(194 days)
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.
The Aquilion Lightning 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, cardiac, extremities, head and inner ear applications.
The Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i is an 80-row CT system that is a whole body, multi-slice helical CT scanner, consisting of a gantry, couch and 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. 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 (DCNN) methods. This reconstruction algorithm is predicated on AiCE reconstruction algorithm previously 510(k) cleared per K192832 on the Canon CT scanner Aquilion Prime SP (TSX-303B/8) V10.2 with AiCE-i, which serves as a reference predicate for this submission. The DCNN 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 for every patient.
The provided text describes a 510(k) premarket notification for the "Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i" system. The acceptance criteria and the study proving the device meets them are outlined, primarily focusing on phantom studies rather than clinical performance for the new AiCE-i feature.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Metric | Predicate Performance (Baseline) | Reported Device Performance (AiCE-i) |
|---|---|---|---|
| Image Quality (Phantom Study) | Contrast-to-Noise Ratios (CNR) | Not explicitly stated, inferred from predicate equivalence | Found substantially equivalent to predicate |
| CT Number Accuracy | Not explicitly stated, inferred from predicate equivalence | Found substantially equivalent to predicate | |
| Uniformity | Not explicitly stated, inferred from predicate equivalence | Found substantially equivalent to predicate | |
| Slice Sensitivity Profile (SSP) | Not explicitly stated, inferred from predicate equivalence | Found substantially equivalent to predicate | |
| Modulation Transfer Function (MTF)-Wire | Not explicitly stated, inferred from predicate equivalence | Found substantially equivalent to predicate | |
| Standard Deviation of Noise (SD) | Not explicitly stated, inferred from predicate equivalence | Found substantially equivalent to predicate | |
| Noise Power Spectra (NPS) | Not explicitly stated, inferred from predicate equivalence | Found substantially equivalent to predicate | |
| Low Contrast Detectability (LCD) | Not explicitly stated (for phantom study) | Found substantially equivalent to predicate | |
| Quantitative Spatial Resolution (Phantom Study) | High Contrast Spatial Resolution | AIDR 3D performance | Double the high contrast spatial resolution versus AIDR 3D for body (AiCE Body Sharp) |
| Quantitative Body LCD, Noise Improvement & Dose Reduction (Phantom Study) | Low Contrast Detectability (Body) | Not explicitly stated | 15% improved low contrast detectability compared to AIDR 3D (at the same dose) |
| Noise Reduction (Body) | AIDR 3D performance | 29% noise reduction compared to AIDR 3D (at the same dose) | |
| Dose Reduction | FBP performance | Up to 82.9% dose reduction, relative to FBP | |
| Noise Appearance/Texture | Noise appearance/texture | Filtered Back Projection (FBP) | Similar to filtered backprojection |
| Overall Equivalence | Substantial Equivalence to Predicate | Aquilion Lightning (TSX-036A/1) V8.4 (K170019) | Demonstrated |
| Safety and Standards Compliance | Compliance with Medical Device Standards | Various IEC, NEMA, and CFR standards | Conformance demonstrated |
| Software Validation | Software Documentation (Moderate Level of Concern) | Not applicable (new feature) | Verification and validation met |
| Cybersecurity | Cybersecurity Documentation | Not applicable (new feature) | Documentation included |
2. Sample size used for the test set and the data provenance
The document does not mention clinical test sets or human subject data. All performance claims for the AiCE-i feature are based on phantom studies. Therefore, there is no information about data provenance (country of origin, retrospective/prospective) or sample size in terms of patient numbers.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The evaluation was based on phantom studies and quantitative measurements, not expert interpretation of clinical images.
4. Adjudication method for the test set
Not applicable, as the evaluation was based on phantom studies and quantitative measurements, not expert interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done or reported. The document explicitly states: "It was determined that representative clinical images were not necessary to demonstrate substantial equivalence of the subject device." The focus was on demonstrating the technical performance of the AiCE-i algorithm using phantoms.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance evaluation primarily focused on the standalone performance of the AiCE-i algorithm as applied to phantom images. The reported improvements in spatial resolution, low contrast detectability, and noise reduction are algorithm-only metrics.
7. The type of ground truth used
The ground truth used was based on phantom measurements. These are objective, reproducible physical properties measured from the phantom, rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set
The document does not specify the sample size for the training set used for the Deep Convolutional Network (DCNN) methods of AiCE-i. It mentions that AiCE-i is predicated on the AiCE reconstruction algorithm previously cleared under K192832, implying it leverages that established training.
9. How the ground truth for the training set was established
The document does not explicitly state how the ground truth for the training set was established. It describes AiCE as "learning to differentiate structure from noise" using DCNN methods. Typically, for such deep learning models, the training ground truth involves pairs of noisy and "clean" or "reference" images, where the "clean" image serves as the ground truth. This could be generated through various methods, such as extremely low-noise scans, statistical models, or simulations, but the specific method is not detailed here.
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January 12, 2021
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Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K201836
Trade/Device Name: Aquilion Lightning (TSX-036A/7) 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: December 9, 2020 Received: December 10, 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 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 (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
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Indications for Use
510(k) Number (if known)
K201836
Device Name
Aquilion Lightning (TSX-036A/7) V10.2 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 Lightning 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, cardiac, extremities, head and inner ear applications.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Made For life
510(k) SUMMARY
SUBMITTER'S NAME: Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
2. OFFICIAL CORRESPONDENT: Fumiaki Teshima Senior Manager, Quality Assurance Department
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:
June 30, 2020
6. TRADE NAME(S):
Aquilion Lightning (TSX-036A/7) 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: 800-421-1968 2441 Michelle Drive, Tustin, CA 92780
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10. PREDICATE DEVICE:
| Product | Marketed by | RegulationNumber | RegulationName | Product Code | 510(k)Number | Clearance Date |
|---|---|---|---|---|---|---|
| Aquilion Lightning,TSX-036A/1, V8.4(Primary PredicateDevice) | CanonMedicalSystems, USA | 21 CFR892.1750 | ComputedTomographyX-ray System | JAK:System, X-ray,Tomography,Computed | K170019 | February 2, 2017 |
| Aquilion Prime SP(TSX-303B/8) V10.2with AiCE-i(Reference Device) | CanonMedicalSystems, USA | 21 CFR892.1750 | ComputedTomographyX-ray System | JAK:System, X-ray,Tomography,Computed | K192832 | February 21, 2020 |
11. REASON FOR SUBMISSION:
Modification of a cleared device
12. DEVICE DESCRIPTION:
Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i. The Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i is an 80-row CT system that is a whole body, multi-slice helical CT scanner, consisting of a gantry, couch and 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. 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 (DCNN) methods. This reconstruction algorithm is predicated on AiCE reconstruction algorithm previously 510(k) cleared per K192832 on the Canon CT scanner Aquilion Prime SP (TSX-303B/8) V10.2 with AiCE-i, which serves as a reference predicate for this submission. The DCNN 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 for every patient.
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 Lightning 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.
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14. SUBSTANTIAL EQUIVALENCE:
The Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i, is substantially equivalent to the Aquillion Lightning (TSX-036A/1) V8.4, which received premarket clearance under K170019 and is marketed by Canon Medical Systems USA. The intended use of the Aquilion Lightning is the same as that of the predicate device. The changes made to the subject device include the addition of AiCE-i (Advanced intelligent Clear-IQ Engine-integrated), a reconstruction algorithm that utilizes Deep Convolutional Neural Network methods to reduce image noise and improve image quality, previously cleared under K192832. A comparison of the technological characteristics between the subject and the predicate device is included below.
| Item | Aquilion Lightning (TSX-036A/7) V10.2with AiCE-i | Aquilion Lightning (TSX-036A/1) V8.4 |
|---|---|---|
| 510(k) ClearanceNumber | N/A | K170019 |
| Anatomical Region | AIDR 3D (Whole Body) | AIDR 3D (Whole Body) |
| Noise ReductionProcessing | AiCE (Abdomen and Pelvis, Chest,Cardiac, Extremities, Brain, Inner ear)AIDR 3DAIDR 3D EnhancedQuantum Denoising Smoothing (QDS)AiCE | AIDR 3DAIDR 3D EnhancedQuantum Denoising Smoothing (QDS) |
| Processingcapability | Console CKCN-020CReconstruction processing system(AiCE-i: CSAL-001A) | Console CKCN-020CReconstruction processing system(N/A) |
| Image QualityClaim | - Improved Quantitative high contrastSpatial Resolution over AIDR 3D withreduced noise- Improved Quantitative Dose Reductionover FBP- Better Low-contrast Detectability thanAIDR 3D for abdomen at the samedose-Noise appearance/texture similar tofiltered backprojection | -N/A |
| Operating System | Microsoft Windows 10 | Microsoft Windows 10 |
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.
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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.
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), Low Contrast Detectability (LCD). It was concluded that the AiCE-i images are substantially equivalent to the predicate device as demonstrated by the results of the above testing.
Quantitative Spatial Resolution
A phantom study was conducted to compare spatial resolution performance between AiCE, filtered backprojection and AIDR 3D. It was determined that there is double the high contrast spatial resolution versus AIDR 3D for body (AiCE Body Sharp).
Quantitative Body LCD, Noise Improvement and Dose Reduction
A dose reduction study was conducted using AiCE and based on the results, a dose reduction claim of up to 82.9%, relative to FBP, is supported as well as 15% improved low contrast detectability and noise reduction of 29% at the same dose for body compared to AIDR 3D.
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 included as part of this submission. This documentation includes justification for the Moderate Level of Concern determination as well as testing which demonstrates that the verification and validation requirements for the modifications described above have been met.
It was determined that representative clinical images were not necessary to demonstrate substantial equivalence of the subject device.
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 Lightning (TSX-036A/7) V10.2 with AiCE-i is substantially equivalent to Aquilion Lightning (TSX-036A/1) V8.4, which was cleared via Pre-Market Notification 510(k), K170019. The
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Aquilion Lightning (TSX-036A/7) 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.
§ 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.