CARESTREAM PACS, MODEL CARESTREAM PACS VII

K083673 · Carestream Health, Inc. · LLZ · Dec 30, 2008 · Radiology

Device Facts

• Record ID: K083673
• Device Name: CARESTREAM PACS, MODEL CARESTREAM PACS VII
• Applicant: Carestream Health, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians.

Device Story

Carestream PACS is a multi-modality radiology reading and reporting station for hospitals/clinics. It ingests volumetric data from various modalities (CT, MRI, PET). Core functionality includes 3D image registration and PET-CT analysis. Registration methods include: Full Automatic (user-initiated, no point selection); Manual (user-defined anatomical points); Refine (local similarity-based adjustment); and Treat as Registered (bypassing frame-of-reference checks). PET-CT analysis includes standardized uptake value (SUV) calculation for semi-quantitative assessment of FDG uptake. Radiologists and physicians use the system to review, dictate, and report findings. By synchronizing and superimposing volumetric datasets, the device facilitates comparative analysis of studies taken at different times or via different modalities, aiding clinical decision-making and diagnostic workflow efficiency.

Clinical Evidence

Bench testing only. Performance testing was conducted to verify design outputs against design inputs and to validate conformance to user needs. Nonclinical testing was performed under simulated use conditions. Predefined acceptance criteria were met, demonstrating performance equivalent to the predicate device.

Technological Characteristics

Multi-modality radiology reading and reporting station. Software-based image processing. Rigid space transformation algorithm for 3D registration. Supports DICOM-compliant image data. Features include volumetric synchronization, side-by-side/superimposed viewing, and SUV calculation for PET-CT.

Indications for Use

Indicated for use by radiologists and physicians in hospital and clinical settings for the management, analysis, and comparison of multi-modality medical images, including 3D registration and PET-CT image review.

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

• Mirada Solutions Ltd, Fusion 7D (K020546)

Submission Summary (Full Text)

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K083673

Carestream PACS

.

Traditional 510(k): Carestream Health, Inc.

# "510(k) Summary"

| | DEC 30 2008 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner Name: | Carestream Health, Inc. |
| 510(k) Owner Address: | 150 Verona Street<br>Rochester, New York 14608 |
| 510(k) Owner Phone: | 585 627-6543 |
| 510(k) Owner Fax: | 585 454-1894 |
| Contact Name & Info: | Linda Stewart<br>Regulatory Affairs Director, Medical Imaging<br>[e-mail]<br>972-517-1481 |
| Date Summary Prepared: | November 26, 2008 |
| Device Trade Name: | Carestream PACS |
| Device Common Name: | PACS |
| Classification Name: | System, Image Processing, Radiological |
| Regulation Name: | Picture Archiving and Communication System |
| Device Class: | Class II |
| Device Code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
| Predicate Device: | Mirada Solutions Ltd, Fusion 7D<br>Manufactured by Siemens Medical Solutions, Inc<br>510(k) No. - K020546 (April 26, 2002) |

:

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#### Device Description:

Carestream PACS, a multi-modality radiology reading and reporting station, provides support for 3D registration of studies taken at different times or by different modalities (CT and MRI), and for reading PET-CT images. The volumetric data sets are synchronized allowing the user to view reformatted series side by side and superimposed images. In all methods the algorithm is only using a rigid space transformation.

The registration in the "Volume Matching" application can be created by these methods:

. Register Studies

Full Automatic registration: The user is able to register two datasets by simply clicking on the windows that present these datascts, with no other additional input. The algorithm will not take into account the exact clicking points.

- Manually Register Studies .
The user is able to "manually" register two datasets by providing additional inputs to the registration algorithm. The matching of the two volumes is done based on the planes of the two studies and on the position of the two clicking points. This input should be enough to match the two dataset. The user should try to click on the same anatomical location in both studies. while both planes are already swiveled to represent the same anatomical plane.

- . Refine Registration
The user is able to adjust the registration. The refine algorithm is actually a local registration algorithm that tries to match two volumes based on local, rather than global, similarity. Practically, it can serve the user when he/she wants to focus on a certain region and to compare it in the two datasets. In such cases, local registration is preferable, even if it means that the global registration will be of a poorer quality.

- Treat Studies as Registered .
The application supports the "treat studies as registered" feature - the ability for the user to select datasets / all datasets for which the system should treat as if they are fully registered to one another. This is needed to support places where although the data doesn't have the same frame of reference, they were registered in a "black-box" and only then copied to the PACS. The algorithm is ignoring the exact clicking point.

Reading PET-CT images require both specific image-manipulation capabilities and standardized uptake value presentation. PET scanning utilizes a radioactive molecule that is similar to glucose, called fluorodeoxyglucose (FDG). FDG accumulates within malignant cells because of their high rate of glucose metabolism, and is currently the radiotraccr most commonly used for PET' imaging.

The standardized uptake value (SUV) is a scmi-quantitative value that allows expression of FDG untake in a lesion relative to the injected dose. The

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standardized uptake value (SUV) is defined as the ratio of activity in tissue per millimeter to the activity in the injected dose per patient body weight.

#### Intended Use:

The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians.

#### Comparison of Technological Characteristics:

The modifications to the CARESTREAM PACS do not alter the fundamental scientific technology of the device. The only device modification was to the software. No new image manipulation tools are implemented that do not exist in the Fusion7D device. The device modifications raise no new issues of safety or effectiveness.

#### Discussion of Testing

Performance testing was conducted to verify the design output met the design input requircments and to validate the device conformed to the defined user needs and intended uses. Nonclinical testing was conducted under simulated use conditions. Predefined acceptance criteria was met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.

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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 features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized eagle with three stripes extending from its back, representing health, human services, and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### DEC 3 0 2008

Ms. Linda Stewart Regulatory Affairs Director, Medical Imaging Carestream Health, Inc. 150 Verona Street ROCHESTER NY 14608

Re: K083673

Trade/Device Name: Carestream PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 9, 2008 Received: December 11, 2008

Dear Ms. Stewart:

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 (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.

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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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

hope M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Intended Use

510(k) Number (if known):

Device Name:

Indications for Use:

083673

### CARESTREAM PACS

The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

C.S.R. Pohank (acting)

Division Sign-Off Division of Reproductive, Abdominal. and Radiological Devi

TITLE: Statement of Intended Use Carestream PACS 11510(k) Number PART #: 8G7623 VERSION # 1.0

Unrestricted Internal Use (U) PAGE 1 of 1