AQUILION ONE VISION

K133497 · Toshibamedical Systems Corporation · JAK · Feb 10, 2014 · Radiology

Device Facts

• Record ID: K133497
• Device Name: AQUILION ONE VISION
• Applicant: Toshibamedical Systems Corporation
• Product Code: JAK · Radiology
• Decision Date: Feb 10, 2014
• 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

Aquilion ONE Vision (TSX-301C/3, 301C/4, 301C/5) is a 320-row (or 160-row) CT system. Captures cross-sectional volume data sets via X-ray; processes and displays images on a console. Operated by trained physicians in clinical settings. System utilizes gantry, couch, and console for data acquisition and display. Software controls limit data acquisition in specific configurations. Output consists of diagnostic-quality volume sets of whole organs. Healthcare providers use these images for specialized clinical studies and decision-making. Benefits include single-rotation whole-organ imaging capability.

Clinical Evidence

Bench testing only. Evaluated detector sensitivity and image quality metrics (spatial resolution, CT number, contrast-to-noise ratio, noise properties, uniformity) using phantoms. Representative diagnostic images of brain, chest, abdomen, and peripheral exams were reviewed by an American Board Certified Radiologist to confirm diagnostic quality.

Technological Characteristics

320-row (TSX-301C/3, 301C/4) or 160-row (TSX-301C/5) CT system. X-ray ionizing radiation source. Conforms to IEC 60601-1, IEC 60601-2-44, NEMA XR-25, NEMA XR-26, and 21 CFR 1020. Software-controlled data acquisition. Moderate level of concern software.

Indications for Use

Indicated for whole-body cross-sectional imaging, including head and whole organs (e.g., brain, heart, pancreas) in a single rotation, for use by trained physicians.

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/1 and 301C/2, v6.00 (K132222)

Reference Devices

• Neuro Package (K072693)
• Vessel View (K063184)
• Body Perfusion (K090504)
• Colon View (K090220)
• Lung Volume Analysis (K113715)
• Sure Cardio Scoring (K072737)
• CT Cardiac Function Analysis Software (K023760)
• Sure Plaque (K043111)

Submission Summary (Full Text)

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

FEB 10 2014

ТОВНІВА АМЕРІСА MEDICAL БУБТЕМS, INC. 2441 Michelle Drive, Tustin, CA 92780 Phone: [phone]

#### 510(k) SUMMARY

- 1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
- 2. ADDRESS: 2441 Michelle Drive Tustin, CA 92780-2068
- 3. ESTABLISHMENT REGISTRATION: 2020563
- 4. CONTACT PERSON: Paul Biggins Director, Regulatory Affairs [phone]
- 5. Date Prepared: January 21, 2014
- 6. TRADE NAME(S): Aquilion ONE Vision, TSX-301C/3, 301C/4 and 301C/5, v6.00
- 7. COMMON NAME: System, X-ray, Computed Tomography
- 8. DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)

# 9. PRODUCT CODE / DESCRIPTION:

JAK - System, Computed Tomography

## 10. PERFORMANCE STANDARD:

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

#### 11. PREDICATE DEVICE:

| Product | Marketed by | 510(k) Number | Clearance Date |
|---------------------------------------------------------|------------------------------------|---------------|------------------|
| Aquilion ONE Vision,<br>TSX-301C/1 and 301C/2,<br>v6.00 | Toshiba America Medical<br>Systems | K132222 | November 7, 2013 |

## 12. REASON FOR SUBMISSION:

Modification of a cleared device

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

#### 13. DEVICE DESCRIPTION:

The Aquilion ONE Vision, TSX-301C/3 and 301C/4, v6.00 are 320-row CT Systems and the TSX-301C/5, v6.00 is a 160-row CT system consisting of the same gantry, couch and console used for data processing and display. These devices capture cross sectional volume data sets used to perform specialized studies, using indicated software, by a trained and qualified physician. These systems are 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:

This device is substantially equivalent to the Aquilion ONE Vision, TSX-301C/1 and 301C/2, v6.00 which was cleared via Pre-Market Notification 510(k), K132222, marketed by Toshiba America Medical Systems. The Aquilion ONE Vision, TSX-301C/4 and 301C/5, v6.00, incorporates modifications to the cleared device which include implementation of a new detector that meets the specifications of the current detector and software controls that limit the data acquisition in the TSX-301C/5 configuration. The method of operation and manufacturing process of the CT system remain unchanged from the cleared device.

A complete comparison table is included in this submission. See below for a brief summary of changes from Aquilion ONE Vision, TSX-301C/1 and 301C/2, v6.00:

| Item | Aquilion ONE Vision<br>TSX-301C/3, 301C/4 and<br>301C/5<br>v6.00 | Aquilion ONE Vision<br>TSX-301C/1 and<br>301C/2<br>v6.00 | Comments |
|---------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------|
| 510(k) Number | This submission | K132222 | |
| Number of detector<br>elements | 320 x 0.5 mm rows | 320 x 0.5 mm rows | No Change |
| Maximum scan slice<br>thickness | 0.5mm x 320 slices<br>(TSX-301C/3 and TSX-301C/4)<br>0.5mm x 160 slices<br>(TSX-301C/5) | 0.5mm x 320 slices | Software<br>controls limit<br>data<br>acquisition |

The following applications have been implemented with the subject device:

Neuro Package (K072693), Vessel View (K063184), Body Perfusion (K090504), Colon View (K090220), Lung Volume Analysis (K113715), Sure Cardio Scoring (K072737), CT Cardiac Function Analysis Software (K023760), Sure Plaque (K043111)

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

K133497
page 3 of 3

## 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 IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-1-6, IEC60601-1-9, 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 requirements for the modifications made to the system have been met. The modified system was evaluated to assess detector sensitivity, which demonstrated an improvement and image quality metrics, utilizing phantoms, which validated that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number and contrast-to-noise ratio, noise properties and uniformity performance. Additionally, representative diagnostic images, reviewed by an American Board Certified Radiologist, including brain, chest, abdomen and peripheral exams were 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 modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.

#### 18. CONCLUSION

The modifications incorporated into the Aquilion ONE Vision, TSX-301C/3, 301C/4 and 301C/5, v6.00 do not change the indications for use or the intended use of the 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 devices.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

#### February 10, 2014

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

Re: K133497

Trade/Device Name: Aquilion ONE Vision, TSX-301C/3, 301C/4 and 301C/5, v6.00 Regulation Number: 21 CFR 892.1750 Regulation Name: System, Computed Tomography, X-Ray Regulatory Class: Il Product Code: JAK Dated: November 12, 2013 Received: November 14, 2013

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 (reporting of medical device-related adverse events) (2) 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.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

. . . . . . . . . . . . . . . . . . . .

## Indications for Use

510(k) Number (if known):

K133497

Device Name:

## Aquilion ONE Vision, TSX-301C/3, 301C/4 and 301C/5, v6.00

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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Sm.h.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 1 of _ 1