Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4

K161009 · Toshibamedical Systems Corporation · JAK · Jul 22, 2016 · Radiology

Device Facts

• Record ID: K161009
• Device Name: Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
• Applicant: Toshibamedical Systems Corporation
• Product Code: JAK · Radiology
• Decision Date: Jul 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Indications for Use

This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to imaqe whole orqans in a sinqle rotation. Whole organs include but are not limited to brain, heart, pancreas, etc. The Aquilion ONE has the capability to provide volume sets of the entire orqan. These volume sets can be used to perform specialized studies, usinq indicated software/hardware, of the whole organ by a trained and qualified physician. FIRST 2.0 is an iterative reconstruction alqorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac and extremities applications.

Device Story

Aquilion ONE Vision with FIRST 2.0 is a multi-slice helical CT scanner comprising gantry, couch, and console. Device acquires cross-sectional volume data sets of whole body/organs in single rotation. FIRST 2.0 iterative reconstruction algorithm processes raw data to reduce radiation exposure dose while maintaining/improving high-contrast spatial resolution compared to filtered back projection (FBP). Used in clinical settings by trained physicians to perform specialized diagnostic studies. Output consists of reconstructed volume sets displayed on console for clinical interpretation. Physician uses images to inform diagnostic decision-making. Benefits include reduced patient radiation dose and enhanced image quality for abdomen, pelvis, chest, cardiac, and extremity applications.

Clinical Evidence

Bench testing only. Performance evaluated using phantoms to measure CT image quality metrics (contrast-to-noise ratio, CT number accuracy, uniformity, slice sensitivity profile, MTF, low-contrast detectability). Quantitative dose reduction evaluation showed up to 84.6% dose reduction with 60% noise reduction vs FBP. Model observer evaluation confirmed equivalent low-contrast detectability to FBP at significantly lower doses. Diagnostic quality confirmed via review of representative clinical images (chest, abdomen, pelvis, extremity, cardiac) by an American Board Certified Radiologist.

Technological Characteristics

Multi-slice helical CT scanner. Materials per ISO 13485. Iterative reconstruction algorithm (FIRST 2.0). Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-4, 60601-1-6, 60601-2-28, 60601-2-32, 60601-2-44, IEC 60825-1, IEC 62304, IEC 62366, NEMA PS 3.1-3.18, NEMA XR-25, NEMA XR-26. Radiation safety per 21 CFR 1010/1020.

Indications for Use

Indicated for whole-body cross-sectional imaging, including head, in patients requiring CT scans. Enables single-rotation whole-organ imaging (e.g., brain, heart, pancreas). FIRST 2.0 algorithm indicated for abdomen, pelvis, chest, cardiac, and extremities applications to reduce exposure dose and improve high-contrast spatial resolution.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) (K151673)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

July 22, 2016

Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K161009

Trade/Device Name: Aquilion One Vision with First 2.0 (CCRS-001B) V7.4 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 15, 2016 Received: June 16, 2016

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. 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 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.

{1}------------------------------------------------

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

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

Sincerely yours.

Michael 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

{2}------------------------------------------------

## Indications for Use

## 510(k) Number (if known)

K161009

Device Name

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B)V7.4

#### Indications for Use (Describe)

This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to imaqe whole orqans in a sinqle rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.

The Aquilion ONE has the capability to provide volume sets of the entire orqan. These volume sets can be used to perform specialized studies, usinq indicated software/hardware, of the whole organ by a trained and qualified physician.

FIRST 2.0 is an iterative reconstruction alqorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac and extremities applications.

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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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}------------------------------------------------

#### 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:

Akinori Hatanaka Senior Manager, Regulatory Affairs and Vigilance

# 3. ESTABLISHMENT REGISTRATION:

9614698

## 4. CONTACT PERSON:

Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc 2441 Michelle Drive Tustin, CA 92780 [phone]

#### 5. Date Prepared:

April 8, 2016

## 6. TRADE NAME(S):

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4

#### 7. COMMON NAME:

System, X-ray, Computed Tomography

## 8. DEVICE CLASSIFICATION (Regulatory Class, CFR Reference, Name): Class II (per 21 CFR 892.1750, Computed Tomography X-ray System)

#### 9. PRODUCT CODE / DESCRIPTION:

JAK / Computed Tomography X-Ray System

#### 10. PERFORMANCE STANDARD:

This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]

{4}------------------------------------------------

## 11. PREDICATE DEVICE:

| Product | Marketed by | Regulation<br>Number | Regulation<br>Name | Product Code | 510(k)<br>Number | Clearance<br>Date |
|-------------------------------------------------------------|------------------------------------------|----------------------|----------------------------------------|---------------------------------------------------|------------------|-------------------|
| Aquilion<br>ONE Vision<br>with FIRST<br>1.0 (CCRS-<br>001A) | Toshiba<br>America<br>Medical<br>Systems | 21 CFR<br>892.1750 | Computed<br>Tomography<br>X-ray System | JAK:<br>System, X-ray,<br>Tomography,<br>Computed | K151673 | 11/27/2015 |

## 12. REASON FOR SUBMISSION:

Modification of an existing device.

## 13. DEVICE DESCRIPTION:

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 is a whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. This device captures cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Toshiba CT systems. In addition, the subject device incorporates the latest iterative reconstruction technology, FIRST 2.0, intended to reduce exposure dose while maintaining and/or improving image quality.

## 14. INDICATIONS FOR USE:

This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.

The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.

FIRST 2.0 is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac and extremities applications.

## 15. SUBSTANTIAL EQUIVALENCE:

The Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4, is substantially equivalent to the Aquilion ONE Vision with FIRST 1.0 (CCRS-001A), that received premarket clearance under K151673 and is marketed by Toshiba America Medical Systems. The changes made to the subject device include the addition of FIRST 2.0, CCRS-001B, an iterative reconstruction algorithm that allows the exposure dose to be reduced while maintaining and/or improving image quality as seen when using FBP (filtered back projection) and improves spatial resolution over FBP. A comparison of the technological characteristics between the subject and the predicate devices is included below.

{5}------------------------------------------------

| Item | Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 | Aquilion ONE with FIRST 1.0 (CCRS-001A) |
|--------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|
| 510(k) Number | This submission | K151673 |
| Anatomical Region | Abdomen, pelvis, chest, cardiac and extremities | Chest (excluding cardiac), abdomen and pelvis |
| Exposure Dose Reduction | AIDR 3D<br>FIRST 2.0 | AIDR 3D<br>FIRST 1.0 |
| Quantitative Dose Reduction<br>Claim | Yes | Yes |
| Image Quality Claim | Improved Spatial Resolution over<br>Filtered Back Projection | Improved Spatial Resolution over<br>Filtered Back Projection |

## 16. 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 following standards IEC60601-1-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-4, IEC60601-1-6, IEC60601-2-28, IEC60601-2-32, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25 and NEMA XR-26. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.

## 17. TESTING

Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrates that the established specifications for the device have been met.

## Image Quality Evaluation

CT image quality metrics were performed, utilizing phantoms, which demonstrated that the subject device is substantially equivalent to or demonstrates an improvement to the predicate device with regard to contrast-to noise ratio, CT number accuracy, uniformity, slice sensitivity profile, modulation transfer function, line pair gauge, low contrast detectability, standard deviation of noise and noise power spectra.

## Quantitative Dose Reduction/Spatial Resolution Evaluations

The subject device demonstrated a dose reduction claim of up to 84.6% with 60% noise reduction compared to filtered back projection. A model observer evaluation showed that equivalent low contrast detectability to FBP (range from 0.6 - 0.686) can be achieved with 71.4% to 84.6% less dose using FIRST2.0 at Standard setting for thin (0.5 mm) reconstruction slice thickness in simulated body phantom (MITA-FDA phantom with a body ellipse surrounding it).

## Low Contrast Detectability

Evaluations were conducted to measure low-contrast detectability using Aquilion ONE Vision CT systems with current detector (CDAS-052A/3) and previous detector (CDAS-052A/2) configurations. It was concluded that CTDIvol values at which the low-contrast object can be identified were improved with the use of FIRST 2.0 as compared to filtered back projection and AIDR 3D.

{6}------------------------------------------------

Representative diagnostic images, reviewed by an American Board Certified Radiologist, including chest, abdomen and pelvis, extremity and cardiac exams were also obtained using the subject device which demonstrates that the device produces images of diagnostic quality and; therefore, performs 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 included as part of this submission.

Additionally, testing of the subject device was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.

## 18. CONCLUSION

The Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4, performs in a manner similar to and is intended for the same use as the predicate device, as indicated in product labeling. 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.