The Emprint™ Procedure Planning 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 intervention planning for video-assisted thoracoscopic surgery (VATS) and ablation procedures using the Emprint Ablation System. The software is not intended for diagnosis.

Device Description

The Emprint™ Procedure Planning Application is a stand-alone software product that is intended to be used to view and compare CT image sets. The system is composed of image review and planning software and a Windows-based computer. The system includes tools that provide 3-D rendering of the image sets, pre-procedure planning of interventional thermal ablation procedures, and post-procedure review of interventional thermal ablation procedures. The Emprint™ Procedure Planning Application does not prescribe therapy and is not intended for the diagnosis or treatment of any disease. It does not control or alter the functions or parameters of any medical device and has no direct patient contact.

AI/ML Overview

The provided text is a 510(k) Summary for the Emprint™ Procedure Planning Application. This document describes the device's intended use and technological characteristics but does not contain the detailed performance study results, acceptance criteria, or sample sizes typically found in a full validation study report.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment cannot be extracted from this document.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated Goal)	Reported Device Performance
Evaluate all functions performed by the software as configured on the computer workstation.	The system was tested and passed all criteria established by the design specifications and verification/validation test plans.

Missing Information: Specific quantitative acceptance criteria (e.g., accuracy, precision targets for measurements, rendering display fidelity) are not provided. The document only states that the system "passed all criteria." No reported metrics (e.g., specific accuracy values, error rates) are given.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not mentioned.
Data Provenance: Not mentioned. (e.g., country of origin, retrospective/prospective)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.
Role of Experts: It's unclear if "experts" were formally used to establish ground truth or if it was based on engineering design specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Adjudication Method: Not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: Not mentioned. The device is described as a "procedure planning application" that "aids in the intervention planning." It's a visualization and measurement tool, not primarily an AI-driven diagnostic aid that would typically undergo MRMC studies to compare human reader performance with and without AI. It explicitly states, "The software is not intended for diagnosis."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: The document states, "The Emprint™ Procedure Planning Application was tested in accordance with a test plan to evaluate all functions performed by the software as configured on the computer workstation." This implies standalone testing of the software's functionality, though specific quantitative results are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: Not explicitly stated. Given the description of testing "all functions performed by the software as configured," the ground truth likely refers to the expected output according to the software's design specifications for measurement accuracy, rendering fidelity, and data import/display. It's not based on external medical ground truth like pathology or outcomes.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable/not mentioned. This device is described as software for viewing, rendering, and planning, not a machine learning model that would have a "training set" in the traditional sense. It processes DICOM data from CT scanners.

9. How the ground truth for the training set was established:

Ground Truth for Training Set: Not applicable/not mentioned, as it's not described as a device that uses a training set in the machine learning context.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 17, 2014

Covidien LLC % Ms. Heather V. Nigro Global Senior Director, Regulatory Affairs 15 Hampshire Street MANSFIELD MA 02048

Re: K142048

Trade/Device Name: Emprint™ Procedure Planning Application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 29, 2014 Received: July 30, 2014

Dear Ms. Nigro:

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. 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 (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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Smh.f)

for

Janine M. Morris 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) K142048

Device Name Emprint Procedure Planning Application

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Date summary prepared: August 19, 2014

510(k) Submitter/Holder

Covidien, Inc. 15 Hampshire Street Mansfield, MA 02048

Contact

Heather V. Nigro Global Senior Director, Regulatory Affairs Telephone: 508-452-1936 Fax: 508-452-1941 Email: heather.nigro@covidien.com

Name of Device

Trade Name:	Emprint™ Procedure Planning Application
Common Name:	Radiological Image Processing System
Classification Name:	System, Image Processing, Radiological (21 CFR §892.2050,Class II, LLZ).

Purpose of Submission

The purpose of this submission is to gain clearance for a new procedure planning application.

Predicate Devices

Emprint™ Procedure Planning Application described in this submission is substantially equivalent to the following commercially available predicate devices:

Trade Name:	LiverAnalysis/LiverViewer Software
Device Common Name:	Picture Archiving Communications System
510(k) Number:	K051528
Manufacturer:	MeVis
Trade Name:	Table
Device Common Name:	Radiological Image Processing System
510(k) Number:	K140093

Device Description

The Emprint™ Procedure Planning Application is a stand-alone software product that is intended to be used to view and compare CT image sets. The system is composed of

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image review and planning software and a Windows-based computer. The system includes tools that provide 3-D rendering of the image sets, pre-procedure planning of interventional thermal ablation procedures, and post-procedure review of interventional thermal ablation procedures. The Emprint™ Procedure Planning Application does not prescribe therapy and is not intended for the diagnosis or treatment of any disease. It does not control or alter the functions or parameters of any medical device and has no direct patient contact.

Intended Use

The Emprint™ Procedure Planning 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 the intervention planning for videoassisted thoracoscopic surgery (VATS) and ablation procedures using the Emprint Ablation System. The software is not intended for diagnosis.

Technological Characteristics

The Emprint™ Procedure Planning Application is a stand-alone software product installed on a Windows-based computer workstation. The system imports DICOM data from CT scanners and can display the images in standard axial, coronal, or sagittal views and render the images in 3-D views. The substantial equivalence of the Emprint™ Procedure Planning Application to the predicates is shown by similarity in intended use, indications for use, materials, and performance.

Principals of Operation

The Emprint™ Procedure Planning Application is composed of software running on a standard Windows-based computer that allows the user to import multiple DICOM compatible CT image sets, render them into 3-D and compare them. The software also provides tools to mark and measure anatomical features and to overlay anticipated thermal ablation zones as defined by the ablation tables associated with the Emprint Ablation System settings for a given type of tissue (provided in K133821 labeling and also included as an Attachment to this 510k Summary).

Performance Data

The Emprint™ Procedure Planning Application was tested in accordance with a test plan to evaluate all functions performed by the software as configured on the computer workstation. The system was tested and passed all criteria established by the design specifications and verification/validation test plans.

Substantial Equivalence Discussions

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, the Emprint™ Procedure Planning Application has been

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shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness.

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).