(66 days)
Not Found
No
The document mentions "image processing" but does not contain any explicit references to AI, ML, deep learning, or related concepts. The performance studies focus on verifying "Parametric Imaging function" calculations, which doesn't inherently imply AI/ML.
No.
The device is used for image processing and display in conjunction with an angiography system, which are diagnostic functions, not therapeutic.
Yes
The device processes and displays 2D and 3D images from an interventional angiography system for diagnostic purposes in various procedures across the whole body.
No
The device is described as a "Workstation" which typically implies a hardware component (a computer or dedicated system) running the software, and it interacts with "Diagnostic Imaging System and Workstation" hardware. The description focuses on image processing and display, which are functions of software, but the context of a "Workstation" and interaction with other hardware systems suggests it is not purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Angio Workstation (XIDF-AWS801) is described as a device that processes and displays images obtained from an interventional angiography system. This system uses imaging modalities (like X-rays) to visualize blood vessels within the body.
- Lack of Biological Sample Analysis: The description does not mention the analysis of any biological samples from the patient. The device works with images generated from an imaging system, not with patient specimens.
Therefore, the Angio Workstation falls under the category of medical imaging devices, not in vitro diagnostics.
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 anglography procedures for the heart, chest, abdomen, pelvis, and brain.
Product codes
OWB, 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
Not Found
Anatomical Site
whole body (includes heart, chest, abdomen, brain and extremity), heart, chest, abdomen, pelvis, 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
Software verification and validation testing was conducted using archived image data sets. Validation and performance testing objective was to verify Parametric Imaging function correctly calculated and displayed the obtained parameter values, using testing conditions that were representative of clinical conditions using DSA image data.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation and performance testing concluded the Parametric Imaging Function correctly calculates and displays the parameter values under clinical conditions. No limitations were observed based on these tests. The results of this testing verified that the performance of the changes was within the specified requirements. Additionally, the testing was used to include user information related to the performance of the changes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
XIDF-AWS801, Angio Workstation, V5.31 (K142736)
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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles, suggesting health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 18, 2015
Toshiba Medical Systems Corporation % Ms. Janine Reyes Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K150967
Trade/Device Name: XIDF-AWS801, Angio Workstation, V6.10 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: April 13, 2015 Received: April 13, 2015
Dear Ms. Reyes:
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.
For
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) K150967
Device Name XIDF-AWS801, Angio Workstation, V6.10
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 anglography 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) |
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510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS
1. CLASSIFICATION and DEVICE NAME:
| Classification Name: | Image-Intensified Fluoroscopic X-Ray System |
|---|---|
| Regulation Number: | 21 CFR 892.1650 (Class II) |
| Product Code: | OWB (Primary), JAA (Secondary) |
| Trade Proprietary Name: | XIDF-AWS801, Angiography Workstation |
| Model Number: | XIDF-AWS801 V6.10 |
2. ESTABLISHMENT REGISTRATION: 9614698
3. CONTACT PERSON, U.S. AGENT and ADDRESS:
Official Correspondent /U.S. Agent:
Paul Biggins Director, Regulatory Affairs (714) 730-5000 Fax: (714) 730-1310 pbiggins@tams.com
Contact Person:
Janine Reyes Manager, Regulatory Affairs (714) 669-7853 Fax: (714) 730-1310 jfreyes@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
5. Date OF SUBMISSION:
April 13th, 2015
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6. PERFORMANCE STANDARD:
21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
7. PRODUCT CODE:
The Primary Product Code is OWB and the Secondary Product Code is JAA
8. PREDICATE DEVICE:
XIDF-AWS801, Angio Workstation, V5.31 (K142736)
9. REASON FOR SUBMISSION:
Modification of a cleared device
10. SUBMISSION TYPE:
Traditional 510(k)
11. 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.
12. 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 of 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 with selective catheter angiography procedures for the heart, chest abdomen, pelvis and brain.
13. SUMMARY OF CHANGE(S)
This submission is to report modification of Parametric Imaging Function software application which is meant to provide the user with information that is to be used in adjunct to the normal images provided by the Angio System. Modifications to the cleared device include:
- a. Color Coded Circulation (CCC): Color Coded Circulation creates movies by gradually shifting the color scale to easily understand vessel flow.
- b. Parameters for Imaging:
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- i. Time To Arrival (TTA): the period of time required to reach peak contrast enhancement.
- ii. Time To Arrival α (TTAα): Parametric Image created based on the Time To Arrival (TTA) and Peak Height (PH) values for each pixel.
- Mean Transit Time (MTT): The contrast medium residence time. iii.
- Mean Transit Time α (MTTa): Parametric Image created based on the iv. Mean Transit Time (MTT) and Peak Height (PH) values for each pixel.
- Time To Peak α (TTPα): Parametric Image created based on the Time V. To Peak (TTP) and Peak Height (PH) values for each pixel.
Parametric Imaging is intended for use with existing imaging from the cleared device. The software is not intended for stand-alone use or diagnosis.
14. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the XIDF-AWS801, Angio Workstation V5.31 (K142736), marketed by Toshiba America Medical Systems. XIDF-AWS801 (V6.10) includes modifications to the cleared device which includes improvements to the parametric imaging function. Testing was performed using archived clinical images. This testing demonstrated that the implementation of the modifications retained the safety and effectiveness of the cleared device.
15. 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 IEC standards.
16. Testing:
Software verification and validation testing was conducted using archived image data sets. Validation and performance testing objective was to verify Parametric Imaging function correctly calculated and displayed the obtained parameter values, using testing conditions that were representative of clinical conditions using DSA image data.
Validation and performance testing concluded the Parametric Imaging Function correctly calculates and displays the parameter values under clinical conditions. No limitations were observed based on these tests. The results of this testing verified that the performance of the changes was within the specified requirements. Additionally, the testing was used to include user information related to the performance of the changes.
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17. Conclusion:
The modifications incorporated into the XIDF-AWS801, V6.10, 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.