(187 days)
Acquisition and display of axial x-ray images of the whole body to include the head.
The Aquilion CXL is a whole body multi-slice helical CT System, consisting of a gantry, patient couch and console. The system generates up to 128 slices per rotation using a selectable slice-thickness multi-row detector. Additionally, the Aquilion CXL will utilize the new dose-reduction technologies adopted from Aquilion ONE (currently under FDA review), the system substantially reduces patient exposure dose and improves image quality.
- Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state numerical acceptance criteria in a formal table or a direct comparison of the device's performance against such criteria. Instead, it relies on a statement of "substantial equivalence" to a predicate device and notes that "Testing was conducted utilizing phantoms and accepted image quality metrics. The results of this testing is contained in the user information for the device." This implies that the device's performance was deemed acceptable based on meeting standard image quality metrics in phantom studies, but the specific metrics and their target values are not detailed in this summary.
Therefore, a table cannot be constructed with specific numerical acceptance criteria and reported performance values based solely on the provided text.
- Sample Size Used for the Test Set and Data Provenance:
The document mentions that "Testing was conducted utilizing phantoms." This indicates that the "test set" consisted of phantoms, which are artificial objects used to simulate human tissue for imaging purposes. Consequently, there is no human patient data test set.
- Sample Size for Test Set: Not applicable as real patient data was not used. Instead, phantoms were used for testing. The number or type of phantoms used is not specified.
- Data Provenance: Not applicable as no human patient data was used.
- Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable, as phantoms were used for testing, and image quality metrics from these phantoms would be objectively measured rather than requiring expert ground truth establishment in the traditional sense of clinical diagnosis.
- Adjudication Method for the Test Set:
Not applicable, as expert adjudication is not relevant for phantom-based image quality testing.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The document states that "Testing was conducted utilizing phantoms and accepted image quality metrics." This type of testing is focused on the device's technical image quality, not its impact on human reader performance.
- Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone performance assessment was conducted through "Testing... utilizing phantoms and accepted image quality metrics." This evaluated the device's inherent image quality capabilities (such as resolution, contrast, noise reduction) without human intervention in the diagnostic process.
- Type of Ground Truth Used:
For the phantom-based testing, the "ground truth" would be the known physical properties and internal structures of the phantoms, against which the reconstructed images' accuracy and quality metrics (e.g., spatial resolution, contrast-to-noise ratio, signal-to-noise ratio) were measured.
- Sample Size for the Training Set:
The document does not mention the use of a "training set" in the context of device performance evaluation. This device is a CT scanner, and typical performance evaluation for such devices involves physical and technical testing against established standards and metrics using phantoms, rather than AI model training on a dataset. The "Application of AIDR algorithm" is mentioned as a new feature, suggesting the use of an algorithm, but the document does not provide details about its development or training data.
- How the Ground Truth for the Training Set Was Established:
Not applicable, as a training set for an algorithm is not described or detailed in the provided information.
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APR 1 0 2012
Toshiba America Medical Systems, I Pre-Market Notification 510(k) Aquilion CXL, TSX-101A/Q
510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS
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- SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
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- ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
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- ESTABLISHMENT REGISTRATION: 2020563
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- CONTACT PERSON: Paul Biggins Director, Regulatory Affairs (714) 730-5000
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- SUBMISSION DATE October 5, 2011
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- TRADE NAME(S): Aquilion CXL, TSX-101A/Q
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- COMMON NAME: Scanner, Computed Tomography, X-ray
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- DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)
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- PRODUCT CODE / DESCRIPTION: JAK - Computed tomography X-ray system
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- PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
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- PREDICATE DEVICE: TSX-101A/H,/I Aquilion 32/64 SP CT System (K080211)
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- REASON FOR SUBMISSION: Modification of a cleared device
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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Aquilion CXL.TSX-101A/Q
13. DEVICE DESCRIPTION:
The Aquilion CXL is a whole body multi-slice helical CT System, consisting of a gantry, patient couch and console. The system generates up to 128 slices per rotation using a selectable slice-thickness multi-row detector. Additionally, the Aquilion CXL will utilize the new dose-reduction technologies adopted from Aquilion ONE (currently under FDA review), the system substantially reduces patient exposure dose and improves image quality.
14. SUMMARY OF INTENDED USES:
This device is designed to produce cross-sectional images of a human body by reconstruction of x-ray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastro intestinal lesions, abdominal and pelvic malignancies and hepatic metastases. CT is also used to evaluate intestinal obstructions, as intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the market place.
15. SUBSTANTIAL EQUIVALENCE:
Toshiba Medical Systems Corporation believes that the Aquilion CXL, TSX-101A/Q CT Scanner is substantially equivalent to TSX-101A/H,/I Aquilion 32/64 SP CT System (K080211).
| New feature | |
|---|---|
| Maximum number of slices | Changed from 64 to 128 |
| Application of AIDR algorithm | Not available on previous version |
| Computer system is updated | Faster reconstruction |
| Additional data storage | |
| Addition of SureXtension | Previously cleared via K093891 |
| Availability of ColonViewsoftware | Cleared via K090220 |
| Table weight is extended to300kg (660lbs.) | Previous weight was 450lbs. |
| Active collimation to reducepenumbra effect during helicalscanning. | Not available on predicate |
16. SAFETY:
The device is designed and manufactured under the Quality System Requlations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the
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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Aquilion CXL,TSX-101A/Q
Page 3 of 3
applicable parts of the IEC60601-1 standards and its collateral standards. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via an initial report.
17. SUMMARY OF TESTING:
Testing was conducted utilizing phantoms and accepted image quality metrics. The results of this testing is contained in the user information for the device.
18. CONCLUSION
The Aquilion CXL, TSX-101A/Q CT Scanner complies with the same or equivalent standards and has the same intended use as the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
APR 1 0 2012
Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K112989
Trade/Device Name: Aquilion CXL, TSX-101A/Q Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 12, 2012 Received: March 14, 2012
Dear Mr. Biggins:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Toshiba America Medical Systems, Inc.
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| 510(k) Number (if known): | |
|---|---|
| Device Name: | Aquilion CXL, TSX-101A/Q |
Indications for Use:
Acquisition and display of axial x-ray images of the whole body to include the head.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) Number | |
|---|---|
| --------------- | -- |
Page 1 of _______
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K112989
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Indication for Use
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510k: Aquilion CXL, TSX-101A/Q Page 13 of 2110 . ' ·
§ 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.