Vitrea Software Toshiba Package; VSTP-001A

K171222 · Toshibamedical Systems Corporation · LLZ · Jun 8, 2017 · Radiology

Device Facts

• Record ID: K171222
• Device Name: Vitrea Software Toshiba Package; VSTP-001A
• Applicant: Toshibamedical Systems Corporation
• Product Code: LLZ · Radiology
• Decision Date: Jun 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

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.

Device Story

Vitrea Software Toshiba Package (VSTP-001A) is a post-processing software suite for medical imaging workstations. It processes multi-dimensional digital images (CT, XA, MR) to assist physicians in specialized measurements. Applications include: 1) CT/XA Cerebral Artery Morphological Analysis: extracts/segments user-identified cerebral aneurysms; measures size and aspect ratio. 2) MR Wall Motion Tracking: performs cardiac functional analysis; provides global/regional myocardial function measurements. 3) MR Coronary Tracking: performs qualitative/quantitative coronary artery analysis; measures lumen diameter and area. Physicians use these tools to aid diagnosis and clinical decision-making. The software operates on the Vitrea diagnostic system platform. Benefits include improved visualization and quantification of anatomical structures and functional parameters, supporting clinical assessment of heart disease and vascular conditions.

Clinical Evidence

Bench testing used numerical phantoms to verify accuracy of coronary artery extraction, display, and lumen dimension/area measurements. Clinical evaluations were conducted to demonstrate the MR Coronary Tracking application performed as intended, confirming results were comparable to commercially released software and user measurements.

Technological Characteristics

Post-processing software for medical imaging workstations. Conforms to IEC 62304 (software lifecycle) and IEC 62366 (usability). Operates on Vitrea diagnostic system. Features include automated and manual centerline extraction, contour-based lumen diameter/area measurement, and myocardial function tracking. Designed under ISO 13485 and 21 CFR 820 quality systems.

Indications for Use

Indicated for patients with suspected heart disease requiring cardiac functional analysis (MR Wall Motion Tracking) and patients requiring qualitative/quantitative analysis of coronary arteries (MR Coronary Tracking). Also indicated for extraction/segmentation of cerebral aneurysms (CT/XA Cerebral Artery Morphological Analysis).

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 (K151093)
• Fuji Synapse 3D (K120636)

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right features three stylized human profiles facing right, stacked on top of each other, creating a sense of depth and unity.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 8, 2017

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

Re: K171222

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 24, 2017 Received: April 26, 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

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)

k171222

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.

Type of Use (Select one or both, as applicable)

| <div><span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|-----------------------------------------------------------------------------------------------|
| <div><span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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Image /page/3/Picture/1 description: The image contains the logo for Toshiba. The word "TOSHIBA" is in large, red, bold letters. Below the company name is the slogan "Leading Innovation" in black font, followed by three gray arrows pointing to the right.

TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 Michelle Drive, Tustin, CA 92780 Phone: [phone]

## 510(k) SUMMARY

1. SUBMITTER'S NAME: Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550

## 2. OFFICIAL CORRESPONDENT: Naofumoi 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:

April 21, 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)<br>Control # | Status |
|----------------------------------------------|-----------------|---------------------|---------|
| MR Wall Motion Tracking | VSTP-001A | K151093 | Cleared |
| CT/XA Cerebral Artery Morphological Analysis | VSTP-001A | K151093 | Cleared |
| MR Coronary Tracking | Fuji Synapse 3D | K120636 | NEW |

# 12. REASON FOR SUBMISSION:

Adding existing software applications to an imaging workstation (Vitrea; Product Code LLZ). MR Coronary Tracking which provides an analysis tool to determine the diameter and area of the coronary vessel lumen.

# 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 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.

# 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), and MR Wall Motion Tracking (K151093), remain unchanged.

The additional software, MR Coronary Tracking underwent both bench and clinical use study to verify its efficacy. The comparison of features to the predicate device, Fuji Synapse 3D (MR Coronary Analysis) demonstrates that substantial equivalence against commercially available

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products has been established. The subject and predicate device applications are post processing applications used to aid physicians with performing specialized measurement and analysis of MR image data.

Complete comparison tables are included in this submission. See below for a brief summary of technological characteristics of the software applications:

| ltem | MR Coronary Tracking | Fuji Synapse 3D - MR<br>Coronary Artery Analysis |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Clearance | Subject Device | K120636 |
| Type of Input Data | - A MR volume data of entire<br>heart (Toshiba MRI) | - A MR volume data (Multiple<br>vendors/systems) |
| Anatomical Region | Coronary Arteries | Coronary Arteries |
| Extraction of<br>coronary<br>information | Centerline of coronary arteries<br>(automatic and manual editing)<br>Diameter measurement of lumen<br>of coronary arteries by using<br>contour (automatic and manual<br>editing) | Centerline of coronary arteries<br>(automatic and manual editing)<br>Diameter measurement of lumen<br>of coronary arteries (manual<br>editing) |
| Measurement | Diameter and area of lumen | Diameter area and signal value<br>of lumen<br>Measures stenosis percentage |

# 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 MR Coronary Tracking application has been met. Bench studies were conducted using numerical phantoms to analyze the accuracy of extraction/display of the coronary arteries as well as measurement calculations for lumen dimensions and areas. Additionally, clinical evaluations were conducted to demonstrate that the MR Coronary Tracking application performed as intended. The results confirmed that the MR Coronary Tracking application was comparable to commercially released software and user measurements.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in

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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.