ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE

K040876 · Vital Images, Inc. · LLZ · Apr 19, 2004 · Radiology

Device Facts

• Record ID: K040876
• Device Name: ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE
• Applicant: Vital Images, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Apr 19, 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

iConnection™ 3D' is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. In addition, the iConnection system has the following specific intended uses: Advanced Vessel Analysis is an option within the iConnection system intended to aid clinicians in the study and analysis of selected vessels, the inspection of circulatory anatomy, the quantification of stenosis, distance measurements and cross-sectional diameters, volume measurements, and assist in the planning and monitoring of vascular therapies. The feature operates with CT and MRI data. Pet Visualization is an option within the iConnection system that provides for the overlay, inspection, and measurement of two different image modalities (primarily PET/CT), and includes the ability to measure Standard Uptake Values on PET datasets. The overlay operation enables clinicians to obtain a better understanding of the joint information that would otherwise have to be compared separately. It is important to note that the clinician retains the ultimate responsibility for making pertinent diagnosis based on their standard procedures, including visual comparison of separate images. Collaboration Mode is a capability within the iConnection system that allows multiple users to collaboratively interact with iConnection system features and tools.

Device Story

iConnection 3D is a web-based enterprise medical image processing software. Inputs: multi-dimensional digital images from CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF modalities. System architecture: server-side centralized data management/processing and thin-client web viewer. Operation: clinicians/referring physicians access, review, and visualize patient data. Features: Advanced Vessel Analysis (vessel study, stenosis quantification, distance/diameter/volume measurements, vascular therapy planning); PET Visualization (modality overlay, Standard Uptake Value measurement); Collaboration Mode (multi-user interaction). Output: processed images, measurements, and reports for diagnostic review. Benefit: streamlines clinical workflow, enables integrated diagnostic review, and provides enhanced visualization of multi-modal data to support clinical decision-making.

Clinical Evidence

Bench testing only. The device underwent internal design, development, and validation procedures. Integration and verification testing were performed, followed by Beta validation. Potential hazards were addressed via a Risk Management Plan. No clinical trial data was required or provided.

Technological Characteristics

Medical image processing software; thin-client web-based viewer with centralized application server. Supports DICOM protocol for image communication. Features include volumetric processing, vessel analysis, and multi-modal image overlay. Software-based; no specific hardware materials or energy sources defined. Connectivity via networked client-server architecture.

Indications for Use

Indicated for clinicians requiring processing, analysis, review, and distribution of multi-dimensional digital images (CT, MR, CR/DR/DX, SC, US, NM, PET, XA, RF) for diagnostic purposes. Includes advanced vessel analysis (CT/MRI) and PET/CT overlay/measurement. No specific age or gender contraindications stated.

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)
• iConnection (K012779)

Submission Summary (Full Text)

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# APR 1 9 2004

## 6.0 510(k) Summary

#### Submitter's Name / Contact Person

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

#### General Information

| Trade Name | iConnection, Version 3.2.0.0<br>Medical Image Processing Software |
|---------------------|-----------------------------------------------------------------------------------------------------|
| Common / Usual 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>iConnection (K012779)<br>Hinnovation, Inc. |

#### Device Description

iConnection provides an online enterprise solution for secure access and on-demand foothoution promatic images, reports, clinical applications and services. The iConnection and offers fully integrated diagnostic reviewing, volumetric processing, and collaborative System offers in a clinically familiar ubiquitous diagnostic environment. It enables its users, rarronohulklob in & olinious and referring physicians, to streamline clinical workflow and access, review, and visualize patient data with high-end applications.

The iConnection system has an applications server which provides centralized data management and application processing and a thin-client web-based viewer.

An iConnection system consists of the follow components: 1) a server; 2) one or more client computers (referred to as client); and 3) the Client/Server communication.

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# Intended Use

iConnection™ 3D' is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. In addition, the iConnection system has the following specific intended uses:

Advanced Vessel Analysis is an option within the iConnection system intended to aid Advanced vessel Andiysis is an option the room, the inspection of circulatory anatomy,
clinicians in the study and analysis of selected vessels, the inspectors wolves climitalis in the study and analysis of selection we works, we works, the facture the qualifined of Steriosis, distance moation of vascular therapies. The feature operates with CT and MRI data.

Pet Visualization is an option within the iConnection system that provides for the overlay, inspection, and measurement of two different image modalities (primarily directed at inspection, and measurement of two american mage we datasets.

The overlay operation enables clinicians to obtain a better understanding of the joint i fie ovehal openation enables timbland to be compared separately. It is important to note that Information that would bincities have to be other the nexting pertinent diagnosis based on their standard procedures, including visual comparison of separate images.

Collaboration Mode is a capability within the iConnection system that allows multiple users to collaboratively interact with iConnection system features and tools.

- 1 The final product name has not yet been determined. The iConnection system refers to the Hinnovation, Inc. product from which the capabilities are derived.
## Predicate Device Comparison

The iConnection 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 iConnection 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 iConnection system has very similar intended uses and very similar technological characteristics
. The iConnection in the interior in the indifferences do not raise any The Connection system has very Similar interest of the entire increases do not raise any new as compared to the predicate device. Think to the iConnection system is substantially equivalent to the referenced predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2004

Vital Images, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K040876

Trade/Device Name: iConnection, Version 3.2.0.0 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: March 31, 2004 Received: April 5, 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 adultcration.

If your device is classified (see above) into cither 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); 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) I his letter will anow you to ocgainmance of substantial equivalence of your device to a legally premarket notification. The PDF intuiling 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 If you desire specific advice to: your do 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 Alburonally, for questions on any please note the regulation entitled, "Misbranding Other of Comphanos at (201) eration" (21CFR Part 807.97) you may obtain. Other general by relevelice to premarked notified in the Act may be obtained from the Division of Strall information on your responsionalited and Consumer Assistance at its toll-free number [phone] or Manufacturers, Thiernational and Octobern http://www.fda.gov/cdrfv/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

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#### 3.0 Intended Use Statement

510(k) Number (if known): K 04 0 8 7 L

# Device Name: iConnection™ 3D Medical Image Processing Software

iConnection 3D' is a medical diagnostic software system intended to process, loonhoodies.
analyze, review, and distribute multi-dimensional digital images acquired from a analyze, Forrent, and wices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and vanory of linked to the iConnection system has the following specific intended uses:

Advanced Vessel Analysis is an option within the iConnection system intended to aid Alivans in the study and analysis of selected vessels, the inspection of circulatory oliniolane in the suantification of stenosis, distance measurements and cross-sectional and my).
diameters, volume measurements, and assist in the planning and monitoring of vascular therapies. The feature operates with CT and MRI data.

Pet Visualization is an option within the iConnection system that provides for the overlay, inspection, and measurement of two different image modalities (primarily overlay, meposition, and includes the ability to measure Standard Uptake Values on PET datasets.

The overlay operation enables clinicians to obtain a better understanding of the joint information that would otherwise have to be compared separately. It is important to informater.
note that the clinician retains the ultimate responsibility for making pertinent diagnosis here than weir standard procedures, including visual comparison of separate images.

Collaboration Mode is a capability within the iConnection system that allows multiple users to collaboratively interact with iConnection system features and tools.

1 The final product name has not yet been determined. The iConnection system refers to the HInnovation, Inc. product from which the capabilities are derived.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------|---------------------------------------------------------|
| Prescription Use | |
| | <div> <img alt="Signature" src="signature.png"/> </div> |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K040876 |

March 25, 2004 Abbreviated 510(k) Premarket Notification