Who is the manufacturer of Vitrea Software Package, VSTP-002A?

Canon Medical Systems Corporation filed the 510(k) submission for Vitrea Software Package, VSTP-002A (K223336).

What is the FDA product code for Vitrea Software Package, VSTP-002A?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Vitrea Software Package, VSTP-002A?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Vitrea Software Package, VSTP-002A?

Vitrea Software Package, VSTP-001A (K213504).

Who can help prepare an FDA 510(k) submission like Vitrea Software Package, VSTP-002A?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Vitrea Software Package, VSTP-002A

K223336 · Canon Medical Systems Corporation · LLZ · Jan 9, 2023 · Radiology

Device Facts

Record ID	K223336
Device Name	Vitrea Software Package, VSTP-002A
Applicant	Canon Medical Systems Corporation
Product Code	LLZ · Radiology
Decision Date	Jan 9, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2

Intended 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.

Device Story

Vitrea Software Package (VSTP-002A) is a software application suite for the Canon Medical Informatics Vitrea workstation; used by physicians to process, review, and analyze multi-dimensional digital images. The Auto MPR application takes 3D volumetric CT brain images as input; automatically aligns images into a standard anatomical position; and reformats images for review. The device operates within the Vitrea workstation environment; no external network or internet connectivity. Output is intended for PACS display systems. The device automates manual image alignment processes; assisting physicians in specialized measurements and analysis; potentially improving workflow efficiency and diagnostic review consistency.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed Auto MPR output image alignment into standard anatomical positions and assessed performance under various conditions. Results demonstrated the device met all established specifications.

Technological Characteristics

Software-based medical image management and processing system. Operates on Canon Medical Informatics Vitrea workstations. Conforms to ISO 13485, IEC 62304, IEC 60601-1-6, IEC 60601-1-9, and IEC 62366-1. Standalone software application within the Vitrea workstation environment; no external network connectivity.

Indications for Use

Indicated for use by clinicians to process, review, and analyze multi-dimensional digital images from various imaging devices. The Auto MPR application is indicated for post-processing CT brain images to align them into a standard anatomical position for review.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Vitrea Software Package, VSTP-001A (K213504)

Reference Devices

CT CoPilot (K161322)

Related Devices

K240705 — Vitrea Software Package, VSTP-002A V2.0 · Canon Medical Systems Corporation · Jul 17, 2024
K032748 — VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE · Vital Images, Inc. · Oct 29, 2003
K060378 — VITREA2 VERSION 3.8.1 · Vital Images, Inc. · Mar 9, 2006
K192923 — Vitrea Software Package · Canon Medical Systems Corporation · Feb 14, 2020
K182230 — Multi Modality Viewer · Vital Images, Inc. · Sep 7, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223336 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) | |---------------------------------------------------------------------------------------------------------| |---------------------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(k) Summary 1. 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 - 4. DATE PREPARED October 31, 2022 - 5. DEVICE NAME(S) Vitrea Software Package, VSTP-002A - 6. 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] Image /page/3/Picture/15 description: The image shows the text "Made For life" in a bold, sans-serif font. The words are arranged horizontally, with "Made" and "For" in a slightly larger font size than "life". The text is black against a white background, creating a high contrast and making it easily readable. K223336 {4}------------------------------------------------ #### 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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Canon Medical Systems USA, INC. The word "Canon" is in red, and the rest of the text is in black. The logo is simple and clean, and it is easy to read. The text is left-aligned. #### 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: {6}------------------------------------------------ | 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 | {7}------------------------------------------------ ## 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.