(80 days)
Not Found
No
The document describes standard image processing software and does not mention AI, ML, or related concepts.
No
The device is described as a diagnostic imaging system (digital radiography/fluoroscopy system) used for diagnostic and angiographic procedures, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The system is indicated for use in diagnostic and angiographic procedures for blood vessels...".
No
The device description explicitly states that the system consists of hardware components such as a C-arm, X-ray tube, beam limiter, X-ray receptor, X-ray controller, and a patient radiographic table, in addition to computers with software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices 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 provided description clearly states that this device is a digital radiography/fluoroscopy system that uses X-rays to image blood vessels within the body. It does not involve the analysis of samples taken from the body.
- Intended Use: The intended use is for diagnostic and angiographic procedures for blood vessels in various anatomical sites. This is an in vivo (within the living body) imaging procedure, not an in vitro (in glass/outside the living body) diagnostic test.
Therefore, based on the provided information, this device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
This device is a digital radiography/fluoroscopy system used in a diagnostic 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, V6.40, 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. This system offers an optional hybrid (aSi/CMOS) 12 inch flat panel detector (TFP-1200C) to provide high definition (HD) imaging.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
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
Bench Testing was conducted to determine that equivalent or improved imaging performance resulted when compared to the predicate device. This testing included spatial resolution, low contrast resolution, dynamic range, artifacts and contrast.
Summary of Performance Studies
Bench Testing was conducted to determine that equivalent or improved imaging performance resulted when compared to the predicate device. This testing included spatial resolution, low contrast resolution, dynamic range, artifacts and contrast. The results of this testing provided evidence that the modification to the predicate device did result in equivalent or improved performance when compared to the predicate.
Key Metrics
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
June 16, 2017
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Toshiba Medical Systems Corporation % Paul Biggins Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, California 92780
Re: K170909
Trade/Device Name: INFX-8000V, V6.40 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, IZI Dated: March 24, 2017 Received: March 28, 2017
Dear Paul 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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
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/ResourcesforYou/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.
Michael D. O'Hara
For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name INFX-8000V, Version 6.4
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 angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
| 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) |
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92
1. CLASSIFICATION and DEVICE NAME
| Classification Name | Solid State X-ray System, Interventional |
|---|---|
| Regulation Number | 21 CFR 892.1650 (Class II) |
| Product Code | OWB - Interventional Fluoroscopic X-ray System |
| Trade Proprietary Name | Infinix |
| Model Number | INFX-8000V, V6.40 |
2. SUBMITTER'S NAME
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
3. OFFICIAL CORRESPONDENT
Akinori Hatanaka Senior Manager, Regulatory Affairs and Vigilance
4. CONTACT PERSON, U.S. AGENT and ADDRESS
Paul Biggins Director Regulatory Affairs 2441 Michelle Drive Tustin, CA 92780 P. (714) 669-7808 F. (714) 730-1310 pbiggins@tams.com
5. MANUFACTURING SITE
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
6. ESTABLISHMENT REGISTRATION 9614698
-
- DATE PREPARED March 24, 2017
-
- DEVICE NAME INFX-8000V, V6.40
-
- TRADE NAME
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INFX-8000V, V6.40
10. CLASSIFICATION NAME
Interventional Fluoroscopic X-ray System
-
- CLASSIFICATION PANEL
Radiology
- CLASSIFICATION PANEL
-
- DEVICE CLASSIFICATION
Class II (per 21 CFR 892.1650)
- DEVICE CLASSIFICATION
13. PRODUCT CODE / DESCRIPTION
Product Code: OWB – Interventional Fluoroscopic X-ray System
14. PERFORMANCE STANDARD
This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard].
15. PREDICATE DEVICE
INFX-8000V, V6.35 (K162614)
| Product | Marketed by | 510(k) Number | Clearance Date |
|---|---|---|---|
| INFX-8000V, V6.35 | Toshiba America Medical Systems | K162614 | October 17, 2016 |
16. REASON FOR SUBMISSION
Modification of a cleared device
17. SUBMISSION TYPE
Traditional
18. DEVICE DESCRIPTION
INFX-8000V, V6.40, 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. This system offers an optional hybrid (aSi/CMOS) 12 inch flat panel detector (TFP-1200C) to provide high definition (HD) imaging.
19. 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.
20. SUMMARY OF CHANGE(S)
This notification is being submitted to inform the Food and Drug Administration of Toshiba Medical System intent to market a new image receptor, TFP-1200C. This notification contains the required information for the hardware change (primary) and the software changes required to support this change in hardware (secondary)
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21. 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 60601-2-43 and IEC60601-2-28. 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.
LIST OF APPLICABLE STANDARDS
- . IEC60601-1:2005
- . IEC60601-1-2:2007
- . IEC60602-1-3: 2008
- IEC60601-1-6: 2010
- . IEC60601-2-28: 2010
- IEC60601-2-43:2010
- . IEC62304:2006
- . IEC62366:2007
Testing of this device demonstrated that the radiation output does not exceed the normal mode of operation limit of 88mGy/min as described in the Federal Standard. In order to reduce the risk of unnecessary radiation exposure when the system is configured with TP-1200C High Definition Detector the Toshiba XDIF-DTS802 Dose Tracking System is incorporated in the configuration. Additionally, Live Zoom is not allowed in HD mode and requires an FOV of 6" or greater.
22. 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 Electromechanical Commission (IEC) for Medical Devices and XR Systems. Additional testing is provided per FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Systems." Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained 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.
Bench Testing was conducted to determine that equivalent or improved imaging performance resulted when compared to the predicate device. This testing included spatial resolution, low contrast resolution, dynamic range, artifacts and contrast. The results of this testing provided evidence that the modification to the predicate device did result in equivalent or improved performance when compared to the predicate.
23. SUBSTANTIAL EQUIVALENCE
This device is substantially equivalent to the INFX-8000V, V6.35, (K162614), marketed by Toshiba America Medical Systems. INFX-8000V, V6.40, includes a new Solid State Image receptor that is a continuum of previously introduced devices of this nature. The basic system
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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.
24. CONCLUSION
The subject device is substantially equivalent to the INFX-8000V, V6.35, which was cleared via Pre-Market Notification 510(k), K162614. The INFX-8000V, V6.40, incorporates modifications to the cleared device which include a new solid state imaging receptor and software modifications required to support the hardware. 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.