Aquilion ONE (TSX-305A/3) V7.3

K160587 · Toshibamedical Systems Corporation · JAK · Jun 9, 2016 · Radiology

Device Facts

• Record ID: K160587
• Device Name: Aquilion ONE (TSX-305A/3) V7.3
• Applicant: Toshibamedical Systems Corporation
• Product Code: JAK · Radiology
• Decision Date: Jun 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended 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.

Device Story

Whole-body multi-slice helical CT scanner; consists of gantry, couch, and console. Inputs: X-ray radiation attenuated by patient anatomy. Transformation: Detector array (896 channels x 320 rows) captures projection data; console performs image reconstruction (TCOT+ method) and processing. Outputs: Cross-sectional volume sets displayed on console. Used in clinical settings by trained physicians/technicians. Output used for diagnostic visualization and specialized organ studies (e.g., cardiac, perfusion, vessel analysis). Benefits: Enables single-rotation whole-organ imaging, reducing scan time and motion artifacts; supports advanced clinical analysis packages for improved diagnostic accuracy.

Clinical Evidence

Bench testing only. Performance validated using phantoms to assess spatial resolution, CT number uniformity, noise, and low-contrast detectability. Diagnostic image quality verified by American Board Certified Radiologist across head, chest, abdomen/pelvis, extremity, and cardiac exams.

Technological Characteristics

Multi-slice helical CT scanner. Detector: 896 channels x 320 rows. Gantry: 780mm opening, +/- 30-degree tilt. X-ray: 80-135 kV, 10-900 mA. Reconstruction: TCOT+ method, SEMAR (metal artifact reduction). Connectivity: DICOM (NEMA PS 3.1-3.18). Standards: IEC 60601-1 series, IEC 62304, IEC 62366, NEMA XR-25/26. Software: Moderate level of concern.

Indications for Use

Indicated for whole-body cross-sectional imaging, including head and whole organs (e.g., brain, heart, pancreas), in patients requiring CT diagnostic studies. No specific age or gender contraindications stated.

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, TSX-301C/6-8, V7.0 (K142465)

Reference Devices

• Sure Subtraction for Neck (K051833)
• vHP (Variable Helical Pitch) (K142465)
• Neuro Package (K072693)
• Vessel View (K063184)
• Body Perfusion (K090504)
• Colon View (K090220)
• Lung Volume Analysis (K113715)
• suRECardio Scoring (K072737)
• Dental Package (K142465)
• CT Cardiac Function Analysis Software (K023760)
• surEPlaque (K043111)
• Subtraction Protocol (K142465)
• sureSubtraction Ortho (K130960)
• surESubtraction Lung (K133324)
• MyoPerfusion (K132523)
• Dual Energy System Package (K132813)
• 4D Orthopedic Analysis (K142465)
• 4D Cerebral Artery Morphological Analysis (K142465)
• Adaptive Motion Correction (K143294)
• 4D Airways Analysis (K143294)
• surEExposure 3D (K142465)

Submission Summary (Full Text)

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

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

June 9, 2016

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

Re: K160587

Trade/Device Name: Aquilion ONE (TSX-305A/3) V7.3 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 29, 2016 Received: March 2, 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,

Robert Ochs

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)

K160587

#### Device Name

Aquilion ONE (TSX-305A/3) V7.3

#### 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 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 orqan by a trained and qualified physician.

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

ال 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:

May 24, 2016

- 6. TRADE NAME(S): Aquilion ONE (TSX-305A/3) V7.3
- 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 Number | Regulation Name | Product Code | 510(k) Number | Clearance Date |
|---------------------------------------------------|------------------------------------------|--------------------|----------------------------------------|---------------------------------------------------|---------------|----------------|
| Aquilion<br>ONE Vision,<br>TSX-301C/<br>6-8, V7.0 | 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 | K142465 | 03/10/2015 |

# 12. REASON FOR SUBMISSION:

New device.

# 13. DEVICE DESCRIPTION:

Aquilion ONE (TSX-305A/3) V7.3 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.

# 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.

# 15. SUBSTANTIAL EQUIVALENCE:

The Aquilion ONE (TSX-305A/3) V7.3, is substantially equivalent to the Aquilion ONE Vision, TSX-301C/1-8, V7.0, which received premarket clearance under K142465, marketed by Toshiba America Medical Systems. The Indications for Use for the subject device are identical to those of the predicate device. A comparison of the technological characteristics between the subject and the predicate devices is included below.

| ltem | Aquilion ONE<br>(TSX-305A/3) V7.3 | Aquilion ONE<br>(TSX-301C/6-8) V7.0 |
|-----------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| 510(k) Number | This submission | K142465 |
| Gantry Rotation Speed | 0.35s<br>(Optional max 0.275s available<br>with software upgrade kit) | 0.275s<br>(Standard on /6 model,<br>available with software<br>upgrade kit for /7 and /8<br>models) |
| View rate | Maximum: 2910 views/s | Maximum: 2910 views/s |
| Detector | 896 channels x 320 rows | 896 channels x 320 rows |
| Pitch factor | 0.555 to 1.575 | 0.555 to 1.5 |
| FOV (field of view) | 240/320/500mm | 180/240/320/400/500mm |

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

| Item | Aquilion ONE<br>(TSX-305A/3) V7.3 | Aquilion ONE<br>(TSX-301C/6-8) V7.0 | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| 510(k) Number | This submission | K142465 | |
| Wedge filter types | Two types | Three types | |
| X-ray tube voltage / X-ray tube<br>current | Max. 72 kW (Max.90kW*)<br>80/100/120/135 kV<br><br>10 to 600 mA (10-900 mA*)<br>(in steps of 10 mA)<br><br>*Option: Available when Fast<br>Scan Kit and X-ray Power Up Kit,<br>CGS-56A, is installed | TSX-301C/6:<br>Max. 90 kW<br>80/100/120/135 kV<br><br>10 to 900 mA<br>(in steps of 10 mA)<br><br>TSX-301C/7 and /8:<br>Max. 72 kW<br>80/100/120/135 kV<br><br>10 to 600 mA<br>(in steps of 10 mA) | |
| | Image reconstruction time | Up to 80 images/s | Up to 50 images/s |
| | Helical reconstruction method | 20 rows or more: TCOT+ | 16 rows or more: TCOT+ |
| | Metal artifact reduction | SEMAR (Volume, Helical )<br>SEMAR (ECG gated) | SEMAR (Volume, Helical) |
| Patient Couch Type | Long Long Short Short | Long Short | |
| Couch-top stroke (mm) | 2390 2190 1890 1890 | 2390 1890 | |
| Scan permissible range (mm, Conventional) | 2000 1800 1500 1500 | 2000 1500 | |
| Scan permissible range (mm, Helical) | 1950 1750 1450 1450 | 1950 1450 | |
| Max. guaranteed weight (kg) | 300 205 300 205 | 300 300 | |
| Lowest couch height (mm) | 332 312 332 312 | 332 332 | |
| Gantry opening size | 780 mm in diameter | 780 mm in diameter | |
| Gantry tilt angle | $\pm$ 30° | $\pm$ 22° | |
| Minimum area for installation | 27m² (24.7m², Short couch) | 37.2m² (31.6 m², Short couch) | |
| Area finder | Optional | NA | |

Previously cleared software options being implemented to the subject device:

| Application | 510(k) Clearance | Comments |
|----------------------------------------------------------------------------|-------------------------------------|-----------|
| Orbital-synchronization helical scan system<br>(Sure Subtraction for Neck) | Previously cleared<br>under K051833 | No change |
| vHP (Variable Helical Pitch) | Previously cleared<br>under K142465 | No change |
| Neuro Package | Previously cleared<br>under K072693 | No change |
| Vessel View | Previously cleared<br>under K063184 | No change |
| Body Perfusion | Previously cleared<br>under K090504 | No change |

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

| Application | 510(k) Clearance | Comments | |
|----------------------------------------------------------|-------------------------------------|------------------------------------------------|--|
| Colon View | Previously cleared<br>under K090220 | No change | |
| Lung Volume Analysis | Previously cleared<br>under K113715 | Workflow improvement(s)<br>implemented in V7.3 | |
| suRECardio Scoring | Previously cleared<br>under K072737 | No change | |
| Dental Package | Previously cleared<br>under K142465 | No change | |
| CT Cardiac Function Analysis Software | Previously cleared<br>under K023760 | No change | |
| surEPlaque | Previously cleared<br>under K043111 | No change | |
| Subtraction Protocol<br>(SURESubtraction Scan System) | Previously cleared<br>under K142465 | No change | |
| sureSubtraction Ortho<br>(CSSO-001A) | Previously cleared<br>under K130960 | No change | |
| surESubtraction Lung<br>(CSSL-001A) | Previously cleared<br>under K133324 | Workflow improvement(s)<br>implemented in V7.3 | |
| MyoPerfusion<br>(CSMP-001A) | Previously cleared<br>under K132523 | Workflow improvement(s)<br>implemented in V7.3 | |
| Dual Energy System Package<br>(CSDP-001A) | Previously cleared<br>under K132813 | Workflow improvement(s)<br>implemented in V7.3 | |
| 4D Orthopedic Analysis<br>(CSOA-001A) | Previously cleared<br>under K142465 | No change | |
| 4D Cerebral Artery Morphological Analysis<br>(CSAM-001A) | Previously cleared<br>under K142465 | No change | |
| Adaptive Motion Correction<br>(CSMC-001A) | Previously cleared<br>under K143294 | No change | |
| 4D Airways Analysis<br>(CSAA-001A) | Previously cleared<br>under K143294 | Workflow improvement(s)<br>implemented in V7.3 | |
| surEExposure 3D | Previously cleared<br>under K142465 | No change | |

# 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, 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 demonstrate that the established specifications for the device have been met. CT image quality metrics were performed, utilizing phantoms, which validated that the substantially equivalent to

{7}------------------------------------------------

the predicate device with regard to spatial resolution, CT number magnitude/uniformity, noise properties and low contrast detectability/CNR performance.

Representative diagnostic images, reviewed by an American Board Certified Radiologist, including head, chest, abdomen/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 (TSX-305A/3) V7.3 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.