(19 days)
Not Found
No
The description focuses on image registration algorithms and standard image processing techniques (like SUV calculation for PET-CT) without mentioning AI or ML. The "Full Automatic registration" is described as an algorithm that doesn't require additional input beyond selecting the datasets, which is not necessarily indicative of AI/ML.
No.
The device is an image management system with tools for analyzing and comparing 3D images, primarily for radiologists and physicians to aid in diagnosis, not for providing direct therapeutic treatment.
No
The device is an image management system and reading/reporting station for medical images. While it assists radiologists and physicians in analyzing and comparing images, including tools for 3D image analysis and PET-CT image review, it does not explicitly state that it provides a diagnosis or diagnostic output itself. Its function is to facilitate the review and analysis of images that may be used for diagnosis, rather than making the diagnosis.
No
The device description explicitly mentions it is a "multi-modality radiology reading and reporting station," which implies it includes hardware components for image display, processing, and reporting, not just software. While it performs software-based image processing and registration, the overall system is not solely software.
Based on the provided information, the CARESTREAM PACS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is focused on image management, archiving, distribution, retrieval, and display of medical images from various modalities. It also includes tools for analyzing and comparing 3D images and integrating review, dictation, and reporting. This is consistent with a Picture Archiving and Communication System (PACS).
- Device Description: The description details features related to image registration, viewing, and manipulation of medical images (CT, MRI, PET-CT). It also mentions the calculation of Standardized Uptake Value (SUV) for PET-CT images, which is a quantitative measure derived from imaging data, not from in vitro testing of biological samples.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CARESTREAM PACS does not perform any such analysis on biological samples. Its function is centered around processing and displaying medical images.
While the system provides tools that can aid radiologists and physicians in making diagnoses, the device itself is not performing the diagnostic test on a biological sample. It is a tool for managing and presenting the results of imaging modalities.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, PET-CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists and physicians / hospital and related institutions/sites
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 |
| Rochester, New York 14608 | |
| 510(k) Owner Phone: | 585 627-6543 |
| 510(k) Owner Fax: | 585 454-1894 |
| Contact Name & Info: | Linda Stewart |
| Regulatory Affairs Director, Medical Imaging | |
| linda.stewart@carestreamhealth.com | |
| 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 |
| Manufactured by Siemens Medical Solutions, Inc | |
| 510(k) No. - K020546 (April 26, 2002) |
:
1
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
2
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.
3
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.
4
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). 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 (800) 638-2041 or (240) 276-3150 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
5
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