(179 days)
Not Found
No
The document describes image processing and reconstruction techniques, but there is no mention of AI, ML, or related terms, nor is there information about training or test sets typically associated with AI/ML development.
No.
The devices are image processing software intended to aid in diagnosis and treatment planning, not to provide therapy or directly treat a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "This software may aid in the diagnosis and follow-up treatment of bronchial diseases" and the "Device Description" section states that both software features are "to aid physicians in analysis of CT coronary angiography images for diagnosis and treatment planning" and "to aid physicians in analysis of chest CT images for diagnosis and treatment planning."
No
The device description explicitly states that the software is available "on 320 row Aquilion ONE CT systems," indicating it is integrated with or runs on specific hardware, not a standalone software application.
Based on the provided information, neither of these devices are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The provided descriptions clearly state that both devices are software used to process and analyze medical images (CT scans) of the human body. They do not involve the analysis of biological samples.
- The intended use and device descriptions focus on image processing and analysis for diagnosis and treatment planning based on anatomical structures visible in the images. This is characteristic of medical imaging software, not IVDs.
In summary, these devices are medical imaging software intended to aid physicians in interpreting CT scans. They do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Adaptive Motion Correction (AMC) software is intended to be used as an adjunct to the current cardiac reconstruction methods in cases where motion of the coronary arteries creates artifacts. This software can be applied to these images, without additional dose to the patient, to enhance the visibility of the coronary arteries.
4D Airways Analysis is a post processing software that may be used in conjunction with chest CT images to provide automatic (semi-automatic) seqmentation of the bronchial tree. This software may aid in the diaqnosis and follow-up treatment of bronchial diseases.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Adaptive Motion Correction (AMC), CSMC-001A, is a reconstruction method available on 320 row Aquilion ONE CT systems, which have system software V7.0 or later installed, to aid physicians in analysis of CT coronary angiography images for diagnosis and treatment planning.
4D Airways Analysis, CSAA-001A, is a post-processing software used on 320 row Aquillion ONE CT systems, which have system software V7.0 or later installed, to aid physicians in analysis of chest CT images for diagnosis and treatment planning.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Cardiac, Chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical evaluations were performed by qualified users to ensure that the final images presented met user needs. The clinical evaluation of the Adaptive Motion Correction software demonstrated improved visualization of the coronary arteries with the exception of RCA. The clinical evaluation of the 4D Airways Analysis software demonstrated that the user variability associated with this type of measurement was reduced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2015
Toshiba Medical Systems Corporation % Mr. Orlando Tadeo Manager, Regulatory Affairs Toshiba America Medical System, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K143294
Trade/Device Name: Adaptive Motion Correction, CSMC-001A and 4D Airways Analysis. CSAA-001A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 23, 2015 Received: April 24, 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
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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.
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,
Hole 2. Mild
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)
K143294
Device Name
Adaptive Motion Correction (AMC), CSMC-001A, and 4D Airways Analysis, CSAA-001A
Indications for Use (Describe)
Adaptive Motion Correction (AMC) software is intended to be used as an adjunct to the current cardiac reconstruction methods in cases where motion of the coronary arteries creates artifacts. This software can be applied to these images, without additional dose to the patient, to enhance the visibility of the coronary arteries.
4D Airways Analysis is a post processing software that may be used in conjunction with chest CT images to provide automatic (semi-automatic) seqmentation of the bronchial tree. This software may aid in the diaqnosis and follow-up treatment of bronchial diseases.
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)
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FOR FDA USE ONLY
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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:
January 9, 2015 (Updated May 12, 2015)
6. TRADE NAME(S):
Adaptive Motion Correction (AMC) and 4D Airways Analysis
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
10. PERFORMANCE STANDARD:
None
11. PREDICATE DEVICES:
| Product | Marketed by | 510(k) Number | Regulation Reference | Product Code | Clearance Date |
|---|---|---|---|---|---|
| THORACIC VCAR | GE Healthcare | K103480 | 21 CFR 892.2050 | 90LLZ | March 7, 2011 |
| CardIQ Xpress 2.0 with | |||||
| SnapShot Freeze Option | GE Healthcare | K120910 | 21 CFR 892.1750 | 90JAK | June 18, 2012 |
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12. REASON FOR SUBMISSION:
New software applications intended to be used with 510(k) cleared Aquillion ONE CT systems which have system software V7.0 or later installed.
13. DEVICE DESCRIPTION:
Adaptive Motion Correction (AMC), CSMC-001A, is a reconstruction method available on 320 row Aquilion ONE CT systems, which have system software V7.0 or later installed, to aid physicians in analysis of CT coronary angiography images for diagnosis and treatment planning.
4D Airways Analysis, CSAA-001A, is a post-processing software used on 320 row Aquillion ONE CT systems, which have system software V7.0 or later installed, to aid physicians in analysis of chest CT images for diagnosis and treatment planning.
14. INDICATIONS FOR USE:
Adaptive Motion Correction (AMC) software is intended to be used as an adjunct to the current cardiac reconstruction methods in cases where motion of the coronary arteries creates artifacts. This software can be applied to these images, without additional dose to the patient, to enhance the visibility of the coronary arteries.
4D Airways Analysis is a post processing software that may be used in conjunction with chest CT images to provide automatic (semi-automatic) segmentation of the bronchial tree. This software may aid in the diagnosis and follow-up treatment of bronchial diseases.
15. SUBSTANTIAL EQUIVALENCE:
Adaptive Motion Correction (AMC) is substantially equivalent to and performs in a manner similar to CardIQ Xpress 2.0 with SnapShot Freeze Option, with regard to motion correction (both devices are intended to reduce coronary artery motion blurring) and anatomical region of use. 4D Airways Analysis is substantially equivalent to and performs in a manner similar to the predicate device, Thoracic VCAR, in that both devices may be used to provide segmentations of the airways and to display various measurements including luminal area/diameter, bronchial area and wall area.
| Item | Adaptive Motion Correction
(AMC) | CardIQ Xpress 2.0 with
SnapShot Freeze Option |
|-----------------------------------------|-------------------------------------|------------------------------------------------------|
| 510(k) Number | This submission | K103480 |
| Anatomical region
(CT field of view) | Cardiac | Cardiac |
| Segmentation area | Coronary arteries | Coronary arteries |
| Motion estimation
parameter | Motion path | Motion path and velocity of the
coronary arteries |
| Registration for
motion estimation | Non-rigid registration | Non-rigid registration |
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| Item | 4D Airways Analysis | Thoracic VCAR |
|---|---|---|
| 510(k) Number | This submission | K120910 |
| Anatomical region | ||
| (CT field of view) | Chest | Chest |
| Target for | ||
| measurement | Airways | Airways and lungs |
| Target for | ||
| Input data | Multiple volumes | Single volume |
| Measurement | Lumen diameter and wall area | Lumen diameter and wall area |
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 applicable parts of the IEC62304 and IEC62366.
17. TESTING
Hazard analysis, verification/validation and performance testing conducted through bench testing are included in this submission which demonstrates that the design specifications established for the device have been met.
For both software features clinical evaluations were performed by qualified users to ensure that the final images presented met user needs. The clinical evaluation of the Adaptive Motion Correction software demonstrated improved visualization of the coronary arteries with the exception of RCA. The clinical evaluation of the 4D Airways Analysis software demonstrated that the user variability associated with this type of measurement was reduced.
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.
18. CONCLUSION
Adaptive Motion Correction (AMC) and 4D Airways Analysis, perform in a manner similar to and are intended for similar use as the predicate devices. 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 devices.