VITREA2 VERSION 3.5

K040305 · Vital Images, Inc. · LLZ · Feb 24, 2004 · Radiology

Device Facts

• Record ID: K040305
• Device Name: VITREA2 VERSION 3.5
• Applicant: Vital Images, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Feb 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

Vitrea 2 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. In addition, the Vitrea 2 system has the following specific indication: Fusion7D is an option within the Vitrea 2 system and is intended to register pairs of anatomical and functional volumetric images (e.g., MRI-SPECT, MRI-PET, CT-SPECT, CT-PET), or pairs of anatomical volumetric images (e.g., MRI-MRI, CT-CT, and MRI-CT) as a means to ease the comparison of image data. The result of the registration operations aims to help the clinician obtain a better understanding of the joint information that would otherwise have to be compared separately. This is useful for a wide range of clinical and therapeutic applications. It is important to note that the clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard procedures, including visual comparison of the separate unregistered images. Fusion7D is a complement to these standard procedures. Softread is an option within the Vitrea 2 system and is intended to allow the examination and manipulation of a series of 2D images in a variety of modalities, including CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The option also enables clinicians to compare multiple series' for the same patient, side-by-side, and to switch to Vitrea to further examine the data in a 3D volume.

Device Story

Vitrea 2 is medical diagnostic software for processing, reviewing, and analyzing multi-dimensional digital images; inputs include DICOM-compliant images from various modalities (CT, MR, PET, etc.). System features include Fusion7D for volumetric image registration (anatomical/functional pairs) and Softread for 2D image manipulation and side-by-side series comparison. Clinicians operate the system via a user interface to retrieve images, visualize anatomy/pathology in 2D/3D, annotate, measure, and record findings. Output includes processed views for film/paper printing, web-based reporting, or DICOM export. System aids clinical decision-making by facilitating image comparison and visualization; clinician retains ultimate diagnostic responsibility. Benefits include improved understanding of joint image information and streamlined clinical workflow.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including software design, development, integration testing, verification testing, and Beta validation performed according to written procedures. Risk management plan implemented.

Technological Characteristics

Medical image processing software; DICOM-compliant; supports multi-dimensional visualization, 2D/3D image manipulation, and volumetric registration. Operates on networked hardware. Software-based processing.

Indications for Use

Indicated for clinicians requiring processing, review, and analysis of multi-dimensional digital images (CT, MR, CR/DR/DX, SC, US, NM, PET, XA, RF) for diagnostic purposes. Includes image registration for anatomical/functional volumetric pairs (MRI, SPECT, PET, CT) to aid comparison. No specific age or gender restrictions.

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 2, Version 3.4 (K032748)
• Fusion7D (K020546)

Submission Summary (Full Text)

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FEB 2 4 2004

#### 6.0 510(k) Summary

#### Submitter's Name / Contact Person

Timothy J. Kappers, RAC Manager, Regulatory Affairs Vital Images, Inc. 3300 Fernbrook Lane N, Suite 200 Plymouth, MN 55447

#### General Information

| Trade Name | Vitrea 2, Version 3.5 Medical Image Processing Software |
|------------------------|-------------------------------------------------------------------------------------------------------|
| Common / Usual<br>Name | System, Image Processing, Radiological |
| Classification Name | LLZ, Class II, CFR 21 892.2050 |
| Predicate Devices | Vitrea 2, Version 3.4 (K032748)<br>Vital Images, Inc.<br>Fusion7D (K020546)<br>Mirada Solutions, Ltd. |

#### Device Description

The Vitrea 2 system is a medical diagnostic device that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea 2, Version 3.5 is an upgrade to Vitrea 2, Version 3.4 (cleared under K032748).

The Vitrea 2 system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea 2 user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:

- . Retrieve image data over the network via DICOM
- . Display images that are automatically adapted to exam type via dedicated protocols
- . Select images for closer examination from a gallery of up to six 2D or 3D views
- . Interactively manipulate an image in real-time to visualize anatomy and pathology
- . Annotate, tag, measure, and record selected views
- � Output selected views to standard film or paper printers, or post a report to an Intranet Web server or export views to another DICOM device
- . Retrieve reports that are archived on a Web server

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### Intended Use

Vitrea" 2 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. In addition, the Vitrea 2 system has the following specific indication:

Fusion?D™ is an option within the Vitrea 2 system and is intended to register pairs of anatomical and functional volumetric images (e.g., MRI-SPECT, MRI-PET, CT-SPECT, CT-PET), or pairs of anatomical volumetric images (e.g., MRI-MRI, CT-CT, and MRI-CT) as a means to ease the comparison of image data. The result of the registration operations aims to help the clinician obtain a better understanding of the joint information that would otherwise have to be compared separately. This is useful for a wide range of clinical and therapeutic applications. It is important to note that the clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard procedures, including visual comparison of the separate unregistered images. Fusion7D is a complement to these standard procedures.

Softread, is an option within the Vitrea 2 system and is intended to allow the examination and manipulation of a series of 2D images in a variety of modalities, including CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The option also enables clinicians to compare multiple series' for the same patient, side-by-side, and to switch to Vitrea to further examine the data in a 3D volume.

#### Predicate Device Comparison

The Vitrea 2, Version 3.5 system and its predicate devices allow for the analysis, communication and media interchange of digital images acquired from a variety of acquisition devices support the DICOM protocol for communication of images with other medical imaging devices.

## Summary of Studies

The software utilized was designed, developed, tested, and validated according to written procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating and maintenance.

The Vitrea 2, Version 3.5 system will successfully complete integration testing/verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release. In addition, potential hazards have been studied and controlled by a Risk Management Plan.

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# Conclusion

The Vitrea 2, Version 3.5 system has the same intended use as the predicate device and has very similar technological characteristics. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device. Thus, the Vitrea 2, Version 3.5 system is substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2004

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

Re: K040305 Trade/Device Name: Vitrea™ 2 Version 3.5 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: February 4, 2004 Received: February 9, 2004

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.

If your 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.

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.

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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely 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

Page 2

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#### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Vitrea 2, Version 3.5 Medical Image Processing Software

K646205

Indications for Use:

Vitrea 2 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. In addition, the Vitrea 2 system has the following specific indication:

Fusion7D" is an option within the Vitrea 2 system and is Intended to register pairs of anatomical and functional volumetric images (e.g., MRI-SPECT, MRI-PET, CT-SPECT, CT-PET), or pairs of anatomical volumetric images (e.g., MRI-MRI, CT-CT, and MRI-CT) as a means to ease the comparison of image data. The result of the registration operations aims to help the clinician obtain a better understanding of the joint information that would otherwise have to be compared separately. This is useful for a wide range of clinical and therapeutic applications. It is important to note that the clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard procedures, including visual comparison of the separate unregistered Images. Fusion?D is a complement to these standard procedures.

Softread, is an option within the Vitrea 2 system and is intended to allow the examination and manipulation of a series of 2D images in a variety of modalities, including CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The option also enables clinicians to compare multiple serles' for the same patient, side-by-side, and to switch to Vitroa to further examine the data in a 3D volume.

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

oncurrence of CDRH, Office of Device Evaluation (ODE

Prescription Use

Daniel R. Legere

Reproductive, Abdominal,