INFINIX ANGIO WORKSTATION W/DTS SOFTWARE

K132106 · Toshiba America Medical Systems, In.C · JAA · Nov 12, 2013 · Radiology

Device Facts

• Record ID: K132106
• Device Name: INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: JAA · Radiology
• Decision Date: Nov 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

XIDF-AWS801 Angio Workstation provides 2D/3D image post-processing and Dose Tracking System (DTS) functions. DTS calculates estimated patient skin radiation dose distribution and rate in real-time during fluoroscopic and radiographic procedures. Inputs include exposure technique parameters and geometry from connected X-ray imaging systems (Infinix-i, INFX-8000V/C). Output is a color-mapped dose distribution overlay on a 3D patient model. Used in clinical settings by physicians; assists in monitoring radiation exposure to potentially reduce patient dose. Modification adds XIDF-DTS802 software, expanding functionality to general angiography/radiography and improving C-arm position/field-of-view dose estimation.

Clinical Evidence

Bench testing only. Performance verified using anthropomorphic and Lexan phantoms to validate accuracy of estimated skin dose distribution and rate calculations.

Technological Characteristics

Workstation hardware: PC, monitor, hub, keyboard, mouse, calibration unit, CAN I/F card. Software: 3D reconstruction, 3D/multimodality roadmap, TAVR support, Dose Tracking System (DTS). Connectivity: Integrated with Infinix-i series angiography systems. Conformance: IEC60601-1, 21 CFR 1020.

Indications for Use

Indicated for patients undergoing selective catheter angiography of the heart, chest, and abdomen using Infinix-i series, INFX-8000V, or INFX-8000C systems. Patient population includes males (130-200 cm), females (117-187 cm), and children (50-150 cm).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Toshiba Dose Tracking Software (K123097)
• Toshiba XIDF-AWS801 Angio Workstation (K120073)

Submission Summary (Full Text)

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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.
- 2. ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
- 3. ESTABLISHMENT REGISTRATION: 2020563

# 4. CONTACT PERSON:

Paul Biggins Director, Regulatory Affairs [phone]

- 5. Date: November 7, 2013
- 6. TRADE NAME(S): XIDF-AWS801; Angiography Workstation
- 7. COMMON NAME: System, X-ray, Fluoroscopic, Image-Intensified
- 8. DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1650)
- 9. PRODUCT CODE / DESCRIPTION: JAA; System, X-ray, Fluoroscopic, Image-Intensified
- 10. 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:

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.

### 14. SUMMARY OF INTENDED USES:

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.

### 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-AWS801<br>with Dose Tracking System<br>XIDF-DTS802 |
| 510(k) Number | K120073 (INFX-8000V) | |
| Intended use | This device is used for images input from Diagnostic Imaging System and<br>Workstation, image processing and display. The processed images can be<br>outputted to Diagnostic Imaging System and Workstation. This device<br>provides the image information and measurement results that are required<br>when performing Angiography Procedures. | The same |
| Standard<br>hardware<br>configuration | PC. Monitor, HUB, Keyboard, Mouse, Calibration unit | The same |
| Option<br>hardware<br>configuration | CAN I/F card and cable | The same |
| Standard<br>Software | 3D reconstruction | The same |
| Option<br>Software | 3D Roadmap<br>Multimodality Roadmap<br>TAVR support | 3D Roadmap<br>Multimodality Roadmap<br>TAVR support<br>Dose Tracking System kit |

.

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| | Table 2. Predicate Device Comparisontable | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ITEM | Dose Tracking System<br>XIDF-DTS801 | Dose Tracking System kit<br>XIDF-DTS802 |
| 510(k) Number | K123097 | |
| Configurations | | |
| Type of device | Software | Software |
| Required<br>hardware | PC is required | XIDF-AWS801 |
| < Intended use > | | |
| Indications for<br>use | DTS is intended to display an approximation of both<br>skin dose distribution and skin dose rate in real time<br>during fluoroscopic interventional procedures of<br>cardiac angiography.<br><br>This software is intended for use on the Toshiba<br>INFX-8000F CSi cardiac labs. | DTS is intended to display an<br>approximation of both skin<br>dose distribution and skin<br>dose rate in real time during<br>fluoroscopic interventional<br>procedures and radiographic<br>procedures. |
| Intended<br>procedures | Cardiacangiography | Cardiacangiography<br>General angiography<br>All radiography exposures |
| Intended patient<br>information | Male: Height from 130 cm to 200 cm<br>Female: Height from 117 cm to 187 cm | Male: Height from 130 cm to<br>200 cm<br>Female: Height from<br>117 cm to 187 cm<br>Child: Height from 50 cm to<br>150 cm |
| Systems | INFX-8000F | INFX-8000V<br>INFX-8000C |

| ITEM | Dose Tracking System | Dose Tracking System kit |
|----------------------------------------|----------------------|--------------------------|
| | XIDF-DTS801 | XIDF-DTS802 |
| <Software functionality> | | |
| 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
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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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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