CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0

K052537 · American Medical Sales, Inc. · LLZ · Nov 16, 2005 · Radiology

Device Facts

• Record ID: K052537
• Device Name: CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0
• Applicant: American Medical Sales, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 16, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended 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 PACS 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 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 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.

Device Story

Catella Diagnostic Workstation v4.0 is a multi-modality PC-based PACS for viewing, processing, and managing medical images. Inputs include DICOM-compliant images from modalities like MR, CT, and Ultrasound. System operates on Windows, utilizing high-resolution monitors, trackballs, and keyboards. Features include zoom, pan, window/level, multi-planar reformatting, and DICOM query/retrieve. Used by radiologists and clinicians in clinical environments to review patient data and images. Output is displayed on medical-grade monitors or sent to DICOM-compliant printers/archives. Facilitates workflow by integrating with RIS/HIS and third-party image processing systems. Benefits include improved image management and accessibility for diagnostic review, excluding primary mammography interpretation.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through risk analysis, design verification, and validation testing.

Technological Characteristics

PC-based workstation running Windows OS. Hardware includes high-performance computer, medical-grade high-resolution monitors, video cards, and input peripherals (mouse, keyboard, foot pedal). Connectivity via DICOM standards for query/retrieve and printing. Supports JPEG and JPEG2000 image compression. Software architecture supports standalone, web-based, and SDK formats.

Indications for Use

Indicated for use as a medical image and information management system for viewing, processing, and archiving multimodality medical images (MR, CT, DR, CR, X-ray, Angiography, Ultrasound, digitizers) in clinical settings. Contraindicated for primary diagnostic interpretation of mammographic images.

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

• Seno Advantage (K033400)
• Sectra IDS5 Radiology Workstation (K033712, K040376)

Submission Summary (Full Text)

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K052537

00012

## NOV 1 6 2005

7

# 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, Radiological<br>21 CFR 892.2050 (Product Code LLZ) |
| Manufacturer: | American Medical Sales, Inc.<br>4928 West Rosecrans Avenue<br>Hawthorne, 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 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

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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 [phone] or [phone] 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

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## 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 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.

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

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