EMPRINT PROCEDURE PLANNING APPLICATION

K142048 · Covidien, LLC · LLZ · Sep 17, 2014 · Radiology

Device Facts

• Record ID: K142048
• Device Name: EMPRINT PROCEDURE PLANNING APPLICATION
• Applicant: Covidien, LLC
• Product Code: LLZ · Radiology
• Decision Date: Sep 17, 2014
• 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™ 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.

Device Story

Emprint Procedure Planning Application is stand-alone software on Windows-based workstation; imports DICOM CT image sets. Physician-operated; provides 3D rendering, annotation, and measurement tools. Enables pre-procedure planning and post-procedure review for VATS and thermal ablation. Overlays anticipated thermal ablation zones based on Emprint Ablation System settings (K133821). Output aids clinical decision-making by visualizing anatomy and ablation zones; does not control medical devices or provide diagnosis. Benefits include improved procedural planning and visualization for interventional thermal ablation.

Clinical Evidence

Bench testing only. System performance evaluated via verification and validation test plans to confirm all software functions met design specifications.

Technological Characteristics

Stand-alone software on Windows-based computer workstation. Imports DICOM CT data. Features: axial/coronal/sagittal views, 3D volume rendering, annotation, measurement, and ablation zone overlay. No direct patient contact.

Indications for Use

Indicated for physicians to visualize and compare CT imaging data to aid in intervention planning for video-assisted thoracoscopic surgery (VATS) and ablation procedures using the Emprint Ablation System. 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

• LiverAnalysis/LiverViewer Software (K051528)
• Table (K140093)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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)

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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: [phone] Fax: [phone] Email: [e-mail]

### 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,<br>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.