STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE

K081512 · Medtronic Navigation, Inc. · LLZ · Jul 18, 2008 · Radiology

Device Facts

• Record ID: K081512
• Device Name: STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE
• Applicant: Medtronic Navigation, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jul 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Stealth Viz is a software application indicated for use in 2D/3D surgical planning and image review and analysis. It enables: importing digital diagnostic and functional imaging datasets (e.g. MR, MRA, CT, CTA, fMRI, X-ray, DSA, PET, SPECT, MEG, MSI, US) reviewing and analyzing the data in various 2D and 3D presentation formats, performing image fusion (co-registration) of datasets, segmenting structures in the images with manual and automatic tools and converting them into 3D objects for display, exporting results to other Medtronic Navigation planning applications, to a PACS or to Medtronic Navigation surgical navigation systems such as the StealthStation System. The StealthDTI Package is a subset of StealthViz that implements a special case of segmenting 3D structures from the datasets. It is indicated for use in the processing of diffusion-weighted MRI sequences into 3D objects that represent white-matter tracts. Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis. Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.

Device Story

StealthViz is a software application for surgical planning and image analysis; operates on standard computers. Inputs include digital diagnostic/functional imaging datasets (MR, CT, PET, etc.) via LAN, internet, or physical media. Device performs image fusion (co-registration), manual/automatic segmentation, and 3D object conversion. StealthDTI package processes diffusion-weighted MRI sequences to calculate Fractional Anisotropy and Apparent Diffusion Coefficient; performs white matter tractography (fiber tracking) based on user-defined regions-of-interest (ROI). Outputs include 2D/3D visualizations and 3D objects exported to PACS or Medtronic surgical navigation systems (e.g., StealthStation). Used by clinicians for pre-operative planning; output assists in surgical decision-making and visualization of anatomical/functional structures.

Clinical Evidence

No clinical data provided. Testing was limited to bench-level verification and validation performed by the third-party developer (Visage Imaging) and in-house by Medtronic to ensure requirements were met and compatibility with the StealthStation system was maintained.

Technological Characteristics

Software-based image processing application. Runs on standard computer hardware. Supports DICOM standard for image data. Features include automated/manual image fusion, segmentation, and diffusion tensor calculations for white matter tractography. Connectivity via LAN, internet, or local media. No specific hardware materials or sterilization required as it is a software-only device.

Indications for Use

Indicated for use in 2D/3D surgical planning, image review, and analysis of diagnostic/functional imaging datasets (MR, MRA, CT, CTA, fMRI, X-ray, DSA, PET, SPECT, MEG, MSI, US). StealthDTI package indicated for processing diffusion-weighted MRI sequences into 3D white-matter tract objects. Prescription use only.

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).

Submission Summary (Full Text)

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K081512

# 510(k) Premarket Notification for Medtronic Navigation, Inc.'s StealthViz Advanced Planning Application with StealthDTI Package

## 510k Summary

JUL 1 8 2008

May 16, 2008

| Subject: | 510(k) Summary of Safety and Effectiveness Information for the StealthViz Advanced Planning Application with StealthDTI Package |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | John Adams<br>Regulatory Affairs Manager<br>Medtronic Navigation, Inc.<br>826 Coal Creek Circle<br>Louisville, CO 80027 |
| Proprietary Name: | StealthViz Advanced Planning Application with StealthDTI Package |
| Common Name and Classification: | Picture Archival and Communications System |
| Device Description: | StealthViz is a general purpose 2D/3D surgical planning and image review and analysis software application running on a standard computer. It enables: |
| | <ul><li>importing digital diagnostic and functional imaging datasets (e.g. MR, MRA, CT, CTA, fMRI, X-ray, DSA, PET, SPECT, MEG, MSI, US) across a LAN, the internet or a modem, or via local transfer from physical media (e.g. CD, DVD, USB drive),</li><li>reviewing and analyzing the data (e.g. making measurements) in various 2D and 3D presentation formats,</li><li>performing image fusion (co-registration) of datasets using automated or a manual image-matching technique,</li><li>segmenting structures in the images with manual and automatic tools and converting them into 3D objects for display,</li><li>creating hybrid datasets by filling in segmented regions slice-by-slice on anatomical datasets, and</li><li>exporting results to other Medtronic Navigation planning applications, to a PACS or to other Medtronic Navigation surgical navigation systems such as the StealthStation System.</li></ul> |
| | The StealthDTI Package provides the following additional capabilities: |
| | <ul><li>import diffusion-weighted sequence datasets (gradients),</li><li>co-register the gradients with anatomical studies using an automatic</li></ul> |

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# 510(k) Premarket Notification for Medtronic Navigation, Inc.'s Stealth Viz Advanced Planning Application with StealthDTI Package

## 510k Summary

algorithm or a manual technique,

- perform diffusion tensor calculations to create intermediate datasets such as Fractional Anisotropy and Apparent Diffusion Coefficient and the ability to display these results with, for example, Directionally Encoded Color or grayscale mapping,
- enable the user to define regions-of-interest (ROI) from which to . perform white matter tractography (WMT, also known as fiber tracking). The user can define multiple ROIs or use previously segmented objects as ROIs (e.g. an fMRI activation area that has been segmented into a 3D object).
- calculated fiber tracts can be displayed and converted into 3D . objects,
- all results can be exported as noted for the base StealthViz . application description.

StealthViz is a software application indicated for use in 2D/3D surgical Intended Use: planning and image review and analysis. It enables:

- importing digital diagnostic and functional imaging datasets (e.g. . MR, MRA, CT, CTA, fMRI, X-ray, DSA, PET, SPECT, MEG, MSI, US )
- . reviewing and analyzing the data in various 2D and 3D presentation formats.
- . performing image fusion (co-registration) of datasets,
- . segmenting structures in the images with manual and automatic tools and converting them into 3D objects for display,
- . exporting results to other Medtronic Navigation planning applications, to a PACS or to Medtronic Navigation surgical navigation systems such as the StealthStation System.

The StealthDTI Package is a subset of StealthViz that implements a special case of segmenting 3D structures from the datasets. It is indicated for use in the processing of diffusion-weighted MRI sequences into 3D objects that represent white-matter tracts.

Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis. Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.

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# 510(k) Premarket Notification for Medtronic Navigation, Inc.'s StealthViz Advanced Planning Application with StealthDTI Package

## 510k Summary

Test Testing was performed in two phases. Testing was performed by Visage Discussion: Imaging, the third party developer, to ensure that all Requirements were met by the product. This testing is referenced in the Trace Matrix which ensures that all requirements were successfully verified.

> A subset of testing was also performed in-house to verify compatibility with the Stealth application. This is represented in Product Design Verification and Validation Testing protocols/reports.

Test Conclusion:

Results of the testing performed by Visage Imaging, as well as in-house testing, demonstrate that the StealthDTI package is as safe, as effective, and performs as well as or better than the legally marketed device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines representing the branches of government. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Navigation, Inc. % Mr. Kevin Morningstar Senior Consultant Morningstar Consulting Group LLC 3025 Perry Street DENVER CO 80212

# JUL 1 8 2008

Re: K081512

Trade/Device Name: Stealth Viz Advanced Planning Application with StealthDTT Package Regulation Number: 21 CFR 892.2050

Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 16, 2008 Received: May 30, 2008

### Dear Mr. Morningstar:

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.

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincercly yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Premarket Notification for Medtronic Navigation, Inc. 's StealthViz Advanced Planning Application with StealthDTI Package

## Indications for Use

510(k) Number (if known):

## Device Name:

StealthViz Advanced Planning Application with StealthDTI Package

Intended Use: Indications for Use:

> Stealth Viz is a software application indicated for use in 2D/3D surgical planning and image review and analysis. It enables:

- importing digital diagnostic and functional imaging datasets (e.g. . MR, MRA, CT, CTA, fMRI, X-ray, DSA, PET, SPECT, MEG, MSI, ग्राद है
- reviewing and analyzing the data in various 2D and 3D presentation � · formats,
- 송 performing image fusion (co-registration) of datasets,
- segmenting structures in the images with manual and automatic tools ● and converting them into 3D objects for display,
- exporting results to other Medtronic Navigation planning . applications, to a PACS or to Medtronic Navigation surgical navigation systems such as the StealthStation System.

The StealthDTI Package is a subset of StealthViz that implements a special case of segmenting 3D structures from the datasets. It is indicated for use in the processing of diffusion-weighted MRI sequences into 3D objects that represent white-matter tracts.

Only DICOM for presentation images can be used on an FDA annroved monitor for mammography for primary image diagnosis. Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR Over-The-Counter Use | |
| (21 CFR 807 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE).

Arzu M. Whay

Division of Reproductive, Abdominal 10(k) Number