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.

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.

AI/ML Overview

Based on the provided text, the Emprint™ Visualization Application is a standalone software product (Software as a Medical Device - SaMD) that allows physicians to visualize and compare CT and MRI imaging data to aid in ablation procedures. It is not intended for diagnosis. The performance testing described focuses on various aspects of software quality and usability rather than a comparative effectiveness study with human readers or a standalone AI performance evaluation for diagnostic purposes.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, according to the provided document:

Acceptance Criteria and Reported Device Performance

The document describes performance testing that focused on software verification and human factors engineering. Explicit quantitative acceptance criteria are not presented in a table format with corresponding performance metrics for features like sensitivity, specificity, or accuracy in a diagnostic sense. Instead, the performance is described in terms of compliance with standards and functional verification.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion (Implicit/Explicit)	Reported Device Performance
Functional Performance & Accuracy:
- Ability to import and view standard DICOM images in 3-dimensions.	Software receives CT and MRI images by supporting DICOM connections with CT/MRI scanners and hospital PACS. User can import standard DICOM images and view them in 3-dimensions.
- Ability to select and view specific anatomical features.	User can select and view specific anatomical features (e.g., soft-tissue lesions, anatomical landmarks).
- Ability to measure and mark critical anatomical features/areas.	User can measure and mark critical anatomical features / areas of interest. System-level testing verified the application's measurement accuracy (`+/- 2 voxels`).
- Ability to overlay and position virtual images (antenna/ablation zone).	User can overlay and position virtual images of the Emprint™ ablation antenna and the anticipated thermal ablation zone onto the medical image. The device references zone charts (look-up tables) that characterize Emprint™ Ablation System performance for sizing and displaying predicted ablation zones.
- Ability to add textual annotations.	User can add textual annotations to images.
- Ability to export annotated plans.	User can export annotated plans for the patient's medical record or for use in a radiology or operating suite.
- Ability to view and compare imported images simultaneously.	User can view and compare any 2 of the imported images simultaneously. Ability to compare images across patients is also mentioned.
- No alteration of medical images.	The software's DICOM image viewer does not in any way alter the medical images.
Software Quality & Compliance:
- Compliance with NEMA PS 3.1-3.20:2016, DICOM standard.	Demonstrated compliance. The device is a DICOM image viewer and supports DICOM connections.
- Compliance with IEC 62304:2006, Medical Device Software Life Cycle.	Demonstrated compliance.
Usability/Human Factors:
- Meets user needs and expectations.	A human-factors engineering (HFE) process was followed, and simulated-use, validation testing was conducted to confirm that the visualization application met user needs and expectations. Optimizations for workflow and user interface were performed based on intraprocedural use in the CT suite.

Study Details:

Sample sizes used for the test set and data provenance:
- The document does not specify a sample size for a "test set" in the context of image data for diagnostic performance.
- It mentions "extensive software verification testing" including "software subsystem and system-level verification" and "simulated-use, validation testing" for human factors.
- The data provenance of the images used in these tests (e.g., country of origin, retrospective or prospective) is not explicitly stated. The device uses patient CT and MRI images, which would be from clinical practice, implicitly retrospective for testing purposes if not generated specifically for the study.
Number of experts used to establish the ground truth for the test set and their qualifications:
- This information is not provided. Since the device is "not intended for diagnosis" and the testing focused on functional verification and usability (measurement accuracy, workflow), the concept of "ground truth" established by experts for diagnostic performance (e.g., presence/absence of disease) is not applicable or described in this submission summary. The "ground truth" for the measurement accuracy test (e.g., +/- 2 voxels) would likely be based on known geometric properties of test objects or simulated environments rather than expert interpretation of pathology.
Adjudication method for the test set:
- Not applicable/described as there's no mention of a diagnostic performance study requiring expert adjudication of cases.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- No, a MRMC comparative effectiveness study was not done.
- The device is a visualization and planning tool, not an AI for diagnosis or a system designed to directly improve human reader performance in interpreting images for diagnostic tasks. Its purpose is to aid in ablation procedures by displaying, annotating, and volume rendering medical images.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document doesn't describe a standalone performance evaluation in the typical sense of an AI algorithm making a diagnostic decision. The device itself is a "stand-alone software product" (SaMD), but its function is visualization and planning aid, not autonomous decision-making. Its "standalone" nature refers to it being a software app distinct from a hardware device. Performance testing focused on software functions, DICOM compliance, and measurement accuracy, which are "algorithm-only" in the sense that the software correctly performs its programmed tasks.
The type of ground truth used:
- For measurement accuracy: The document states "system-level testing was conducted to verify the application's measurement accuracy (+/- 2 voxels)". The ground truth for this would likely be an engineered or known value within test objects or simulated datasets, not expert consensus or pathological findings from real patients.
- For functional correctness: The ground truth is the expected behavior and output of the software as per its design specifications and standard compliance (e.g., DICOM standard conformance, correct display of images, faithful representation of ablation zones based on look-up tables).
- For usability: The ground truth is user needs and expectations, assessed through human factors engineering and simulated-use validation testing.
The sample size for the training set:
- The document does not mention a "training set" in the context of machine learning or AI models that learn from data. The device's description suggests it primarily uses rule-based logic (e.g., referencing "zone charts (look-up tables)" for ablation zones) and established imaging principles rather than a deep learning model requiring a large training dataset.
How the ground truth for the training set was established:
- Not applicable, as no training set for a machine learning model is described. The "zone charts" mentioned for ablation zone prediction are likely derived from preclinical studies or physical principles of the ablation systems, not from ground truth established by experts interpreting images.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K192038

Device Name

Emprint™ Visualization Application

Indications for Use (Describe)

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)

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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).

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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 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.

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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 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).

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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.

Regulation Number and Section

§ 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).