Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System

K192828 · Canon Medical Systems Corporation · JAK · Feb 13, 2020 · Radiology

Device Facts

• Record ID: K192828
• Device Name: Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
• Applicant: Canon Medical Systems Corporation
• Product Code: JAK · Radiology
• Decision Date: Feb 13, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: AI/ML

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Noise reduction	Deep Convolutional Neural Network	—	32% noise reduction at the same dose for body AiCE compared to AIDR 3D	—	—	Clinical image review of abdomen/pelvis, brain, inner ear, and extremity images.	1 (American Board Certified Radiologist)
Low contrast detectability	Deep Convolutional Neural Network	—	18.4% improvement in low contrast detectability	—	—	—	—

Indications for Use

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. FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications. AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, inner ear and extremities applications. The Spectral Imaging System allows the system to acquire two nearly simultaneous CT images of an anatomical location using distinct tube voltages and/or tube currents by rapid KV switching. The X-ray dose will be the sum of the dose at each respective tube voltage and current in a rotation. Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in X-ray attenuation between these distinct energies. When used by a qualified physician, a potential application is to determine the course of treatment.

Device Story

Whole-body multi-slice helical CT scanner; consists of gantry, couch, and console. Inputs: X-ray attenuation data acquired via rapid kV switching (Spectral Imaging) or standard rotation. Transforms: Uses FIRST (iterative reconstruction) to reduce dose/improve resolution and AiCE (Deep Convolutional Neural Network) to reduce noise/improve image quality. Outputs: Cross-sectional volume sets, basis material images, monochromatic images, iodine maps, and virtual non-contrast images. Used in clinical settings by radiologists/physicians. Output viewed on console for diagnostic assessment and treatment planning. Benefits: Improved image quality, reduced noise, and material characterization via spectral data.

Clinical Evidence

No clinical trials; evidence based on bench testing and clinical image review. Bench testing used phantoms to assess CNR, CT number accuracy, uniformity, SSP, MTF, noise, and LCD. AiCE demonstrated 69-81% dose reduction vs FBP, 18.4% improvement in LCD, and 32% noise reduction vs AIDR 3D. Spectral imaging claims supported by phantom studies showing reduced beam hardening and correlation between CT number and iodine concentration. Clinical image quality confirmed by American Board Certified Radiologist review of representative abdomen/pelvis, lung, extremity, brain, and inner ear images.

Technological Characteristics

Multi-slice helical CT scanner. Materials: Standard medical-grade CT components. Energy: X-ray source with rapid kV switching. Connectivity: Networked console for processing/display. Software: FIRST (iterative reconstruction), AiCE (Deep Convolutional Neural Network). Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-4, 60601-1-6, 60601-2-28, 60601-2-44, 60825-1, 62304, 62366, NEMA XR-25, XR-26, XR-29. Sterilization: N/A (non-invasive imaging).

Indications for Use

Indicated for acquisition and display of cross-sectional volumes of whole body, including head and whole organs (e.g., brain, heart, pancreas) in a single rotation. Used by trained physicians for specialized studies and treatment planning. No specific age or gender contraindications listed.

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-306A/3) V10.0 (K192188)

Reference Devices

• Aquilion ONE (TSX-305A/6) V8.9 with AiCE (K183046)
• Dual Energy System Package, CSDP-001A (K132813)
• Revolution CT (K163213)

Submission Summary (Full Text)

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February 13, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

# Re: K192828

Trade/Device Name: Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: December 30, 2019 Received: December 31, 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

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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.

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

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# Indications for Use

510(k) Number (if known)

### K192828

Device Name

Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System

### 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.

FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.

AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, inner ear and extremities applications.

The Spectral Imaging System allows the system to acquire two nearly simultaneous CT images of an anatomical location using distinct tube voltages and/or tube currents by rapid KV switching. The X-ray dose will be the sum of the dose at each respective tube voltage and current in a rotation.

Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in X-ray attenuation between these distinct energies.

When used by a qualified physician, a potential application is to determine the course of treatment.

| Type of Use (Select one or both, as applicable) |
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| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image contains the text "K192828" on the top line, with the phrase "Made For life" on the second line. The text is in a simple, sans-serif font, with the phrase "Made For life" in a slightly larger and bolder font than the code above it. The text is black against a white background.

## 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 ONE (TSX-306A/3) V10.0 with Spectral Imaging System
#### 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

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

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#### 10. PREDICATE DEVICE:

| Product | Marketed by | Regulation<br>Number | Regulation<br>Name | Product Code | 510(k)<br>Number | Clearance<br>Date |
|---------------------------------------------------------------|----------------------------------|----------------------|----------------------------------------|---------------------------------------------------|------------------|-------------------|
| Primary:<br>Aquilion ONE (TSX-<br>306A/3) V10.0 | 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 | K192188 | 09/06/2019 |
| Reference:<br>Aquilion ONE (TSX-<br>305A/6) V8.9 with<br>AiCE | 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 | 06/12/2019 |
| Reference:<br>Dual Energy System<br>Package, CSDP-001A | 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 | K132813 | 02/06/2014 |
| Reference:<br>Revolution CT | GE Medical<br>Systems,<br>L.L.C. | 21 CFR<br>892.1750 | Computed<br>Tomography<br>X-ray System | JAK:<br>System, X-ray,<br>Tomography,<br>Computed | K163213 | 12/16/2016 |

#### 11. REASON FOR SUBMISSION:

Modification of existing medical device

#### 12. DEVICE DESCRIPTION:

Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System 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 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/hardware, of the whole organ by a trained and qualified physician.

FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.

AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Network methods for abdomen, pelvis, lung, cardiac, brain, inner ear and extremities applications.

The Spectral Imaging System allows the system to acquire two nearly simultaneous CT images of an anatomical location using distinct tube voltages and/or tube currents by rapid KV switching. The Xray dose will be the sum of the dose at each respective tube voltage and current in a rotation.

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Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in X-ray attenuation between these distinct energies. When used by a qualified physician, a potential application is to determine the course of treatment.

#### 14. SUBSTANTIAL EQUIVALENCE:

The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System is substantially equivalent to Aquilion ONE (TSX-306A/3) V10.0, which received premarket clearance under K192188, and is marketed by Canon Medical Systems USA. The intended use of the Aquilion ONE is the same as that of the predicate device. The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System includes changes made to the predicate device including implementation of Spectral Imaging System, AiCE and FIRST. 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) V10.0 with<br>Spectral Imaging System | Aquilion ONE<br>(TSX-306A/3) V10.0 | |
| 510(k) Number | This submission | K192188 | |
| Spectral Imaging System<br>(CSDE-004A) | Available | N/A | Reference Predicate<br>Device: K132813 |
| • Scan Type | -Rapid kV Switching | | -Two consecutive volume<br>scans with short tube<br>voltage switching |
| • Scan Regions | -Abdomen and pelvis,<br>Chest and Extremities | | -Whole Body |
| • Spectral Reconstruction<br>Images | -Basis material image<br>-Monochromatic image<br>-Iodine Map<br>-VNC (virtual non-<br>contrast) image | | N/A |
| Advanced Intelligent Clear-IQ<br>Engine (AiCE) | Available | N/A | Reference Predicate<br>Device: K183046 |
| • Scan Regions | Abdomen and Pelvis<br>Chest<br>Cardiac<br>Extremities*<br>Brain*<br>Inner ear* | | Abdomen and Pelvis<br>Chest<br>Cardiac<br>*New scan regions |
| FIRST<br>(Forward projected model-<br>based Iterative Reconstruction<br>Solution) | Available | N/A | |
| Reconstruction processing<br>unit (CCRS-003A*) | Available | N/A | * Includes FIRST and AiCE |

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#### 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, IEC60601-1-4, 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 lonizing 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.

### Spectral Imaging Performance Testing - Bench

### 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, Standard Deviation of Noise (SD), Noise Power Spectra (NPS) and Low Contrast Detectability (LCD). It was concluded that the Spectral Images are substantially equivalent to the predicate device as demonstrated by the results of the above testing.

## Catphan and Body Phantom Evaluation

A side-by-side study was conducted to compare the image quality between the predicate dual energy scanning versus the subject Spectral Imaging scanning at varying dose levels.

Other studies using various phantoms were conducted to support the following Spectral Imaging claims:

- । Spectral Imaging reduces beam hardening artifact (relative to AIDR3D/FBP)
- । High linear correlation between CT number and iodine concentration

### Spectral Imaging Performance Testing – Clinical Images

Representative abdomen/pelvis, lung, and extremity Spectral Images, reviewed by an American Board Certified Radiologist, were obtained using the subject device and it was confirmed that the Spectral Imaging reconstructed images using the subject device were of diagnostic quality.

### Non-Spectral Imaging and AiCE Performance Testing – Bench

### 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),

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Modulation Transfer Function (MTF)-Wire, Standard Deviation of Noise (SD), Noise Power Spectra (NPS), Low Contrast Detectability (LCD) and Pediatric phantom/protocol. It was concluded that AiCE is substantially equivalent to the predicate device as demonstrated by the results of the above testing.

### Quantitative Body LCD, Noise Improvement, Dose Reduction

A model observer evaluation was conducted and the subject device demonstrated a dose reduction of 69-81% compared to filtered back projection, a 18.4% improvement in low contrast detectability and 32% noise reduction at the same dose for body AiCE compared to AIDR 3D.

Other studies using various phantoms were conducted to support the following claims:

- Streak and beam hardening artifacts appeared the same with AiCE as when FBP and AIDR 3D were used and additional artifacts were not introduced
- Twice the high contrast spatial resolution of AIDR 3D with reduced noise for AiCE Body Sharp at 10% of the MTF
- AiCE noise appearance/texture more similar to high dose filtered backprojection (compared to FIRST)
- AiCE noise appearance/texture more similar to filtered backprojection (compared to FIRST)
- AiCE has improved noise appearance/texture (compared to FIRST)
- AiCE has more natural noise texture (compared to FIRST)
- Effective 144 (180 with option) kW max. equivalent generator power with AIDR

### AiCE Imaging Performance Testing – Clinical Images

Representative abdomen/pelvis, brain, inner ear and extremity AiCE images were reviewed by an American Board Certified Radiologist. All images were obtained using the subject device and it was confirmed that the 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.

#### 17. CONCLUSION

The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System 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

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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.