(100 days)
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.
Aquilion ONE (TSX-305A/3) V7.3 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aquilion ONE (TSX-305A/3) V7.3:
1. Table of Acceptance Criteria and Reported Device Performance:
The document is a 510(k) summary for a premarket notification for a Computed Tomography X-ray System. It is not a clinical study report with specific acceptance criteria directly tied to a diagnostic performance metric (like sensitivity or specificity) of a disease-detecting AI algorithm. Instead, it demonstrates substantial equivalence to a predicate device, focusing on technical specifications and image quality for general diagnostic use.
Therefore, the "acceptance criteria" here relate to demonstrating that the new device performs acceptably for its intended use and is equivalent to the predicate. The "performance" is primarily a comparison of technical specifications and image quality metrics against the predicate.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Intended Use | The device is capable of acquiring and displaying cross-sectional volumes of the entire body, including the head, with the capability to image whole organs in a single rotation (e.g., brain, heart, pancreas). These volume sets should be usable for specialized studies by trained physicians. (Identical to predicate) | Aquilion ONE (TSX-305A/3) V7.3 has identical Indications for Use as the predicate Aquilion ONE Vision, TSX-301C/1-8, V7.0. It is a whole-body multi-slice helical CT scanner for acquiring and displaying cross-sectional volumes and whole organs. |
| Technical Specifications (Substantial Equivalence) | Technical specifications should be comparable to the predicate device, or any differences should not raise new questions of safety and effectiveness. (e.g., gantry rotation speed, view rate, detector, pitch factor, FOV, wedge filter types, X-ray tube voltage/current, image reconstruction time, helical reconstruction method, metal artifact reduction, patient couch type, size, weight capacity, gantry opening, gantry tilt angle, minimum area for installation, area finder. Also, existing cleared software options being implemented should function as previously cleared.) | Similarities:- View rate: Maximum 2910 views/s (same)- Detector: 896 channels x 320 rows (same)- Pitch factor: Range 0.555 to 1.575 / 0.555 to 1.5 (very similar)- FOV: 240/320/500mm / 180/240/320/400/500mm (subject has slightly reduced range, but still within typical diagnostic needs)- Metal artifact reduction: SEMAR (Volume, Helical, ECG gated) / SEMAR (Volume, Helical) (subject has added ECG gated capability)- Gantry opening size: 780 mm (same)- All previously cleared software options are listed as "no change" in functionality, with some having "workflow improvements" (e.g., Lung Volume Analysis, surESubtraction Lung, MyoPerfusion, Dual Energy System Package, 4D Airways Analysis) which are enhancements rather than regressions.Differences (addressed through testing or not raising new concerns):- Gantry Rotation Speed: 0.35s (Optional max 0.275s) for subject vs. 0.275s (Standard or optional) for predicate. This indicates a minor hardware difference, likely addressed by showing image quality is maintained.- Wedge filter types: Two types for subject vs. Three for predicate. This is a minor design change.- X-ray tube voltage/current: Max 72kW (Optional Max 90kW) for subject vs. Max 90kW (for one model) or Max 72kW (for others) for predicate. Comparable.- Image reconstruction time: Up to 80 images/s for subject vs. Up to 50 images/s for predicate. Improvement in subject device.- Helical reconstruction method: 20 rows or more: TCOT+ for subject vs. 16 rows or more: TCOT+ for predicate. Improvement in subject device (more rows).- Patient Couch Type and related dimensions/weights: Various configurations/differences between subject and predicate models, indicating design variations but within expected functional range.- Gantry tilt angle: ±30° for subject vs. ±22° for predicate. Improvement in subject device.- Minimum area for installation: Smaller for subject (27m² vs 37.2m²). Improvement in subject device.- Area finder: Optional for subject vs. NA for predicate. New feature on subject device. |
| Image Quality | Image quality metrics (spatial resolution, CT number magnitude/uniformity, noise properties, low contrast detectability/CNR performance) should meet established specifications and be comparable to the predicate device. Images obtained should be of diagnostic quality. | CT image quality metrics performed using phantoms demonstrated that the subject device is substantially equivalent to the predicate device with regard to: spatial resolution, CT number magnitude/uniformity, noise properties, and low contrast detectability/CNR performance. Representative diagnostic images (head, chest, abdomen/pelvis, extremity, cardiac) were also reviewed and demonstrated diagnostic quality. |
| Safety and Standards Compliance | The device must be designed and manufactured under Quality System Regulations (21 CFR 820, ISO 13485) and conform to applicable performance standards for ionizing radiation-emitting products (21 CFR, Subchapter J, Part 1020). It must also comply with various IEC, NEMA, and other relevant standards. | The device is designed and manufactured under QSR and ISO 13485. It conforms to applicable performance standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020] and numerous international standards including IEC60601-1 series, IEC60601-2 series, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25 and NEMA XR-26. |
| Software Validation | Software documentation must comply with FDA guidance for a Moderate Level of Concern, and validation testing should be successfully completed. | Software Documentation for a Moderate Level of Concern was included. Successful completion of software validation is cited in the conclusion. |
| Risk Management | Risk analysis should be conducted. | Risk analysis was conducted. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Description: The "test set" for this submission primarily consists of:
- Phantoms: Used for evaluating CT image quality metrics (spatial resolution, CT number, noise, low contrast detectability). The number and specific types of phantoms are not explicitly stated but are typically standard phantoms used in CT performance testing.
- Representative Diagnostic Images: Clinical images covering various body regions (head, chest, abdomen/pelvis, extremity, cardiac). The number of cases/patients is not specified.
- Data Provenance: The document does not explicitly state the country of origin for the diagnostic images. Given Toshiba Medical Systems Corporation is based in Japan and Toshiba America Medical Systems, Inc. is in the US, the data could originate from either region or a combination. The document also does not specify if the data was retrospective or prospective. However, for a 510(k) clearance based on substantial equivalence, particularly for a hardware/software update to a CT scanner, diagnostic images are often retrospectively collected or acquired as part of internal validation.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: One (1) expert is explicitly mentioned.
- Qualifications of Experts: An "American Board Certified Radiologist." No specific years of experience are stated. This expert reviewed the representative diagnostic images to confirm diagnostic quality.
4. Adjudication Method for the Test Set:
- The document describes a single American Board Certified Radiologist reviewing images to confirm diagnostic quality. This indicates no formal adjudication method involving multiple readers (like 2+1 or 3+1) was used for this specific part of the evaluation. The assessment of image quality from phantoms would not typically involve expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document is for a general-purpose CT scanner system, not an AI-specific diagnostic tool that assists human readers. Therefore, there is no mention of an effect size for human reader improvement with or without AI assistance.
6. If a Standalone (Algorithm-Only Without Human-in-the-Loop Performance) Study Was Done:
- No, a standalone performance study in the context of an AI algorithm was not done. The Aquilion ONE (TSX-305A/3) V7.3 is a complete CT system where the "algorithm" refers to the image reconstruction and processing capabilities, which are inherent to the device's function. The study validates the overall system's ability to produce diagnostic images, not a separate AI algorithm's diagnostic accuracy. The performance is assessed on the system output.
7. The Type of Ground Truth Used:
- For the phantom studies, the "ground truth" is typically known physical properties of the phantoms (e.g., known dimensions, densities, contrast levels).
- For the representative diagnostic images, the "ground truth" for confirming "diagnostic quality" is based on the expert opinion/consensus of an American Board Certified Radiologist. This is a form of expert consensus, albeit from a single expert in this stated context. There is no mention of pathology or outcomes data being used as ground truth for this submission.
8. The Sample Size for the Training Set:
- The document does not specify a separate "training set" sample size. This submission is for a medical imaging device (CT scanner) rather than a deep learning AI algorithm that undergoes distinct training. The underlying algorithms for image reconstruction and processing (e.g., TCOT+, SEMAR) are developed and refined through engineering and iterative testing, but not typically in the same "training set" paradigm as AI for diagnostic interpretation. The software validation is mentioned, which refers to standard software development lifecycle testing.
9. How the Ground Truth for the Training Set Was Established:
- As a "training set" in the context of AI development is not explicitly mentioned as relevant to this submission, the establishment of ground truth for a training set is not applicable/described. The "ground truth" during the development of a CT scanner's image reconstruction algorithms would typically involve engineering specifications, physical models, and potentially early clinical data used for empirical tuning and validation, but not a formally labeled training set in the AI sense.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 9, 2016
Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K160587
Trade/Device Name: Aquilion ONE (TSX-305A/3) V7.3 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 29, 2016 Received: March 2, 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.
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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,
Robert Ochs
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Aquilion ONE (TSX-305A/3) V7.3
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 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 orqan by a trained and qualified physician.
Type of Use (Select one or both, as applicable)
ال Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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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:
May 24, 2016
-
- TRADE NAME(S): Aquilion ONE (TSX-305A/3) V7.3
-
- COMMON NAME: System, X-ray, Computed Tomography
-
- 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 |
|---|---|---|---|---|---|---|
| AquilionONE Vision,TSX-301C/6-8, V7.0 | ToshibaAmericaMedicalSystems | 21 CFR892.1750 | ComputedTomographyX-ray System | JAK:System, X-ray,Tomography,Computed | K142465 | 03/10/2015 |
12. REASON FOR SUBMISSION:
New device.
13. DEVICE DESCRIPTION:
Aquilion ONE (TSX-305A/3) V7.3 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.
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.
15. SUBSTANTIAL EQUIVALENCE:
The Aquilion ONE (TSX-305A/3) V7.3, is substantially equivalent to the Aquilion ONE Vision, TSX-301C/1-8, V7.0, which received premarket clearance under K142465, marketed by Toshiba America Medical Systems. The Indications for Use for the subject device are identical to those of the predicate device. A comparison of the technological characteristics between the subject and the predicate devices is included below.
| ltem | Aquilion ONE(TSX-305A/3) V7.3 | Aquilion ONE(TSX-301C/6-8) V7.0 |
|---|---|---|
| 510(k) Number | This submission | K142465 |
| Gantry Rotation Speed | 0.35s(Optional max 0.275s availablewith software upgrade kit) | 0.275s(Standard on /6 model,available with softwareupgrade kit for /7 and /8models) |
| View rate | Maximum: 2910 views/s | Maximum: 2910 views/s |
| Detector | 896 channels x 320 rows | 896 channels x 320 rows |
| Pitch factor | 0.555 to 1.575 | 0.555 to 1.5 |
| FOV (field of view) | 240/320/500mm | 180/240/320/400/500mm |
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| Item | Aquilion ONE(TSX-305A/3) V7.3 | Aquilion ONE(TSX-301C/6-8) V7.0 | |
|---|---|---|---|
| 510(k) Number | This submission | K142465 | |
| Wedge filter types | Two types | Three types | |
| X-ray tube voltage / X-ray tubecurrent | Max. 72 kW (Max.90kW*)80/100/120/135 kV10 to 600 mA (10-900 mA*)(in steps of 10 mA)*Option: Available when FastScan Kit and X-ray Power Up Kit,CGS-56A, is installed | TSX-301C/6:Max. 90 kW80/100/120/135 kV10 to 900 mA(in steps of 10 mA)TSX-301C/7 and /8:Max. 72 kW80/100/120/135 kV10 to 600 mA(in steps of 10 mA) | |
| Image reconstruction time | Up to 80 images/s | Up to 50 images/s | |
| Helical reconstruction method | 20 rows or more: TCOT+ | 16 rows or more: TCOT+ | |
| Metal artifact reduction | SEMAR (Volume, Helical )SEMAR (ECG gated) | SEMAR (Volume, Helical) | |
| Patient Couch Type | Long Long Short Short | Long Short | |
| Couch-top stroke (mm) | 2390 2190 1890 1890 | 2390 1890 | |
| Scan permissible range (mm, Conventional) | 2000 1800 1500 1500 | 2000 1500 | |
| Scan permissible range (mm, Helical) | 1950 1750 1450 1450 | 1950 1450 | |
| Max. guaranteed weight (kg) | 300 205 300 205 | 300 300 | |
| Lowest couch height (mm) | 332 312 332 312 | 332 332 | |
| Gantry opening size | 780 mm in diameter | 780 mm in diameter | |
| Gantry tilt angle | $\pm$ 30° | $\pm$ 22° | |
| Minimum area for installation | 27m² (24.7m², Short couch) | 37.2m² (31.6 m², Short couch) | |
| Area finder | Optional | NA |
Previously cleared software options being implemented to the subject device:
| Application | 510(k) Clearance | Comments |
|---|---|---|
| Orbital-synchronization helical scan system(Sure Subtraction for Neck) | Previously clearedunder K051833 | No change |
| vHP (Variable Helical Pitch) | Previously clearedunder K142465 | No change |
| Neuro Package | Previously clearedunder K072693 | No change |
| Vessel View | Previously clearedunder K063184 | No change |
| Body Perfusion | Previously clearedunder K090504 | No change |
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| Application | 510(k) Clearance | Comments | |
|---|---|---|---|
| Colon View | Previously clearedunder K090220 | No change | |
| Lung Volume Analysis | Previously clearedunder K113715 | Workflow improvement(s)implemented in V7.3 | |
| suRECardio Scoring | Previously clearedunder K072737 | No change | |
| Dental Package | Previously clearedunder K142465 | No change | |
| CT Cardiac Function Analysis Software | Previously clearedunder K023760 | No change | |
| surEPlaque | Previously clearedunder K043111 | No change | |
| Subtraction Protocol(SURESubtraction Scan System) | Previously clearedunder K142465 | No change | |
| sureSubtraction Ortho(CSSO-001A) | Previously clearedunder K130960 | No change | |
| surESubtraction Lung(CSSL-001A) | Previously clearedunder K133324 | Workflow improvement(s)implemented in V7.3 | |
| MyoPerfusion(CSMP-001A) | Previously clearedunder K132523 | Workflow improvement(s)implemented in V7.3 | |
| Dual Energy System Package(CSDP-001A) | Previously clearedunder K132813 | Workflow improvement(s)implemented in V7.3 | |
| 4D Orthopedic Analysis(CSOA-001A) | Previously clearedunder K142465 | No change | |
| 4D Cerebral Artery Morphological Analysis(CSAM-001A) | Previously clearedunder K142465 | No change | |
| Adaptive Motion Correction(CSMC-001A) | Previously clearedunder K143294 | No change | |
| 4D Airways Analysis(CSAA-001A) | Previously clearedunder K143294 | Workflow improvement(s)implemented in V7.3 | |
| surEExposure 3D | Previously clearedunder K142465 | No change |
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, 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 demonstrate that the established specifications for the device have been met. CT image quality metrics were performed, utilizing phantoms, which validated that the substantially equivalent to
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the predicate device with regard to spatial resolution, CT number magnitude/uniformity, noise properties and low contrast detectability/CNR performance.
Representative diagnostic images, reviewed by an American Board Certified Radiologist, including head, chest, abdomen/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 (TSX-305A/3) V7.3 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.
§ 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.