(84 days)
Not Found
Yes
The device description explicitly mentions "AiCE (Advanced intelligent Clear-IQ Engine), intended to reduce image noise and improve image quality by utilizing Deep Convolutional Neural Network methods". Deep Convolutional Neural Networks are a type of machine learning algorithm.
No.
The device is indicated for acquiring and displaying cross-sectional volumes for diagnostic purposes, not for treating conditions.
Yes
The device "acquire[s] and display[s] cross-sectional volumes of the whole the head" and the volume sets "can be used to perform specialized studies." The performance studies include "Image Quality Evaluation utilizing phantoms to assess CNR, CT Number Accuracy, Uniformity, SSPz, MTF-Wire, MTF-Edge, SD, NPS, LCD and Pediatric conditions" and "Quantitative Spatial Resolution Improvement study to support high contrast spatial resolution improvement claim for Bone, Inner Ear, and Brain CTA." These indicate the device is used to produce diagnostic images.
No
The device description clearly states it is a "whole body multislice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display." This indicates it 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. CT scanners acquire images of the inside of the body using X-rays. This is an in vivo (within the living body) diagnostic imaging technique, not an in vitro test.
- Intended Use: The intended use is to "acquire and display cross-sectional volumes of the whole the head" and perform specialized studies using these volumes. This aligns with the function of a medical imaging device.
- Device Description: The description details the components of a CT scanner (gantry, couch, console, detector, tube) and its imaging capabilities.
- Performance Studies: The performance studies focus on image quality metrics (CNR, CT Number Accuracy, MTF, etc.) and clinical image review, which are relevant to the performance of an imaging device.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" explicitly states "Not Found".
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 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 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 Precision (TSX-304A/4) V10.14 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/hardware, by a trained and qualified physician. In addition, the subject device incorporates the latest reconstruction technology, FIRST, intended to reduce exposure dose while maintaining and/or improving image quality as well as, AiCE (Advanced intelligent Clear-IQ Engine), intended to reduce image noise and improve image quality by utilizing Deep Convolutional Neural 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
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, extremities, head, and inner ear applications.
AiCE (Advanced intelligent Clear-IQ Engine), intended to reduce image noise and improve image quality by utilizing Deep Convolutional Neural Network methods to 1024x1024 HR/SHR images.
Input Imaging Modality
Computed Tomography X-ray
Anatomical Site
whole body, head, 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)
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.
Quantitative Spatial Resolution Improvement:
A spatial resolution comparison study was conducted to support a high contrast spatial resolution improvement claim of 5.37 lp/cm improvement for Bone in HR mode, 7.50 lp/cm improvement for Inner Ear in HR mode, and 11.31 lp/cm improvement for Brain CTA in HR mode, all compared to hybrid iterative reconstruction at 10% MTF and at the same dose.
Performance Testing – Clinical Images:
Representative Abdomen Bone, Brain CTA, and Inner Ear images, 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): 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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 7, 2023
Canon Medical Systems Corporation % Orlando Tadeo Sr. Manager, Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive TUSTIN, CA 92780
Re: K223726
Trade/Device Name: Aquilion Precision (TSX-304A/4) V10.14 with AiCE Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: February 14, 2023 Received: February 15, 2023
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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of 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)
Device Name
Aquilion Precision (TSX-304A/4) V10.14 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 Network methods for abdomen, pelvis, lung, cardiac, 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: 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: November 29, 2022
- TRADE NAME(S): Aquilion Precision (TSX-304A/4) V10.14 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/4) V10.10 | ||||||
| with AiCE | Canon | |||||
| Medical | ||||||
| Systems, USA | 21 CFR | |||||
| §892.1750 | Computed | |||||
| Tomography | ||||||
| X-ray System | JAK: | |||||
| System, X-ray, | ||||||
| Tomography, | ||||||
| Computed | K220986 | September | ||||
| 12, 2022 |
11. REASON FOR SUBMISSION:
Modification of existing medical device
12. DEVICE DESCRIPTION:
Aquilion Precision (TSX-304A/4) V10.14 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/hardware, by a trained and qualified physician. In addition, the subject device incorporates the latest reconstruction technology, FIRST, intended to reduce exposure dose while maintaining and/or improving image quality as well as, AiCE (Advanced intelligent Clear-IQ Engine), intended to reduce image noise and improve image quality by utilizing Deep Convolutional Neural 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, cardiac, extremities, head, and inner ear applications.
14. SUBSTANTIAL EQUIVALENCE:
The Aquilion Precision (TSX-304A/4) V10.14 with AiCE is substantially equivalent to Aquillion Precision (TSX-304A/4) V10.10 with AiCE, which received premarket clearance under K220986, 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) V10.14 with AiCE includes changes made to the predicate device that expand the use of AiCE to extremities, head, and inner ear applications. A comparison of the technological characteristics between the subject and the predicate device is included below.
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| Subject Device | Predicate Device | Comment | |
|---|---|---|---|
| Device Name, | |||
| Model Number | Aquilion Precision (TSX- | ||
| 304A/4) V10.14 with AiCE | Aquilion Precision (TSX- | ||
| 304A/4) V10.10 with AiCE | |||
| 510(k) Number | This submission | K220986 | |
| AiCE Modifications | |||
| • Scan Regions | Abdomen and Pelvis/ | ||
| Chest/Cardiac/ | |||
| Extremities*/Brain*/ | |||
| Inner Ear* | Abdomen and Pelvis/ | ||
| Chest/Cardiac | *Added | ||
| • Magnified | |||
| reconstruction - | |||
| Available | |||
| magnification | |||
| Size (D-FOV) | BODY / BODY SHARP: | ||
| Min. 100 mm |
LUNG:
Min. 100 mm
CARDIAC:
Min. 70 mm
BONE / INNER EAR:
Min. 50 mm
BRAIN CTA:
Min. 100 mm
Max. 500 mm | BODY / BODY SHARP:
Min. 100 mm
LUNG:
Min. 100 mm
CARDIAC:
Min. 70 mm
Max. 500 mm | The minimum FOV
differs depending
on the anatomical
region. |
| • Reconstruction
processing
system [AiCE]
(CSAL-002A) | Option
[Reconstruction Processing
Unit required] | N/A
[AiCE implemented with
Reconstruction Processing
Unit (CCRS-003B)] | |
| • Applicable
anatomical
regions | • BODY and BODY SHARP
(For Abdomen and
Pelvis)
• LUNG (For Chest)
• CARDIAC (For Cardiac)
• BONE (For extremities)*
• BRAIN CTA (For brain)*
• INNER EAR (For inner
ear)* | • BODY and BODY SHARP
(For Abdomen and
Pelvis)
• LUNG (For Chest)
• CARDIAC (For Cardiac) | *Added |
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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.
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.
Quantitative Spatial Resolution Improvement
A spatial resolution comparison study was conducted to support a high contrast spatial resolution improvement claim of 5.37 lp/cm improvement for Bone in HR mode, 7.50 lp/cm improvement for Inner Ear in HR mode, and 11.31 lp/cm improvement for Brain CTA in HR mode, all compared to hybrid iterative reconstruction at 10% MTF and at the same dose.
Performance Testing – Clinical Images
Representative Abdomen Bone, Brain CTA, and Inner Ear images, 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 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.
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17. CONCLUSION
The Aquilion Precision (TSX-304A/4) V10.14 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.