DOSE TRACKING SYSTEM MODEL XIDF-DTS801

K123097 · Toshiba America Medical Systems, In.C · JAA · Feb 13, 2013 · Radiology

Device Facts

• Record ID: K123097
• Device Name: DOSE TRACKING SYSTEM MODEL XIDF-DTS801
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: JAA · Radiology
• Decision Date: Feb 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

DTS is intended to display an approximation of both skin dose distribution and skin dose rate in real time during fluoroscopic interventional procedures of cardiac angiography. This software is intended for use on the Toshiba INFX-8000F CSi cardiac labs.

Device Story

Dose Tracking System (DTS) is application software for Toshiba Infinix-i X-ray systems; calculates estimated patient skin radiation dose during cardiac angiography. Inputs: exposure technique parameters and exposure geometry from X-ray system. Processing: uses reference dose tables to compute dose distribution. Output: real-time color-mapped dose distribution on 3D patient model; cumulative peak skin dose; skin dose rate; fluoroscopy time. Used in cardiac labs by clinicians; provides real-time feedback to assist in managing radiation exposure during interventional procedures. Benefits: enables clinicians to monitor and potentially minimize patient skin radiation exposure.

Clinical Evidence

Bench testing only. Performance verified using anthropomorphic and Lexan phantoms to validate accuracy of displayed estimated dose.

Technological Characteristics

Software application for X-ray angiography systems. Calculates dose based on exposure parameters and geometry. Displays results as 3D color map. Conforms to IEC 60601-1 and 21 CFR 1020.

Indications for Use

Indicated for patients undergoing fluoroscopic interventional cardiac angiography procedures to monitor skin dose distribution and skin dose rate in real time.

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

• Siemens CAREGRAPH (K982319)

Reference Devices

• Toshiba INFX-8000F (K081624)

Submission Summary (Full Text)

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K123097

Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) XIDF-DTS801; Dose Tracking Software

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

FEB 1 3 2013

- 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. TRADE NAME(S): XIDF-DTS801; Dose Tracking System
- 6. COMMON NAME: Accessory, System, X-ray Angiography
- 7. DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1650)

## 8. PRODUCT CODE / DESCRIPTION: JAA, Image-intensified fluoroscopic x-ray system.

- 9. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
- 10. PREDICATE DEVICE: Siemens CAREGRAPH, K982319

## 11. REASON FOR SUBMISSION: Modification of a cleared device - INFX-8000F; K081624

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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) XIDF-DTS801; Dose Tracking Software

## 12. DEVICE DESCRIPTION:

The dose tracking system (DTS) is an application software package intended to provide the estimated dose distribution information during X-ray 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 (Toshiba Infinix-i) and presents the cumulative results in a color mapping on a 3D graphic of the patient model.

#### 13. SUMMARY OF INTENDED USES:

DTS is intended to display an approximation of both skin dose distribution and skin dose rate in real time during fluoroscopic interventional procedures of cardiac angiography.

This software is intended for use on the Toshiba INFX-8000F CSi cardiac labs.

#### 14. SUBSTANTIAL EQUIVALENCE:

The primary intended use of the devices is to provide the user with estimated dose information being administered to the patient in real time. The methods for calculation and presentation of this information vary. Below is a table that provides similarities and differences.

| Company | Toshiba | Siemens |
|------------------------|-------------------------------|-----------------------------|
| 510(k) Control number | Subject device | K982319 |
| Device | DTS (Software) | Caragraph |
| Intended use | Displaying dose information | Displaying dose information |
| Combined system | Toshiba Angiography system | Siemens Angiography system |
| Dose calculation | Reference dose table | Dose area product |
| Dose map display | Color display on the 3D | Color display on the 2D |
| Radiation area display | Yes | Yes |
| Display value | | |
| Cumulative peak skin | Yes | Yes (max. Hot spot) |
| Dose rate | Yes (Reference point) | No |
| Fluoro. time | Yes | Yes |
| Patient information | Yes | Yes |
| Dose area product | No (X-ray system can display) | Yes |
| Report function | Yes | Yes |

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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) XIDF-DTS801; Dose Tracking Software

Page 3 of 3

#### 15. 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.

#### 16. 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.

## 17. CONCLUSION

The additional features that are being added to the INFX-8000F at this time do 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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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 13, 2013

Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems 2441 Michelle Drive TUSTIN CA 92780

Re: K123097

Trade/Device Name: Dose Tracking System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: February 07, 2013 Received: February 08, 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. Ilsting 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

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Page 2-Mr. Biggins

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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.

# Sean M. Boyd -S

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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## Indications for Use

510(k) Number (if known): K123097

Device Name: XDIF-DTS801; Dose Tracking Systems

Indications For Use:

DTS is intended to display an approximation of both skin dose distribution and skin dose rate in real time during fluoroscopic interventional procedures of cardiac angiography.

This software is intended for use on the Toshiba INFX-8000F CSi cardiac labs.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Sean M. Boyd -S

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