(90 days)
No Reference Device (s) K/DEN numbers were found in the text.
No
The summary mentions "image processing" but does not contain any terms like AI, ML, deep learning, neural networks, or descriptions of training/testing data sets typically associated with AI/ML development. The performance studies focus on dose estimation verification using phantoms, not AI/ML model validation.
No
The device is described as an Angio Workstation used for image processing and display in angiography procedures, which are diagnostic in nature. It does not exert a therapeutic effect on the patient.
Yes
The device is described as "image processing and display" for images input from a "Diagnostic Imaging System and Workstation," specifically for "2D and 3D imaging in selective catheter angiography procedures for the whole body." Angiography procedures are typically used to diagnose blockages or other abnormalities in blood vessels. While the device processes and displays images, the information provided relates to the diagnostic capabilities of the broader system it integrates with, and the output images would contribute to diagnosis.
No
The device is described as a "Workstation" which typically implies a hardware component (a computer or dedicated console) in addition to the software for image processing and display. The description also mentions input from "Diagnostic Imaging System and Workstation" and outputting to the same, further suggesting it's part of a larger hardware system.
Based on the provided information, the Angio Workstation (XIDF-AWS801) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the Angio Workstation clearly states it is used in combination with an interventional angiography system to provide 2D and 3D imaging of the whole body. It processes and displays images obtained directly from the patient's body, not from a specimen taken from the body.
- The intended use and device description focus on imaging and image processing. There is no mention of analyzing biological samples or providing diagnostic information based on the analysis of such samples.
Therefore, the Angio Workstation falls under the category of medical imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging in selective catheter angiography procedures for the whole body (includes heart, chest, abdomen, brain and extremity).
When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used in selective catheter angrography procedures for the heart, chest, abdomen, pelvis and brain.
Product codes
JAA
Device Description
The XIDF-AWS801 Angio Workstation is used for images input from Diagnostic Imaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System and Workstation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Interventional angiography system
Anatomical Site
whole body (includes heart, chest, abdomen, brain and extremity); heart, chest, abdomen, pelvis and brain.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Testing has been performed using commercially available phantom and measurement tools. The testing was performed to verify the estimated dose displayed by the software with the actual measured dose on the phantom within the gantry field of exposure.
Summary of Performance Studies
Testing, which conforms to the testing of the predicate device, has been performed to verify the additions to the software do not affect the effectiveness of the performance. This software is a dose management tool and as such does not provided an indicated use. The intended use of the device and predicate remain the same, to provide an estimated skin dose in real time during angiography procedures.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2014
Toshiba Medical Systems Corporation % Mr. Paul Biggins U.S. Agent/Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K141541
Trade/Device Name: XIDF-AWS801, Angio Workstation, v5.31 Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: June 9, 2014 Received: June 10, 2014
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. 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.
Smh.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name XIDF-AWS801; Angio Workstation v5.31
Indications for Use (Describe)
The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging in selective catheter angiography procedures for the whole body (includes heart, chest, abdomen, brain and extremity).
When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used in selective catheter angrography procedures for the heart, chest, abdomen, pelvis and brain.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS
1. CLASSIFICATION and DEVICE NAME:
| Classification Name: | Picture archiving and communications system, |
|---|---|
| Regulation Number: | 21 CFR 892.1650 (Class II) |
| Product Code | JAA – Image Processing/WorkStation |
| Trade Proprietary Name: | XIDF-AWS801, Angiography Workstation |
| Model Number: | XIDF-AWS801 V5.31 |
2. ESTABLISHMENT REGISTRATION: 9614698
3. CONTACT PERSON, U.S. AGENT and ADDRESS:
Contact/U.S. Agent:
Paul Biggins Director, Regulatory Affairs (714) 730-5000 Fax: (714) 730-1310 pbiggins@tams.com
Establishment Name and Address:
Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, Ca. 92780
4. MANUFACTURING SITE
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan CONTACT: AKINORI HATANAKA
-
- Date OF SUBMISSION: June 9, 2014
-
- PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
7. PREDICATE DEVICE:
XIDF-AWS801. Angio Workstation (K132106)
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8. REASON FOR SUBMISSION:
Modification of a cleared device
9. SUBMISSION TYPE:
Traditional 510(k)
10. DEVICE DESCRIPTION:
The XIDF-AWS801 Angio Workstation is used for images input from Diagnostic lmaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System and Workstation.
11. SUMMARY OF INTENDED USES:
The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Infinix-I series systems and INFX series systems) to provide 2D and 3D imaging in selective catheter angiography procedure for the whole body (includes heart, chest, abdomen, brain and extremity.)
When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used in selective catheter angiography procedure for the heart, chest abdomen, pelvis and brain.
12. SUMMARY OF CHANGE(S)
Dose Tracking Software has been expanded to provide estimated skin dose for the head. Additionally, the software has been improved over the previous versions to allow simultaneous tracking of dual tubes in bi-plane and dual plane operations.
13. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the XIDF-AWS801, Angio Workstation w/Dose Tracking System (K132106), marketed by Toshiba America Medical Systems. XIDF-AWS801 (v5.31) includes modifications to the cleared device which includes improvements to the Dose Tracking System. Testing, which conforms to the testing of the predicate device, has been performed to verify the additions to the software do not affect the effectiveness of the performance. This software is a dose management tool and as such does not provided an indicated use. The intended use of the device and predicate remain the same, to provide an estimated skin dose in real time during angiography procedures.
14. 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 IEC standards.
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15. TESTING
Testing has been performed using commercially available phantom and measurement tools. The testing was performed to verify the estimated dose displayed by the software with the actual measured dose on the phantom within the gantry field of exposure.
16. CONCLUSION
The modifications incorporated into the XIDF-AWS801, v5.31, do not change the indications for use or the intended use of the device. Safety and effectiveness have been verified via risk management and application of design controls to the modifications. Testing has verified that that the changes perform as intended.