Vitrea Software Toshiba Package VSTP-001A

K173088 · Toshibamedical Systems Corporation · LLZ · Jan 31, 2018 · Radiology

Device Facts

• Record ID: K173088
• Device Name: Vitrea Software Toshiba Package VSTP-001A
• Applicant: Toshibamedical Systems Corporation
• Product Code: LLZ · Radiology
• Decision Date: Jan 31, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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. The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries. The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images. The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement. The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

Device Story

Vitrea Software Toshiba Package (VSTP-001A) is a post-processing software suite for the Vitrea diagnostic platform. It ingests DICOM-formatted multi-dimensional images (CT, XA, MR, US) to assist physicians in specialized clinical analysis. Applications include: CT/XA Cerebral Artery Morphological Analysis (aneurysm segmentation/measurement); MR Wall Motion Tracking (cardiac functional analysis); MR Coronary Tracking (coronary artery analysis); SUREVolume Synthesis (multi-modality image fusion); Angio Viewer (XA cine display, subtraction, measurement); and US Cardiac Fusion (fusion of US wall motion and CT coronary analysis). Physicians operate the software in clinical settings to perform measurements and qualitative/quantitative assessments. Output is displayed on the Vitrea workstation, aiding clinical decision-making by providing functional metrics and fused anatomical visualizations. The device benefits patients by facilitating precise diagnostic measurements and improved visualization of complex vascular and cardiac structures.

Clinical Evidence

Clinical evaluations were conducted for SUREVolume Synthesis and US Cardiac Fusion. SUREVolume Synthesis demonstrated successful fusion of various data sets; manual alignment was successful in all cases where automatic alignment was not achieved. US Cardiac Fusion showed 74% automatic alignment success (range 64-89%) and 90% successful manual adjustment (range 86-93%). Angio Viewer underwent bench testing against the predicate (INFX-8000F), demonstrating measurement replication within a tolerance of ≤1%.

Technological Characteristics

Software-based post-processing suite for DICOM images. Operates on the Vitrea platform. Features include rigid registration, MPR, 3D rendering, cine display, and DSA subtraction. Conforms to IEC 62304 (software lifecycle) and IEC 62366 (usability). Designed under ISO 13485 and 21 CFR 820 quality systems.

Indications for Use

Indicated for patients with suspected heart disease (MR Wall Motion Tracking) and patients requiring analysis of cerebral artery aneurysms or coronary arteries. Used for processing, review, and analysis of multi-dimensional digital images from CT, XA, MR, and US systems.

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

• VSTP-001A (K151091)
• VSTP-001A (K171222)
• Miranda XD (K101228)
• Toshiba INFX-8000F (K081624)
• GE CardIQ Fusion (K061370)

Submission Summary (Full Text)

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January 31, 2018

Toshiba Medical Systems Corporation % Mr. Paul Biggins Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K173088

Trade/Device Name: Vitrea Software Toshiba Package VSTP-001A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 27, 2017 Received: December 28, 2017

Dear Mr. Biggins:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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## Page 2 - Mr. Paul Biggins

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'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) K173088

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 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.

The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### 510(k) SUMMARY

- 1. SUBMITTER'S NAME: Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
## 2. OFFICIAL CORRESPONDENT: Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance

- 3. ESTABLISHMENT REGISTRATION: 9614698
- 4. CONTACT PERSON:

Paul Biggins Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, CA 92780 [phone]

#### 5. Date Prepared:

September 25, 2017

## 6. TRADE NAME(S):

Vitrea Software Toshiba Package, VSTP-001A

#### 7. COMMON NAME:

Radiological Image Processing Software

#### 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

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## 11. PREDICATE DEVICES:

| Application | Predicate | 510(k) Control# | Classification and Product Code | Status |
|-------------------------------------------------|-----------------------|-----------------|---------------------------------|---------|
| MR Wall Motion Tracking | VSTP-001A | K151091 | 21 CFR 892.2050<br>90LLZ | Cleared |
| CT/XA Cerebral Artery<br>Morphological Analysis | VSTP-001A | K151091 | 21 CFR 892.2050<br>90LLZ | Cleared |
| MR Coronary Tracking | VSTP-001A | K171222 | 21 CFR 892.2050<br>90LLZ | Cleared |
| SUREVolume Synthesis | Miranda XD | K101228 | 21 CFR 892.2050<br>90LLZ | New |
| Angio Viewer | Toshiba<br>INFX-8000F | K081624 | | New |
| US Cardiac Fusion | GE CardIQ<br>Fusion | K061370 | 21 CFR 892.2050<br>90LLZ | New |

#### 12. REASON FOR SUBMISSION:

New software applications

## 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, currently includes three post processing applications, CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, and MR Coronary 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.

The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.

The SUREVolume Synthesis application is intended to load volume images acquired by wholebody X-ray CT scanners,

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X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

#### 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 previously cleared devices. CT/XA Cerebral Artery Morphological Analysis (K151093), MR Wall Motion Tracking (K151093) and MR Coronay Tracking (K171222), remain unchanged.

There are three additional software applications that are being included in this submission. Volume Synthesis and US Cardiac Fusion both underwent user evaluation at clinical sites, while the Angio Viewer software package underwent bench testing at the design site against its predicate device, to verify efficacy. The comparison of each new application to its respective predicate device demonstrates that substantial equivalance against commercially available products have been established. The subject and predicated devices are all post processing applications that are used to aid physicians with performing measurement and analysis of diagnotic images.

| Item | Angio Viewer | Infinix Celeve-I: INFX-8000F |
|-------------------|-----------------------|------------------------------|
| 510(k) Clearance | (Subject Device) | (K081624) |
| Anatomical Region | whole body | whole body |
| Input | XA 2D image | XA 2D image |
| Image Display | 2D | 2D |
| Subtraction | DSA image subtraction | DSA image subtraction |
| Pixel-Shift | automatic<br>manual | automatic<br>manual |
| Distance | manual | manual |
| Angle | manual | manual |

A complete comparison table is included in this submission. See below for a brief summary of technological characteristics of the devices:

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| Item | SUREVolume Synthesis | Mirada XD |
|-------------------|--------------------------------------------------------|---------------------------------------------------------------------|
| 510(k) Clearance | (Subject Device) | (K101228) |
| Anatomical region | whole body | whole body |
| Input | - CT, XA, MR (DICOM format)<br>- Rendering information | - CT, MR,PET, SPECT, planar NM<br>(DICOM format) |
| Registration | Rigid-Registration<br>Manual adjustment | Rigid-Registration<br>None- Rigid-Registration<br>Manual adjustment |
| Image Display | MPR / 3D | MPR |

| ltem | US Cardiac Fusion | GE: CardIQ Fusion |
|-------------------|-------------------------|------------------------|
| 510(k) Clearance | (Subject Device) | (K061370) |
| Anatomical Region | Heart | Heart |
| Input | - CT, US (DICOM format) | - CT, PET, SPECT |
| Image Display | MPR / 3D / polar plot | MPR / 3D / polar plot |
| Registration | Automatic | Automatic |
| | Manual | Manual |

#### 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 SUREVolume Synthesis and US Cardiac Fusion applications performed as intended. The results confirmed that SUREVolume Synthesis was able to successfully fuse various combinations of data sets at an acceptable level. In those cases were automatic alignment was not obtainable the evaluation showed that manual alignment was successful on all cases. US Cardiac Fusion was successfully evaluated to show successful alignment of CCTA images and 3D Wall motion tracking images as follows; Automatic alignment success of 74% (64 to 89%) and successful manual adjustment of 90% (86 to 93%). In both studies users of varying levels of experience reviewed all images and performed manual alignments as required. The Angio Viewer evaluation was conducted head on against the predicate device using repeated measurements. The test concluded that it was possible to replicate the image measurements from one device to the other within the stated tolerance of less than or equal to 1% which demonstrated successful integration of the INFX-8000F software to the VSTP-001A application.

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This device is not subject to Cybersecurity Requirements as it has no access to an outside environment. All images being queued by the VSTP-001A are resident on the host Vitrea platform. The host Vitrea platform conducts all external data transactions.

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 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.