VITREA ENDOVASCULAR STENT PLANNING SOFTWARE

K091498 · Vital Images, Inc. · LLZ · Jun 5, 2009 · Radiology

Device Facts

• Record ID: K091498
• Device Name: VITREA ENDOVASCULAR STENT PLANNING SOFTWARE
• Applicant: Vital Images, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jun 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. In addition, Vitrea has the following additional indication: The Endovascular Stent Planning Software application is intended for use with CT (computed tomography) images to assist medical professionals in the analysis, treatment and follow-up of aortic vascular disorders that may require a stent procedure. The software provides 3D segmentation of the aorta and initializes stent measurements based on a template provided by the stent manufacturers. The user can review the 2D and 3D images, verify and correct the results of the segmentation and initialization, and generate a report with the stent measurements.

Device Story

Software module for Vitrea system; processes CT images for aortic vascular disorder management. Inputs: CT image data. Processing: automated 3D segmentation of aorta and thrombus; initialization of measurements (diameters, lengths, angles, volumes) using manufacturer-specific stent-graft templates. Outputs: 2D/3D visualizations, stent-graft sizing measurements, and clinical reports. Used in clinical settings by physicians/radiologists for pre-treatment planning and post-treatment follow-up. Workflow includes side-by-side comparative review; user verifies and edits automated segmentation and measurement results. Benefits: facilitates accurate stent sizing and procedural planning.

Clinical Evidence

Bench testing only. Software verification and validation testing confirmed that features function according to requirements and do not negatively impact existing Vitrea system functionality.

Technological Characteristics

Radiological image processing software module; operates on Vitrea platform. Features automated 3D segmentation and measurement initialization based on stent-graft templates. Connectivity: integrates with CT imaging systems. Software-based analysis.

Indications for Use

Indicated for medical professionals to assist in the analysis, treatment, and follow-up of patients with aortic vascular disorders requiring stent procedures using CT images.

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

• Vitrea®, Version 4.0 Medical Image Processing Software (K071331)
• Vitrea2, version 2.1 (K002519)
• Preview® Treatment Planning Software (K040852)
• GE AVA II/Vessel Xpress (K060779)

Submission Summary (Full Text)

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K091498
Page 1 of 2

JUN - 5 2009

## 2. 510(K) SUMMARY AS REQUIRED BY 21 CFR 807.92

510(k) Number: K

Date Prepared: May 5, 2009

| SUBMITTER INFORMATION | | |
|-----------------------------|----------------------------------------------------------|-------------------------------|
| Submitter: | Vital Images, Inc. | Contact Person |
| Street Address: | 5850 Opus Parkway Suite 300<br>Minnetonka, MN 55343-4414 | Darin Busch |
| Establishment registration: | 2134213 | Manager, Regulatory Affairs |
| | | Phone: [phone] |
| | | Fax: [phone] |
| | | Email: [e-mail] |

## DEVICE INFORMATION

| Trade Name | Endovascular Stent Planning Software |
|----------------------------|----------------------------------------|
| Common Name | Radiological Image Processing Software |
| Classification Name | System, Image Processing, Radiological |
| Regulation /Product Code | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Classification: | Class II |
| Device Panel: | Radiology |

The Endovascular Stent Planning Software is substantially equivalent to the following predicate devices.

| Predicate Device | Manufacturer | FDA 510(k) |
|-----------------------------------------------------------|-------------------------------|------------|
| Vitrea®, Version 4.0 Medical Image<br>Processing Software | Vital Images, Inc | K071331 |
| Vitrea2, version 2.1 | Vital Images, Inc | K002519 |
| Preview® Treatment Planning<br>Software | MEDICAL MEDIA SYSTEMS,<br>INC | K040852 |
| GE AVA II/Vessel Xpress<br>(AVA II/Vessel Xpress) | GE HealthCare<br>Waukesha, WI | K060779 |

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KC91498
Page 2 of 2

### 2.1. Device Description

The Endovascular Stent Planning Software, an application module for the Vitrea software, enables visualization and measurements of the aortic vessel for evaluation, treatment and follow up for aortic vascular disorders that may require a stent procedure. It has the following features:

- Automated segmentation of the aortic vessel, including thrombus .
- Custom and manufacturer-recommended stent-graft worksheets and report . templates for stent sizing
- Automatic initialization of endovascular measurements (diameters, lengths, . angles, volumes) based on the stent template selection, with easy centerline and contour editing tools
- Workflows for pre-treatment (stent, surgery) planning and post-treatment . follow up, including a side-by-side comparative review layout

### 2.2. Intended Use/Indications for Use

Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. In addition, Vitrea has the following additional indication:

The Endovascular Stent Planning Software application is intended for use with CT (computed tomography) images to assist medical professionals in the analysis, treatment and follow-up of aortic vascular disorders that may require a stent procedure. The software provides 3D segmentation of the aorta and initializes stent measurements based on a template provided by the stent manufacturers. The user can review the 2D and 3D images, verify and correct the results of the segmentation and initialization, and generate a report with the stent measurements.

#### 2.3. Summary of Testing

The software was designed, developed and tested according to written procedures. Software testing was completed to insure the Endovascular Stent Planning Software features function according to the requirements and interact without impact to existing functionality. The test results support a determination of substantial equivalence.

#### 2.4. Conclusions

Vitrea Endovascular Stent Planning software has similar intended use as the predicate devices and essentially identical technological characteristics. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device. The Vitrea Endovascular Stent Planning Software application performs as intended, and presents with no unacceptable risks to the intended patient population or end user. Vitrea Endovascular Stent Planning Software is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of four stylized human figures in profile, arranged in a stacked formation. The figures are depicted in a simple, abstract manner.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## IIIN - 5 2009

Vital Images, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K091498

Trade/Device Name: Vitrea® Endovascular Stent Planning Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class:_II Product Code; LLZ Dated: May 19, 2009

Received: May 20, 2009

#### Dear Mr. Job:

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 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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Page 2

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.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology). | (240)-276-0115 |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Samme M. Marre

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 1. INDICATIONS FOR USE STATEMENT

# Indications for Use

510(k) Number (if known): K09/498

Device Name: Vitrea® Endovascular Stent Planning Software

Indications for Use:

Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. Vitrea has the following additional indication:

The Endovascular Stent Planning Software application is intended for use with CT (computed tomography) images to assist medical professionals in the analysis, treatment and follow-up of aortic vascular disorders that may require a stent procedure. The software provides 3D segmentation of the aorta and initializes stent measurements based on a template provided by the stent manufacturers. The user can review the 2D and 3D images, verify and correct the results of the segmentation and initialization, and generate a report with the stent measurements.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helene

(Division'Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number