- 2 voxels). Human factors engineering (HFE) and simulated-use validation testing confirmed user needs and expectations. No animal or clinical studies were conducted.
Technological Characteristics
DICOM image viewer; SaMD; Windows™ 7/10 compatible. Complies with IEC 62304 (software lifecycle) and NEMA PS 3.1-3.20 (DICOM). Principle of operation: manual annotation and overlay of virtual ablation zones based on look-up tables (zone charts).
Indications for Use
Indicated for physicians to visualize and compare CT imaging data to aid in soft-tissue ablation procedures using Emprint™ ablation systems. Not intended for diagnosis.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- Emprint™ Procedure Planning Application (K142048)
Reference Devices
Submission Summary (Full Text)
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March 21, 2018
Covidien LLC % Ms. Patti Arndt Principal Regulatory Affairs Specialist 5920 Longbow Drive BOULDER CO 80301
Re: K180192
Trade/Device Name: Emprint™ Ablation Visualization Application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 23, 2018 Received: January 25, 2018
Dear Ms. Arndt:
We have reviewed vour 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 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.
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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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'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
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# Indications for Use
510(k) Number (if known)
K180192
Device Name
Emprint™ Ablation Visualization Application
Indications for Use (Describe)
The Emprint™ Ablation Visualization is a stand-alone software product that allows physicians to visualize and compare CT 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) | |
|--------------------------------------------------------------------------|--|
| <div> <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | |
| <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | |
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# 510(k) Summary - K180192
## 510(k) Submitter/Holder
Covidien IIc 15 Hampshire Street Mansfield, MA 02048
## Contact
Patti Arndt Principal Regulatory Affairs Specialist Phone: 303-581-6668 Fax: 303-530-6313 Email: patti.l.arndt@medtronic.com
### Date of Summary Preparation
March 19, 2018
### Name of Device
| Device Trade Name: | Emprint™ Ablation 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:<br>(1) Digital Imaging and Communications in Medicine (DICOM) Standard<br>(2) Joint Photographic Experts Group (JPEG) Standard, Society of Motion Picture and Television Engineers; (SMPTE) Test Pattern<br>Note: The JPEG Standard does not apply, as the subject device does not include motion imaging. |
#### Predicate Device
The Emprint™ Ablation Visualization Application described in this submission is substantially equivalent to the following, commercially available predicate device:
| Device Trade Name: | Emprint™ Procedure Planning Application |
|---------------------|-----------------------------------------|
| Device Common Name: | DICOM Viewer |
| 510(k) Numbers: | K142048 |
| Manufacturer: | Covidien IIc |
## Device Description
The Emprint™ Ablation Visualization Application is a software product that achieves its medical purpose without being part of the hardware of a medical device (SaMD).
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The visualization application is a DICOM image viewer that allows surgeons and interventionists to utilize a health care facility's PACS (Picture Archiving and Communications System) server (or other digital media transfer process) to view and interact with CT images. Using preprocedure, intra-procedure and post-procedure CT images, physicians can both plan and evaluate soft-tissue ablation procedures conducted with the Emprint™ Ablation System (K133821) and the Emprint™ SX Ablation Platform (K171358). The application is designed to streamline and enhance the procedure planning, execution and evaluation process; it is not required for the safe and effective conduct of an Emprint™ ablation procedure.
Using the application's three ablation workflows (Liver, Lung and Kidney Ablation), physicians can prepare for or evaluate an Emprint™ system ablation procedure by viewing and annotating patient-specific anatomy. The visualization's Compare Workflow facilitates the comparison of images across patients, or the comparison of images from the same patient before and after an ablation procedure. Physicians can use the software to perform the following, key, workflow-based tasks:
- Import standard DICOM images and render 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
- . Save annotated plans for future viewing
- 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 DICOM datasets, simultaneously
The visualization application is designed for installation and use on Windows™-based computers (Windows™ 7 or 10) and is compatible with procedure plans that were generated with the predicate device (Emprint™ Procedure Planning Application, K142048).
## Indications for Use
The Emprint™ Ablation Visualization Application is a stand-alone software product that allows physicians to visualize and compare CT 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.
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## 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 user interface for the visualization's workflows. 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™ Ablation Visualization Application's compliance with the following international standards.
| | International Standard |
|---|-------------------------------------------------------------------------------|
| 1 | IEC 62304:2006, Medical Device Software – Software Life Cycle Processes |
| 2 | NEMA PS 3.1-3.20:2014, 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 and Similarities
There are two principal differences between the subject and predicate device. First, the Emprint™ Procedure Planning Application (K142048) was provided to users on a dedicated Japtop computer, while the Emprint™ Visualization is a stand-alone software product. This decoupling of the procedure planning software from a dedicated hardware platform allows users to install and use the software on a compatible computer of their choice. Secondly, the new software product does not include a VATs workflow that was designed for use by thoracic surgeons for the planning of non-ablation, surgical procedures. The subject device is configured to meet the procedure planning and evaluation needs of physicians conducting soft tissue ablation procedures using Emprint™-branded systems only.
The Emprint™ Ablation Visualization 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 Emprint™ Procedure Planning Application (K142048) to size and display predicted ablation zones in the software's Liver and Lung Ablation Workflows, as well as in the new Kidney Ablation Workflow. Like the predicate device, the Emprint Ablation Visualization does not calculate predicted ablation zones automatically, but references zone charts (look-up tables) that characterize the performance of the 510(k)-cleared Emprint Ablation System (K133821).
## Conclusion
The Emprint™ Ablation Visualization is used to plan and evaluate soft-tissue ablation procedures conducted with Emprint™-branded ablation systems in the same way as the predicate Emprint™ Procedure Planning Application. The subject and predicate devices are both DICOM image viewers and comply with the associated NEMA DICOM Standard.
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Differences between the subject and predicate devices include minor configuration changes 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™ Ablation Visualization (subject device) and Emprint™ Procedure Planning Application (predicate device) are substantially equivalent.
