(202 days)
Not Found
No
The document describes standard PACS functionality and image processing tools, but does not mention AI or ML. The "Automatic vessel segmentation" feature is described as using a rigid space transformation algorithm, which is not indicative of AI/ML.
No
The device is an image management system used for archiving, distributing, retrieving, and displaying medical images and data for radiologists and physicians. It is not intended for treatment or therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section states that the CARESTREAM PACS Lightweight Viewer provides a "diagnostic viewer of medical images substantially equivalent to the CARESTREAM PACS software". Although its Lightweight Viewer component is not intended to replace a full diagnostic workstation, the core PACS system's description mentions enabling "diagnostic reading through industry standard interfaces."
Yes
The device description explicitly states "It is a software only solution". While it integrates with off-the-shelf hardware components, the device itself is described as solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CARESTREAM PACS is an image management system. Its primary function is to archive, distribute, retrieve, and display medical images and data from various imaging modalities (CR, DR, CT, MR, NM, US). It also provides tools for analyzing and comparing these images.
- Lack of Biological Sample Analysis: The description clearly focuses on the handling and display of medical images, which are generated by imaging equipment, not from the analysis of biological samples.
Therefore, the CARESTREAM PACS falls under the category of medical imaging software and systems, not In Vitro Diagnostics.
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.
The CARESTREAM PACS Lightweight Viewer software program is used for patient management by the referral community in order to access and display patient data, medical reports, and medical images from different modalities including CR, DR, CT, MR, NM and US after the primary reading has been completed on dedicated diagnostic workstations.
The CARESTREAM PACS Lightweight Viewer provides wireless and portable access to medical images for referral purposes. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography.
Product codes
LLZ
Device Description
CARESTREAM PACS is an image management system whose intended use is to provide completely scalable 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.
It is a software only solution that 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. It offers an intuitive user interface which includes a tab concept, grouping features, and functions with the same context together such as Image display, Monitor layout, Comparison, Wide area user tab, etc.
The device provides functionality to allow remote site access to image and patient data enabling diagnostic reading through industry standard interfaces. It is designed using an open architecture that allows for various proprietary and off the shelf software components to be integrated with off the shelf hardware components and configured meeting the user's specific needs in a single-site or multi-site environment.
Carestream PACS provides support for 3D registration of studies taken at different times or by different modalities for reading of CT/MRI or 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. Automatic vessel segmentation suggests a segmentation that that can either be accepted, ignored or fine tuned by the user.
The CARESTREAM PACS LightWeight Viewer feature addresses the need for a fast and simple web based tool to access patient records and images. It allows for high speed distribution of image data to users in a wide area setup. The software technology uses HTML5 which allows browser enabled devices to run the application without local software installation. The LightViewer has a simple GUI for viewing including zoom, pan, windowing, basic measurements, cine, etc.
The CARESTREAM PACS Lightweight Viewer provides wireless and portable access to medical images for referral purposes. It provides a diagnostic viewer of medical images substantially equivalent to the CARESTREAM PACS software, with portable device characteristics and functionality. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. The CARESTREAM PACS LightWeight Viewer software is not to be used for mammography in the US.
The CARESTREAM PACS LightWeight Viewer operates on "off-the-shelf 'portable hardware devices and is therefore subject to factors not typical for reading room workstations (e.g. screen size, environmental variability, network dependencies, etc.). It is therefore required that the user follows the operating instructions and adhere to the risk mitigation guidelines.
CARESTREAM PACS does not drive or influence the use of the source device. It does not directly drive a decision regarding treatment or therapy without the intervention of subsidiary means. Images must be evaluated and the decision regarding treatment or therapy is determined by the user based on their standard procedures. CARESTREAM PACS is a complement to these standard procedures.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, DR, CT, MR, NM and US
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
Performance testing was conducted to verify the design output met the design input requirements and to validate the device conformed to the defined user needs and intended uses. 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.
Carestream Health conducted display performance testing using the CARESTREAM PACS Lightweight Viewer software on the iPad device. Testing measured contrast response and evaluated test patterns for luminosity, resolution, and noise according to IEC 62563-1 and AA PM TG18 guidelines. Carestream Health also performed multiple studies with qualified radiologists using a variety of modalities, specifically CR, DR, CT, MR, NM and US under different environmental conditions.
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 requirements and to validate the device conformed to the defined user needs and intended uses. 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.
Carestream Health conducted display performance testing using the CARESTREAM PACS Lightweight Viewer software on the iPad device. Testing measured contrast response and evaluated test patterns for luminosity, resolution, and noise according to IEC 62563-1 and AA PM TG18 guidelines. Carestream Health also performed multiple studies with qualified radiologists using a variety of modalities, specifically CR, DR, CT, MR, NM and US under different environmental conditions. Results of these studies affirm the diagnostic image viewing capabilities of CARESTREAM PACS LightWeight Viewer when used as indicated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image contains the word "Carestream" in a stylized font. The letters are outlined with a slightly rough or textured edge, giving them a distinct appearance. The word is presented in a single line and appears to be the primary focus of the image.
OCT 2 0 2011
Carestream Health Inc.
150 Verona Street Rochester, NY 14608
"510(k) Summary"
.
| 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: | John Pardo |
| Director, Regulatory Affairs and Quality Systems | |
| John.pardo@carestreamhealth.com | |
| 585-627-6543 | |
| Date Summary Prepared: | 7/15/2011 |
| 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: | Carestream PACS |
| Manufactured by Carestream Health, Inc. | |
| 510(k) No. - K083673 (December 30, 2008) |
.
1
Image /page/1/Picture/0 description: The image contains the word "Carestream" in a stylized font. The letters are outlined with a double border, giving them a distinct appearance. The word is presented in a horizontal orientation, filling the majority of the frame. The font choice and outlining contribute to the visual prominence of the text.
Carestream Health Inc. 150 Verona Street Rochester, NY 14608
Device Description:
CARESTREAM PACS is an image management system whose intended use is to provide completely scalable 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.
It is a software only solution that 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. It offers an intuitive user interface which includes a tab concept, grouping features, and functions with the same context together such as Image display, Monitor layout, Comparison, Wide area user tab, etc.
The device provides functionality to allow remote site access to image and patient data enabling diagnostic reading through industry standard interfaces. It is designed using an open architecture that allows for various proprietary and off the shelf software components to be integrated with off the shelf hardware components and configured meeting the user's specific needs in a single-site or multi-site environment.
Carestream PACS provides support for 3D registration of studies taken at different times or by different modalities for reading of CT/MRI or 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. Automatic vessel segmentation suggests a segmentation that that can either be accepted, ignored or fine tuned by the user.
The CARESTREAM PACS LightWeight Viewer feature addresses the need for a fast and simple web based tool to access patient records and images. It allows for high speed distribution of image data to users in a wide area setup. The software technology uses HTML5 which allows browser enabled devices to run the application without local software installation. The LightViewer has a simple GUI for viewing including zoom, pan, windowing, basic measurements, cine, etc.
The CARESTREAM PACS Lightweight Viewer provides wireless and portable access to medical images for referral purposes. It provides a diagnostic viewer of medical images substantially equivalent to the CARESTREAM PACS software, with portable device characteristics and functionality. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. The CARESTREAM PACS LightWeight Viewer software is not to be used for mammography in the US.
2
Image /page/2/Picture/0 description: The image shows the word "Carestream" in a stylized font. The letters are outlined with a double border, giving them a distinct appearance. The text is horizontally oriented and appears to be a logo or brand name.
Carestream Health Inc. 150 Verona Street Rochester, NY 14608
The CARESTREAM PACS LightWeight Viewer operates on "off-the-shelf 'portable hardware devices and is therefore subject to factors not typical for reading room workstations (e.g. screen size, environmental variability, network dependencies, etc.). It is therefore required that the user follows the operating instructions and adhere to the risk mitigation guidelines.
CARESTREAM PACS does not drive or influence the use of the source device. It does not directly drive a decision regarding treatment or therapy without the intervention of subsidiary means. Images must be evaluated and the decision regarding treatment or therapy is determined by the user based on their standard procedures. CARESTREAM PACS is a complement to these standard procedures.
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.
The CARESTREAM PACS Lightweight Viewer software program is used for patient management by the referral community in order to access and display patient data. medical reports, and medical images from different modalities including CR, DR, CT, MR, NM and US after the primary reading has been completed on dedicated diagnostic workstations.
The CARESTREAM PACS Lightweight Viewer provides wireless and portable access to medical images for referral purposes. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography,
3
Image /page/3/Picture/0 description: The image shows the word "Carestream" in a stylized font. The letters are outlined in black, giving them a distinct appearance. The word is presented in a clear and legible manner, making it easily readable.
Carestream Health Inc. 150 Verona Street Rochester. NY 14608
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 currently exist in the Carestream PACS device.
The differences in the Indication Statements between Carestream PACS and CARESTREAM PACS LightWeight Viewer describe specific restrictions on how CARESTREAM PACS LightWeight Viewer is to be used, given the hardware and portability differences between these two devices. CARESTREAM PACS LightWeight Viewer adds the explicate requirement that it should only be used when there is no access to a workstation, and that it is not to be used for mammography in the US.
Discussion of Testing
Performance testing was conducted to verify the design output met the design input requirements and to validate the device conformed to the defined user needs and intended uses. 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.
Carestream Health conducted display performance testing using the CARESTREAM PACS Lightweight Viewer software on the iPad device. Testing measured contrast response and evaluated test patterns for luminosity, resolution, and noise according to IEC 62563-1 and AA PM TG18 guidelines. Carestream Health also performed multiple studies with qualified radiologists using a variety of modalities, specifically CR, DR, CT, MR, NM and US under different environmental conditions. Results of these studies affirm the diagnostic image viewing capabilities of CARESTREAM PACS LightWeight Viewer when used as indicated.
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Mr. John Pardo Senior Director, Regulatory Affairs and Quality. Systems Carestream Health, Inc. 150 Vernon Street ROCHESTER NY 14608
Re: K110919
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: September 29, 2011 Received: September 30, 2011
Dear Mr. Pardo:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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 Parts 801 and 809); medical device reporting (reporting of
5
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Statement of Intended Use
510(k) Number (if known): K110919
Device Name:
CARESTREAM PACS
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.
The CARESTREAM PACS Lightweight Viewer software program is used for patient management by the referral community in order to access and display patient data, medical reports, and medical images from different modalities including CR, DR, CT, MR, NM and US after the primary reading has been completed on dedicated diagnostic workstations.
The CARESTREAM PACS Lightweight Viewer provides wireless and portable access to medical images for referral purposes. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography.
Prescription Use
AND/OR
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Marr Stadel
Office of In Vitro
510K K110919