(76 days)
No
The summary describes a standard CT system and post-processing software without mentioning AI or ML capabilities. The Lung Volume Analysis software is explicitly stated as unchanged since a previous clearance.
No
Explanation: The device is described as a CT system intended to acquire and display cross-sectional volumes of the whole body. There is no mention of it being used for treatment or therapy.
Yes
The device is a Computed Tomography (CT) system that acquires and displays cross-sectional volumes of the entire body. The "Summary of Performance Studies" explicitly states, "Representative diagnostic images...were also obtained using the subject device which demonstrates that the device produces images of diagnostic quality." This indicates its use in diagnosing medical conditions by producing images that a trained physician can interpret.
No
The device description explicitly states it is a "40-row CT System," which is a hardware device. While it includes software components (like the Lung Volume Analysis), the core device is a physical CT scanner.
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 to visualize internal structures of the body.
- Device Description: The device is described as a "40-row CT System." CT systems are imaging devices, not devices used to examine specimens derived from the human body.
- Input Imaging Modality: The input is "Computed tomography x-ray system," which is an imaging modality.
- Anatomical Site: The device is used on the "whole body, to include the head," which refers to the patient's body directly.
- IVD Definition: In vitro diagnostics are defined as medical devices and accessories used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform tests on such samples.
While the device can be used with "specialized studies, usinq indicated software/hardware," and mentions "Lung Volume Analysis" software, the core function of the device itself is image acquisition and display, not in vitro testing. The software mentioned is a post-processing tool for analyzing the acquired images, not a diagnostic test performed on a biological sample.
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 has the capability to provide volume sets. These volume sets can be used to perform specialized studies, usinq indicated software/hardware, by a trained and qualified physician.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The Aquilion LB, TSX-201A/3, v6.0 is a 40-row CT System that is intended to acquire and display cross-sectional volumes of the whole body, including the head. This system is 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
Computed Tomography X-ray
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 evaluated to assess detector sensitivity and noise properties (including standard deviation of noise) which demonstrated improvement in both studies.
Additional image quality metrics, utilizing phantoms, were conducted to validate that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number and contrast-to-noise ratio and uniformity performance.
The algorithm for Lung Volume Analysis, a system independent post processing software application that uses standard non-contrast enhanced chest volume (helical) acquisitions, has not been changed since clearance under K133715. As previously demonstrated through the use of an electronic phantom, LungMan Phantom and image data sets of the chest, this software accurately displays volume calculations. Integration testing was conducted to verify that this application functions as intended on the Aquilion LB system.
Representative diagnostic images, reviewed by an American Board Certified Radiologist, including brain, chest, abdomen and peripheral exams were also obtained using the subject device which demonstrates that the device produces images of diagnostic quality and; therefore, performs as intended.
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.
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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" arranged around the perimeter. Inside the circle is a stylized design 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
March 19, 2015
Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K150003
Trade/Device Name: Aquilion LB, TSX-201A/3, V6.0 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: December 30, 2014 Received: January 2, 2015
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.
Robert A Ochs
Robert Ochs. Ph.D. Acting 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)
K150003
Device Name
Aquilion LB, TSX-201A/3, V6.0
Indications for Use (Describe)
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.
The Aquilion has the capability to provide volume sets. These volume sets can be used to perform specialized studies, usinq indicated software/hardware, 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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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:
December 30, 2014 (Updated March 18, 2015)
6. TRADE NAME(S):
Aquilion LB, TSX-201A/3, V6.0
7. COMMON NAME: System, X-ray, Computed Tomography
8. DEVICE CLASSIFICATION:
Class II (per 21 CFR 892.1750, Computed Tomography X-ray System)
9. PRODUCT CODE / DESCRIPTION:
90JAK / Computed Tomography X-Ray System
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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 |
|---|---|---|---|
| Aquilion LB Triton, | |||
| TSX-201A/2, v4.91 | Toshiba America | ||
| Medical Systems | K123500 | May 2, 2013 |
12. REASON FOR SUBMISSION:
Modification of a cleared device
13. DEVICE DESCRIPTION:
The Aquilion LB, TSX-201A/3, v6.0 is a 40-row CT System that is intended to acquire and display cross-sectional volumes of the whole body, including the head. 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.
The Aquilion 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.
15. SUBSTANTIAL EQUIVALENCE:
The subject device is substantially equivalent to the Aquilion LB Triton, TSX-201A/2, v4.91, K123500, marketed by Toshiba America Medical Systems. The Aquilion LB, TSX-201A/3, v6.0, incorporates modifications to the cleared device which include implementation of a new detector that meets the specifications of the current detector and addition of a previously cleared optional software feature. The method of operation and manufacturing process for the Aquilion LB remain unchanged from the cleared device.
5
A complete comparison table is included in this submission. See below for a brief summary of changes from Aquilion LB Triton, TSX-201A/2, v4.91:
| ltem | Aquilion LB | Aquilion LB Triton |
|---|---|---|
| TSX-201A/3, v6.0 | TSX-201A/2, v4.91 | |
| 510(k) Number | This submission | K123500 |
| Detector | 994 channels x 40 rows | 994 channels x 40 rows |
| Number of detector elements | 16 x 0.5 mm rows | 16 x 0.5 mm rows |
| Console Operating System | Microsoft Windows 7 | Microsoft Windows XP |
Previously cleared software options being implemented to the modified device:
| Lung Volume Analysis | Previously cleared per K113715 |
|---|---|
| ---------------------- | -------------------------------- |
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 are included in this submission which demonstrates that the requirements for the modifications made to the system have been met. The modified system was evaluated to assess detector sensitivity and noise properties (including standard deviation of noise) which demonstrated improvement in both studies.
Additional image quality metrics, utilizing phantoms, were conducted to validate that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number and contrast-to-noise ratio and uniformity performance.
The algorithm for Lung Volume Analysis, a system independent post processing software application that uses standard non-contrast enhanced chest volume (helical) acquisitions, has not been changed since clearance under K133715. As previously demonstrated through the use of an electronic phantom, LungMan Phantom and image data sets of the chest, this software accurately displays volume calculations. Integration testing was conducted to verify that this application functions as intended on the Aquilion LB system.
6
Representative diagnostic images, reviewed by an American Board Certified Radiologist, including brain, chest, abdomen and peripheral 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 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 LB, TSX-201A/3, v6.0 do not change the indications for use or the intended use of the device. Based upon bench testing, representative clinical images, successful completion of software validation and application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use.