(59 days)
No
The document mentions image processing but does not contain any terms related to AI, ML, deep learning, neural networks, or any description of training or test sets typically associated with AI/ML development.
No.
The device is used for imaging, image processing, and display, which are diagnostic functions, not therapeutic.
Yes
The device description states it is used for "images input from Diagnostic Imaging System and Workstation, image processing and display." The "Intended Use / Indications for Use" section further clarifies its use in "selective catheter angiography procedures" to provide "2D and 3D imaging." Angiography is a diagnostic procedure used to visualize blood vessels and identify conditions such as blockages or aneurysms. The processing and display of these images for clinical assessment directly supports diagnosis.
No
The device description explicitly states it is a "Workstation" and is used in combination with "interventional angiography systems" and "Diagnostic Imaging System and Workstation" for image input and output. While it performs image processing, the context strongly suggests it is a hardware-based workstation with integrated software, not a standalone software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 in 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, not a device that analyzes biological samples.
- Input Imaging Modality: The input is described as images from diagnostic imaging systems, specifically two-dimensional data for 3D reconstruction. This is consistent with medical imaging data, not data from in vitro tests.
- Anatomical Site: The device is used for imaging various anatomical sites within the body.
- Intended User/Care Setting: The intended user is described as being under the supervision of a cardiologist or radiologist, which are medical professionals involved in imaging procedures, not laboratory professionals who typically use IVDs.
IVD devices are designed to examine specimens (like blood, urine, tissue) obtained from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on biological samples. It processes and displays medical images acquired from 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 angiography 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, V7.0 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 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission. Software modules were subject to verification and/or validation testing to ensure that they were properly integrated into the existing software platform. Additionally, the design controls used for this device included risk management and all known risks were mitigated to an acceptable level.
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
§ 892.1650 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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Toshiba Medical Systems Corporation % Ms. Janine Reyes Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K172646
Trade/Device Name: XIDF-AWS801, Angio Workstation, V7.0 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: August 31, 2017 Received: September 1, 2017
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
October 30, 2017
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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 (DICE) 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. 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 (DICE) 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,
Michael D. O'Hara For
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) K172646
Device Name XIDF-AWS801, Angio Workstation, V7.0
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 angiography 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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92
1. CLASSIFICATION and DEVICE NAME
| Classification Name | Solid State X-ray System, Interventional |
|---|---|
| Regulation Number | 21 CFR 892.1650 (Class II) |
| Product Code | OWB, JAA |
| Trade Proprietary Name | XIDF-AWS801, Angio Workstation |
| Model Number | XIDF-AWS801, V7.0 |
2. SUBMITTER'S NAME
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
3. OFFICIAL CORRESPONDENT
Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance
4. CONTACT PERSON, U.S. AGENT and ADDRESS
Contact Person
Janine Reyes Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive, Tustin, CA 92780 (714) 669-7853 Fax: (714) 730-1310 jfreyes@tams.com
Official Correspondent/U.S. Agent
Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive, Tustin, CA 92780 (714) 730-5000 Fax: (714) 730-1310 pbiggins@tams.com
5. MANUFACTURING SITE
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
6. ESTABLISHMENT REGISTRATION 9614698
7. DATE PREPARED August 31, 2017
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8. TRADE NAME(S)
XIDF-AWS801, Angio Workstation, V7.0
-
- CLASSIFICATION PANEL
Radiology
- CLASSIFICATION PANEL
-
- DEVICE CLASSIFICATION Class II (per 21 CFR 892.1650)
-
- PRODUCT CODE / DESCRIPTION
Product Code: OWB, JAA
12. PERFORMANCE STANDARD
This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard].
13. PREDICATE DEVICE
XIDF-AWS801, Angio Workstation, V6.20 (K152785)
| Product | Marketed by | 510(k) Number | Clearance Date |
|---|---|---|---|
| XIDF-AWS801, Angio | |||
| Workstation, V6.20 | Toshiba America | ||
| Medical Systems | K152785 | November 25, 2015 |
14. REASON FOR SUBMISSION
Modification of a cleared device
15. SUBMISSION TYPE
Traditional 510(k)
16. DEVICE DESCRIPTION
The XIDF-AWS801, Angio Workstation, V7.0 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.
17. 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 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.
18. SUMMARY OF CHANGE(S)
This submission is to report the following items have been changed:
- . PC, GPU, HUB, Monitor: changed for XIDF-AWS801/B1
- Supplemental Symbol: addition of /B2 model (XIDF-AWS801/B2) ●
- Software change from V6.20 to V7.0:
- oLCI image quality improvement: Implementation of pulse width modulation during 3D reconstruction. This function has been migrated from INFX-8000V,
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Image /page/5/Picture/1 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is written in large, bold, red letters on the top line. Below it, the word "MEDICAL" is written in the same font and color, but slightly smaller. The logo is simple and clean, with a focus on the brand name.
previously cleared under K162614.
- oClinical analysis application IV-LINQ (OCT/IVUS integration module): Images from IVUS or OCT can be imported and used under the supervision of a cardiologist or radiologist to facilitate enhanced stent visualization and measure stent dimensions. OCT/IVUS Integration module (IV-LINQ) is added to CAAS Workstation by Pie Medical Imaging B.V., previously cleared under K151780.
- o Dynamic Device Stabilizer improvement
- o DTS (Dose Tracking System) improvement
- o 3D Calibration improvement
- o Serviceability improvement
- o Renewal of 3D Road Map and 3D Viewer
- o Provisions of 3D 3D/CBCT artifact (RFC [Ring free correction] / BHC [Beam hardening correction])
- oWorkflow Improvements:
- | Measurement and segmentation may be performed on 3D-WS
- Multiple data (volume, object) and analysis results provided by clinical applications are available on 3D-RM application
- Ease to define working angles
- . Security Kit for DoD: the Security Kit for DoD (software) is available for XIDF-AWS801/B1. This kit is to meet the security requirement of the U.S. Department of Defense.
- . Cerebral Aneurysm Analysis: this application is intended to facilitate the extraction and segmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio. Main software of Cerebral Aneurysm Analysis is introduced from Vitrea Software Toshiba Package, VSTP-001A, previously cleared under K151091. The following items are newly added for this software:
- o Communication with Angio Workstation 3D viewer (image data, image storage condition, etc.)
- o Communication with Infinix-i Interventional Angiography systems (3D image angle, etc.)
- Two dimensional data (512 x 512 x 12/16 bits) inputs are available for 3D reconstruction
19. 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 IEC60601-1 standards. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via product report.
LIST OF APPLICABLE STANDARDS
- IEC60601-1-2:2007 ●
- IEC62304:2006 .
- IEC62366:2007 ●
- . IEC60950-1:2005
- . ISO 14971:2007
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20. 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 Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission. Software modules were subject to verification and/or validation testing to ensure that they were properly integrated into the existing software platform. Additionally, the design controls used for this device included risk management and all known risks were mitigated to an acceptable level.
21. SUBSTANTIAL EQUIVALENCE
This device is substantially equivalent to the XIDF-AWS801, Angio Workstation, V6.20 (K152785), marketed by Toshiba America Medical Systems. XIDF-AWS801, Angio Workstation, V7.0, includes modifications to the cleared device consisting of software change from V6.20 to V7.0, addition of supplemental symbol /B2 model (XIDF-AWS801/B2), two dimensional data (512 x 512 x 12/16bits) inputs are available for 3D reconstruction, clinical analysis application IV-LINQ (OCT/IVUS integration module) and Cerebral Aneurysm Analysis application.
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.
22. CONCLUSION
The subject device is substantially equivalent to the XIDF-AWS801, Angio Workstation, V6.20, which was cleared via Pre-Market Notification 510(k), K152785. XIDF-AWS801, Angio Workstation, V7.0 has the same Indications for Use as the predicate and neither the modifications nor the labeling introduce new intended use. The subject device has new technological characteristics (see Section No. 18 – Summary of Changes). These different technological characteristics raise the same questions of safety and effectiveness including questions of image quality, computed data accuracy, and system reliability. These questions of safety and effectiveness are addressed through design controls and software verification and validation testing which demonstrated that the subject device is substantially equivalent to the XIDF-AWS801, Angio Workstation, V6.20.