(87 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or functionalities that would typically involve AI/ML, such as automated detection, segmentation, or analysis beyond basic image acquisition and display.
No.
The device is described as an 80-row CT System intended to acquire and display cross-sectional volumes of the body, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is a CT system that acquires and displays cross-sectional volumes of the whole body, which are then used by a trained physician for specialized studies. This process of acquiring and presenting anatomical data for medical evaluation is characteristic of diagnostic devices.
No
The device description explicitly states it is an 80-row and 40-row CT system, which are hardware devices. The summary also mentions hardware components and verification/validation testing related to the system itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "acquire and display cross-sectional volumes of the whole body, to include the head." This describes an imaging device used for diagnostic purposes on the patient's body, not for testing samples in vitro (outside the body).
- Device Description: The device is described as a "CT System," which is a type of medical imaging equipment.
- Input Imaging Modality: The input modality is "Computed Tomography (CT)," which is an imaging technique.
- Anatomical Site: The device is used on the "Whole body, to include the head," indicating direct interaction with the patient.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such tests.
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.
The Aquilion PRIME 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.
Product codes
JAK
Device Description
The Aquilion PRIME TSX-303A/2, v5.00 is an 80-row CT System and the TSX-303A/6, v5.00 is a 40-row CT system that is intended to produce axial scans of the whole body to include the head. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
whole body, to include the head
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)
Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrates that the requirements for the modifications made to the system have been met. The modified system was also evaluated according to an image quality metrics study, utilizing phantoms, which validated that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number and contrast-tonoise ratio and noise properties.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K130645
Page 1 of 3
JUN 0 6 2013
TOSHIBA AMERICA MEDICAL SYBTEMS, INC. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000
510(k) SUMMARY
-
- SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
-
- ADDRESS: 2441 Michelle Drive Tustin, CA 92780-2068
-
- ESTABLISHMENT REGISTRATION: 2020563
4. CONTACT PERSON:
Paul Biggins Director, Regulatory Affairs (714) 730-5000
-
- Date Prepared: March 8, 2013
-
- TRADE NAME(S): Aquilion PRIME, TSX-303A/2 and 303A/6, v5.00
7. COMMON NAME: System, X-ray, Computed Tomography
DEVICE CLASSIFICATION: 8.
Class II (per 21 CFR 892.1750)
PRODUCT CODE / DESCRIPTION: 9.
JAK - System, Computed Tomography
10. PERFORMANCE STANDARD:
This device conforms to applicable Performance Standards for lonizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]
11. PREDICATE DEVICE:
| Product | Marketed by | 510(k) Number | Clearance Date |
|---|---|---|---|
| TSX-302A/2, Aquilion | |||
| Prime CT System | Toshiba America | ||
| Medical Systems | K120710 | April 6, 2012 |
1
12. REASON FOR SUBMISSION:
Modification of a cleared device
13. DEVICE DESCRIPTION:
The Aquilion PRIME TSX-303A/2, v5.00 is an 80-row CT System and the TSX-303A/6, v5.00 is a 40-row CT system that is intended to produce axial scans of the whole body to include the head. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.
14. SUMMARY OF INTENDED USES:
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.
The Aquilion Prime 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.
15. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the TSX-302A/2, Aquilion Prime CT System, K120710, marketed by Toshiba America Medical Systems. The Aquilion PRIME TSX-303A/2 and 303A/6, v5.00, incorporates modifications to the cleared device which include a smaller gantry size, addition of optional software features and new patient couches. The method of operation, base software and manufacturing process remain unchanged from the cleared device.
A complete comparison table is included in this submission. See below for a brief summary of changes from TSX-302A/2, Aquilion Prime CT System:
| Item | Aquilion PRIME | TSX-302A/2, |
|---|---|---|
| X-ray Tube Substitution | TSX-303A/2 and 303A/6, v5.00 | Aquilion Prime CT System |
| X-ray tube capacity | ||
| Maximum tube cooling rate | ||
| Continuous tube cooling rate | 7.5 MHU | |
| 1386 kHU/min | ||
| 1008 kHU/min | 7.5 MHU | |
| 1386 kHU/min | ||
| 1008 kHU/min | ||
| Gantry Size | W=2150mm, H=1870mm, D=870mm | W=2430mm, H=2030mm, |
| D=1070mm | ||
| Gantry Tilt Angle | $\u00b130\u00b0$ | $\u00b122\u00b0$ |
| Gantry Scan Switch | Standard | N/A |
| Lamp for Indication of | ||
| Breathing | Breath-hold time indication added | N/A |
2
K130645
Page 3 of 3
(Continued)
| Item | Aquilion PRIME
TSX-303A/2 and 303A/6, v5.00 | TSX-302A/2,
Aquilion Prime CT System |
|----------------------|------------------------------------------------|-----------------------------------------|
| Helical Shuttle Scan | Optional | N/A |
| Lung Volume Analysis | Optional
(Previously cleared under K113715) | N/A |
-
- X-ray tube substitution
-
- Smaller gantry
- ന് Increased gantry tilt angle
-
- New gantry scan switch and breath-hold indication
- Previously cleared software options are being added
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 IEC60601-1, IEC60601-1-2, 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, NEMA PS 3.1-3.18and NEMA XR-25. 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 requirements for the modifications made to the system have been met. The modified system was also evaluated according to an image quality metrics study, utilizing phantoms, which validated that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number and contrast-tonoise ratio and noise properties.
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.
18. CONCLUSION
The modifications incorporated into the Aquilion PRIME TSX-303A/2 and 303A/6, v5.00 do not change the indications for use or the intended use of the device. Based upon bench testing, successful completion of software validation, application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use.
Page 3 of 3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms or lines extending from the body. The figure is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2013
Toshiba Medical Systems Corporation % Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K130645
Trade/Device Name: Aquilion PRIME TSX-303A/2 and 303A/6, v5.00 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 8, 2013 Received: March 11, 2013
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 .- Isting 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.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely yours.
Smh.P.
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
5
Indications for Use
510(k) Number (if known): K130645
Device Name: Aquilion PRIME, TSX-303A/2 and 303A/6, v5.00
Indications for Use:
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.
The Aquilion PRIME 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.
Prescription
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K130645
Page 1 of 1