AQUILION PRIME, V5.00

K130645 · Toshibamedical Systems Corporation · JAK · Jun 6, 2013 · Radiology

Device Facts

• Record ID: K130645
• Device Name: AQUILION PRIME, V5.00
• Applicant: Toshibamedical Systems Corporation
• Product Code: JAK · Radiology
• Decision Date: Jun 6, 2013
• 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. The Aquilion PRIME has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

Device Story

Aquilion PRIME (TSX-303A/2, 303A/6) is an 80-row or 40-row CT system; produces axial cross-sectional images of whole body/head. Inputs: X-ray radiation data; transforms via CT reconstruction algorithms into volume sets. Used in clinical settings by trained physicians. Modifications from predicate include smaller gantry, increased tilt angle, new scan switch, breath-hold indication, and optional software (e.g., Helical Shuttle Scan, Lung Volume Analysis). Output: cross-sectional volume sets displayed for diagnostic review. Benefits: enables specialized diagnostic studies through high-resolution imaging. System includes patient couch and gantry; operates under physician supervision.

Clinical Evidence

Bench testing only. Image quality metrics study using phantoms validated spatial resolution, CT number, and contrast-to-noise ratio against predicate. No clinical data presented.

Technological Characteristics

80-row (TSX-303A/2) or 40-row (TSX-303A/6) CT system. X-ray tube: 7.5 MHU capacity, 1386 kHU/min max cooling. Gantry: 2150x1870x870mm, ±30° tilt. Standards: 21 CFR 1020, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-1-9, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-2-44, IEC 60825-1, IEC 62304, IEC 62366, NEMA PS 3.1-3.18, NEMA XR-25. Software: Moderate Level of Concern.

Indications for Use

Indicated for acquisition and display of cross-sectional whole-body volumes, including head, for specialized studies 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

• TSX-302A/2, Aquilion Prime CT System (K120710)

Reference Devices

• Lung Volume Analysis (K113715)

Submission Summary (Full Text)

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K130645
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JUN 0 6 2013

TOSHIBA AMERICA MEDICAL SYBTEMS, 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: March 8, 2013
- 6. TRADE NAME(S): Aquilion PRIME, TSX-303A/2 and 303A/6, v5.00

## 7. COMMON NAME: System, X-ray, Computed Tomography

#### DEVICE CLASSIFICATION: 8.

Class II (per 21 CFR 892.1750)

#### PRODUCT CODE / DESCRIPTION: 9.

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 |
|-----------------------------------------|------------------------------------|---------------|----------------|
| TSX-302A/2, Aquilion<br>Prime CT System | Toshiba America<br>Medical Systems | K120710 | April 6, 2012 |

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#### 12. REASON FOR SUBMISSION:

Modification of a cleared device

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### 13. DEVICE DESCRIPTION:

The Aquilion PRIME TSX-303A/2, v5.00 is an 80-row CT System and the TSX-303A/6, v5.00 is a 40-row CT system that is intended to produce axial scans of the whole body to include the head. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.

#### 14. SUMMARY OF INTENDED USES:

This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.

The Aquilion Prime has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software, by a trained and qualified physician.

#### 15. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the TSX-302A/2, Aquilion Prime CT System, K120710, marketed by Toshiba America Medical Systems. The Aquilion PRIME TSX-303A/2 and 303A/6, v5.00, incorporates modifications to the cleared device which include a smaller gantry size, addition of optional software features and new patient couches. The method of operation, base software and manufacturing process remain unchanged from the cleared device.

A complete comparison table is included in this submission. See below for a brief summary of changes from TSX-302A/2, Aquilion Prime CT System:

| Item | Aquilion PRIME | TSX-302A/2, |
|----------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------|
| X-ray Tube Substitution | TSX-303A/2 and 303A/6, v5.00 | Aquilion Prime CT System |
| X-ray tube capacity<br>Maximum tube cooling rate<br>Continuous tube cooling rate | 7.5 MHU<br>1386 kHU/min<br>1008 kHU/min | 7.5 MHU<br>1386 kHU/min<br>1008 kHU/min |
| Gantry Size | W=2150mm, H=1870mm, D=870mm | W=2430mm, H=2030mm,<br>D=1070mm |
| Gantry Tilt Angle | $\u00b130\u00b0$ | $\u00b122\u00b0$ |
| Gantry Scan Switch | Standard | N/A |
| Lamp for Indication of<br>Breathing | Breath-hold time indication added | N/A |

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K130645
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#### (Continued)

| Item | Aquilion PRIME<br>TSX-303A/2 and 303A/6, v5.00 | TSX-302A/2,<br>Aquilion Prime CT System |
|----------------------|------------------------------------------------|-----------------------------------------|
| Helical Shuttle Scan | Optional | N/A |
| Lung Volume Analysis | Optional<br>(Previously cleared under K113715) | N/A |

- 1. X-ray tube substitution
- 2. Smaller gantry
- ന് Increased gantry tilt angle
- 4. New gantry scan switch and breath-hold indication

5. Previously cleared software options are being added

#### 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, IEC60601-1-2, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-1-9, IEC60601-2-28, IEC60601-2-32, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18and NEMA XR-25. 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 also evaluated according to an image quality metrics study, utilizing phantoms, which validated that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number and contrast-tonoise ratio and noise properties.

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 PRIME TSX-303A/2 and 303A/6, v5.00 do not change the indications for use or the intended use of the device. Based upon bench testing, successful completion of software validation, application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms or lines extending from the body. The figure is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

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

June 6, 2013

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

Re: K130645

Trade/Device Name: Aquilion PRIME TSX-303A/2 and 303A/6, v5.00 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 8, 2013 Received: March 11, 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 .- Isting 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.

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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" (21CFR 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/Resourcesfor You/Industrv/default.htm.

Sincerely yours.

Smh.P.

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

for

Enclosure

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# Indications for Use

510(k) Number (if known): K130645

Device Name: Aquilion PRIME, TSX-303A/2 and 303A/6, v5.00

Indications for Use:

This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.

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

Prescription

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K130645

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