(61 days)
Not Found
No
The summary mentions "image processing" but does not explicitly mention AI, ML, deep learning, or any related terms. The description of testing focuses on bench tests, simulations, and archived data, without detailing the type of algorithms used or any training/test set specifics typically associated with AI/ML development.
No.
The device is described as an Angio Workstation used for image processing and display in conjunction with angiography systems, not for direct therapeutic intervention.
Yes
The device processes and displays images from diagnostic imaging systems for use in angiography procedures across the whole body, which is inherently a diagnostic application.
No
The device description explicitly states it is a "Workstation" which implies a hardware component, and it processes and displays images, which typically requires hardware. It also mentions being used "in combination with an interventional angiography system," which are hardware devices.
Based on the provided information, the Angio Workstation (XIDF-AWS801) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used in combination with an interventional angiography system to provide 2D and 3D imaging for selective catheter angiography procedures. This involves imaging the internal structures of the body using contrast agents and X-rays, which is an in vivo procedure, not an in vitro (outside the body) diagnostic test.
- Device Description: The description focuses on image input, processing, and display from diagnostic imaging systems. This aligns with an imaging workstation used in a clinical setting for interpreting medical images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Angio Workstation's function is centered around processing and displaying medical images acquired within the patient's body.
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 (comma separated list FDA assigned to the subject device)
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Interventional angiography system (Infinix-i series systems and INFX series systems)
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 was conducted using bench (phantom) tests, simulations and archived image data sets.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was conducted using bench (phantom) tests, simulations and archived image data sets. This testing demonstrated that the implementation of the modifications retained the safety and effectiveness of the cleared device.
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.
Not Found
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
§ 892.1650 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image 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
November 25, 2015
Toshiba Medical Systems Corporation % Ms. Janine Reyes Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K152785
Trade/Device Name: XIDF-AWS801, Angio Workstation, V6.20 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: September 25, 2015 Received: September 25, 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,
Robert Ocko
Robert Ochs. Ph.D. 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) K152785
Device Name
XIDF-AWS801, Angio Workstation, V6.20
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) |
|---|
| ☑ 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, JAA |
| Trade Proprietary Name: | XIDF-AWS801, Angiography Workstation |
| Model Number: | XIDF-AWS801, V6.20 |
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 paul.biggins@toshiba.com
Contact Person:
Janine Reyes Manager, Regulatory Affairs (714) 669-7853 Fax: (714) 730-1310 janine.reyes@toshiba.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 PREPARED:
September 25, 2015
-
- TRADE NAME(S): XIDF-AWS801, Angio Workstation, V6.20
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7. DEVICE CLASSIFICATION:
Class II (per 21 CFR 892.1650)
8. PERFORMANCE STANDARD:
This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J. Federal Diagnostic X-ray Equipment Standard].
9. PREDICATE DEVICE:
XIDF-AWS801, Angio Workstation, V6.10 (K150967)
| Product | Marketed by | 510(k) Number | Clearance Date |
|---|---|---|---|
| XIDF-AWS801, Angio | |||
| Workstation, V6.10 | Toshiba America | ||
| Medical Systems | K150967 | June 18, 2015 |
10. REASON FOR SUBMISSION:
Modification of a cleared device
11. SUBMISSION TYPE:
Traditional 510(k)
12. 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.
13. 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.
14. SUMMARY OF CHANGE(S)
This submission is to report the following items have been changed:
- a. Dynamic Device Stabilizer function: provides real-time multi-frame image display during live fluoroscopy or DA, which makes a stent appear stationary.
- b. 3D-LD image display: 3D-DA performed at low dose. 3D-LD acquisition is intended for use in high-contrast vascular imaging studies such as pediatric pulmonary arteriography and for confirming therapeutic effectiveness immediately after IVR. Note that this technique should not be used for definitive diagnosis or for measurement.
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15. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the XIDF-AWS801, Angio Workstation, V6.10 (K150967), marketed by Toshiba America Medical Systems. XIDF-AWS801, Angio Workstation, V6.20, includes modifications to the cleared device consisting of the addition of Dynamic Device Stabilizer function and 3D-LD image display. Testing was conducted using bench (phantom) tests, simulations and archived image data sets. This testing demonstrated that the implementation of the modifications retained the safety and effectiveness of the cleared device.
The basic system configuration, method of operation, base software and manufacturing process remain unchanged from the cleared device. There are no new indications for use or intended use of the device.
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 IEC standards.
17. TESTING:
This submission contains test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system. Testing of the modified system was conducted in accordance with the applicable standards published by the International Electromechanical Commission (IEC) for Medical Devices and XR Systems.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software 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 Electromechanical Commission (IEC) for Medical Devices and XR Systems.
18. CONCLUSION
The subject device is substantially equivalent to the XIDF-AWS801, Angio Workstation, V6.10, which was cleared via Pre-Market Notification 510(k), K150967 (See TAB 1). The modifications incorporated into the XIDF-AWS801, Angio Workstation, V6.20, 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.