Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

K192832 · Canon Medical Systems Corporation · JAK · Feb 21, 2020 · Radiology

Device Facts

• Record ID: K192832
• Device Name: Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
• Applicant: Canon Medical Systems Corporation
• Product Code: JAK · Radiology
• Decision Date: Feb 21, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Prime SP 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. AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction that improves image quality and reduces image noise by employing Deep Convolutional Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications.

Device Story

Aquilion Prime SP (TSX-303B/8) V10.2 is a 40-row (expandable to 80-row) CT scanner. Inputs: X-ray projection data. Transformation: Reconstruction of cross-sectional volumes using AiCE-i (Advanced Intelligent Clear-IQ Engine), a deep convolutional network-based noise reduction algorithm. Output: High-quality CT images with reduced noise and improved low-contrast detectability. Used in clinical settings by radiologists/technicians. Healthcare providers view images on a console to perform diagnostic assessments. Benefits: Improved image quality, reduced radiation dose (up to 82% vs FBP), and more natural noise texture compared to model-based iterative reconstruction (MBIR).

Clinical Evidence

Bench testing only. Phantom studies assessed CNR, CT number accuracy, uniformity, SSP, MTF, SD, NPS, and LCD. Results: 82% dose reduction vs FBP; 13.8% improved LCD and 21.4% noise reduction vs AIDR 3D. Noise texture analysis confirmed similarity to high-dose FBP. Radiologist review of clinical images (abdomen/pelvis, lung, cardiac, brain, extremities, inner ear) confirmed diagnostic quality.

Technological Characteristics

40-row (optional 80-row) CT system. Materials: Standard medical CT components. Energy: Ionizing radiation. Connectivity: Networked console (Windows 10). Software: Deep Convolutional Network (AiCE-i). Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-44, NEMA XR-25/26/29.

Indications for Use

Indicated for patients requiring cross-sectional whole-body CT imaging, including head, abdomen, pelvis, lung, cardiac, and extremities. Used by trained physicians for specialized studies.

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 Prime SP, TSX-303B/1, v8.4 (K172188)

Reference Devices

• Aquilion ONE (TSX-305A/6) V8.9 with AiCE (K183046)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows 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.

February 21, 2020

Canon Medical Systems Corporation % Orlando Tadeo, Jr. Senior Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K192832

Trade/Device Name: Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: January 17, 2020 Received: January 21, 2020

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

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

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-reportingcombination-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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) K192832

Device Name

Aquilion Prime SP (TSX-303B/8) V 10.2 with AiCE-i

#### Indications for Use (Describe)

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

The Aquilion Prime SP 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.

AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction that improves image quality and reduces image noise by employing Deep Convolutional Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</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 [e-mail]

"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}------------------------------------------------

# Made For life

#### 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 [phone]

#### 5. Date Prepared:

September 30, 2019

#### 6. TRADE NAME(S):

Aquilion Prime SP (TSX-303B/8) V10.2 with AiCE-i

#### 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 – System, Computed Tomography

PHONE: [phone] Michelle Drive, Tustin, CA 92780

K192832

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

#### 10. PREDICATE DEVICE:

| Product | Marketed by | Regulation<br>Number | Regulation<br>Name | Product Code | 510(k)<br>Number | Clearance Date |
|-------------------------------------------------------------------------|----------------------------------|----------------------|----------------------------------------|---------------------------------------------------|------------------|-----------------|
| Aquilion Prime SP,<br>TSX-303B/1, v8.4<br>(Primary Predicate<br>Device) | Canon<br>Medical<br>Systems, USA | 21 CFR<br>892.1750 | Computed<br>Tomography<br>X-ray System | JAK:<br>System, X-ray,<br>Tomography,<br>Computed | K172188 | October 6, 2017 |
| Aquilion ONE (TSX-<br>305A/6) V8.9 with<br>AiCE<br>(Reference Device) | Canon<br>Medical<br>Systems, USA | 21 CFR<br>892.1750 | Computed<br>Tomography<br>X-ray System | JAK:<br>System, X-ray,<br>Tomography,<br>Computed | K183046 | June 12, 2019 |

#### 11. REASON FOR SUBMISSION:

Modification of a cleared device

#### 12. DEVICE DESCRIPTION:

The Aquilion Prime SP (TSX-303B/8) V10.2 with AiCE-i is a 40-row CT System that is intended to acquire and display cross-sectional volumes of the whole body, including the head. An optional Dynamic Volume CT Upgrade Kit can be installed in order to expand the active detector rows to 80. This system is based upon the technology and materials of previously marketed Canon CT systems. In addition, the subject device incorporates the latest reconstruction technology, AiCE-i (Advanced intelligent Clear-IQ Engine - integrated), intended to reduce image noise and improve image quality by utilizing Deep Convolutional Network methods. These methods can more fully explore the statistical properties of the signal and noise. By learning to differentiate structure from noise, the algorithm produces fast, high quality CT reconstruction.

#### 13. 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 SP 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.

AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications.

#### 14. SUBSTANTIAL EQUIVALENCE:

The Aquilion Prime SP (TSX-303B/8) V10.2 with AiCE-i is substantially equivalent to Aquilion Prime SP, TSX-303B/1, v8.4, which received premarket clearance under K172188 and is marketed by Canon Medical Systems USA. The changes made to the subject device include the addition of AiCE (Advanced intelligent Clear-IQ Engine), a reconstruction that utilizes Deep Convolutional

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

Neural Network methods to reduce image noise and improve image quality. A comparison of the technological characteristics between the subject and the predicate device is included below.

| Item | Aquilion Prime SP (TSX-303B/8)<br>V10.2 with AiCE-i | Aquilion Prime SP (TSX-303B/1) V8.4 |
|-------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| 510(k) Clearance<br>Number | N/A | K172188 |
| Anatomical Region | AIDR 3D (Whole Body) | AIDR 3D (Whole Body) |
| Noise Reduction<br>Processing | AiCE (Abdomen and Pelvis, Chest,<br>Cardiac, Extremities, Brain, Inner ear) | AIDR 3D<br>AIDR 3D Enhanced<br>Quantum Denoising Smoothing (QDS) |
| | AIDR 3D | |
| | AIDR 3D Enhanced<br>Quantum Denoising Smoothing (QDS)<br>AiCE | |
| Processing capability | Console CKCN-020C | Console CKCN-017B |
| | Reconstruction processing system<br>(AiCE-i: CSAL-001A) | Reconstruction processing system<br>(N/A) |
| | | |
| Display console kit | CGS-72B (Optional) | CGS-72A: TSX-303B/1 (Optional) |
| Image Quality Claims | - Improved Quantitative high contrast<br>Spatial Resolution over AIDR 3D with<br>reduced noise | No change |
| | - Improved Quantitative Dose<br>Reduction over FBP | |
| | - Better Low-contrast Detectability<br>than AIDR 3D for abdomen at the<br>same dose | |
| | -Noise appearance/texture more<br>similar to high dose filtered<br>backprojection compared to MBIR | |
| | | |
| Operating System | Microsoft Windows 10 | Microsoft Windows 7 |

#### 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, IEC60601-1-9, IEC60601-1-2, IEC60601-1-3, 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]

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

#### 16. TESTING

Risk analysis and verification/validation activities conducted through bench testing demonstrate that the established specifications for the device have been met.

#### Image Quality Evaluation

CT image quality metrics were performed, utilizing phantoms, to assess Contrast-to-Noise Ratios (CNR), CT Number Accuracy, Uniformity, Slice Sensitivity Profile (SSP), Modulation Transfer Function (MTF)-Wire, Modulation Transfer Function (MTF)-Edge, Standard Deviation of Noise (SD), Noise Power Spectra (NPS), Low Contrast Detectability (LCD) and Pediatric phantom/protocol. It was concluded that the AiCE images are substantially equivalent to the predicate device as demonstrated by the results of the above testing.

A dose reduction study was conducted using AiCE and based on the results, a dose reduction claim of 82%, relative to FBP, is supported as well as 13.8% improved low contrast detectability and noise reduction of 21.4 at the same dose for body compared to AIDR 3D.

#### Low Contrast Detectability

A phantom study was conducted in order to support claims of low-contrast detectability of 1.5 mm at 0.3%, 21.8mGy, using AiCE Body

#### Noise Texture Reader Study

An analysis of the NPS and kurtosis values for FBP, FIRST and AiCE was conducted and the results of the study support the following claims:

- "Noise appearance/texture more similar to high dose filtered backprojection compared to MBIR"
- "Noise appearance/texture more similar to filtered backprojection compared to MBIR"
- "Improved noise appearance/texture compared to MBIR"
- "More natural noise texture compared to MBIR"

Representative abdomen/pelvis, lung, cardiac, brain, extremities and inner ear diagnostic images, reviewed by an American Board Certified Radiologist, were obtained using the subject device and it was confirmed that the AiCE reconstructed images were of diagnostic quality.

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.

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

#### 17. CONCLUSION

The Aquilion Prime SP (TSX-303B/8) V10.2 with AiCE-i 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.