ComPACS is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, viewing, printing, processing, analyzing, reporting and communicating medical digital studies such as cardiac catheterization, echocardiography or general radiological studies.

Device Description

ComPACS is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, archiving, viewing, processing, analyzing, reporting and communicating medical digital studies such as cardiac cathetetization, echocardiography or general radiological studies.

ComPACS is a modular software device composed of different software modules operating in synergy and each responsible of different functions. The modules can be distinguished into general review station components, analysis components, reporting components, server components and gateway components.

General Review Station Components: CornPACS viewer constitutes the basic module for a review station providing viewing capabilities and retrieving capabilities from DICOM files in removable media. ComPACS Archive introduces archiving and retrieving of studies on the local review station. ComPACS Net Client allows a review station to archive and retrieve studies from a ComPACS Net Archive or from a third party DICOM compliant PACS. ComPACS Multi-Media extends ComPACS Archive to import and archive multi-media files with conversion to the DICOM format. ComPACS audio introduces digital audio management capabilities.

Analysis Components: The review station can be extended with different analysis modules. ComPACS QCA and ComPACS LVA provide respectively quantitative coronary analysis and left ventricular analysis on angiographic images. ComPACS Echocardiac, ComPACS Stress Echo provide different echo analysis features. ComPACS IVUS allows measurements and longitudinal image reconstruction on IVUS images.

Reporting Components: ComPACS Reporting allows report creation and management. This component can be further subdivided into subcomponents in relation to the different type of reports: Generic, Echocardiac, angiographic, etc. ComPACS Dictation extends the reporting module to allow for audio dictation into the report.

Server Components: ComPACS Net Archive is the basic server modules allowing and retrieving of studies from remote workstations equipped with a ComPACS Net Client module. ComPACS Security introduces user activity logging and user rights profiles management. ComPACS Storage Server provides DICOM network storage services as SCP. ComPACS Dictation Server manages the dictated reports and transfers them to an external transcription service. ComPACS Small Business Server and ComPACS Enterprise Server provide DICOM network services for small and large size networks respectively.

Gateway Components: ComPACS Recorder is a device capable of digitizing analog video signals and converting to DICOM compliant files for storage on media or network transfer to a DICOM server.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the ComPACS device based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in a structured table. Instead, it relies on demonstrating substantial equivalence to predicate devices. The core "acceptance criteria" presented throughout the document is that the ComPACS device is "as safe, as effective, and performs as well or better than" its legally marketed predicate devices.

Implicit Acceptance Criteria (based on substantial equivalence claims):

Criterion Type	Details from Document	Reported ComPACS Performance
Safety	The device must not introduce new safety concerns compared to predicate devices.	Stated as "does not affect the safety" of the new device and "is as safe" as predicate devices. The advanced image management, wider DICOM support, and broader modality support "add to the safety and effectiveness."
Effectiveness	The device must perform its intended functions effectively, comparable to predicate devices.	Stated as "does not affect the... effectiveness" and "is as effective and performs as well or better than" predicate devices. Advanced features (e.g., multi-window/monitor, wider DICOM support, broader modality analysis, audio data management) are stated to "add to the effectiveness" of the device.
Intended Use	To be used by qualified medical professionals for capturing, archiving, viewing, processing, analyzing, reporting, and communicating medical digital studies (e.g., cardiac catheterization, echocardiography, general radiological studies).	ComPACS is described as fulfilling this intended use. It is a "software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, archiving, viewing, processing, analyzing, reporting and communicating medical digital studies such as cardiac cathetetization, echocardiography or general radiological studies." This functionality is stated as equally performing compared to predicate devices.
Technical Equivalence	Image storage, query, retrieval, and DICOM network connectivity similar to predicate devices. DICOM format support and proprietary format support (DSR-TIFF, DEFF) similar to predicate devices. Range of search criteria for study query purposes similar to predicate devices. Multi-window and multi-monitor display capabilities comparable to predicate devices.	ComPACS performance for image storage, query, and retrieval, including DICOM network connectivity, was tested using image sets from different imaging devices from various manufacturers. It showed "wider support of both DICOM formats and proprietary formats (DSR-TIFF, DEFF) and in a wider range of search criteria for study query purposes." It also has "added support in ComPACS multi-window and multi-monitor display" compared to its own past product (In-Vision View).
Analysis Support	Ability to perform analysis on different types of image modalities.	ComPACS "appears to provide analysis support for a wider set of modalities than any of the single equivalent devices although there no modality for which ComPACS provides unique support." This is stated to "add to the effectiveness of the device without compromising the safety." Specific modules mentioned include QCA, LVA, Echocardiac, Stress Echo, and IVUS. Also, the device supports measurement functions on IVUS images (equivalent to In-Vision View).
Audio/Reporting	Management of audio data and report dictation.	ComPACS offers management of audio data and report dictation, which is noted as "adding to the effectiveness of the device."

Study Details

The document describes non-clinical tests to demonstrate substantial equivalence, rather than a traditional comparative effectiveness study with specific endpoints like sensitivity or specificity.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a number of cases or images.
Data Provenance: The document states that "image storage, query and retrieval, including DICOM network connectivity, have been tested using image sets from different imaging devices from different manufactures." This implies a diverse set of images, but no specific countries of origin or whether the data was retrospective or prospective are mentioned. The nature of the device (PACS software) suggests testing would likely involve retrospective imaging data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The assessment focused on functional and technical equivalence rather than diagnostic accuracy that would typically require ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided. The non-clinical tests described focus on software functionality (e.g., DICOM compliance, image display, archival) rather than clinical accuracy adjudicated by a consensus method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done or described. The device is a Picture Archiving and Communication System (PACS) software with analysis modules, not an AI-assisted diagnostic tool for human readers in the sense of improving their diagnostic performance. The document focuses on the device's performance and capabilities being equivalent or superior to predicate devices.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, in spirit. The "non-clinical tests" evaluated the ComPACS software's functionality in a standalone manner, assessing its ability to store, query, retrieve, display, and analyze images according to its specifications and in comparison to predicate device capabilities. The document asserts that ComPACS "performs as well or better than" predicate devices on its own.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the functional and technical tests described (e.g., DICOM compliance, image display, archival, processing), the "ground truth" would be the expected functional behavior and technical standards (e.g., DICOM standard compliance, successful image retrieval, correct display of image content, accurate execution of analysis algorithms). It does not appear to involve clinical ground truth like pathology or outcomes data.

8. The sample size for the training set:

Not applicable / Not provided. The ComPACS device is a PACS system and analysis software, not a machine learning or AI algorithm that would typically require a "training set" in the context of learning from data. Its functionality is based on programmed logic and adherence to standards rather than learned patterns.

9. How the ground truth for the training set was established:

Not applicable / Not provided for the same reasons as in point 8.

Summary

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K04 1581

'JUN 2 2 2004

Image /page/0/Picture/2 description: The image shows the logo for MediMatic. The logo consists of a circular arrangement of letters spelling out "medicati" and the word "MediMatic" in bold, black letters. Below the word "MediMatic" is the text "Intelligent Images S.r.l. - www.medimatic.com".

Intelligent Images S.r.l.

Page 1 of 10

Amministrazione e Uffici:

Viale Cembrano 4C/4, 16148 GENOVA, ITALY el: +39 010 3071634 Fax: +39 010 3074548

ComPACS 510 (k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21 CFR 807.92(a).

807.92(a)(1)

Submitter Information

Intelligent Images S.r.l. 4C/4 Viale Cembrano 16148 Genova, ITALY

Phone:	+39 0103071634
Fax:	+39 0103074548
Contact Person:	Maria Rosa Bellisario
Date:	May 20, 2004

807.92(a)(2)

Device Name

Trade Name: ComPACS, ComPACS Components ComPACS Common Name:
Classification Name(s): System, Image Processing

892.2050 Classification Number:

LLZ Product Code:

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Image /page/1/Picture/0 description: The image shows a circular arrangement of eight smaller circles, each containing a letter. Reading clockwise, the letters spell out 'medication'. The letters are 'm', 'e', 'd', 'i', 'c', 'i', 't', and 'a'.

Image /page/1/Picture/1 description: The image shows the word "MediMatic" in a large, bold, sans-serif font. Below the word "MediMatic" is the text "Intelligent Images S.r.l. - www.medimatic.com" in a smaller font. The text appears to be the name of a company and its website address.

Intelligent Images S.r.I.

Image /page/1/Picture/3 description: The image shows a handwritten note with the text "K041581" at the top. Below this, there is another line of text that appears to be a signature or a word written in cursive. The writing is in black ink on a white background, and the overall quality of the image suggests it may be a scan or photograph of a physical document.

Amministrazione e Uffici:

Viale Cembrano 4C/4, 16148 GENOV
Tel: +39 010 3071634 Fax: +39 010 3

807.92(a)(3)

ComPACS 510 {k} Summary - Predicate Device(s)

Manufacturer:	AETMED, S.P.A.VIA SIFFREDI 58GENOVA, I-16153, ITALY
Tradename:	AETMED IMAGE PROCESSING SOFTWARE
510(k) Number:	K012093
Manufacturer:	PROBLEM SOLVING CONCEPTS, INC.8020 CASTLEWAY DR.INDIANAPOLIS, IN 46250, USA
Tradename:	PROSOLV® CARDIOVASCULAR
510(k) Number:	K023112
Manufacturer:	TOMTEC IMAGING SYSTEMS, GMBHEDISONSTRASSE 6UNTERSCHLEISSHEIM, D-85716, GERMANY
Tradename:	IMAGE-ARENA
510(k) Number:	K040546
Manufacturer:	INTELLIGENT IMAGES SRLVIALE CEMBRANO 4C/4GENOVA, I-16148, ITALY
Tradename:	IN-VISION VIEW WITH MEASUREMENTS MODULE
510(k) Number:	K022940

Additional substantial equivalence information is provided in the following substantial equivalence section.

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K041581
Page 3 of 6

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MediMatic
Intelligent Images S.r.l. - www.medimatic.com

Amministrazione e Uffici:

ale Cembrano 4C/4, 16148 GENOVA, ITALY Tel: +39 010 3071634 Fax: +39 010 3074548

ComPACS 510 (k) Summary - Device Description 807.92(a)(4)

General Review Station Components

CornPACS viewer constitutes the basic module for a review station providing viewing capabilities and retrieving capabilities from DICOM files in removable media. ComPACS Archive introduces archiving and retrieving of studies on the local review station. ComPACS Net Client allows a review station to archive and retrieve studies from a ComPACS Net Archive or from a third party DICOM compliant PACS. ComPACS Multi-Media extends ComPACS Archive to import and archive multi-media files with conversion to the DICOM format. ComPACS audio introduces digital audio management capabilities.

Analysis Components

The review station can be extended with different analysis modules. ComPACS QCA and ComPACS LVA provide respectively quantitative coronary analysis and left ventricular analysis on angiographic images. ComPACS Echocardiac, ComPACS Stress Echo provide different echo analysis features. ComPACS IVUS allows measurements and longitudinal image reconstruction on IVUS images.

Reporting Components

ComPACS Reporting allows report creation and management. This component can be further subdivided into subcomponents in relation to the different type of reports: Generic, Echocardiac, angiographic, etc. ComPACS Dictation extends the reporting module to allow for audio dictation into the report.

Server Components

ComPACS Net Archive is the basic server modules allowing and retrieving of studies from remote workstations equipped with a ComPACS Net Client module. ComPACS Security introduces user activity logging and user rights profiles management. ComPACS Storage Server provides DICOM network storage services as SCP. ComPACS Dictation Server manages the dictated reports and transfers them to an external transcription service.

ComPACS Small Business Server and ComPACS Enterprise Server provide DICOM network services for small and large size networks respectively.

Gateway Components

ComPACS Recorder is a device capable of digitizing analog video signals and converting to DICOM compliant files for storage on media or network transfer to a DICOM server.

Intelligent Images S.r.l.

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Image /page/3/Picture/0 description: The image shows a handwritten text that appears to be a note or a label. The text is written in a cursive style, with some letters being more legible than others. The writing is in black ink on a white background, and the overall impression is that of a quick, informal message.

Image /page/3/Picture/1 description: The image shows the logo for MediMatic. The logo consists of a circular arrangement of smaller circles, each containing a letter, spelling out "medimatic". To the right of the circular arrangement is the word "MediMatic" in a bold, sans-serif font. Below the word "MediMatic" is the text "Intelligent Images S.r.l. - www.medimatic.com".

Amministrazione e Uffici:

Viale Cembrano 4C/4, 16148 GENOVA, ITALY Tel: +39 010 3071634 Fax: +39 010 3074548

807.92(a)(5)

ComPACS 510 (k) Summary - Intended Use(s)

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Image /page/4/Picture/1 description: The image shows a circular arrangement of eight smaller circles. Each circle contains a letter, spelling out the word 'medicate' in a clockwise direction. The letters are 'a', 'm', 'e', 'd', 'i', 'c', 't', and 'i'.

Amministrazione e Uffici:

ale Cembrano 4C/4, 16148 GENOVA, ITALY +39 010 3071634 Fax: +39 010 3074548

807.92(a)(6)

ComPACS 510 (k) Summary -Substantial Equivalence

CornPACS is substantially equivalent to Aetmed Image Processing Software, Prosolv® Cardiovascular, and Image-Arena. While there are some technological differences between ComPACS and the substantially equivalent devices, these differences do not affect the safety or effectiveness of the new device.

The primary difference between ComPACS and these three substantially equivalent devices is in the image management flexibility and DICOM format support. ComPACS appears to have a more advanced multi-window and multi-monitor image management and a wider support of the DICOM format in the different color encoding and compression options as well as a greater tolerance to slightly non compliant files. These features add to the safety and effectiveness of the device.

While all the devices are capable of performing analysis on different type of image modalities, ComPACS appears to provide analysis support for a wider set of modalities than any of the single equivalent devices although there no modality for which ComPACS provides unique support. This adds to the effectiveness of the device without compromising the safety.

Another difference between ComPACS and these three substantially equivalent devices is the management of audio data and report dictation, adding to the effectiveness of the device.

ComPACS is also substantially equivalent to In-Vision View with Measurements Module, an stand-alone software from Intelligent Images. The substantial equivalence is related to the ComPACS viewer and ComPACS IVUS components for the viewing and measurement functions on IVUS images. The only significant difference is ComPACS ability to support multi-window and multi-monitor display.

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KREBS
Kinetik

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MediMatic
Intelligent Images S.r.l. - www.medimatic.com

Amministrazione e Uffici:

no 4C/4 16148 GENOVA

ComPACS 510 (k) Summary

807.92(b)(1)(2)

Non Clinical Tests

ComPACS performance is substantially equivalent to Aetmed Image Processing Software, Prosolv® Cardiovascular, and Image-Arena. While there are some technological differences between ComPACS and the substantially equivalent devices, these differences do not affect the safety or effectiveness of the new device.

ComPACS image storage, query and retrieval, including DICOM network connectivity, have been tested using image sets from different imaging devices from different manufactures. The primary differences between ComPACS these three substantially equivalent devices appears to be in the wider support of both DICOM formats and proprietary formats (DSR-TIFF, DEFF) and in a wider range of search criteria for study query purposes. These features add to the safety and effectiveness of the device.

ComPACS performance is also substantially equivalent to In-Vision View with Measurements Module, a stand-alone software from Intelligent Images with an added support in ComPACS multi-window and multi-monitor display. These features add to the safety and effectiveness of the device.

807.92(b)(3)

Non Clinical Tests - Conclusions

The nonclinical and clinical tests demonstrate that ComPACS is substantially equivalent to Aetmed Image Processing Software, Prosolv® Cardiovascular, Image-Arena and In-Vision View with Measurements Module. The tests show that ComPACS is as safe, as effective and performs as well or better than such legally marketed predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 2004

Intelligent Images S.r.l. (MediMatic) % Mr. Daniel W. Lehtonen Staff Engineer Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K041581

Trade/Device Name: ComPACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ

Dated: June 12, 2004 Received: June 14, 2004

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device vio neve rove 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 nay, 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 that I Dri has 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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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin hantoung of substantial equivalence of your device to a legally premarket notincation. The FDF member of 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 In you desire specific advice for your dence on one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Auditionally, for questions on the promotes as a measure the regulation entitled, "Misbranding Other of Compliance at (301) 597 - 1037. 1253) you may obtain. Other general by reletence to premarked notified in (= 1) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = (200) = 2 = 1 = (200) = 2 = 1 = (200) = 2 = 1 information on your responsionales and consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogden

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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MediMatic
Intelligent Images S.r.l. - www.medimatic.com

Amministrazione e Uffici:

Viale Cembrano 4C/4, 16148 GENOVA, ITALY Tel: +39 010 3071634 Fax: +39 010 3074548

ComPACS 510 (k) Summary - Indications for Use Statement

Vcr/ 3 - 4/24/96

Applicant: Intelligent Images S.r.l.

K041581 510(k) Number (if known): _

Device Name: ComPACS

Indications For Use:

ComPACS is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, viewing, printing, processing, Instalation on and communicating medical digital studies such as cardiac catheterization, echocardiography or general radiological studies.

The software can be used in a variety of network configurations ranging from a stand-alone workstation The votwork of workstations connected to a ComPACS server configuration. DICOM compatible imaging devices can transfer studies directly to the ComPACS archive using DICOM network protocols or. DICOM removable media.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Miller Hodgson

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

(Per 21 CFR 801.109)

Prescription Use (Per 21 CFR 801.109) Page 15 of 75

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).