(28 days)
Not Found
No
The summary describes a standard X-ray system with processing software, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance testing. The testing focuses on traditional imaging performance metrics.
No.
The device is used for diagnostic procedures, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a digital radiography/fluoroscopy system used in a diagnostic interventional angiography configuration" and "is indicated for use in diagnostic and anqioqraphic procedures."
No
The device description explicitly states it is an "X-ray system" consisting of hardware components like a C-arm, X-ray tube, beam limiter, X-ray receptor, X-ray controller, and a patient radiographic table, in addition to computers and software.
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 Description: The provided description clearly states that this device is an X-ray system used for radiographic and fluoroscopic studies in an interventional setting. It involves generating X-rays and capturing images of the internal structures of the body.
- Intended Use: The intended use is for diagnostic and angiographic procedures for blood vessels in various parts of the body. This involves imaging the patient directly, not analyzing samples taken from the patient.
Therefore, based on the provided information, this device falls under the category of medical imaging devices, 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 anqioqraphic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Product codes
OWB, JAA, IZI
Device Description
INFX-8000V, V6.35, 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.
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
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 included spatial resolution, low contrast resolution, dynamic range, DQE, MTF, artifacts/contrast/dynamic range of DSA, CNR, S/N ratio and density resolution. 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.
Summary of Performance Studies
Not Found
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2016
Toshiba Medical Systems Corporation % Ms. Janine F. Reyes Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K162614
Trade/Device Name: Infinix, INFX-8000V, V6.35 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA, IZI Dated: September 16, 2016 Received: September 19, 2016
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.
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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.
Michael D.'Hara
For
Robert 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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Reset Form
Indications for Use
510(k) Number (if known)
Device Name
Infinix, INFX-8000V, V6.35
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)
✔ | 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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Image /page/3/Picture/0 description: The image shows the logo for Toshiba Medical. The logo is in red and features the word "TOSHIBA" in a bold, sans-serif font on the top line. Below it, the word "MEDICAL" is stacked, also in a bold, sans-serif font. The overall design is simple and emphasizes the brand name.
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
| Regulation 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 - Image-Intensified Fluoroscopic X-Ray System (secondary) | |
| IZI - System, X-ray, Angiographic (secondary) | |
| Trade Proprietary Name | Infinix, INFX-8000V, V6.35 |
| Model Number | INFX-8000V, V6.35 |
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
Contact Person
Janine Reves Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive, Tustin, CA 92780 (714) 669-7853 Fax: (714) 730-1310 jfreyes@tams.com
5. MANUFACTURING SITE
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
ESTABLISHMENT REGISTRATION 6. 9614698
7. DATE PREPARED September 16, 2016
8. DEVICE NAME
Infinix, INFX-8000V, V6.35
Official Correspondent/U.S. Agent
Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive, Tustin, CA 92780 (714) 730-5000 Fax: (714) 730-1310 pbiggins@tams.com
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Image /page/4/Picture/0 description: The image shows the words "TOSHIBA MEDICAL" stacked on top of each other. The words are in a bold, sans-serif font and are colored red. The word "TOSHIBA" is on the top line, and the word "MEDICAL" is on the bottom line.
Image /page/4/Picture/1 description: The image shows the text "Made For life" in a bold, sans-serif font. The text is black and appears to be on a white background. The words are arranged horizontally, with "Made" and "For" in a slightly smaller font size than "life."
9. TRADE NAME
INFX-8000V, V6.35
10. CLASSIFICATION NAME
Interventional Fluoroscopic X-ray System Image-Intensified Fluoroscopic X-Ray System System, X-ray, Angiographic
11. CLASSIFICATION PANEL
Radiology
12. DEVICE CLASSIFICATION
Class II (per 21 CFR 892.1650)
13. PRODUCT CODE / DESCRIPTION
Primary Product Code: OWB – Interventional Fluoroscopic X-ray System Secondary Product Codes: JAA - Image-Intensified Fluoroscopic X-Ray System Secondary Product Code: IZI - System, X-ray, Angiographic
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, V6.20 (K152696)
| Product | Marketed by | 510(k) Number | Clearance Date |
|---|---|---|---|
| INFX-8000V, V6.20 | Toshiba America Medical Systems | K152696 | January 12, 2016 |
16. REASON FOR SUBMISSION
Modification of a cleared device
17. SUBMISSION TYPE
Special 510(k)
18. DEVICE DESCRIPTION
INFX-8000V, V6.35, 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.
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 submission is to report virtual ROI function and the addition of pulse width modulation during low contrast image acquisition.
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Image /page/5/Picture/0 description: The image shows the words "TOSHIBA MEDICAL" stacked on top of each other. The word "TOSHIBA" is on the top line, and the word "MEDICAL" is on the second line. Both words are written in a bold, sans-serif font and are colored red.
- . Virtual ROI function: this function enables the display of virtual X-ray field before X-ray exposure.
- . Pulse width modulation during low contrast image (LCI) acquisition: pulse width modulation enables uniform brightness of projection data during acquisition.
- . Grid material change from an aluminum to a fiber grid (TFP-1216A/A1 and TFP-1216A/C1)
- High-speed LCI acquisition feature of TFP-1200A ●
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 ●
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 included spatial resolution, low contrast resolution, dynamic range, DQE, MTF, artifacts/contrast/dynamic range of DSA, CNR, S/N ratio and density resolution. 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.
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.
23. SUBSTANTIAL EQUIVALENCE
This device is substantially equivalent to the INFX-8000V, V6.20, (K152696), marketed by Toshiba America Medical Systems. INFX-8000V, V6.35, includes virtual ROI function and the addition of pulse width modulation during low contrast image acquisition. 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.
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Image /page/6/Picture/0 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is in large, bold, red letters on the top line. Below that, the word "MEDICAL" is in smaller, bold, red letters. The logo is simple and clean, with a focus on the company name.
24. CONCLUSION
The subject device is substantially equivalent to the INFX-8000V, V6.20, which was cleared via Pre-Market Notification 510(k), K152696. The INFX-8000V, V6.35, incorporates modifications to the cleared device which include virtual ROI function and the addition of pulse width modulation during low contrast image acquisition. 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.