(161 days)
Yes
The device description explicitly mentions "AiCE (Advanced intelligent Clear-IQ Engine)" which "utilizes Deep Convolutional Network methods" and "By learning to differentiate structure from noise, the algorithm produces fast, high quality CT reconstruction." Deep Convolutional Networks are a type of machine learning algorithm.
No
The device is described as an imaging device (CT scanner) used for acquisition and display of images, and its intended use is to acquire and display cross-sectional volumes of the head for specialized studies. It does not mention treating or preventing any disease or condition.
Yes
The device is indicated to acquire and display cross-sectional volumes of the entire head, and these volume sets can be used "to perform specialized studies" by a trained physician, implying the use of these images for diagnostic purposes. Additionally, the clinical performance studies mention a "Review of representative body, cardiac and low dose chest images, as well as images of diseased patients with low contrast and small lesions, by an American Board Certified Radiologist. Confirmed reconstructed images were of diagnostic quality," which confirms its intended use in diagnostics.
No
The device description explicitly states it is a "whole body multislice 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, FIRST), 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 head and whole body using a CT scanner. This is a medical imaging device used for diagnostic purposes on the patient, not for testing samples in vitro (outside the body).
- Device Description: The description clearly outlines a CT scanner system (gantry, couch, console) and its components for acquiring and processing imaging data from the patient.
- Input Imaging Modality: The input is a Computed Tomography X-ray System, which is an in-vivo imaging modality.
- Anatomical Site: The device is used on the whole body and specific anatomical sites within the body.
- Performance Studies: The performance studies focus on image quality metrics (CNR, MTF, NPS, etc.) and clinical image review, which are relevant to the performance of an imaging device, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device operates directly on the patient to produce images.
No
The letter does not 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 the head. The Aquilion Precision 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.
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, lung, and cardiac applications.
Product codes
JAK
Device Description
Aquilion Precision (TSX-304A/4) V10.10 with AiCE is an ultra-high resolution whole body multislice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. Aquilion Precision incorporates a 160-row, 0.25 mm detector, a 5.7- MHU large-capacity tube, and 0.35 s scanning, enabling wide-range scanning with short scan times to capture cross sectional volume data sets used to perform specialized studies, using indicated software, c by a trained and qualified physician. In addition, the subject device incorporates the latest reconstruction technology, AiCE (Advanced intelligent Clear-IQ Engine), intended to reduce image noise and improve image quality by utilizing Deep Convolutional Network methods to 1024x1024 HR/SHR images. 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.
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.
FIRST: abdomen, pelvis, chest, cardiac, extremities and head applications.
AiCE: abdomen, pelvis, lung, and cardiac applications.
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 (SSPz), 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 conditions. AiCE is substantially equivalent to the predicate device as demonstrated by the results of the above testing.
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 claims that AiCE images have a more natural noise texture compared to FIRST images, AiCE noise texture is as natural as filtered backprojection and is distinct from MBIR images.
Quantitative Spatial Resolution Improvement: A spatial resolution comparison study was conducted to support a high contrast spatial resolution improvement claim of 16.5 lp/cm improvement for Body in HR mode, 10.5 lp/cm improvement for Cardiac in HR mode, 15 lp/cm improvement for Lung in HR mode and more than 10 lp/cm improvement across all AiCE available body regions, all compared to hybrid iterative reconstruction with conventional scanning at the same dose.
Dose Neutral/Equivalent LCD and High Contrast Spatial Resolution Improvement: A study was conducted comparing the Aquilion Precision in HR (High Resolution) mode with AiCE Body Sharp and AiCE Cardiac to the Aquilion Precision NR (Normal Resolution) mode with AIDR Body and AIDR Cardiac. Results of the study determined that High Resolution mode with AiCE is dose neutral relative to AIDR normal resolution mode, High Resolution mode with AiCE has equivalent Low Contrast Detectability relative to normal resolution mode and AiCE has equivalent Low Contrast Detectability with 10lp/cm more high contrast spatial resolution for body.
Lung Cancer Screening: CT image quality metrics were performed, utilizing phantoms, relevant to Lung Cancer Screening to assess CT Number Accuracy, Uniformity, Slice Sensitivity Profile (SSP), Modulation Transfer Function (MTF)-Edge, Standard Deviation of Noise (SD) and Noise Power Spectra (NPS). Results demonstrated that equivalent or improved performance for the Aquilion Precision in HR and SHR mode reconstructed with AiCE DLR, relative to the Aquilion ONE GENESIS with AIDR, for Lung Cancer Screening.
Performance Testing - Clinical Images
Representative body, cardiac and low dose chest images, as well as images of diseased patients with low contrast and small lesions, reviewed by an American Board Certified Radiologist, were obtained using the subject device and it was confirmed that the reconstructed images using the subject device were of diagnostic quality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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September 12, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 Sr. Manager, Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive TUSTIN CA 92780
Re: K220986
Trade/Device Name: Aquilion Precision (TSX-304A/4) V10.10 with AiCE Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: August 9, 2022 Received: August 11, 2022
Dear Orlando 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
1
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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Laurel Burk Assistant Director Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220986
Device Name
Aquilion Precision (TSX-304A/4) V10.10 with AiCE
Indications for Use (Describe)
This device is indicated to acquire and display cross-sectional volumes of the whole the head. The Aquilion Precision 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.
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, lung, and cardiac applications.
Type of Use (Select one or both, as applicable)
| Residential Use (Part 21 CFR 601.2 Subject Drugs) | |
|---|---|
| Commercial Use (Non-Subject Use) |
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
Made For life
-
- SUBMITTER'S NAME: Fumiaki Teshima Senior Manager, Quality Assurance Department Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
-
- ESTABLISHMENT REGISTRATION: 9614698
3. OFFICIAL CORRESPONDENT/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:
March 31, 2022
- DATE PREPARED:
5. TRADE NAME(S):
Aquilion Precision (TSX-304A/4) V10.10 with AiCE
COMMON NAME: 6.
Computed Tomography X-ray System
7. DEVICE CLASSIFICATION:
a) Classification Name: Computed Tomography X-ray system b) Regulation Number: 21 CFR §892.1750 c) Regulatory Class: Class II
8. PRODUCT CODE:
JAK
9. 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
10. PREDICATE DEVICE:
| Product | Marketed by | Regulation Number | Regulation
Name | Product Code | 510(k)
Number | Clearance
Date |
|-------------------------------------------------------------|----------------------------------|---------------------|----------------------------------------|---------------------------------------------------|------------------|-------------------|
| Aquilion Precision
(TSX-304A/1 and /2)
V8.8 with AiCE | Canon
Medical
Systems, USA | 21 CFR
§892.1750 | Computed
Tomography
X-ray System | JAK:
System, X-ray,
Tomography,
Computed | K182901 | July 5, 2019 |
11. REASON FOR SUBMISSION:
Modification of existing medical device
12. DEVICE DESCRIPTION:
Aquilion Precision (TSX-304A/4) V10.10 with AiCE is an ultra-high resolution whole body multislice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. Aquilion Precision incorporates a 160-row, 0.25 mm detector, a 5.7- MHU large-capacity tube, and 0.35 s scanning, enabling wide-range scanning with short scan times to capture cross sectional volume data sets used to perform specialized studies, using indicated software, c by a trained and qualified physician. In addition, the subject device incorporates the latest reconstruction technology, AiCE (Advanced intelligent Clear-IQ Engine), intended to reduce image noise and improve image quality by utilizing Deep Convolutional Network methods to 1024x1024 HR/SHR images. 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 Precision has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software, 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, and cardiac applications.
14. SUBSTANTIAL EQUIVALENCE:
The Aquilion Precision (TSX-304A/4) V10.10 with AiCE is substantially equivalent to Aquillion Precision (TSX-304A/1 and /2) V8.8 with AiCE, which received premarket clearance under K182901, and is marketed by Canon Medical Systems USA. The intended use of the Aquilion Precision is the same as that of the predicate device. The Aquilion Precision (TSX-304A/4) V10.10 with AiCE includes changes made to the predicate device that expand the use of AiCE to lung/cardiac applications and gantry tilt operability. The subject device has been retrained to fit for the updated/novel indications. A comparison of the technological characteristics between the subject and the predicate device is included below.
5
| Subject Device | Predicate Device | Comment | |
|---|---|---|---|
| Device Name, | |||
| Model Number | Aquilion Precision (TSX - | ||
| 304A/4) V10.10 with AiCE | Aquilion Precision (TSX - | ||
| 304A/1 and /2) V8.8 with AiCE | |||
| 510(k) Number | This submission | K182901 | |
| AiCE Modifications | |||
| ● Scan Regions | Abdomen and Pelvis / Chest / Cardiac | Abdomen and Pelvis | |
| ● Available Scan | |||
| Types | - Helical scan |
- Volume scan
- vHP* | - Helical scan
(Not applicable to tilt scans) - Volume scan
(Not applicable to W-Volume tilt scans) - vHP* |
| | ● ECG-gated scan | Available in BODY SHARP,
LUNG and CARDIAC | N/A |
| | ● Respiratory-
gated scan | Available in BODY SHARP,
LUNG and CARDIAC | N/A |
| | ● Applicable
anatomical
regions | - BODY and BODY SHARP
(For Abdomen and Pelvis) - LUNG (For Chest)
- CARDIAC (For Cardiac) | - BODY (For Abdomen and
Pelvis) |
| | ● Image thickness | 0.25, 0.5, 1, 2, 3*, 4, 5, 7*, 8
and 10 mm | 0.25 and 0.5 mm |
| | ● Magnified
reconstruction -
Available
magnification
Size (D-FOV) | BODY / BODY SHARP: Min.
100 mm
LUNG: Min. 100 mm
CARDIAC: Min. 70 mm
Max. 500 mm | Min. 100 mm
Max. 500 mm |
| | Gantry tilt | ±30°
Axial and helical scanning
• Tilt scans are applicable
with AiCE BODY SHARP,
LUNG and CARDIAC
• For BODY parameters,
ECG-gated scan,
respiratory-gated scan,
W-Volume tilt scan and
tilt helical scan cannot be
applied | ±30°
Axial and helical scanning
• Helical and W-Volume tilt
scans are not applicable
with AiCE |
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| Subject Device | Predicate Device | Comment | |
|---|---|---|---|
| Device Name, | |||
| Model Number | Aquilion Precision (TSX - | ||
| 304A/4) V10.10 with AiCE | Aquilion Precision (TSX - | ||
| 304A/1 and /2) V8.8 with AiCE | |||
| 510(k) Number | This submission | K182901 | |
| Console | AiCE/FIRST (CCRS-003B) can | ||
| be installed in the console | |||
| unit | Separate unit, I-REC BOX, was | ||
| used as the AiCE/FIRST (CCRS- | |||
| 002A) server |
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, IEC60601-1-2, 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]
16. 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 (SSPz), 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 conditions. AiCE is substantially equivalent to the predicate device as demonstrated by the results of the above testing.
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 claims that AiCE images have a more natural noise texture compared to FIRST images, AiCE noise texture is as natural as filtered backprojection and is distinct from MBIR images.
Quantitative Spatial Resolution Improvement
A spatial resolution comparison study was conducted to support a high contrast spatial resolution improvement claim of 16.5 lp/cm improvement for Body in HR mode, 10.5 lp/cm improvement for Cardiac in HR mode, 15 lp/cm improvement for Lung in HR mode and more than 10 lp/cm improvement across all AiCE available body regions, all compared to hybrid iterative reconstruction with conventional scanning at the same dose.
7
Dose Neutral/Equivalent LCD and High Contrast Spatial Resolution Improvement A study was conducted comparing the Aquilion Precision in HR (High Resolution) mode with AiCE Body Sharp and AiCE Cardiac to the Aquilion Precision NR (Normal Resolution) mode with AIDR Body and AIDR Cardiac. Results of the study determined that High Resolution mode with AiCE is dose neutral relative to AIDR normal resolution mode, High Resolution mode with AiCE has equivalent Low Contrast Detectability relative to normal resolution mode and AiCE has equivalent Low Contrast Detectability with 10lp/cm more high contrast spatial resolution for body.
Lung Cancer Screening
CT image quality metrics were performed, utilizing phantoms, relevant to Lung Cancer Screening to assess CT Number Accuracy, Uniformity, Slice Sensitivity Profile (SSP), Modulation Transfer Function (MTF)-Edge, Standard Deviation of Noise (SD) and Noise Power Spectra (NPS). Results demonstrated that equivalent or improved performance for the Aquilion Precision in HR and SHR mode reconstructed with AiCE DLR, relative to the Aquilion ONE GENESIS with AIDR, for Lung Cancer Screening.
Performance Testing - Clinical Images
Representative body, cardiac and low dose chest images, as well as images of diseased patients with low contrast and small lesions, reviewed by an American Board Certified Radiologist, were obtained using the subject device and it was confirmed that the reconstructed images using the subject device were of diagnostic quality.
A summary of the risk analysis and verification/validation testing conducted through bench and clinical testing is included in this submission which demonstrates that the requirements for the system have been met.
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 in 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.
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.
17. CONCLUSION
The Aquilion Precision (TSX-304A/4) V10.10 with AiCE 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.