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.

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.

AI/ML Overview

This document is a 510(k) summary for the Toshiba Medical Systems Corporation's XIDF-AWS801, Angio Workstation, V7.0. It is a modification of a previously cleared device (XIDF-AWS801, Angio Workstation, V6.20, K152785). The submission primarily focuses on establishing substantial equivalence to the predicate device and does not provide detailed acceptance criteria or a specific study demonstrating performance against such criteria.

However, based on the provided text, we can infer some information relevant to the request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It focuses on the substantial equivalence argument, asserting that "system modifications result in performance that is equal to or better than the predicate system." The key performance aspects implicitly covered by the modifications and safety assessment are:

Acceptance Criteria (Inferred from device changes and safety statement)	Reported Device Performance (Summary from text)
Image Quality (oLCI image quality improvement, 3D Calibration improvement, 3D Road Map and 3D Viewer renewal, 3D/CBCT artifact provisions)	"o LCI image quality improvement: Implementation of pulse width modulation during 3D reconstruction." This function was migrated from a previously cleared device (K162614). "Renewal of 3D Road Map and 3D Viewer." "Provisions of 3D 3D/CBCT artifact (RFC [Ring free correction] / BHC [Beam hardening correction])". These changes are intended to maintain or improve image quality compared to the predicate.
Computed Data Accuracy (Cerebral Aneurysm Analysis, IV-LINQ integration)	"Cerebral Aneurysm Analysis...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 introduced from K151091). "Clinical 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." (Module added from K151780). These indicate the system's ability to provide accurate measurements and visualizations.
System Reliability (Dynamic Device Stabilizer improvement, Serviceability improvement, DTS improvement)	"Dynamic Device Stabilizer improvement." "DTS (Dose Tracking System) improvement." "Serviceability improvement." These imply enhancements to the system's robust operation.
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." Risks were mitigated to an acceptable level.
Functionality (Workflow Improvements, communication with other systems, 2D data input for 3D reconstruction)	"Workflow 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." "Communication with Angio Workstation 3D viewer (image data, image storage condition, etc.)" and "Communication with Infinix-i Interventional Angiography systems (3D image angle, etc.)" for Cerebral Aneurysm Analysis. "Two dimensional data (512 x 512 x 12/16 bits) inputs are available for 3D reconstruction."
Security	"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."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" for performance evaluation in terms of number of cases or data provenance. The assessment relies on the modifications made to the predicate device and the validation of those changes.
The text mentions "test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system." However, no details on the size or characteristics of this test data are provided. It does not mention retrospective or prospective studies or the country of origin for any data used in this specific submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not detail a specific "test set" with ground truth established by experts for this submission.
For the "Cerebral Aneurysm Analysis" and "IV-LINQ (OCT/IVUS integration module)" applications, it mentions that the IV-LINQ module is "[imported] and used under the supervision of a cardiologist or radiologist." For the Cerebral Aneurysm Analysis, it states "[the software] can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio." This implies that the ground truth for these features would typically be clinical assessment by qualified specialists (cardiologists or radiologists), but the number of experts or their years of experience for any specific validation data is not provided in this document.

4. Adjudication Method for the Test Set

No details on an adjudication method (e.g., 2+1, 3+1, none) are provided as there is no explicitly defined external "test set" with expert review mentioned for this submission. The internal testing refers to "software verification and validation testing."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. There is no mention of human readers improving with or without AI assistance, nor any effect size. This submission focuses on modifications to an existing workstation and demonstrating substantial equivalence, not a comparative efficacy study of AI assistance.

6. Standalone (Algorithm Only) Performance Study

The document does not explicitly describe a standalone (algorithm only) performance study. The device, XIDF-AWS801, Angio Workstation, V7.0, is an "Angio Workstation" and includes "Angio Workstation 3D viewer" and is "used in combination with an interventional angiography system." While it contains sophisticated software modules (e.g., Cerebral Aneurysm Analysis, IV-LINQ), the submission positions them as part of an integrated workstation and does not report on their isolated algorithmic performance. The focus is on the integrated system's equivalence.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance validation. However, given the nature of the applications (Cerebral Aneurysm Analysis, IV-LINQ for stent visualization and measurement), it can be inferred that:

For the Cerebral Aneurysm Analysis, ground truth for aneurysm detection and measurement would ideally come from definitive clinical diagnosis and potentially other validated imaging modalities or surgical findings.
For IV-LINQ, the ground truth for stent visualization and measurement would likely be based on expert clinical assessment by cardiologists or radiologists using intravascular ultrasound (IVUS) or optical coherence tomography (OCT) images, potentially compared with angiographic or other invasive measurements.
For general image quality improvements, the ground truth would be based on qualitative and quantitative assessments against established imaging standards and clinical expectations.

8. Sample Size for the Training Set

The document does not specify the sample size used for any training set. It describes software modifications and the integration of modules "migrated" or "introduced" from previously cleared devices (K162614, K151780, K151091). These previously cleared devices or modules may have undergone their own training and validation, but details are not included in this K172646 submission.

9. How the Ground Truth for the Training Set Was Established

As no training set is described, the document does not provide information on how ground truth was established for any training set.

Summary

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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)

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

1. CLASSIFICATION PANEL
  Radiology
1. DEVICE CLASSIFICATION Class II (per 21 CFR 892.1650)
1. 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, AngioWorkstation, V6.20	Toshiba AmericaMedical Systems	K152785	November 25, 2015

14. REASON FOR SUBMISSION

Modification of a cleared device

15. SUBMISSION TYPE

Traditional 510(k)

16. DEVICE DESCRIPTION

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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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.

Regulation Number and Section

§ 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.