VITALConnect, Version 4.1 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. VTALConnect is not meant for primary image interpretation in mammography. In addition. the VITALConnect system has the following specific intended use:

Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross sectional measurements can be obtained using standard Vital Images software measuring tools. Clinicians can manually measure the lumen width to obtain percentage stenosis calculations, based on the ratio of the smallest to the largest diameter. In addition, clinicians can manually measure vessel length along the centerline in standard curved MPR views and examine Hounsfield Units statistics.

CT Coronary Artery Analysis is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians can select any coronary artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at 90 degree angles to each other, and cross sections of the clinician can semiautomatically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unit statistics.

Device Description

The ViTALConnect 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.

The ViTALConnect system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The ViTALConnect system 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 .

AI/ML Overview

The provided text does NOT describe specific acceptance criteria with numerical targets (e.g., sensitivity, specificity, accuracy thresholds) or a detailed study proving the device meets said criteria.

Instead, it offers a general overview of the device, its intended use, a comparison to predicate devices, and a high-level summary of the validation process.

Here's a breakdown of the requested information based on the provided text, highlighting what is missing:

Information Requested	Response from Text
1. Table of acceptance criteria and reported device performance	No specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) are provided. The text states: - "The ViTALConnect 4.1 system will successfully complete integration testing/verification testing prior to Beta validation." - "Software Beta testing/validation will be successfully completed prior to release." This indicates a general requirement for successful completion of tests, but no quantifiable performance metrics are reported.
2. Sample size used for the test set and the data provenance	Not specified. The document mentions "Software Beta testing/validation" but does not provide details on the sample size of cases/images used in this testing, nor the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and their qualifications	Not specified. The document does not mention the use of experts to establish a ground truth for any test set or their qualifications.
4. Adjudication method for the test set	Not specified. There is no mention of any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.	No. The document does not mention an MRMC comparative effectiveness study or any effect size related to human readers improving with AI assistance. The device is a "Medical Image Processing Software" intended for clinicians to "process, analyze, review," and in the case of "CT Coronary Artery Analysis," it can "semiautomatically determine contrasted lumen boundaries, stenosis measurements," but there is no study described that compares human performance with and without this assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done	Not explicitly stated as a standalone performance evaluation with metrics. The description of "CT Coronary Artery Analysis" suggests semi-automatic functions (e.g., "semiautomatically determine contrasted lumen boundaries"), implying an algorithm-only component. However, the document does not report specific standalone performance metrics (like sensitivity, specificity, or accuracy) for these semi-automatic functions. The overall system is described as assisting clinicians in their analysis and measurements, not as a fully autonomous diagnostic tool.
7. The type of ground truth used	Not specified. Since no specific performance studies or test sets with ground truth are detailed, the type of ground truth (e.g., expert consensus, pathology, outcomes data) is not mentioned.
8. The sample size for the training set	Not specified. The document refers to the general software development process ("designed, developed, tested, and validated according to written procedures") but does not provide any details about a training set or its size, which would typically be associated with machine learning development. Given the 2007 submission date, the device likely predates widespread deep learning applications with distinct "training sets" as understood today.
9. How the ground truth for the training set was established	Not applicable/Not specified. As no training set is mentioned, naturally, how its ground truth was established is not discussed.

Summary

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KO7/362

6.0 510(k) Summary

Submitter's Name / Contact Person

MAY 3 0 2007

Timothy J. Kappers, MBA, RAC Director, Quality Systems, Regulatory & Clinical Affairs Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343

General Information

Device Trade Name	ViTALConnect™ 4.1 - Medical Image Processing Software
Common / Usual Name	System, Image Processing, Radiological
Classification	892.2050 Picture Archiving and Communications System(LLZ; Class II)
Identification ofPredicate Devices	ViTALConnect Version 4.0 (K062154)Vital Images, Inc.Vitrea®, Version 3.9 (K061624)Vital Images, Inc.

Device Description

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

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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 .

Intended Use

Predicate Device Comparison

The VITALConnect 4.1 system and its predicate devices allow for the analysis, communication and media interchange of digital images acquired from a variety of acquisitiondevices. All 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.

Page 25

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The ViTALConnect 4.1 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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Image /page/3/Picture/0 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the left side of the seal. To the right of the text is an image of an eagle. The eagle is drawn with three lines that form the shape of the bird.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 3 0 2007

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

Re: K071362

. Trade/Device Name: VITALConnect™ 4.1 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 14, 2007 Received: May 15, 2007

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 (Premarket Approval), 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.

Image /page/3/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "FDA" are in the center of the logo. Below the letters, the word "Centennial" is written in cursive. Three stars are below the word "Centennial". The text "U.S. Food & Drug Administration" is written around the edge of the circle.

time and Promoting Publio Roalth

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Page 2 -

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 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)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.litm1.

Sincerely yours.

Nancy C Hodgon

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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Vital Images, Inc. VITAL Connect™ Varsion 4.1

3.0 Intended Use Statement

07/202 510(k) Number (if known): Device Name: VITALConnect™ 4.1 Medical Image Processing Software

ViTALConnect, Version 4.1 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. VITALConnect is not meant for primary image interpretation in mammography. In addition, the ViTALConnect system has the following specific intended use:

Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highted vessel in 3D, two rotate-able curved MPR vessel vlews displayed at angles orthogonal to each other, and cross sections of the vessel. Cross sectional measurements can be obtained using standard Vital Images software measuring tools. Clinicians can manually measure the lumen width to obtain percentage stenosis calculations, based on the ratio of the smallest to the largest diameter. In addition, clinicians can manually measure vessel length along the centerline in standard curved MPR views and examine Hounsfield Units statistics.

CT Coronary Artery Analysis is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians can select any coronary artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at 90 degree angles to each other, and cross sections of the vessel. The clinician can semiautomatically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unit statistics.

Prescription Use	X
(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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Page __ of __

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K071362

May 04, 2007Abbreviated 510(k) Premarket Notification	Page 10
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Regulation Number and Section

§ 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).