XIDF-AWS801, ANGIO WORKSTATION, V5.31

K141541 · Toshibamedical Systems Corporation · JAA · Sep 8, 2014 · Radiology

Device Facts

• Record ID: K141541
• Device Name: XIDF-AWS801, ANGIO WORKSTATION, V5.31
• Applicant: Toshibamedical Systems Corporation
• Product Code: JAA · Radiology
• Decision Date: Sep 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended 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 angrography procedures for the heart, chest, abdomen, pelvis and brain.

Device Story

XIDF-AWS801 Angio Workstation processes and displays images from interventional angiography systems (Infinix-i/INFX series). Device provides 2D/3D imaging and real-time estimated skin dose tracking (DTS). Modifications include expanded dose tracking for head and simultaneous tracking of dual tubes in bi-plane/dual-plane operations. Used in clinical settings by physicians during angiography. Output assists clinicians in monitoring radiation exposure and visualizing anatomy. Benefits include real-time dose management and improved procedural imaging.

Clinical Evidence

Bench testing only. Verification performed using commercially available phantoms and measurement tools to compare software-estimated skin dose against actual measured dose within the gantry field of exposure.

Technological Characteristics

Image processing workstation for angiography. Software-based dose management tool. Conforms to 21 CFR 820, ISO 13485, and applicable IEC standards. Connectivity with Infinix-i and INFX series angiography systems.

Indications for Use

Indicated for use in selective catheter angiography procedures for the whole body (heart, chest, abdomen, brain, extremity) to provide 2D/3D imaging and real-time estimated skin dose tracking.

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

• XIDF-AWS801, Angio Workstation (K132106)

Submission Summary (Full Text)

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

September 8, 2014

Toshiba Medical Systems Corporation % Mr. Paul Biggins U.S. Agent/Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K141541

Trade/Device Name: XIDF-AWS801, Angio Workstation, v5.31 Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: June 9, 2014 Received: June 10, 2014

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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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Smh.7)

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

510(k) Number (if known)

K141541

Device Name XIDF-AWS801; Angio Workstation v5.31

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 angrography procedures for the heart, chest, abdomen, pelvis and brain.

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

X 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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### 510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS

#### 1. CLASSIFICATION and DEVICE NAME:

| Classification Name: | Picture archiving and communications system, |
|-------------------------|----------------------------------------------|
| Regulation Number: | 21 CFR 892.1650 (Class II) |
| Product Code | JAA – Image Processing/WorkStation |
| Trade Proprietary Name: | XIDF-AWS801, Angiography Workstation |
| Model Number: | XIDF-AWS801 V5.31 |

#### 2. ESTABLISHMENT REGISTRATION: 9614698

### 3. CONTACT PERSON, U.S. AGENT and ADDRESS:

### Contact/U.S. Agent:

Paul Biggins Director, Regulatory Affairs [phone] Fax: [phone] [e-mail]

#### 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 OF SUBMISSION: June 9, 2014
- 6. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard

#### 7. PREDICATE DEVICE:

XIDF-AWS801. Angio Workstation (K132106)

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## 8. REASON FOR SUBMISSION:

Modification of a cleared device

### 9. SUBMISSION TYPE:

Traditional 510(k)

### 10. DEVICE DESCRIPTION:

The XIDF-AWS801 Angio Workstation is used for images input from Diagnostic lmaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System and Workstation.

### 11. 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 in selective catheter angiography procedure 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 procedure for the heart, chest abdomen, pelvis and brain.

### 12. SUMMARY OF CHANGE(S)

Dose Tracking Software has been expanded to provide estimated skin dose for the head. Additionally, the software has been improved over the previous versions to allow simultaneous tracking of dual tubes in bi-plane and dual plane operations.

### 13. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the XIDF-AWS801, Angio Workstation w/Dose Tracking System (K132106), marketed by Toshiba America Medical Systems. XIDF-AWS801 (v5.31) includes modifications to the cleared device which includes improvements to the Dose Tracking System. Testing, which conforms to the testing of the predicate device, has been performed to verify the additions to the software do not affect the effectiveness of the performance. This software is a dose management tool and as such does not provided an indicated use. The intended use of the device and predicate remain the same, to provide an estimated skin dose in real time during angiography procedures.

#### 14. 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.

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## 15. TESTING

Testing has been performed using commercially available phantom and measurement tools. The testing was performed to verify the estimated dose displayed by the software with the actual measured dose on the phantom within the gantry field of exposure.

## 16. CONCLUSION

The modifications incorporated into the XIDF-AWS801, v5.31, 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.