(88 days)
Yes
The device description explicitly mentions "AiCE (Advanced Intelligent Clear-IQ Engine)" which employs "Deep Convolutional Network methods," a type of machine learning.
No
The device is a CT scanner used for acquiring and displaying cross-sectional images for diagnostic purposes, not for treating conditions.
Yes
This device is a whole body multi-slice helical CT scanner used to acquire and display cross-sectional volumes of the whole body. It generates volume sets that can be used to perform specialized studies by a trained and qualified physician, which is indicative of a diagnostic purpose.
No
The device description explicitly states it is a "whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display," which are hardware components. While it includes software (AiCE), it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "acquire and display cross-sectional volumes of the whole body" and perform "specialized studies" using the acquired data. This describes an imaging device used for diagnostic purposes on the patient, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description clearly states it is a "whole body multi-slice helical CT scanner." CT scanners are imaging devices that work by sending X-rays through the body and detecting the attenuation of those X-rays to create images. This is an in vivo process.
- Input Imaging Modality: The input is "Computed Tomography X-ray," which is an imaging technique applied directly to the patient.
- Anatomical Site: The device is used on the "whole body," indicating it interacts directly with the patient's anatomy.
IVD devices are used to examine specimens such as blood, urine, tissue, etc., outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform such functions.
No
The input letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Exceed LB 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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Aquilion Exceed LB (TSX-202A/3) V10.9 with AiCE-i (Advanced intelligent Clear-IQ Engineintegrated) 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, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Computed Tomography X-ray system
Anatomical Site
whole body, to include the head, abdomen, pelvis, lung, cardiac, extremities, head and inner ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained and qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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), Standard Deviation of Noise (SD), Noise Power Spectra (NPS) and Low Contrast Detectability (LCD). It was concluded that the Aquilion Exceed LB system demonstrated substantially equivalent or improved performance relative to the predicate device as demonstrated by the results of the above testing.
Dual Energy - Electron Density:
Phantom studies were conducted using the CBCT Electron Density Phantom and the results demonstrated that the mean and SD error between the measured and true Electron Density values fall within the established criteria and that precise electron density accuracy is maintained throughout the field of view with monoenergetic images.
Dual Energy – Effective Atomic Number Map:
A phantom study was conducted using the Catphan 700 phantom and the results demonstrated that the mean and SD error between the measured and true Effective atomic number images fall within the established accuracy criteria.
Dual Energy - CT Number Accuracy:
A phantom study was conducted using the Catphan 600 phantom and the results demonstrated that precise CT number accuracy is maintained throughout the field of view on 70keV monoenergetic images.
Representative cardiac 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
0
September 10, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION".
Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive TUSTIN CA 92780
Re: K211828
Trade/Device Name: Aquilion Exceed LB (TSX-202A/3) V10.9 with AiCE-i Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 20, 2021 Received: August 23, 2021
Dear Orlando Tadeo, Jr.:
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 (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) K211828
Device Name
Aquilion Exceed LB (TSX-202A/3) V10.9 with AiCE-i
Indications for Use (Describe)
This device is indicated to acquire and display cross-sectional volumes of the whole the head. The Aquilion Exceed LB has the capability to provide 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, extremities, head and inner ear applications.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
-
- SUBMITTER'S NAME: Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
-
- OFFICIAL CORRESPONDENT: Fumiaki Teshima Senior Manager, Quality Assurance Department
-
- 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
-
- DATE PREPARED:
June 11, 2021
- DATE PREPARED:
-
- TRADE NAME(S): Aquilion Exceed LB (TSX-202A/3) V10.9 with AiCE-i
7. COMMON NAME:
Computed Tomography X-ray system
8. DEVICE CLASSIFICATION:
a) Classification Name: Computed Tomography X-ray system b) Regulation Number: 21 CFR §892.1750 c) Regulatory Class: Class II
-
- PRODUCT CODE:
JAK
- PRODUCT CODE:
10. PERFORMANCE STANDARD:
This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]
PHONE: 800-421-1968 2441 Michelle Drive, Tustin, CA 92780
4
11. PREDICATE DEVICE:
| Product | Marketed by | Regulation
Number | Regulation
Name | Product Code | 510(k)
Number | Clearance
Date |
|---------------------------------------------------------------------|----------------------------------|----------------------|----------------------------------------|---------------------------------------------------|------------------|-------------------|
| Primary:
Aquilion Exceed LB
(TSX-202A/3) V10.6
with AiCE-i | Canon
Medical
Systems, USA | 21 CFR
§892.1750 | Computed
Tomography
X-ray System | JAK:
System, X-ray,
Tomography,
Computed | K203042 | 12/10/2020 |
| Reference:
Dual Energy System
Package, CSDP-001A | Canon
Medical
Systems, USA | 21 CFR
§892.1750 | Computed
Tomography
X-ray System | JAK:
System, X-ray,
Tomography,
Computed | K132813 | 02/06/2014 |
12. REASON FOR SUBMISSION:
Modification of an existing device to expand the clinical use of AiCE to cardiac applications
13. DEVICE DESCRIPTION:
Aquilion Exceed LB (TSX-202A/3) V10.9 with AiCE-i (Advanced intelligent Clear-IQ Engineintegrated) 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, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon 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. The Aquilion Exceed LB 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.
15. SUBSTANTIAL EQUIVALENCE:
The Aquilion Exceed LB (TSX-202A/3) V10.9 with AiCE-i is substantially equivalent to Aquillion Exceed LB (TSX-202A/3) V10.6 with AiCE-i, which received premarket clearance under K203042, and is marketed by Canon Medical Systems USA. The changes made to the subject device include expansion of the clinical use of AiCE to include cardiac applications (previously cleared under K192832), introduction of Dual Energy imaging (originally cleared under K132813) including new features and implementation of SOREStart and Single Energy Metal Artifact Reduction (SEMAR) to the XL scan field. A comparison of the technological characteristics between the subject and the predicate device is included below.
| Subject Device | Primary Predicate Device | |
|---|---|---|
| Device Name, | ||
| Model Number | Aquilion Exceed LB | |
| (TSX-202A/3) V10.9 with AiCE-i | Aquilion Exceed LB | |
| (TSX-202A/3) V10.6 with AiCE-i | ||
| 510(k) Number | This submission | K203042 |
| SUREStart | 12 measurements/s | |
| Applicable to the XL scan field. | 12 measurements/s | |
| Subject Device | Primary Predicate Device | |
| Device Name, Model Number | Aquilion Exceed LB | |
| (TSX-202A/3) V10.9 with AiCE-i | Aquilion Exceed LB | |
| (TSX-202A/3) V10.6 with AiCE-i | ||
| 510(k) Number | This submission | K203042 |
| Parameter editing | Up to 7 pairs of Volume and | |
| Multiview reconstructions can be | ||
| prescribed. | Up to 3 pairs of Volume and | |
| Multiview reconstructions can be | ||
| prescribed. | ||
| Metal Artifact Reduction | Single Energy Metal Artifact | |
| Reduction (SEMAR) | ||
| Applicable to the XL scan field. | Single Energy Metal Artifact | |
| Reduction (SEMAR) | ||
| Noise Reduction | ||
| Processing | Quantum Denoising Software | |
| (QDS) | ||
| Adaptive Integrative Dose | ||
| Reduction 3D (AIDR 3D), | ||
| AIDR 3D Enhanced |
AiCE
(Advanced Intelligent Clear - IQ
Engine)
• Abdomen and Pelvis
• Chest
• Extremities
• Brain
• Inner ear
• Cardiac | Quantum Denoising Software
(QDS)
Adaptive Integrative Dose
Reduction 3D (AIDR 3D),
AIDR 3D Enhanced
AiCE
(Advanced Intelligent Clear - IQ
Engine)
• Abdomen and Pelvis
• Chest
• Extremities
• Brain
• Inner ear |
| Dual energy system
package
(CSDP-001A) | Available
New Features:
Generation of Electron Density
Map
Generation of Effective Atomic
Number Map | N/A |
| Extended field of view
(CSTC-005A) | Available
Can be set with SEMAR | Available |
| Magnified
reconstruction -
Available magnification
Size (D-FOV) | BODY / BODY SHARP: Min. 100 mm
LUNG: Min. 100 mm
BONE: Min. 50 mm
INNER EAR: Min. 50 mm
BRAIN LCD / CTA: Min. 100 mm
CARDIAC: Min. 70 mm
Max. 700 (900*) mm
Option | BODY / BODY SHARP: Min. 100
mm
LUNG: Min. 100 mm
BONE: Min. 50 mm
INNER EAR: Min. 50 mm
BRAIN LCD / CTA: Min. 100 mm
Max. 700 (900) mm
*Option |
5
6
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 following standards IEC60601-1, IEC60601-1-3, IEC60601-1-6, IEC60601-1-6, IEC60601-1-9, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, 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]
17. TESTING
Risk analysis and verification/validation activities conducted through bench testing demonstrate that the established specifications for the device have been met.
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), Standard Deviation of Noise (SD), Noise Power Spectra (NPS) and Low Contrast Detectability (LCD). It was concluded that the Aquilion Exceed LB system demonstrated substantially equivalent or improved performance relative to the predicate device as demonstrated by the results of the above testing.
Dual Energy - Electron Density
Phantom studies were conducted using the CBCT Electron Density Phantom and the results demonstrated that the mean and SD error between the measured and true Electron Density values fall within the established criteria and that precise electron density accuracy is maintained throughout the field of view with monoenergetic images.
Dual Energy – Effective Atomic Number Map
A phantom study was conducted using the Catphan 700 phantom and the results demonstrated that the mean and SD error between the measured and true Effective atomic number images fall within the established accuracy criteria.
Dual Energy - CT Number Accuracy
A phantom study was conducted using the Catphan 600 phantom and the results demonstrated that precise CT number accuracy is maintained throughout the field of view on 70keV monoenergetic images.
Representative cardiac 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.
7
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.
18. CONCLUSION
The Aquilion Exceed LB (TSX-202A/3) V10.9 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.