(29 days)
No
The summary focuses on the mechanical and system integration aspects of a movable gantry base for a CT system, with no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is described as an optional movable gantry base unit for a CT system, designed to support longitudinal movement and allow image acquisition in the z-direction. Its purpose is for imaging, not for treating a condition or disease.
Yes
The device enables the acquisition of images in the z-direction (z-axis) using an Aquilion ONE (TSX-305A) system, which is a dynamic volume CT system. Image acquisition is a core function of diagnostic devices.
No
The device description explicitly details hardware components like a movable gantry base unit, a self-propelled scan base kit, and modifications to the physical system for longitudinal movement and image acquisition in the z-direction. It also mentions replacing the standard CT patient couch with a patient handling system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a movable gantry base unit for a CT system to support longitudinal movement and allow image acquisition in the z-direction. This is a mechanical component that facilitates imaging, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a mechanical kit that attaches to a CT gantry to enable movement and image acquisition. It explicitly states that the intended uses and technological characteristics of the base CT and interventional x-ray systems remain the same, and no modifications were made to the imaging chains.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
The device is clearly described as a component of an imaging system used for interventional procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Optional movable gantry base unit for use with an Aquilion ONE (TSX-305A) system to support longitudinal movement and allow acquisition of images in the z-direction (z-axis).
Note: When installed with the movable gantry base unit, Aquilion ONE can be used with the INFX-8000C system in the same room.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The Infinix 4DCT is composed of the INFX-8000C interventional angiography system and the dynamic volume CT system, Aquilion ONE, TSX-305A/3. This combination enables patient access and efficient workflow for interventional procedures. Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A, is an optional kit intended to be used in conjunction with an Aquilion ONE / INFX-8000C based IVR-CT system. This device is attached to the Aquilion ONE CT gantry to support longitudinal movement and allow image acquisition in the z-direction (Z-axis), both axial and helical. When this option is installed, the standard CT patient couch is replaced with the patient handling system utilized by the interventional x-ray system, INFX-8000C. The Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A, will be used as part of an Aquilion ONE / INFX-8000C based IVR-CT system. Please note, the intended uses and technological characteristics of the Aquilion ONE CT System and the INFX-8000C Interventional X-Ray System remain the same. There have been no modifications made to the imaging chains in these FDA cleared devices and the base system software remains the same. Since both systems will be installed in the same room and to prevent interference during use, system interlocks have been incorporated into the systems.
Please note: The terms "Self-Propelled Scan Base", "Moving Base" and "Movement Base" are used interchangeably throughout this submission. They all refer to the same unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
This submission includes summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met. Evaluation of the modified device included, but was not limited to, confirmation that base movement speed, stop position accuracy, scanogram and axial/helical scan functions, and interlocks including contact detection, emergency stop and slide running performed according to specifications.
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.
Additionally, testing of the modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 14, 2018
Canon Medical Systems USA Orlando Tadeo Sr. Manager, Regulatory Affairs 2441 Michelle Drive TUSTIN, CA 92780
Re: K182223
Trade/Device Name: Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 15, 2018 Received: August 16, 2018
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely.
Hole 2. Nils
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
Indications for Use (Describe)
Optional movable gantry base unit for use with an Aquilion ONE (TSX-305A) system to support longitudinal movement and allow acquisition of images in the z-direction (z-axis).
Note: When installed with the movable gantry base unit, Aquilion ONE can be used with the INFX-8000C system in the same room.
Type of Use (Select one or both, as applicable)
| 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: 1. Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550
-
- OFFICIAL CORRESPONDENT Naofumi Watanabe
-
- ESTABLISHMENT REGISTRATION: 9614698
4. CONTACT PERSON:
Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive Tustin, CA 92780 otadeo@us.medical.canon (714) 669-7459
-
- Date Prepared: August 15, 2018
-
- TRADE NAME(S): Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
COMMON NAME: 7.
Computed Tomography X-Ray System
8. DEVICE CLASSIFICATION:
Regulatory Class: II Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System 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 |
|----------------------------------------------------------------------------|------------------------------------|----------------------|-------------------------------------------------------|-----------------|------------------|------------------|
| CGBA-032A,
Aquilion PRIME
Self-Propelled Scan
Base Kit for IVR-CT | Canon
Medical
Systems
USA | 21 CFR
892.1750 | Computed
Tomography
System | JAK | K143223 | January 12, 2015 |
| Aquilion ONE (TSX-
305A/3) V8.3 with
FIRST 2.1 | Canon
Medical
Systems
USA | 21 CFR
892.1750 | Computed
Tomography
System | JAK | K170177 | June 30, 2017 |
| Alphenix, INFX-
8000C/B, V8.0 | Canon
Medical
Systems
USA | 21 CFR
892.1650 | Image-
intensified
fluoroscopic
x-ray system | OWB | K181804 | August 2, 2018 |
11. REASON FOR SUBMISSION:
Modification of a cleared device.
The purpose of this submission is to seek market clearance for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A.
12. DEVICE DESCRIPTION:
The Infinix 4DCT is composed of the INFX-8000C interventional angiography system and the dynamic volume CT system, Aquilion ONE, TSX-305A/3. This combination enables patient access and efficient workflow for interventional procedures. Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A, is an optional kit intended to be used in conjunction with an Aquilion ONE / INFX-8000C based IVR-CT system. This device is attached to the Aquilion ONE CT gantry to support longitudinal movement and allow image acquisition in the z-direction (Z-axis), both axial and helical. When this option is installed, the standard CT patient couch is replaced with the patient handling system utilized by the interventional x-ray system, INFX-8000C. The Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A, will be used as part of an Aquilion ONE / INFX-8000C based IVR-CT system. Please note, the intended uses and technological characteristics of the Aquilion ONE CT System and the INFX-8000C Interventional X-Ray System remain the same. There have been no modifications made to the imaging chains in these FDA cleared devices and the base system software remains the same. Since both systems will be installed in the same room and to prevent interference during use, system interlocks have been incorporated into the systems.
Please note: The terms "Self-Propelled Scan Base", "Moving Base" and "Movement Base" are used interchangeably throughout this submission. They all refer to the same unit.
5
13. INDICATIONS FOR USE:
Optional movable gantry base unit for use with an Aquilion ONE (TSX-305A) system to support longitudinal movement and allow acquisition of images in the z-direction (z-axis).
Note: When installed with the movable gantry base unit, Aquilion ONE can be used with the INFX-8000C system in the same room.
14. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT, which received premarket clearance under K143223, marketed by Canon Medical Systems USA.
Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A, incorporates modifications to the cleared device in order for the self-propelled scan base unit to be connected to an Aquilion One CT gantry. This allows the CT system to acquire images in the z-direction (Z-axis) when a fixed catheterization table is used for patient support instead of a dedicated CT patient couch. The indications for use, method of operation including the imaging chain, base software and manufacturing process of the CT and Interventional XR systems remain unchanged from the cleared devices.
| Item | Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A | CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT | Comments |
|---|---|---|---|
| CT System | Aquilion ONE | ||
| (K170177) | Aquilion PRIME | ||
| (K141741) | Changed | ||
| X-Ray System | INFX-8000C (V8.2 Software) | ||
| (K181804) | INFX-8000C (V6.01 Software) | ||
| (K113052) | Changed | ||
| Gantry drive | Movement along rails laid on the floor | Movement along rails laid on the floor | Same |
| Cabling | Floor cabling | Floor cabling | Same |
| Digging depth of the floor | Approximately 130 mm | Approximately 152 mm | Reduced digging depth |
| Couch | Fixed catheterization table | ||
| (INFX-8000C System) | Fixed catheterization table | ||
| (INFX-8000C System) | Same | ||
| Scan direction | IN/OUT directions | IN/OUT directions | Same |
| Direction of Scanogram acquisition | IN/OUT directions | IN/OUT directions | Same |
| Gantry Tilt | Max. +/-28° | Max. +/-30° | Changed |
See below for a brief summary of changes from Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A:
6
| Item | Aquilion ONE Self-Propelled Scan
Base Kit for IVR-CT, CGBA-034A | CGBA-032A, Aquilion PRIME Self-
Propelled Scan Base Kit for IVR-CT | Comments |
|------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------|
| Scanoscopy
speed | 90 - 110 mm/s
(Remote access Possible from the
console except Table Up/Down
operation) | 100 mm/s | Changed |
| Scan field in the
longitudinal
direction | Scanoscopy:
Adjustable from 200 mm to 1800 mm
Helical scan: Max. 1800 mm/scan | Scanoscopy:
Adjustable from 200 mm to 1390 mm
Helical scan: Max. 1390 mm/scan | Changed |
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 IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-1-9, IEC60601-2-28, IEC60601-2-32, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, IEC 60825, NEMA PS 3.1-3.18, NEMA XR-25 and NEMA XR-26. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.
16. TESTING
This submission includes summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met. Evaluation of the modified device included, but was not limited to, confirmation that base movement speed, stop position accuracy, scanogram and axial/helical scan functions, and interlocks including contact detection, emergency stop and slide running performed according to specifications.
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.
Additionally, testing of the modified system 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 Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A is substantially equivalent to the predicate device. The subject device function in a manner similar to and is intended for the same use as the predicate device, as described in the labeling. Based upon the bench testing, successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use.