(51 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard image processing and visualization tools.
No
The device explicitly states it "does not prescribe therapy" and is "not intended for the diagnosis or treatment of any disease." It is a planning and visualization tool.
No
The 'Intended Use / Indications for Use' and 'Device Description' sections explicitly state that "The software is not intended for diagnosis" and "is not intended for the diagnosis or treatment of any disease."
No
The device description explicitly states the system is composed of image review and planning software and a Windows-based computer, indicating it includes hardware components.
Based on the provided information, the Emprint™ Procedure Planning Application is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the software is for visualizing and comparing CT imaging data to aid in intervention planning for surgical and ablation procedures. It specifically states, "The software is not intended for diagnosis."
- Device Description: The description reinforces that the software is for viewing, comparing, and planning based on medical images. It also states, "The Emprint™ Procedure Planning Application does not prescribe therapy and is not intended for the diagnosis or treatment of any disease."
- Nature of IVDs: IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This software operates on medical images, not biological specimens.
Therefore, the Emprint™ Procedure Planning Application falls under the category of medical image processing software used for planning and visualization, not for in vitro diagnostic testing.
N/A
Intended Use / 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 intervention planning for video-assisted thoracoscopic surgery (VATS) and ablation procedures using the Emprint Ablation System. The software is not intended for diagnosis.
Product codes
LLZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT imaging data, DICOM data from CT scanners
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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)
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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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.