(69 days)
Not Found
No
The description focuses on standard image processing and alignment techniques, with no mention of AI/ML terms or methodologies.
No
The device is a software package for processing and analyzing medical images. Its intended use is to assist physicians with image review and analysis, not to provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that Vitrea is a "medical diagnostic system." Although the specific Auto MPR application is for post-processing and alignment, it contributes to diagnosis by preparing images for review and analysis by physicians.
Yes
The device description explicitly states "The Vitrea Software Package... is a portfolio of applications software designed to be used in the Canon Medical Informatics Vitrea workstation." and "Auto MPR is a software application". While it operates on CT images from Canon CT Systems, the device itself is described solely as software.
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.
- Device description: The Vitrea Software Package processes and analyzes digital images acquired from imaging devices (specifically CT scans of the brain). It does not analyze biological samples from the patient.
- Intended Use: The intended use is for processing, review, and analysis of multi-dimensional digital images for medical diagnosis. This is distinct from analyzing biological samples.
The software is a medical device used in the diagnostic process, but it falls under the category of medical imaging software rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
Vitrea Software 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 Software Package has the following additional indications:
Auto MPR application is a post processing software of CT brain images that is intended to align images into a standard anatomical position for review. It provides tools to reformat images parallel to a standard anatomical position.
Product codes
LLZ
Device Description
The Vitrea Software Package, VSTP-002A, is a portfolio of applications software designed to be used in the Canon Medical Informatics Vitrea workstation. VSTP-002A currently includes a post processing application, Auto MPR, which use CT brain image data, obtained from Canon CT Systems, to assist physicians in performing specialized measurements and analysis.
Auto MPR is a software application that aligns CT brain images into a standard anatomical position for review.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench studies were conducted to test Auto MPR output image alignment into a standard anatomical position and assessed the impact of various conditions on Auto MPR image alignment. Results of both these studies demonstrated that Auto MPR met established specifications and performed as intended.
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).
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Canon Medical Systems Corporation % Mr. Orlando Tadeo Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K223336
January 9, 2023
Trade/Device Name: Vitrea Software Package, VSTP-002A Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: November 17, 2022 Received: November 17, 2022
Dear Mr. Tadeo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Vitrea Software Package, VSTP-002A
Indications for Use (Describe)
Vitrea Software 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 Software Package has the following additional indications:
Auto MPR application is a post processing software of CT brain images that is intended to align images into a standard anatomical position for review. It provides tools to reformat images parallel to a standard anatomical position.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ---------------------------------------------------------------------------------------------------------- |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
| --------------------------------------------------------------------------------------------------------- |
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510(k) Summary
- SUBMITTER'S NAME Fumiaki Teshima Sr. Manager, Quality Assurance Department Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
2. ESTABLISHMENT REGISTRATION 9614698
3. OFFICIAL CORRESPONDENT/CONTACT PERSON
Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Department Canon Medical Systems USA, Inc. 2441 Michelle Dr. Tustin, CA 92780 (714) 669-7459
-
- DATE PREPARED October 31, 2022
-
- DEVICE NAME(S) Vitrea Software Package, VSTP-002A
-
- TRADE NAME(S) Vitrea Software Package, VSTP-002A
7. COMMON NAME
Radiological Image Processing Software
8. DEVICE CLASSIFICATION
Class II (per 21 CFR 892.2050, Medical Image Management and Processing System) Medical Image Management and Processing System- Product Code: 90LLZ [per 21 CFR 892.2050]
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9. PREDICATE DEVICE
| Product | Marketed by | Regulation Number | Regulation Name | Product Code | 510(k) Number | Clearance Date |
|---|---|---|---|---|---|---|
| Vitrea | ||||||
| Software | ||||||
| Package, | ||||||
| VSTP-001A | ||||||
| (Primary | ||||||
| Predicate) | Canon | |||||
| Medical | ||||||
| Systems | ||||||
| USA | 21 CFR | |||||
| §892.2050 | Medical | |||||
| Image | ||||||
| Management | ||||||
| and | ||||||
| Processing | ||||||
| System | LLZ | K213504 | 2/16/2021 | |||
| CT CoPilot | ||||||
| (Reference | ||||||
| Predicate) | ZepMed, | |||||
| LLC. | 21 CFR | |||||
| §892.2050 | Medical | |||||
| Image | ||||||
| Management | ||||||
| and | ||||||
| Processing | ||||||
| System | LLZ | K161322 | 12/07/2016 |
10. REASON FOR SUBMISSION
New software application
11. DEVICE DESCRIPTION
The Vitrea Software Package, VSTP-002A, is a portfolio of applications software designed to be used in the Canon Medical Informatics Vitrea workstation. VSTP-002A currently includes a post processing application, Auto MPR, which use CT brain image data, obtained from Canon CT Systems, to assist physicians in performing specialized measurements and analysis.
Auto MPR is a software application that aligns CT brain images into a standard anatomical position for review.
12. INDICATIONS FOR USE
Vitrea Software 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 Software Package has the following additional indications:
Auto MPR application is a post processing software of CT brain images that is intended to align images into a standard anatomical position for review. It provides tools to reformat images parallel to a standard anatomical position.
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13. SUBSTANTIAL EQUIVALANCE
The Vitrea Software Package, VSTP-002A, perform in a manner similar to and are intended for the same use as VSTP-001A, 510(k) cleared per K213504. Both are 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. The software application, Auto MPR, included in Vitrea Software Package, VSTP-002A, performs in a manner similar to and is intended for the same use as CT CoPilot, 510(k) cleared per K161322. Both are post processing software used to provide auto reformatting for standard viewing of CT brain images and are intended to automate the current manual process of image alignment. See below for a brief comparison of the technological characteristics between the subject and the predicate device:
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| Device Name | Subject | Primary Predicate | Reference Predicate | |
|---|---|---|---|---|
| Vitrea Software Package | ||||
| (VSTP-002A) V1.0 | Vitrea Software Package | |||
| (VSTP-001A) V8.10 | CT CoPilot | |||
| Available Applications | Auto MPR | Cerebral Aneurysm | ||
| Analysis, MR Wall | ||||
| Motion Tracking, MR | ||||
| Coronary Tracking, | ||||
| SUREVolume Synthesis, | ||||
| Angio Viewer, US | ||||
| Cardiac Fusion, | ||||
| Ultrasound Clinical | ||||
| Applications, Spectral | ||||
| Stone Analysis, Spectral | ||||
| Composition Analysis, | ||||
| Embolization Plan, | ||||
| Spectral Analysis | N/A | |||
| Auto MPR | ||||
| - | Anatomical Region | Brain | N/A | Brain |
| - | Type of Input Data | 3D Volumetric CT image | N/A | CT image |
| - | Type of Output Data | The output is intended | ||
| for PACS display system. | N/A | The output is | ||
| intended for PACS | ||||
| display system. |
- 3D Volumetric
- 2D MPR |
| - | Auto reformat for
standard viewing of
brain images. | Available
(OM plane base) | N/A | Available |
| - | Auto Labeling of
segmentable brain
structures. | N/A | N/A | Available |
| - | Volumetric
quantification of
brain images (CSF
volumes,
Intracranial volume,
Midline shift) | N/A | N/A | Available |
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14. SAFETY
The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC62304, IEC60601-1-6, IEC60601-1-9, and IEC62366-1.
15. TESTING
Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrates that the requirements for the application have been met. Bench studies were conducted to test Auto MPR output image alignment into a standard anatomical position and assessed the impact of various conditions on Auto MPR image alignment. Results of both these studies demonstrated that Auto MPR met established specifications and performed as intended.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also referenced as for this submission.
16. CYBERSECURITY
The VSTP-002A is a portfolio of software applications developed by Canon that are integrated into the Canon Medical Informatics Vitrea workstations. The Vitrea workstation includes all cybersecurity controls and is responsible for importing images into an internal database. The software applications included in VSTP-002A pulls applicable images from the Vitrea directory to be processed and then places the processed images back into the directory within Vitrea. This software has no connections to the internet, wired or wireless networks, etc. All import and export of data is within the domain of the Canon Medical Informatics product.
17. CONCLUSION
The Vitrea Software Package, VSTP-002A, performs in a manner similar to and is intended for the same use as the primary predicate device. The software application, Auto MPR, included in the Vitrea Software Package, VSTP-002A, performs in a manner similar to and is intended for the same use as the reference predicate device. 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 device.