Aquilion ONE (TSX-306A/3) V10.0
Device Facts
| Record ID | K192188 |
|---|---|
| Device Name | Aquilion ONE (TSX-306A/3) V10.0 |
| Applicant | Canon Medical Systems Corporation |
| Product Code | JAK · Radiology |
| Decision Date | Sep 6, 2019 |
| Decision | SESE |
| Submission Type | Special |
| 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 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, 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. Captures cross-sectional volume data sets via X-ray acquisition. Used in clinical settings by trained physicians to perform specialized organ studies. System processes raw X-ray data into volumetric images for diagnostic review. Modifications from predicate include updated X-ray generator, gantry, and detector to support rapid kV switching and acquisition view synchronization. Console OS upgraded to Windows 10. Provides high-resolution volumetric data to assist physicians in clinical decision-making and diagnosis.
Clinical Evidence
Bench testing only. Phantom-based image quality evaluation compared subject device to predicate. Metrics included CT number accuracy, image standard deviation (noise), high-contrast spatial resolution, and low-contrast density resolution. Results demonstrated substantial equivalence; no clinical data deemed necessary.
Technological Characteristics
Multi-slice helical CT scanner. Components: CXXG-018A X-ray generator, CGGT-039A gantry, CDAS-052A/6A detector, CXB-750F X-ray tube. Supports rapid kV switching and view synchronization. OS: Windows 10. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-4, 60601-1-6, 60601-2-28, 60601-2-44, IEC 60825-1, IEC 62304, IEC 62366, NEMA XR-25, XR-26, XR-29. Radiation safety per 21 CFR 1010/1020.
Indications for Use
Indicated for patients requiring cross-sectional volume imaging of the whole body, including head and whole organs (e.g., brain, heart, pancreas). For use by trained and qualified 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 (TSX-305A/6) V8.9 with AiCE (K183046)
Submission Summary (Full Text)
{0}------------------------------------------------
September 6, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive TUSTIN CA 92780
Re: K192188
Trade/Device Name: Aquilion ONE (TSX-306A/3) V10.0 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 12, 2019 Received: August 13, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting
{1}------------------------------------------------
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known)
## K192188
Device Name
Aquilion ONE (TSX-306A/3) V10.0
### Indications for Use (Describe)
This device is indicated to acquire and display cross-sectional volumes of the whole 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, of the whole organ by a trained and qualified physician.
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
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}------------------------------------------------
## 510(k) SUMMARY
- 1. SUBMITTER'S NAME: Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
- 2. OFFICIAL CORRESPONDENT: Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance
- 3. ESTABLISHMENT REGISTRATION: 9614698
### 4. CONTACT PERSON:
Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459
- 5. DATE PREPARED:
August 30, 2019
- 6. TRADE NAME(S): Aquilion ONE (TSX-306A/3) V10.0
### 7. COMMON NAME:
System, X-ray, Computed Tomography
#### 8. DEVICE CLASSIFICATION:
a) Classification Name: Computed Tomography X-ray system b) Regulation Number: 892.1750 c) Regulatory Class: Class II
### 9. PRODUCT CODE / DESCRIPTION:
JAK / Computed Tomography X-Ray System
2441 Michelle Drive, Tustin, CA 92780 PHONE: 800-421-1968
# Made For life
{4}------------------------------------------------
### 10. PREDICATE DEVICE:
| Product | Marketed by | Regulation<br>Number | Regulation<br>Name | Product Code | 510(k)<br>Number | Clearance<br>Date |
|------------------------------------------|----------------------------|----------------------|----------------------------------|---------------------------------------------------|------------------|-------------------|
| Aquilion ONE (TSX-305A/6) V8.9 with AiCE | Canon Medical Systems, USA | 21 CFR 892.1750 | Computed Tomography X-ray System | JAK:<br>System, X-ray,<br>Tomography,<br>Computed | K183046 | 06/12/2019 |
### 11. REASON FOR SUBMISSION:
Modification of existing medical device
### 12. DEVICE DESCRIPTION:
Aquilion ONE (TSX-306A/3) V10.0 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, c by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.
### 13. 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, of the whole organ by a trained and qualified physician.
### 14. SUBSTANTIAL EQUIVALENCE:
The Aquilion ONE (TSX-306A/3) V10.0 is substantially equivalent to Aquilion ONE (TSX-305A/6) V8.9 with AiCE, which received premarket clearance under K183046, and is marketed by Canon Medical Systems USA. The intended use and the indications for use of the Aquilion ONE is the same as that of the predicate device. The Aquilion ONE (TSX-306A/3) V10.0 includes changes made to the predicate device including modifications made to the X-ray generator, gantry and detector in order to support rapid kV switching scans, the Windows operating system version is updated to Windows 10 from Windows 7, and to update the 5085Fluoro operating panel. A comparison of the technological characteristics between the subject and the predicate device is included below.
| | Subject Device | Predicate Device | Comment |
|------------------------------|-----------------------------|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name,<br>Model Number | Aquilion ONE,<br>TSX-306A/3 | Aquilion ONE<br>(TSX-305A/6) V8.9<br>with AiCE | |
| 510(k) Number | This submission | K183046 | |
| X-ray generator<br>(HFG) | CXXG-018A | CXXG-013A | Modifications to support rapid kV<br>switching<br>-X-ray high-voltage generator upgrade<br>kit, Model CXGS-020A, also available to<br>upgrade existing TSX-305A systems.<br>-CXXG-013A with CXGS-020A is<br>equivalent to the high voltage generator<br>used in TSX-306A. Model CXXG-018A. |
{5}------------------------------------------------
| | Subject Device | Predicate Device | Comment |
|--------------------------------------------|-----------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Device Name,<br>Model Number | Aquilion ONE,<br>TSX-306A/3 | Aquilion ONE<br>(TSX-305A/6) V8.9<br>with AiCE | |
| 510(k) Number | This submission | K183046 | |
| Gantry | Model CGGT-039A | CGGT-036A | Modifications to support rapid kV<br>switching and acquisition view<br>synchronization capabilities |
| - Exterior covers | Surface and paint with<br>gloss coating | Surface and paint | Gloss coating is added |
| Detector model | CDAS-052A/6A | CDAS-052A/5A | Modifications to support the rapid kV<br>switching and kV view synchronization.<br>No change in the hardware. |
| Type of X-ray tube | CXB-750F | CXB-750F | Improvement for stabilization during<br>electrical discharge |
| Rear operating<br>panel kit<br>(CAGP-003A) | Option<br>(Paint with gloss coating) | Option<br>(Paint) | Gloss coating is added |
| System Software<br>Version | V10.0 | V8.9 | Change |
| Console operating<br>system | Windows 10 | Windows 7 | Upgrade |
| SURE Fluoro | Option<br>TSXF-004A | Option<br>TSXF-0031 | Change<br>Updated operating panel installed on the<br>patient couch |
| AiCE | N/A | Option | Change |
| FIRST | N/A | Option | Change |
### 15. 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, IEC60601-1-2, IEC60601-1-3, IEC60601-1-3, IEC60601-1-4, IEC60601-1-6, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA XR-25, NEMA XR-26 and NEMA XR-29. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.
This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]
### 16. TESTING:
Risk analysis and verification/validation activities conducted through bench testing demonstrate that the established specifications for the device have been met. An image quality evaluation using phantom-based tests was performed to compare the Aquilion ONE (TSX-306A/3) V10.0 and the predicate device. Results of the testing demonstrated substantial equivalence of image
{6}------------------------------------------------
quality between the systems, with regard to standard deviation of noise (CT number accuracy, image SD, spatial resolution (high contrast detectability) and density resolution (low contrast detectability)). As a result of the phantom-based tests, it was determined that clinical data was not necessary to demonstrate substantial equivalence between the Aquilion ONE (TSX-306A/3) V10.0 and the predicate device.
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.
Cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices " issued on October 2, 2014, 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.
### 17. CONCLUSION:
The Aquilion ONE (TSX-306A/3) V10.0 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 has demonstrated substantial equivalence to the predicate device and is safe and effective for its intended use.
