The Angio Workstation is used in combination with an interventional angiography system (Infinix-i series systems and INFX-8000V and INFX-8000C systems) to provide 2D and 3D imaging and Dose Tracking System functions in selective catheter angiography for the heart, chest, and abdomen.

Device Description

The XIDF-AWS801 Angio Workstatoin is a workstation for post-processing software that displays images in 2-d or 3-d format to provide additional information to the clinician. The software on this device remains unchanged with the exception of XIDF-DTS802 software.

The dose tracking system (DTS) is an application software package intended to provide the estimated dose distribution information during radiographic and fluoroscopic procedures. The dose tracking system (DTS) calculates the radiation dose of the patient's skin using the exposure technique parameters and exposure geometry obtained from the x-ray imaging system and presents the cumulative results in a color mapping on a 3D graphic of the patient model.

AI/ML Overview

This 510(k) submission (K132106) describes a modification to the Toshiba XIDF-AWS801 Angio Workstation, specifically the addition of the XIDF-DTS802 Dose Tracking Software. The submission states that the added functionality does not change the intended use of the DTS and that the test methodology for verification remains unchanged from what was previously reported to the FDA (K123097). Therefore, the acceptance criteria and study details are primarily referred to in previous submissions.

Based on the provided document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for the XIDF-DTS802. Instead, it refers to prior testing and general verification. The performance is summarized as follows:

Feature/Metric	Acceptance Criteria	Reported Device Performance
Dose Tracking System (DTS) Accuracy	Not explicitly stated in this document. Implied adherence to previous validation in K123097.	"Based upon this testing the accuracy of the displayed estimated dose was determined and is included in the user information." (No specific values provided in this document).
Expanded Functionality (General Angiography, Radiography, C-arm positions)	Not explicitly stated. Verified through testing.	Functionality has been added and verified with the same test methodology as previously reported to the Agency (K123097).
Conformance to Standards	IEC60601-1, 21 CFR §820 (Quality System Regulations), ISO 13485, 21 CFR §1020 (Federal Diagnostic Equipment Standard for X-rays).	The device is designed, manufactured, and conforms to applicable parts of these standards.

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

Sample Size: Not explicitly stated in this document. The testing involved "anthropomorphic phantoms and Lexan phantoms." The number of phantoms used or the quantity of data generated from them is not specified.
Data Provenance: Not specified, but likely proprietary data generated by Toshiba America Medical Systems, Inc. through their testing. The document refers to "anthropomorphic phantoms and Lexan phantoms," indicating a laboratory testing environment rather than clinical data from human subjects.

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

Not stated. The ground truth for dose estimation in phantom studies is typically established through direct measurement with dosimeters, which serve as the "true" dose for comparison. Clinical experts are usually involved in designing such studies and interpreting results, but their specific role in establishing the ground truth (i.e., the actual dose delivered to the phantom) is generally not as a human "reader" compared to imaging interpretation studies.

4. Adjudication Method for the Test Set

Not applicable/Not stated. The testing methodology focuses on technical accuracy of dose estimation using phantoms rather than interpretation of clinical images by human readers requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No. This information is not mentioned in the document. The device is a dose tracking system, not an AI-powered diagnostic image interpretation tool that would typically undergo MRMC studies to assess reader improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, implicitly. The testing described as using "anthropomorphic phantoms and Lexan phantoms to verify and validate the performance of the system" to determine the "accuracy of the displayed estimated dose" refers to the standalone performance of the DTS algorithm. The "human-in-the-loop" aspect for a dose tracking system would typically involve the clinician observing the dose display during a procedure, but the accuracy validation itself is a standalone assessment of the calculated dose versus a measured dose.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the test set was based on measured radiation doses in anthropomorphic and Lexan phantoms. For dose estimation systems, physical measurements using calibrated dosimetry equipment (e.g., ionization chambers, thermoluminescent dosimeters) provide the ground truth for comparison.

8. The Sample Size for the Training Set

Not specified. The document does not provide details about a distinct "training set" as one might find for a machine learning algorithm. The DTS calculates dose based on exposure parameters and geometry, which are physics-based models, not typically "trained" on a large dataset in the same way a deep learning model would be. Calibration and underlying physics models would be developed and validated, but a separate "training set" as defined for statistical or AI models is not indicated.

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

Not applicable (based on the lack of a distinct "training set" as described above). The underlying models and calculations within the DTS would have been developed and verified through established physics principles and possibly empirical measurements, which serve as the foundation for the software's accuracy.

Summary

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Toshiba America Medical Systems, Pre-Market Notification 510(k) XIDF-AWS801;Angio Workstation v4.51

510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS

1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
1. ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
1. ESTABLISHMENT REGISTRATION: 2020563

4. CONTACT PERSON:

Paul Biggins Director, Regulatory Affairs (714) 730-5000

1. Date: November 7, 2013
1. TRADE NAME(S): XIDF-AWS801; Angiography Workstation
1. COMMON NAME: System, X-ray, Fluoroscopic, Image-Intensified
1. DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1650)
1. PRODUCT CODE / DESCRIPTION: JAA; System, X-ray, Fluoroscopic, Image-Intensified
1. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard

11. PREDICATE DEVICE:

Toshiba Dose Tracking Software - K123097 Toshiba XIDF-AWS801 Angio Workstation - K120073

12. REASON FOR SUBMISSION:

Modification of a cleared device

NOV 1 2 2013

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13. DEVICE DESCRIPTION:

14. SUMMARY OF INTENDED USES:

15. SUBSTANTIAL EQUIVALENCE: ·

The change to the device is to provide the Dose Tracking Software (DTS) which was market cleared via K123097. Additionally, functionality has been added to the DTS which has been verified with the same test methodology as previously reported to the Agency. The added functionality includes use during general angiography and radiography procedures, as well as expanded C-arm position dose estimations. The addition of this functionality does not change the intended use of the DTS as the device remains intended to provide real-time dose estimation.

In summary both the intended use and the test methodology remain unchanged for the subject devices of this submission. Toshiba believes that substantial equivalence has been established.

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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) XIDF-AWS801;Angio Workstation v4.51

ITEM	Image processor	Image processor
	XIDF-AWS801	XIDF-AWS801with Dose Tracking SystemXIDF-DTS802
510(k) Number	K120073 (INFX-8000V)
Intended use	This device is used for images input from Diagnostic Imaging System andWorkstation, image processing and display. The processed images can beoutputted to Diagnostic Imaging System and Workstation. This deviceprovides the image information and measurement results that are requiredwhen performing Angiography Procedures.	The same
Standardhardwareconfiguration	PC. Monitor, HUB, Keyboard, Mouse, Calibration unit	The same
Optionhardwareconfiguration	CAN I/F card and cable	The same
StandardSoftware	3D reconstruction	The same
OptionSoftware	3D RoadmapMultimodality RoadmapTAVR support	3D RoadmapMultimodality RoadmapTAVR supportDose Tracking System kit

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	Table 2. Predicate Device Comparisontable
ITEM	Dose Tracking SystemXIDF-DTS801	Dose Tracking System kitXIDF-DTS802
510(k) Number	K123097
Configurations
Type of device	Software	Software
Requiredhardware	PC is required	XIDF-AWS801
< Intended use >
Indications foruse	DTS is intended to display an approximation of bothskin dose distribution and skin dose rate in real timeduring fluoroscopic interventional procedures ofcardiac angiography.This software is intended for use on the ToshibaINFX-8000F CSi cardiac labs.	DTS is intended to display anapproximation of both skindose distribution and skindose rate in real time duringfluoroscopic interventionalprocedures and radiographicprocedures.
Intendedprocedures	Cardiacangiography	CardiacangiographyGeneral angiographyAll radiography exposures
Intended patientinformation	Male: Height from 130 cm to 200 cmFemale: Height from 117 cm to 187 cm	Male: Height from 130 cm to200 cmFemale: Height from117 cm to 187 cmChild: Height from 50 cm to150 cm
Systems	INFX-8000F	INFX-8000VINFX-8000C

ITEM	Dose Tracking System	Dose Tracking System kit
	XIDF-DTS801	XIDF-DTS802

Basic algorithm to calculate skin dose	Available	Almost same
Compensation for deep	Available	Available
C-arm angle to calculate		Improved)
skin dose
Compensation for field of	Not available	Available
view to calculate skin
dose
Displayed height and	Not available	Available
weight information on
patient model select window.
Report viewer	Not available	Available

('' When applied to dual arm systems only frontal arm can display the DTS results

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K132106
Page 5 of 6

Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) XIDF-AWS801;Angio Workstation v4.51

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 IEC60601-1 standards and its collateral 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.

17. SUMMARY OF TESTING:

Testing was performed using anthropomorphic phantoms and Lexan phantoms to verify and validate the performance of the system. Based upon this testing the accuracy of the displayed estimated dose was determined and is included in the user information.

18. CONCLUSION

The addition of the XIDF-DTS802 Dose Tracking Software that is being added to the XIDF-AWS801 Angio Workstation at this time does not change the indication for use or the intended use of the device. Safety and effectiveness have been verified via risk management and application of design controls to this modification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center is a stylized depiction of an eagle or bird with three wing-like extensions.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 12, 2013

Toshiba Medical Systems Corporation % Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780-2068

Re: K132106

Trade/Device Name: Infinix Angio Workstation W/dts Software Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: October 11. 2013 Received: October 15, 2013

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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Page 2-Mr. Biggins

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance 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,

Smith

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

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510{k) Number (if known) K132106

Device Name

XIDF-AWS801; Angio Workstaton w/Dose Tracking System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

y 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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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.