(109 days)
Not Found
No
The description focuses on standard image processing techniques (perfusion calculation, subtraction) and does not mention AI, ML, or related concepts. The performance studies describe comparisons to predicate devices based on clinical quality and engineering tests, not AI/ML performance metrics.
No.
The device is an image management system used for processing, archiving, retrieving, and displaying medical images and data, and includes tools for analysis and reporting for diagnostic purposes. It is not used for treating or alleviating a disease or condition.
Yes
The device provides interactive tools for analyzing and comparing 3D, CTP, and DSA images, including automatic calculation and display of blood perfusion parameters and maps (rCBV, rCBF, MTT, TTP, TMAX), which are used for "visualization of vascular anatomy and pathology." This analysis and visualization of medical images and calculated parameters for identifying pathology constitutes diagnostic aid.
No
The device description explicitly states it is an "image management system" and provides functionality for archiving, retrieving, and displaying images from various modalities. While it includes software modules for analysis, the core function and description point to a system that handles and processes medical images, which typically involves hardware components for storage, processing, and display, even if not explicitly detailed in this summary. The mention of "local and wide area PACS solutions" further suggests a system infrastructure beyond just software.
Based on the provided information, the CARESTREAM Vue PACS 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.
- CARESTREAM Vue PACS Function: The CARESTREAM Vue PACS is an image management system that processes, archives, retrieves, and displays medical images obtained from various imaging modalities (CT, MR, XA, etc.). It also provides tools for analyzing these images (perfusion analysis, subtraction).
- Nature of Input: The input to the system is medical imaging data, not biological samples from the patient.
- Purpose: The purpose of the system is to aid in the interpretation and analysis of medical images for diagnostic purposes, not to perform diagnostic tests on biological samples.
While the system is used in a clinical setting and contributes to the diagnostic process, it does so by processing and presenting imaging data, which falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"The CARESTREAM Vue PACS is an image management system whose is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, 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), CT Perfusion (CTP), and Digital Subtraction Angiography (DSA) images. It is a single system that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
The system contains a Perfusion module with interactive tools to ease the process of analyzing and comparing Computed Tomography Perfusion (CTP) images of adult patients. The Arterial Input Function (AIF), Venous Output Function (VOF), and Brain Centerline are automatically detected with the ability for manual correction by the user. Blood perfusion parameters are automatically calculated and displayed as a set of user friendly perfusion maps and perfusion tables summarizing the results. The perfusion maps include relative Cerebral Blood Volume (rCBV), relative Cerebral Blood Flow (rCBF), Mean Transit Time (MTT), Time to Peak (TTP), and Time to maximum impulse response function (TMAX). The perfusion tables include the calculation of parameters related to tissue blood volume.
The system supports Subtractive tools to aid with the analysis of Digital Subtraction Angiography (DSA) images in both interventional radiology and cardiology. Subtraction automatically subtracts a mask from contrast frames of an X-Ray Angiography study for visualization of vascular anatomy and pathology of adult patients.
The Vue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, medical data, and medical images for different modalities including CR, DR, CT, MR, NM, ECG, and US.
Vue Motion provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile device is not intended to replace full workstations and should be used only when there is no access to a workstation. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography."
Product codes
LLZ
Device Description
CARESTREAM Vue PACS is an image management system. It provides functionality to allow remote site access to image and patient data enabling diagnostic reading through industry standard interfaces. The modification to the Vue PACS device described in this submission includes the addition of the following modules:
-
- Perfusion Module The calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
-
- Subtraction Feature Subtraction of two images representing the same part of the anatomy (one with contrast media and one without contrast media) resulting in an image that displays the vascular anatomy/pathology only.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, DR, CT, MR, NM, ECG, US, X-Ray Angiography (XA)
Anatomical Site
Brain (CTP), Vascular anatomy (Digital Subtraction Angiography)
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Hospital and related institutions/sites, radiologists and physicians, clinicians for remote reading or referral purposes.
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
The imaging performance of Carestream Vue PACS Subtraction Feature was validated through Engineering Tests that demonstrated Subtraction was applied correctly to both X-Ray Angiography (XA) test pattern and XA clinical images for all grey shades and boundary conditions using both quantitative and visual tests.
The imaging performance of the Carestream Vue PACS Perfusion Module (investigational device) was compared with the Olea Sphere Perfusion Module (predicate device) in a clinical study. The purpose of the study was to demonstrate equivalent clinical quality between the investigational and predicate devices using a radiologist evaluation of key metrics which are applicable to CTP images.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Engineering Tests for Subtraction Feature
Key Results: In all instances, the Vue PACS Subtraction Feature functioned as intended and the observed results demonstrated substantial equivalence to the Philips Easy Vision Family Workstation Option Vascular Analysis (predicate device).
Study Type: Clinical Study for Perfusion Module
Key Results: The results of this study demonstrated substantial equivalence to the predicate device.
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 shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing right, with flowing lines representing movement or progress. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Carestream Health, Inc. % Ms. Diane Koetter Sr. Manager, Regulatory Affairs and Quality Systems 150 Verona Street ROCHESTER NY 14608
Re: K153103
Trade/Device Name: CARESTREAM Vue PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 11, 2016 Received: January 13, 2016
Dear Ms. Koetter:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153103
Device Name CARESTREAM Vue PACS
Indications for Use (Describe)
"The CARESTREAM Vue PACS is an image management system whose is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, 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), CT Perfusion (CTP), and Digital Subtraction Angiography (DSA) images. It is a single system that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
The system contains a Perfusion module with interactive tools to ease the process of analyzing and comparing Computed Tomography Perfusion (CTP) images of adult patients. The Arterial Input Function (AIF), Venous Output Function (VOF), and Brain Centerline are automatically detected with the ability for manual correction by the user. Blood perfusion parameters are automatically calculated and displayed as a set of user friendly perfusion maps and perfusion tables summarizing the results. The perfusion maps include relative Cerebral Blood Volume (rCBV), relative Cerebral Blood Flow (rCBF), Mean Transit Time (MTT), Time to Peak (TTP), and Time to maximum impulse response function (TMAX). The perfusion tables include the calculation of parameters related to tissue blood volume.
The system supports Subtractive tools to aid with the analysis of Digital Subtraction Angiography (DSA) images in both interventional radiology and cardiology. Subtraction automatically subtracts a mask from contrast frames of an X-Ray Angiography study for visualization of vascular anatomy and pathology of adult patients.
The Vue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, medical data, and medical images for different modalities including CR, DR, CT, MR, NM, ECG, and US.
Vue Motion provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile device is not intended to replace full workstations and should be used only when there is no access to a workstation. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography."
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Carestream
"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: | 585-627-6505 |
| 510(k) Owner Fax: | 585-627-8802 |
| Contact Person & Info: | Diane Koetter |
| Sr. Manager, Regulatory Affairs and Quality | |
| Systems | |
| diane.koetter@carestream.com | |
| 585-627-6505 | |
| Date Summary Prepared: | January 8, 2016 |
| Device Trade Name: | CARESTREAM Vue PACS |
| Device Common Name: | System, image processing, radiological |
| Classification Name: | Picture archiving and communications system |
| Device Class: | Class II |
| Device Code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
| Predicate Devices: | Olea Sphere |
| Manufactured by Olea Medical | |
| 510(k) No. – K120196 (April 19, 2012) |
Olea Sphere v2.3
Manufactured by Olea Medical
510(k) No. – K132095 (December 26, 2013)
Philips Easy Vision Family Workstation Option
Vascular Analysis
Manufactured by Philips Medical Systems, Inc.
510(k) No. – K973835 (January 6, 1998) |
Device Description:
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CARESTREAM Vue PACS is an image management system. It provides functionality to allow remote site access to image and patient data enabling diagnostic reading through industry standard interfaces. The modification to the Vue PACS device described in this submission includes the addition of the following modules:
-
- Perfusion Module The calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
-
- Subtraction Feature Subtraction of two images representing the same part of the anatomy (one with contrast media and one without contrast media) resulting in an image that displays the vascular anatomy/pathology only.
Indications for Use / Intended Use:
The Indications for Use for the modified device, as described in its labeling, are: "The CARESTREAM Vue 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.
The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D), CT Perfusion (CTP), and Digital Subtraction Angiography (DSA) images. It is a single system that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
The system contains a Perfusion module with interactive tools to ease the process of analyzing and comparing Computed Tomography Perfusion (CTP) images of adult patients. The Arterial Input Function (AIF), Venous Output Function (VOF), and Brain Centerline are automatically detected with the ability for manual correction by the user. Blood perfusion parameters are automatically calculated and displayed as a set of user friendly perfusion maps and perfusion tables summarizing the results. The perfusion maps include relative Cerebral Blood Volume (rCBV), relative Cerebral Blood Flow (rCBF), Mean Transit Time (MTT), Time to Peak (TTP), and Time to maximum impulse response function (TMAX). The perfusion tables include the calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
The system supports Subtraction with interactive tools to aid with the analysis of Digital Subtraction Angiography (DSA) images in both interventional radiology and cardiology. Subtraction automatically subtracts a mask from contrast frames of an X-Ray Angiography study for visualization of vascular anatomy and pathology of adult patients.
The Vue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, medical data, and medical images for diagnosis from different modalities including CR, DR, CT, MR, NM, ECG, and US.
6
Vue Motion provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography."
The Indications for Use for the subject device is the same as for the predicate devices and the intended use remains unchanged. Any variation in features or technical specifications have been identified and addressed through testing (described below) to support a substantial equivalence determination.
Comparison of Technological Characteristics:
Based upon information provided within this submission, we believe that the CARESTREAM Vue PACS Perfusion Module and Subtraction Feature are substantially equivalent to the legally marketed Olea Sphere Perfusion Module and Philips Easy Vision Family Workstation Option Vascular Analysis (predicate devices) respectively.
Carestream Vue PACS Perfusion Module and Olea Sphere Perfusion Module both:
- . Provide a Perfusion plug-in to compute optimized parametric maps (rCBV, rCBF, TTP, MTT, TMAX, TMIP) from raw perfusion series
- Provide automatic or manual Arterial Input Function (AIP) ●
- Provide automatic or manual Venous Output Function (VOF) ●
- Provide background segmentation
- Support various deconvolution methods/algorithms ●
- Support motion correction to minimize motion artifacts ●
- Calculate lesion and hypoperfused volumes .
The investigational device differs from the predicate device in that investigational device supports an additional method for the generation of the perfusion maps.
Carestream Vue PACS Subtraction Feature and Philips Easy Vision Family Workstation Option Vascular Analysis both:
- Support the post-processing, or Subtraction, on DSA images .
- Subtract an image without contrast from image(s) without contrast ●
- Apply pixel shifting to correct motion ●
The investigational device differs from the predicate device in that is does not support Run Subtraction which is supported by the investigational device. The predicate device has additional pixel shifting methods which are not supported by the investigational device.
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Discussion of Testing:
The imaging performance of Carestream Vue PACS Subtraction Feature was validated through Engineering Tests that demonstrated Subtraction was applied correctly to both X-Ray Angiography (XA) test pattern and XA clinical images for all grey shades and boundary conditions using both quantitative and visual tests. In all instances, the Vue PACS Subtraction Feature functioned as intended and the observed results demonstrated substantial equivalence to the Philips Easy Vision Family Workstation Option Vascular Analysis (predicate device).
The imaging performance of the Carestream Vue PACS Perfusion Module (investigational device) was compared with the Olea Sphere Perfusion Module (predicate device) in a clinical study. The purpose of the study was to demonstrate equivalent clinical quality between the investigational and predicate devices using a radiologist evaluation of key metrics which are applicable to CTP images. The results of this study demonstrated substantial equivalence to the predicate device.
Substantial Equivalence:
The proposed predicate devices, Olea Sphere Perfusion Module (K120196) and Olea Sphere v2.3 (K132095), have been found substantially equivalent by FDA through the 510(k) process and are legally marketed. Their Indications for Use, though not identical to the modified Carestream Vue PACS Perfusion Module, convey similar information about the intended use of the devices and can therefore be considered for substantial equivalence. Clinical studies verified equivalent clinical quality between the investigational and predicate devices demonstrating a substantial equivalence determination.
The predicate devices provide an additional algorithmic option for generation of the perfusion maps. This does not affect the clinical use of the investigational device as several other algorithms are supported by the predicate and investigational devices.
The proposed predicate device, Philips Easy Vision Family Workstation Option Vascular Analysis has been found substantially equivalent by FDA through the 510(k) process (K973835) and is legally marketed. Its Indications for Use, though not identical to the modified Carestream Vue PACS Subtraction Feature, convey similar information about the intended use of the device and can therefore be considered for substantial equivalence. Engineering Tests validated the Vue PACS Subtraction Feature functioned as intended and the observed results demonstrated substantial equivalence to the predicate device.
The predicate device provides additional options to aid in the visualization of
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the subtracted images; this does not have any impact on the subtraction or clinical use of the product.