(142 days)
Not Found
Yes
The summary explicitly states that "AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Network methods". Deep Convolutional Networks are a type of artificial intelligence/machine learning.
No.
This device is a diagnostic imaging system (CT scanner) used to acquire and display images for diagnostic purposes, not to directly treat a condition. While it can inform treatment decisions, it does not provide therapy itself.
Yes
Explanation: The "Intended Use / Indications for Use" section states: "This device is indicated to acquire and display cross-sectional volumes... These volume sets can be used to perform specialized studies... The Spectral Imaging System allows the system to acquire two nearly simultaneous CT images of an anatomical location... 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." These functions directly support the process of identifying diseases, conditions, or injuries, which is the definition of a diagnostic device. The "Clinical Images" in the performance studies also confirm it generates images of "diagnostic quality".
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." This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a CT scanner that acquires and displays cross-sectional volumes of the body using X-rays. It is an imaging device.
- Intended Use: The intended use is to acquire images for diagnostic purposes, but this is done by imaging the body directly, not by analyzing samples taken from the body.
- Device Description: The description details the components of a CT scanner (gantry, couch, console) and its function in capturing volume data sets.
- Performance Studies: The performance studies focus on image quality metrics (CNR, MTF, noise, etc.) and phantom studies, which are typical for imaging devices, not IVDs.
While the device provides information that can be used by a physician to determine a course of treatment (a diagnostic purpose), the mechanism by which it obtains this information is through imaging the body directly, not through in vitro analysis of biological samples.
No
The document 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, 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 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Aquilion ONE (TSX-306A/3) V10.4 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT
Anatomical Site
whole body, head, whole organs (brain, heart, pancreas), abdomen, pelvis, chest, cardiac, extremities, lung, 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)
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.
Dose Neutral
A phantom study was conducted using the MITA-FDA LCD Body phantom and the results demonstrated that Spectral 70keV was dose neutral with single energy AIDR 120KvP.
Noise Magnitude Reduction and Texture
A phantom study was conducted using phantoms comparing Spectral 70keV and AIDR 120kVp standard deviation results and it was determined that Spectral 70keV images had 50% noise reduction compared to same dose single energy images.
Contrast to Noise Ratio Improvement
A study using the 33cm Gammex dual energy CT phantom was conducted and it was determined that there was a 150% CNR improvement for iodine with Spectral 70keV relative to single energy AIDR, at the same dose.
Iodine Concentration Reduction
A study using the 33cm Gammex dual energy CT phantom with inserts of varying iodine concentration demonstrated that there was a 60% iodine concentration reduction at 60keV relative to 120kVp single energy AIDR.
Spectral Imaging Performance Testing - Clinical Images
Representative abdomen/pelvis, lung, extremity and cardiac 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.
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.
Not Found
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.
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March 24, 2021
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 & 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, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K203225
Trade/Device Name: Aquilion ONE (TSX-306A/3) V10.4 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: February 18, 2021 Received: February 22, 2021
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
1
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) K203225
Device Name
Aquilion ONE (TSX-306A/3) V10.4 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 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 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) | |
|---|---|
| 【区 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
-
- ESTABLISHMENT REGISTRATION: 9614698
OFFICIAL CORRESPONDENT/CONTACT PERSON: 3.
Fumiaki Teshima Senior Manager, Quality Assurance Department Canon Medical Systems Corporation
Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459
-
- DATE PREPARED:
October 30, 2020
- DATE PREPARED:
-
- TRADE NAME(S): Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
6. COMMON NAME:
System, X-ray, Computed Tomography
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 / DESCRIPTION:
JAK / Computed Tomography X-Ray System
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 ONE (TSX-
306A/3) V10.0 with
Spectral Imaging
System | Canon
Medical
Systems, USA | 21 CFR
§892.1750 | Computed
Tomography
X-ray System | JAK:
System, X-ray,
Tomography,
Computed | K192828 | 02/13/2020 |
11. REASON FOR SUBMISSION:
Modification of existing device to extend the range of the Spectral Imaging System to include cardiac and to improve image quality for existing Spectral scan regions.
12. DEVICE DESCRIPTION:
Aquilion ONE (TSX-306A/3) V10.4 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, 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. 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.
5
14. SUBSTANTIAL EQUIVALENCE:
The Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System is substantially equivalent to Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System, which received premarket clearance under K192828, 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) V10.4 with Spectral Imaging System includes changes made to the predicate device including addition of cardiac clinical region for the Spectral Imaging System, addition of marketing that Spectral offers the ability to optimize iodinated contrast media usage* , and image quality improvements to existing Spectral scan regions.
- Optimization of contrast usage is only recommended within the dosing ranges that appear in approved iodinated contrast drug labeling.
| Subject Device | Predicate Device | Comment | |
|---|---|---|---|
| Device Name, | |||
| Model Number | Aquilion ONE | ||
| (TSX-306A/3) V10.4 with | |||
| Spectral Imaging System | Aquilion ONE | ||
| (TSX-306A/3) V10.0 with | |||
| Spectral Imaging System | |||
| 510(k) Number | This submission | K192828 | |
| Spectral Imaging System | |||
| (CSDE-004A) | Available | Available | |
| • Scan Type | -Rapid kV Switching | -Rapid kV Switching | |
| • Scan Regions | -Abdomen and pelvis, | ||
| Chest, Extremities | |||
| and Cardiac | -Abdomen and pelvis, | ||
| Chest and Extremities | Addition of Cardiac | ||
| scan region and image | |||
| quality improvements | |||
| to existing regions | |||
| • Spectral Reconstruction | |||
| Images | -Basis material image | ||
| -Monochromatic | |||
| image | |||
| -Iodine Map | |||
| -VNC (virtual non- | |||
| contrast) image | -Basis material image | ||
| -Monochromatic | |||
| image | |||
| -Iodine Map | |||
| -VNC (virtual non- | |||
| contrast) image | |||
| • Metal Artifact | |||
| Reduction (MAR) | Available | N/A | |
| • ECG-gated scan | Available | N/A | |
| • Gantry tilt | Available | N/A | |
| • Rotation time | 0.275, 0.5, 0.75 and | ||
| 1.0 s | 0.5, 0.75 and 1.0 s |
A comparison of the technological characteristics between the subject and the predicate device is included below.
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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, 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]
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.
Dose Neutral
A phantom study was conducted using the MITA-FDA LCD Body phantom and the results demonstrated that Spectral 70keV was dose neutral with single energy AIDR 120KvP.
Noise Magnitude Reduction and Texture
A phantom study was conducted using phantoms comparing Spectral 70keV and AIDR 120kVp standard deviation results and it was determined that Spectral 70keV images had 50% noise reduction compared to same dose single energy images.
Contrast to Noise Ratio Improvement
A study using the 33cm Gammex dual energy CT phantom was conducted and it was determined that there was a 150% CNR improvement for iodine with Spectral 70keV relative to single energy AIDR, at the same dose.
lodine Concentration Reduction
A study using the 33cm Gammex dual energy CT phantom with inserts of varying iodine concentration demonstrated that there was a 60% iodine concentration reduction at 60keV relative to 120kVp single energy AIDR.
7
Spectral Imaging Performance Testing - Clinical Images
Representative abdomen/pelvis, lung, extremity and cardiac 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.
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) V10.4 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 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.