(169 days)
No
The document describes image processing but does not mention AI, ML, or related terms like deep learning or neural networks. The testing description also does not indicate the use of AI/ML specific validation methods.
No
The device is described as an Angio Workstation used for image processing and display in conjunction with interventional angiography systems. It aids in diagnosis and visualization, rather than directly treating a disease or condition.
No
The device is an Angio Workstation used for image processing and display in conjunction with an interventional angiography system. Its purpose is to provide 2D and 3D imaging, not to independently diagnose conditions. It inputs images from a Diagnostic Imaging System and Workstation, indicating it processes images from diagnostic devices rather than performing diagnosis itself.
No
The device description explicitly states it is a "Workstation," which typically implies a hardware component in addition to software for image processing and display. It also mentions input and output to "Diagnostic Imaging System and Workstation," further suggesting integration with hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device processes medical images: The Angio Workstation (XIDF-AWS801) is described as a device that takes images from an angiography system, processes them, and displays them. It works with imaging data, not biological samples.
- The intended use is image-based procedures: The intended use clearly states it's used in combination with an angiography system for "2D and 3D imaging in selective catheter angiography procedures." This is an imaging-based diagnostic and interventional procedure.
Therefore, the function and intended use of the Angio Workstation align with medical imaging processing and display, not with the analysis of biological samples characteristic of an IVD.
N/A
Intended Use / Indications for 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 angiography procedures for the heart, chest, abdomen, pelvis and brain.
Product codes
OWB, JAA
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Interventional angiography system
Anatomical Site
Whole body (includes heart, chest, abdomen, brain and extremity), pelvis
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
Testing was performed using archived clinical images, simulation testing and bench (phantom) testing.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was conducted using bench (phantom) tests, simulations and archived images data sets. The results of this testing verified that the performance of the changes was within the specified requirements. Additionally, the testing was used to include user information related to the performance of the changes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K141541, K132222, K023760, K110834
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2015
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: K142736
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: OWB, JAA Dated: January 13, 2015 Received: February 18, 2015
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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142736
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 angiography procedures for the heart, chest, abdomen, pelvis and brain.
Type of Use (Select one or both, as applicable)
2 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)
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 | OWB, JAA | ||
| 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 (714) 730-5000 Fax: (714) 730-1310 pbiggins@tams.com
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
-
- Date OF SUBMISSION:
September 22, 2014
- Date OF SUBMISSION:
6. PERFORMANCE STANDARD:
21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
7. PREDICATE DEVICE:
XIDF-AWS801. Angio Workstation (K141541)
Page 1 of 3
4
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)
This submission is to report the addition of several post-processing software applications which are meant to provide the user with information that is to be used in adjunct to the normal images provided by the Angio System. These software packages in Left Atrium Segmentation (automatic segmentation), Parametric Images and MAR (Metal Artifact Reduction) software. All of these features are intended for use with existing imaging from the cleared device. The software are not intended for stand-alone use or diagnosis.
13. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the XIDF-AWS801, Angio Workstation w/ Dose Tracking System (K141541), marketed by Toshiba America Medical Systems. XIDF-AWS801 (v5.31) includes additional software features. The additional software features have the same intended use as the secondary predicate devices, listed below in table one. Testing was performed using archived clinical images, simulation testing and bench (phantom) testing. This testing demonstrated that the implementation of the modifications retained the safety and effectiveness of the cleared device.
Page 2 of 3
5
| 510(k) Number | Clearance Date | Device Name | Manufacturer |
|---|---|---|---|
| K141541 | |||
| Primary Predicate | 9/8/2014 | Angio Workstation | |
| v5.31 | Toshiba Medical | ||
| Systems | |||
| K132222 | |||
| Secondary Predicate | 11/7/2013 | Aquilion ONE Vision | Toshiba Medical |
| Systems | |||
| K023760 | |||
| Secondary Predicate | 11/22/2002 | Cardiac Functional | |
| Analysis Software | Toshiba Medical | ||
| Systems | |||
| K110834 | |||
| Secondary Predicate | 4/26/2011 | AW Volume Share 5 | |
| with Angio Viz Option | GE Healthcare |
Table 1: Predicate Devices
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.
15. TESTING
Testing was conducted using bench (phantom) tests, simulations and archived images data sets. The results of this testing verified that the performance of the changes was within the specified requirements. Additionally, the testing was used to include user information related to the performance of the changes.
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.
Page 3 of 3