The Catella Diagnostic Workstation, Version 4.0, is a medical image and information management system that allows easy viewing, selection, processing, printing, telecommunications, and media interchange of multimodality medical images from a variety of diagnostic imaging systems. The Catella PACS interfaces to various storage and printing devices using DICOM or similar interface standards. The system is available for diagnostic and nondiagnostic workstations, including workstations designed as web-based, remote viewers or CD-viewer workstations. The software may be installed as a PC-based stand alone system, a software application, a web-based or SDK format, and is designed to be integrated with various DICOM compliant OEM systems.

The Catella PACS displays, stores, prints, and telecommunicates images from a number of medical modalities, including but not limited to MR, CT, DR, CR, X-ray, Angiography, Ultrasound, or digitizers. The Catella Diagnostic Workstation, Version 4.0 performs other user-defined post-processing functions, such as multi-planar reformatting of images. The Catella PACS can display processed data from certain FDA-cleared third party image processing systems that create DICOM output. With proper links, the Catella Workstation also can invoke FDA-cleared third party image processing systems for advanced image processing, such as 3D display. It can also access RIS and HIS systems and can be used to review patient information.

The Catella Diagnostic Workstation, Version 4.0, is not intended for use for primary diagnostic interpretation of mammographic images.

Device Description

The Catella Diagnostic Workstation, Version 4.0 is a multi-modality PCdriven review workstation that operates on a standard Windows operating system. Each workstation may include a high performance computer, communications capability, medical grade, high-resolution monitors and video cards, trackball or mouse, microphone, keyboard, foot pedal and ergonomically designed display cart. The system is available for diagnostic and non-diagnostic workstations, including workstations designed as webbased, remote viewers or CD-viewer workstations. The software may be installed as a PC-based stand alone system, a software application, a webbased or SDK format, and is designed to be integrated with various DICOM compliant OEM systems.

The Catella Diagnostic Workstation, Version 4.0 includes the following software features:

The Catella Diagnostic Workstation, Version 4.0 allows the user to . select a study to view, archive, and perform administrative tasks.
. The Catella Diagnostic Workstation, Version 4.0 includes multimodality viewing capabilities, allowing the user to view images from various modalities.
. Digitized mammographic images displayed on the Catella Diagnostic Workstation, Verison 4.0 must not be used for primary diagnostic interpretation.
. Lossy compressed mammographic images should not be used for primary diagnosis and contain a warning.
DICOM query/retrieve and print, which allows retrieval of DICOM . data from any DICOM-compliant device that is configured for query and retrieval.

The Catella Diagnostic Workstation, Version 4.0 also provides various software components described in the User Manual, including:

. Software for viewing images, playing audio, or viewing or dictating reports
. Zoom, pan, window/level
. Menu options
Annotations, standard software tools .
. Stack/Cine viewing mode
. DICOM query/receive
DICOM-compliant methods of lossless and lossy image compression . (JPEG2000 and JPEG)
. Outputs DICOM medical image data to printers that adhere to appropriate regulatory standards.
. Outputs medical imaging data in DICOM format to archives that use appropriate media that are designed to prevent data loss.
. Enables storage and reading of digitized images.

AI/ML Overview

Here's an analysis of the provided text regarding the Catella Diagnostic Workstation, Version 4.0, structured according to your request:

Acceptance Criteria and Study for the Catella Diagnostic Workstation, Version 4.0

The provided 510(k) summary for the Catella Diagnostic Workstation, Version 4.0, focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against pre-defined acceptance criteria through a dedicated study. This is a common approach for PACS systems, where the primary concern is the safe and effective display, storage, and communication of medical images, similar to already-cleared devices.

The document states: "The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes. The Catella Diagnostic Workstation, Version 4.0 provides images and data management capabilities comparable to the predicate devices." This implies that verification and validation were performed to ensure the device functions as intended and safely, consistent with its intended use and comparison to predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, specific quantitative acceptance criteria or detailed performance metrics from a study are not explicitly stated or included. The submission relies on demonstrating substantial equivalence to predicate devices which are already on the market and presumed safe and effective.

Therefore, the table would look like this, reflecting the lack of explicit quantitative criteria often seen in performance claims for AI/CAD devices:

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Not explicitly defined as quantitative performance criteria for a specific clinical task. The basis of acceptance is substantial equivalence to predicate devices.	The device provides "images and data management capabilities comparable to the predicate devices." This implies functional equivalence in viewing, selection, processing, archiving, printing, and media interchange of multi-modality images.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate test set, its sample size, or the provenance of any data used for a performance study. The substantial equivalence argument does not require a clinical performance study with a test set in the same way an AI/CAD device might.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no specific test set or performance study is detailed, there is no information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

As there is no mention of a test set or performance study, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. This type of study demonstrates improved human performance with AI assistance, which is not the type of claim this device is making.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study of an algorithm without human-in-the-loop performance was not done or reported. The device is a "workstation" and focuses on display and management functionality.

7. The Type of Ground Truth Used

Given the nature of the device (a PACS workstation) and the 510(k) summary, which focuses on substantial equivalence rather than a clinical performance claim, there is no mention of a specific "ground truth" used in the context of a diagnostic or algorithmic performance study. The ground truth for a PACS primarily relates to the accurate and lossless display and management of image data, which is typically verified through technical testing and functional validation, not expert consensus on pathology or outcomes.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This device is a software workstation for image management, not an AI/ML algorithm that requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set mentioned or implied for an AI/ML algorithm, the method for establishing ground truth for a training set is not applicable and not detailed in this submission.

Summary

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K052537

00012

NOV 1 6 2005

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87 (h).

1. Identification of Submitter:

Submitter:	American Medical Sales, Inc.
Address:	4928 West Rosecrans Avenue
	Hawthorne, CA 90250-6616
Phone:	310-219-3200
Fax:	310-219-3201
Contact:	Carol M. Lifland
Title:	Vice President, Legal and Regulatory Affairs
Phone:	310-219-3200
Fax:	310-219-3201

2. Identification of Product:

Trade Name:	Catella Diagnostic Workstation, Version 4.0
Common Name:	Picture Archiving and Communications System
Classification Name:	Systems, Image Processing, Radiological21 CFR 892.2050 (Product Code LLZ)
Manufacturer:	American Medical Sales, Inc.4928 West Rosecrans AvenueHawthorne, CA 90250-6616

3. Marketed Devices

The Catella Diagnostic Workstation, Version 4.0, is substantially equivalent to the devices listed below:

Model:	Seno Advantage
Manufacturer:	GE Medical Systems
510 (k) Number:	K033400
Model:	Sectra IDS5 Radiology Workstation
Manufacturer:	Sectra-Imtec Ab
510 (k) Number:	K033712, K040376

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4. Device Description:

The Catella Diagnostic Workstation, Version 4.0 includes the following software features:

The Catella Diagnostic Workstation, Version 4.0 allows the user to . select a study to view, archive, and perform administrative tasks.
. The Catella Diagnostic Workstation, Version 4.0 includes multimodality viewing capabilities, allowing the user to view images from various modalities.
. Digitized mammographic images displayed on the Catella Diagnostic Workstation, Verison 4.0 must not be used for primary diagnostic interpretation.
. Lossy compressed mammographic images should not be used for primary diagnosis and contain a warning.
DICOM query/retrieve and print, which allows retrieval of DICOM . data from any DICOM-compliant device that is configured for query and retrieval.

The Catella Diagnostic Workstation, Version 4.0 also provides various software components described in the User Manual, including:

. Software for viewing images, playing audio, or viewing or dictating reports
. Zoom, pan, window/level
. Menu options
Annotations, standard software tools .
. Stack/Cine viewing mode
. DICOM query/receive

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DICOM-compliant methods of lossless and lossy image compression . (JPEG2000 and JPEG)
. Outputs DICOM medical image data to printers that adhere to appropriate regulatory standards.
. Outputs medical imaging data in DICOM format to archives that use appropriate media that are designed to prevent data loss.
. Enables storage and reading of digitized images.

5. Indications for Use

The Catella Diagnostic Workstation, Version 4.0 is a medical image and information management system that allows easy viewing, selection, processing, printing, telecommunications, and media interchange of multimodality medical images from a variety of diagnostic imaging systems. The Catella Diagnostic Workstation, Version 4.0 interfaces to various storage and printing devices using DICOM or similar interface standards. The system is available for diagnostic and non-diagnostic workstations, including workstations designed as web-based, remote viewers or CD-viewer workstations. The software may be installed as a PC-based stand alone system, a software application, a web-based or SDK format, and is designed to be integrated with various DICOM compliant OEM systems.

The Catella Diagnostic Workstation, Version 4.0 displays, stores, prints, and telecommunicates images from a number of medical modalities, including but not limited to MR, CT, DR, CR, X-ray, Angiography, Ultrasound, or digitizers. The Catella Diagnostic Workstation, Version 4.0 performs other user-defined post-processing functions, such as multi-planar reformatting of images. The PACS can display processed data from certain FDA-cleared third party image processing systems that create DICOM output. With proper links, the Catella Diagnostic Workstation, Version 4.0 also can invoke FDA-cleared third party image processing systems for advanced image processing, such as 3D display. It can also access RIS and HIS systems and can be used to review patient information.

The Catella Diagnostic Workstation, Version 4.0 is not intended for use for primary diagnostic interpretation of mammographic images.

6. Comparison with Predicate Devices

The Catella Diagnostic Workstation Version 4.0 is substantially equivalent to the following picture archiving and communications systems used by radiologists:

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Seno Advantage Workstation GE Medical Systems Manufacturer: K033400 510 (k) Number:

Sectra IDS5 Radiology Workstation Manufacturer: Sectra-Imtec Ab 510 (k) Number: K040376

Each of these workstations allows easy selection, review, processing, archive, printing and media interchange of multi-modality images from a variety of diagnostic imaging systems.

7. Conclusions

The Catella Diagnostic Workstation, Version 4.0 provides specific software features to further integrate radiology department workflow. The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes. The Catella Diagnostic Workstation, Version 4.0 provides images and data management capabilities comparable to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circle around the eagle. The logo is black and white and has a simple, clean design. The eagle is a symbol of strength and freedom, and the text identifies the organization.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2005

Re.: Ms. Carol M. Lifland Vice President, Legal and Regulatory Affairs American Medical Sales, Inc. 4928 West Rosecrans Avenue HAWTHORNE CA 90250

K052537 Trade/Device Name: Catella Diagnostic Workstation, Version 4.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system. Regulatory Class: II Product Code: LLZ Dated: September 13, 2005 Received: September 15, 2005

Dear Ms. Lifland:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave 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 May 20, 1770, the chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include subject to the general vehicle in, 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 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 I Drinas made and regulations administered by other Federal agencies. You must comply with all the 1 oderar building, 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 this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

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00011

6 Indication(s) for Use Statement

510(k) Number:

To be assigned by FDA

Ko52537

Device Name:

Catella Diagnostic Workstation, Version 4.0

Indications for Use:

The Catella Diagnostic Workstation, Version 4.0, is not intended for use for primary diagnostic interpretation of mammographic images.

Prescription Use (Part 21 CFR 801 Subpart D)

Abbreviated 510(k) PreMarket Notification

Catella Diagnostic Workstation, Version 4.0

American Medical Sales, Inc.

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sign-Of
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052537

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).