(81 days)
No
The document describes image processing and analysis tools but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No.
The device is a software application intended to assist physicians with image analysis and measurements for diagnosis, not to directly treat or prevent a disease or condition.
Yes
The software's intended use includes facilitating the extraction and segmentation of aneurysms as an "adjunct to diagnosis" and assisting physicians with "cardiac functional analysis" for patients with "suspected heart disease," which all point to a diagnostic purpose.
Yes
The device is described as an "application package developed for use on Vitrea, a medical image processing software," and its function is to perform post-processing analysis on image data. There is no mention of accompanying hardware components.
Based on the provided information, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Vitrea Software Toshiba Package is a medical image processing software. It analyzes medical images (CT, XA, MR) of the brain and heart to assist physicians with measurements and analysis. It does not perform tests on biological samples.
- Intended Use: The intended use is to facilitate the extraction and segmentation of aneurysms and to assist with cardiac functional analysis based on medical images. This is image-based analysis, not in vitro testing.
Therefore, the device falls under the category of medical image processing software, which is distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
Vitrea Software Toshiba Package is an application package developed for use on Vitrea, a medical image processing software, which includes the following post-processing software applications.
CT/XA Cerebral Artery Morphological Analysis This software is intended to facilitate the extraction and seqmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.
MR Wall Motion Tracking This application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and reqional myocardial function that is used for patients with suspected heart disease.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Vitrea Software Toshiba Package, VSTP-001A, an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images. Inc. Vitrea Software Toshiba Package, VSTP-001A, includes two post processing applications, CT/XA Cerebral Artery Morphological Analysis and MR Wall Motion Tracking, which use brain and cardiac image data, obtained from CT/XA/MR systems, to assist physicians in performing specialized measurements and analysis.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, XA, MR
Anatomical Site
Cerebral arteries, Cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians
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
Bench studies were conducted using numerical phantoms to analyze the accuracy of extraction/display of aneurysm shaped regions as well as measurement calculations and to analyze cardiac function and strain. Additionally, clinical evaluations were conducted to demonstrate that the CT/XA Cerebral Artery Morphological Analysis and MR Wall Motion Tracking applications performed as intended. The results confirmed that CT/XA Cerebral Artery Morphological Analysis was comparable to manual measurements and/or segmentations and that the contour tracking process of the MR Wall Motion Tracking application met the required success ratio.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrates that the requirements for the applications have been met. Bench studies were conducted using numerical phantoms to analyze the accuracy of extraction/display of aneurysm shaped regions as well as measurement calculations and to analyze cardiac function and strain. Additionally, clinical evaluations were conducted to demonstrate that the CT/XA Cerebral Artery Morphological Analysis and MR Wall Motion Tracking applications performed as intended. The results confirmed that CT/XA Cerebral Artery Morphological Analysis was comparable to manual measurements and/or segmentations and that the contour tracking process of the MR Wall Motion Tracking application met the required success ratio.
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.
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).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized caduceus symbol, which is often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 13. 2015
Toshiba Medical Systems Corporation % Mr. Orlando Tadeo Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K151091
Trade/Device Name: Vitrea Software Toshiba Package, VSTP-001 A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 22, 2015 Received: April 23, 2015
Dear Mr. Tadeo:
This letter corrects our substantially equivalent letter of July 13, 2015.
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
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 O'Hara
For
Robert Ochs, Ph.D Acting 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)
Device Name
Vitrea Software Toshiba Package, VSTP-001A
Indications for Use (Describe)
Vitrea Software Toshiba Package is an application package developed for use on Vitrea, a medical image processing software, which includes the following post-processing software applications.
CT/XA Cerebral Artery Morphological Analysis This software is intended to facilitate the extraction and seqmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.
MR Wall Motion Tracking
This application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and reqional myocardial function that is used for patients with suspected heart disease.
Type of Use (Select one or both, as applicable)
ك Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000
510(k) SUMMARY
-
- SUBMITTER'S NAME: Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
2. OFFICIAL CORRESPONDENT: Akinori Hatanaka Senior Manager, Regulatory Affairs and Vigilance
-
- ESTABLISHMENT REGISTRATION: 9614698
4. CONTACT PERSON:
Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459
5. Date Prepared:
April 30, 2015 (Updated 07/07/2015)
6. TRADE NAME(S):
Vitrea Software Toshiba Package, VSTP-001A
-
- COMMON NAME:
Radiological Image Processing Software
- COMMON NAME:
8. DEVICE CLASSIFICATION:
Class II (per 21 CFR 892.2050, Picture Archiving and Communications System)
9. PRODUCT CODE / DESCRIPTION: 90LLZ / Picture Archiving and Communications System
10. PERFORMANCE STANDARD:
None
4
11. PREDICATE DEVICES:
| Device Name | Vitrea, Version 7.0
Medical Image
Processing Software | MRT-301/A5, Vantage
Titan 3T, v2.0
(Reference Device) | Aquilion ONE Vision,
V7.0
(Reference Device) |
|----------------------------|-------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------|
| Application
Name | | Cardiac Analysis
Application
For Superconducting
MRI System | 4D Cerebral Artery
Morphological Analysis |
| Marketed By | Vital Images, Inc. | Toshiba America
Medical Systems | Toshiba America
Medical Systems |
| 510(k) Clearance
Number | K150258 | K120487 | K142465 |
| Clearance Date | March 5, 2015 | May 23, 2012 | March 10, 2015 |
| Product Code | LLZ, Picture Archiving
and Communications
System | LNH, Magnetic
Resonance Diagnostic
Device | JAK, Computed
Tomography X-Ray
System |
12. REASON FOR SUBMISSION:
Adding existing software applications to an imaging workstation (Vitrea; Product Code LLZ). MR Wall Motion Tracking includes an improved Contour Tracking function which allows for heart wall strain analysis. CT/XA Cerebral Artery Morphological Analysis allows for the import of volume data from an interventional system in addition to the cleared CT volume analysis.
13. DEVICE DESCRIPTION:
Vitrea Software Toshiba Package, VSTP-001A, an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images. Inc. Vitrea Software Toshiba Package, VSTP-001A, includes two post processing applications, CT/XA Cerebral Artery Morphological Analysis and MR Wall Motion Tracking, which use brain and cardiac image data, obtained from CT/XA/MR systems, to assist physicians in performing specialized measurements and analysis.
14. INDICATIONS FOR USE:
Vitrea Software Toshiba Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea has the following additional indications:
The CT/XA Cerebral Artery Morphological Analysis application is intended to facilitate the extraction and segmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.
The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.
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15. SUBSTANTIAL EQUIVALENCE:
The software applications included in the Vitrea Software Toshiba Package, VSTP-001A, perform in a manner similar to and are intended for the same use as the predicate devices. These applications include modifications to the originally cleared devices, 4D Cerebral Artery Morphological Analysis (K142465) and Cardiac Analysis Application For Superconducting MRI System (K120487), in order to be available on the Vitrea, Medical Image Processing Software (K150258). The subject and predicate device applications are all post processing applications used to aid physicians with performing specialized measurement and analysis of CT, XA and MR image data.
Complete comparison tables are included in this submission. See below for a brief summary of technological characteristics of the software applications:
| Item | CT/XA Cerebral Artery
Morphological Analysis | 4D Cerebral Artery
Morphological Analysis for
Aquilion ONE |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------|
| 510(k) Clearance | Subject Device | K142465 |
| Type of Input Data | One volume acquired by X-ray
CT system or interventional
angiography system | Multiple volumes acquired by X-
ray CT system |
| Anatomical Region | Cerebral Artery | Cerebral Artery |
| Segmentation
(Extraction Of
Aneurysm-Shaped
Region) | Semi-Automatic Segmentation
With One-Clicked Seed Point | Semi-Automatic Segmentation
with One-Clicked Seed Point |
| Measurement
(Distance, Angle,
Length) | Automatic | Automatic |
| ltem | MR Wall Motion Tracking | Cardiac Analysis Application
For Superconducting MRI
System |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| 510(k) Clearance | Subject Device | K120487 |
| Anatomical Region | Cardiac | Cardiac |
| Myocardium
Contour Detection | Contour tracking | Contour detection applied to all
phases individually |
| Global Cardiac
Function Analysis | Ejection Fraction, Cardiac
Output, Volume Curves are
calculated from shapes of
myocardial contours. | Ejection Fraction, Cardiac
Output, Volume Curves are
calculated from shapes of
myocardial contours. |
| Regional Wall
Motion Analysis | Wall motion, Wall thickness,
Wall thickening are calculated | Wall motion, Wall thickness,
Wall thickening are calculated |
| Strain Analysis | Strain is calculated | None |
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| Result Display | ||
|---|---|---|
| Cine View, | ||
| Polar Map Of Measurement | ||
| Results | ||
| Time-Curve Of Regional | ||
| Measurement | Cine View, | |
| Polar Map Of Measurement | ||
| Results | ||
| Time-Curve Of Regional | ||
| Measurement |
16. SAFETY:
The device is designed and manufactured under the Quality System Requlations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC62304 and IEC62366.
17. TESTING
Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrates that the requirements for the applications have been met. Bench studies were conducted using numerical phantoms to analyze the accuracy of extraction/display of aneurysm shaped regions as well as measurement calculations and to analyze cardiac function and strain. Additionally, clinical evaluations were conducted to demonstrate that the CT/XA Cerebral Artery Morphological Analysis and MR Wall Motion Tracking applications performed as intended. The results confirmed that CT/XA Cerebral Artery Morphological Analysis was comparable to manual measurements and/or segmentations and that the contour tracking process of the MR Wall Motion Tracking application met the required success ratio.
Software Documentation for a Moderate Level of Concern, per the FDA quidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.
18. CONCLUSION
The software applications included in the Vitrea Software Toshiba Package, VSTP-001A, perform in a manner similar to and are intended for the same use as the predicate devices. Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate devices.