(113 days)
Not Found
No
The summary describes standard image processing and system control software, with no mention of AI, ML, or related concepts like deep learning or neural networks. The performance studies focus on demonstrating equivalence to a predicate device and compliance with IEC standards, not on validating AI/ML performance metrics.
No.
The device is described as a diagnostic and interventional angiography system, used for acquiring images of blood vessels, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used in a diagnostic and interventional angiography configuration" and "The system is indicated for use in diagnostic and angiographic procedures".
No
The device description explicitly states that the system consists of hardware components including a C-arm, X-ray tube, beam limiter, X-ray receptor, X-ray controller, computers, and a patient radiographic table, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this device is an X-ray system used for imaging the inside of the body (blood vessels). It uses X-rays to acquire digital images.
- Intended Use: The intended use is for diagnostic and interventional angiography procedures, which involve visualizing blood vessels using imaging techniques, not by analyzing samples taken from the body.
The device operates by generating and detecting X-rays that pass through the patient's body, which is a form of in vivo (within the living body) diagnostic imaging, not in vitro.
N/A
Intended Use / Indications for Use
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Product codes
OWB, JAA, IZI
Device Description
INFX-8000V, V6.20, is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm, which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
The device software is used to control the system, set X-ray conditions, acquire digital images from the X-ray detector, display images on the monitors, perform image processing and recording. This X-ray system has a wireless footswitch option. This X-ray system does not have wireless transmission of data.
Mentions image processing
The device software is used to control the system, set X-ray conditions, acquire digital images from the X-ray detector, display images on the monitors, perform image processing and recording.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
blood vessels in the heart, brain, abdomen and lower extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Interventional setting
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)
This submission contains test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system. Testing of the modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and XR Systems. Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission. Additionally, the design controls used for this device included risk management and all known risks were mitigated to an acceptable level.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines beneath them, possibly representing water or movement. The text is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2016
Toshiba America Medical Systems, Inc. % Ms. Janine Reyes Manager, Regulatory Affairs 2441 Michelle Drive TUSTIN CA 92780
Re: K152696
Trade/Device Name: INFX-8000V. V6.20 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and IZI Dated: December 16, 2015 Received: December 18, 2015
Dear Ms. Reyes:
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 Oolo
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Reset Form
Indications for Use
510(k) Number (if known)
K152696
Device Name
INFX-8000V, V6.20
Indications for Use (Describe)
This device is a digital radiography/fluoroscopy system used in a diagnostic interventional angiography configuration. The system is indicated for use in diagnostic and anqioqraphic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Type of Use (Select one or both, as applicable)
P 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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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
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FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS
1. CLASSIFICATION and DEVICE NAME:
| Classification Name: Image-Intensified Fluoroscopic X-Ray System | ||
|---|---|---|
| Regulation Number: | 21 CFR 892.1650 (Class II) | |
| Product Code: | OWB - Interventional Fluoroscopic X-Ray System (primary) | |
| JAA - System, X-Ray, Fluoroscopic, Image-Intensified (secondary)) | ||
| ZI - System, X-Ray, Angiographic (secondary) | ||
| Trade Proprietary | ||
| Name: | Infinix | |
| Model Number: | INFX-8000V, V6.20 |
2. ESTABLISHMENT REGISTRATION: 9614698
3. U.S. AGENT and ADDRESS:
Official Correspondent/U.S. Agent:
Paul Biggins Director, Regulatory Affairs (714) 730-5000 Fax: (714) 730-1310 paul.biggins@toshiba.com
Contact Person:
Janine Reyes Manager, Regulatory Affairs (714) 669-7853 Fax: (714) 730-1310 janine.reyes@toshiba.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
4
5. DATE PREPARED:
September 18, 2015
6. TRADE NAME(S):
INFX-8000V, V6.20 [Infinix CC-i]
7. COMMON NAME:
Image-Intensified Fluoroscopic X-Ray System Interventional Fluoroscopic X-Rav System System, X-Ray, Fluoroscopic, Image-Intensified System, X-ray, Angiographic
8. REGULATION NAME:
Image-Intensified Fluoroscopic X-Ray System
9. DEVICE CLASSIFICATION:
Class II (per 21 CFR 892.1650)
10. PRODUCT CODE / DESCRIPTION:
Primary Product Code: OWB - Interventional Fluoroscopic X-Ray System Secondary Product Code: JAA - System, X-Ray, Fluoroscopic, Image-Intensified Secondary Product Code: IZI - System, X-ray, Angiographic (secondary)
11. PERFORMANCE STANDARD:
This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard].
12. PREDICATE DEVICE:
INFX-8000V, with Wireless Footswitch (K143225)
| Product | Marketed by | 510(k) Number | Clearance Date |
|---|---|---|---|
| INFX-8000V, with | |||
| Wireless Footswitch | Toshiba America | ||
| Medical Systems | K143225 | January 9, 2015 |
13. REASON FOR SUBMISSION:
Modification of a cleared device
14. SUBMISSION TYPE:
Traditional 510(k)
15. DEVICE DESCRIPTION:
INFX-8000V, V6.20, is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm, which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
5
The device software is used to control the system, set X-ray conditions, acquire digital images from the X-ray detector, display images on the monitors, perform image processing and recording. This X-ray system has a wireless footswitch option. This X-ray system does not have wireless transmission of data.
16. INDICATIONS FOR USES:
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
17. SUMMARY OF CHANGE(S)
This submission is to report improvements to the Auto Pixel Shift (APS) algorithm, the addition of Spot ROI Fluoroscopy and Clinical Mode.
- i. Auto Pixel Shift (APS) - the correction accuracy of the improved APS algorithm was confirmed to be equal to or greater than the correction accuracy of the current APS algorithm.
- ii. Spot ROI (region of interest) Fluoroscopy - allows for peripheral region visualization outside of the area of interest.
- iii. Clinical Mode - provides preset 2D roadmap display settings to enhance user workflow during common clinical cases.
18. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the INFX-8000V, with Wireless Footswitch, (K143225), marketed by Toshiba America Medical Systems. INFX-8000V, V6.20, includes improvements to the Auto Pixel Shift (APS) algorithm, the addition of Spot ROI Fluoroscopy and Clinical Mode. The basic system configuration, method of operation, base software and manufacturing process remain unchanged from the cleared device. There are no new indications for use or intended use of the device.
| Item | Predicate Device:
INFX-8000V with Wireless Footswitch
(K143225) | Subject Device:
INFX-8000V, V6.20 | Notes |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| Intended
Use | This device is a digital
radiography/fluoroscopy system used in a
diagnostic and interventional angiography
configuration. The system is indicated for use
in diagnostic and angiographic procedures for
blood vessels in the heart, brain, abdomen
and lower extremities. | This device is a digital
radiography/fluoroscopy system used in a
diagnostic and interventional angiography
configuration. The system is indicated for use
in diagnostic and angiographic procedures for
blood vessels in the heart, brain, abdomen
and lower extremities. | Same |
| Operation
Principles | The high voltages output by the X-ray
generator are supplied to the X-ray tube, and
the X-ray beams are generated. The X-ray
beams that have passed through the patient
are converted to electrical signals by the flat
panel detector based on the X-ray scintillation
effect. The signals are then sent to the digital
imaging subsystem as digital image signals,
and digital images are processed/recorded. In
addition, the images are displayed on the
monitor and are transferred to the network. | The high voltages output by the X-ray
generator are supplied to the X-ray tube, and
the X-ray beams are generated. The X-ray
beams that have passed through the patient
are converted to electrical signals by the flat
panel detector based on the X-ray scintillation
effect. The signals are then sent to the digital
imaging subsystem as digital image signals,
and digital images are processed/recorded. In
addition, the images are displayed on the
monitor and are transferred to the network. | Same |
6
| Item | Predicate Device:
INFX-8000V with Wireless Footswitch
(K143225) | Subject Device:
INFX-8000V, V6.20 | Notes |
|--------------------------|-----------------------------------------------------------------------|-------------------------------------------|--------|
| Auto Pixel
Shift | Available | Algorithm Improvement | Change |
| Spot ROI
Fluoroscopy | Not Available | Available | Change |
| Clinical
Mode | Not Available | Available | Change |
| Roadmap Function | 2D Roadmap
3D Roadmap
Multimodality Roadmap | 2D Roadmap
3D Roadmap
Not Available | Change |
19. 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, its collateral standards and particular standards: IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-3:2008, IEC 60601-1-6:2010, IEC 60601-2-28:2010, IEC 60601-2-43:2010, IEC 62304:2006, IEC 62366:2007. 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.
20. TESTING:
This submission contains test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system. Testing of the modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and XR Systems. Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission. Additionally, the design controls used for this device included risk management and all known risks were mitigated to an acceptable level.
21. CONCLUSION
The subject device is substantially equivalent to the INFX-8000V, with Wireless Footswitch, which was cleared via Pre-Market Notification 510(k), K143225. The INFX-8000V, V6.20, incorporates modifications to the cleared device which include improvements to the Auto Pixel Shift (APS) algorithm, the addition of Spot ROI Fluoroscopy and Clinical Mode. The changes to this device do not alter the Indications for Use or the intended uses associated with the previously cleared device, as described in the labeling. It is the contention of Toshiba that all new safety issues have been addressed in the design of this change and that adequate evidence of this is presented with this submission.