(134 days)
No
The description focuses on calculating dose based on exposure parameters and geometry, without mentioning AI/ML techniques. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
Explanation: This device is for displaying skin dose distribution and dose rate to estimate radiation exposure during fluoroscopic procedures, not for treating any medical condition or altering the body's structure or function. It provides information to the user but does not directly provide therapy.
No
The device is intended to display an approximation of skin dose distribution and dose rate in real-time during fluoroscopic interventional procedures. It calculates radiation dose based on exposure parameters and presents the cumulative results. This function is for tracking and monitoring radiation exposure, not for diagnosing a medical condition or disease.
No
The device is described as an "application software package" that calculates and displays dose information. However, it explicitly states it is intended for use "on the Toshiba INFX-8000F CSi cardiac labs" and obtains parameters from the "x-ray imaging system (Toshiba Infinix-i)". This indicates a dependency on specific hardware (the Toshiba imaging system) for its input data and operation, making it a software component of a larger medical device system, not a standalone software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The DTS device described here is a software application that uses data from an X-ray imaging system to estimate and display the radiation dose to a patient's skin during a medical procedure. It does not analyze biological samples.
- Intended Use: The intended use is to display skin dose information in real-time during fluoroscopic procedures, which is a form of medical imaging, not a diagnostic test performed on a sample.
The device is clearly related to medical imaging and radiation dose monitoring, not in vitro testing.
N/A
Intended Use / 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.
Product codes
JAA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
-
- SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
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- ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
-
- ESTABLISHMENT REGISTRATION: 2020563
4. CONTACT PERSON:
Paul Biggins Director, Regulatory Affairs (714) 730-5000
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- TRADE NAME(S): XIDF-DTS801; Dose Tracking System
-
- COMMON NAME: Accessory, System, X-ray Angiography
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- DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1650)
8. PRODUCT CODE / DESCRIPTION: JAA, Image-intensified fluoroscopic x-ray system.
-
- PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
-
- 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
4
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 (800) 638-2041 or (301) 796-7100 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
5
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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