(102 days)
Not Found
No
The document describes an "iterative reconstruction algorithm" (FIRST 2.0) which is a common image processing technique in CT, but it does not mention AI, ML, or any related concepts like neural networks, training data, or performance metrics typically associated with AI/ML models.
No
The device is described as a CT scanner indicated for acquiring and displaying cross-sectional volumes and improving image quality, which are diagnostic functions, not therapeutic.
Yes
The device acquires and displays cross-sectional volumes of the whole body and organs, which are then used by a trained physician to perform specialized studies. The mention of "representative diagnostic images" further confirms its role in aiding diagnosis.
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," which are hardware components. While it includes software (FIRST 2.0), 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 describes acquiring and displaying cross-sectional volumes of the body for diagnostic imaging. This is a function of medical imaging devices, not IVDs.
- Device Description: The device is described as a whole body multi-slice helical CT scanner. CT scanners are medical imaging devices that use X-rays to create images of the inside of the body.
- No mention of in vitro testing: There is no mention of analyzing samples (like blood, urine, or tissue) outside of the body, which is the defining characteristic of an IVD.
- Focus on imaging: The entire description and performance studies revolve around image acquisition, processing, and quality.
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform such functions.
N/A
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 imaqe whole orqans in a sinqle 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 orqan. These volume sets can be used to perform specialized studies, usinq indicated software/hardware, of the whole organ by a trained and qualified physician.
FIRST 2.0 is an iterative reconstruction alqorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac and extremities applications.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 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 Toshiba CT systems. In addition, the subject device incorporates the latest iterative reconstruction technology, FIRST 2.0, intended to reduce exposure dose while maintaining and/or improving image quality.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography x-ray system
Anatomical Site
Whole body, to include the head, whole organs (brain, heart, pancreas, etc.), abdomen, pelvis, chest, cardiac and extremities.
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)
Bench Testing: Risk analysis and verification/validation testing demonstrated that established specifications for the device have been met.
Image Quality Evaluation: CT image quality metrics performed using phantoms showed the subject device is substantially equivalent to or improves upon the predicate device for contrast-to-noise ratio, CT number accuracy, uniformity, slice sensitivity profile, modulation transfer function, line pair gauge, low contrast detectability, standard deviation of noise, and noise power spectra.
Quantitative Dose Reduction/Spatial Resolution Evaluations: The subject device demonstrated a dose reduction claim of up to 84.6% with 60% noise reduction compared to filtered back projection. A model observer evaluation showed that equivalent low contrast detectability to FBP (range from 0.6 - 0.686) can be achieved with 71.4% to 84.6% less dose using FIRST 2.0 at Standard setting for thin (0.5 mm) reconstruction slice thickness in simulated body phantom (MITA-FDA phantom with a body ellipse surrounding it).
Low Contrast Detectability: Evaluations measured low-contrast detectability using Aquilion ONE Vision CT systems with current detector (CDAS-052A/3) and previous detector (CDAS-052A/2) configurations. CTDIvol values at which the low-contrast object can be identified were improved with the use of FIRST 2.0 as compared to filtered back projection and AIDR 3D.
Diagnostic Image Review: Representative diagnostic images, reviewed by an American Board Certified Radiologist, including chest, abdomen and pelvis, extremity and cardiac exams were obtained using the subject device, demonstrating that the device produces images of diagnostic quality and performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
-Quantitative Dose Reduction: Up to 84.6% reduction compared to filtered back projection.
-Noise Reduction: 60% noise reduction compared to filtered back projection.
-Low Contrast Detectability: Equivalent to FBP (range from 0.6 - 0.686) with 71.4% to 84.6% less dose using FIRST 2.0.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 22, 2016
Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K161009
Trade/Device Name: Aquilion One Vision with First 2.0 (CCRS-001B) V7.4 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 15, 2016 Received: June 16, 2016
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert 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 Vision with FIRST 2.0 (CCRS-001B)V7.4
Indications for Use (Describe)
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to imaqe whole orqans in a sinqle 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 orqan. These volume sets can be used to perform specialized studies, usinq indicated software/hardware, of the whole organ by a trained and qualified physician.
FIRST 2.0 is an iterative reconstruction alqorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac and extremities applications.
Type of Use (Select one or both, as applicable)
ك Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000
510(k) SUMMARY
1. SUBMITTER'S NAME:
Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
2. OFFICIAL CORRESPONDENT:
Akinori Hatanaka Senior Manager, Regulatory Affairs and Vigilance
3. ESTABLISHMENT REGISTRATION:
9614698
4. CONTACT PERSON:
Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459
5. Date Prepared:
April 8, 2016
6. TRADE NAME(S):
Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
7. COMMON NAME:
System, X-ray, Computed Tomography
8. DEVICE CLASSIFICATION (Regulatory Class, CFR Reference, Name): Class II (per 21 CFR 892.1750, Computed Tomography X-ray System)
9. PRODUCT CODE / DESCRIPTION:
JAK / Computed Tomography X-Ray System
10. PERFORMANCE STANDARD:
This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]
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11. PREDICATE DEVICE:
| Product | Marketed by | Regulation
Number | Regulation
Name | Product Code | 510(k)
Number | Clearance
Date |
|-------------------------------------------------------------|------------------------------------------|----------------------|----------------------------------------|---------------------------------------------------|------------------|-------------------|
| Aquilion
ONE Vision
with FIRST
1.0 (CCRS-
001A) | Toshiba
America
Medical
Systems | 21 CFR
892.1750 | Computed
Tomography
X-ray System | JAK:
System, X-ray,
Tomography,
Computed | K151673 | 11/27/2015 |
12. REASON FOR SUBMISSION:
Modification of an existing device.
13. DEVICE DESCRIPTION:
Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 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 Toshiba CT systems. In addition, the subject device incorporates the latest iterative reconstruction technology, FIRST 2.0, intended to reduce exposure dose while maintaining and/or improving image quality.
14. 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/hardware, of the whole organ by a trained and qualified physician.
FIRST 2.0 is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac and extremities applications.
15. SUBSTANTIAL EQUIVALENCE:
The Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4, is substantially equivalent to the Aquilion ONE Vision with FIRST 1.0 (CCRS-001A), that received premarket clearance under K151673 and is marketed by Toshiba America Medical Systems. The changes made to the subject device include the addition of FIRST 2.0, CCRS-001B, an iterative reconstruction algorithm that allows the exposure dose to be reduced while maintaining and/or improving image quality as seen when using FBP (filtered back projection) and improves spatial resolution over FBP. A comparison of the technological characteristics between the subject and the predicate devices is included below.
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| Item | Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 | Aquilion ONE with FIRST 1.0 (CCRS-001A) |
|---|---|---|
| 510(k) Number | This submission | K151673 |
| Anatomical Region | Abdomen, pelvis, chest, cardiac and extremities | Chest (excluding cardiac), abdomen and pelvis |
| Exposure Dose Reduction | AIDR 3D | |
| FIRST 2.0 | AIDR 3D | |
| FIRST 1.0 | ||
| Quantitative Dose Reduction | ||
| Claim | Yes | Yes |
| Image Quality Claim | Improved Spatial Resolution over | |
| Filtered Back Projection | Improved Spatial Resolution over | |
| Filtered Back Projection |
16. 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 IEC60601-1-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-4, IEC60601-1-6, IEC60601-2-28, IEC60601-2-32, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, 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.
17. TESTING
Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrates that the established specifications for the device have been met.
Image Quality Evaluation
CT image quality metrics were performed, utilizing phantoms, which demonstrated that the subject device is substantially equivalent to or demonstrates an improvement to the predicate device with regard to contrast-to noise ratio, CT number accuracy, uniformity, slice sensitivity profile, modulation transfer function, line pair gauge, low contrast detectability, standard deviation of noise and noise power spectra.
Quantitative Dose Reduction/Spatial Resolution Evaluations
The subject device demonstrated a dose reduction claim of up to 84.6% with 60% noise reduction compared to filtered back projection. A model observer evaluation showed that equivalent low contrast detectability to FBP (range from 0.6 - 0.686) can be achieved with 71.4% to 84.6% less dose using FIRST2.0 at Standard setting for thin (0.5 mm) reconstruction slice thickness in simulated body phantom (MITA-FDA phantom with a body ellipse surrounding it).
Low Contrast Detectability
Evaluations were conducted to measure low-contrast detectability using Aquilion ONE Vision CT systems with current detector (CDAS-052A/3) and previous detector (CDAS-052A/2) configurations. It was concluded that CTDIvol values at which the low-contrast object can be identified were improved with the use of FIRST 2.0 as compared to filtered back projection and AIDR 3D.
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Representative diagnostic images, reviewed by an American Board Certified Radiologist, including chest, abdomen and pelvis, extremity and cardiac exams were also obtained using the subject device which demonstrates that the device produces images of diagnostic quality and; therefore, performs as intended.
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 subject device was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.
18. CONCLUSION
The Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4, 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 is substantially equivalent in safety and effectiveness to the predicate device.