(40 days)
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 in 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 , that 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 provided text is a 510(k) summary for the Toshiba America Medical Systems, Inc. INFX-8000C w/Spot Fluoro Option. This document describes a modification to an existing device, an interventional X-ray system, to improve workflow and reduce radiation exposure via auto-collimation.
However, the 510(k) summary does not contain information about acceptance criteria or a study designed to prove the device meets specific performance metrics.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, details of MRMC or standalone studies, or ground truth information based solely on the provided text.
The document primarily focuses on establishing substantial equivalence to a predicate device (INFX-8000C K081621) due to a modification for workflow improvement and radiation dose reduction, rather than presenting a performance study with detailed acceptance criteria. The modification is specifically noted as: "The modification allows for the auto-collimation to a smaller field of few that the operator sets on the last image displays (LIH)."
The safety section mentions compliance with regulations like Quality System Regulations, ISO 13485, IEC60601-1 standards, and 21 CFR §1020, but these are general regulatory compliances, not specific performance acceptance criteria for a new feature validated by a study.
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KI13052
NOV 2222011
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) INFX-8000C W/ Spot Fluoro Option
510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS
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- SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
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- ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
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- ESTABLISHMENT REGISTRATION: 2020563
4. CONTACT PERSON:
Paul Biggins Director, Regulatory Affairs (714) 730-5000
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- TRADE NAME(S): INFX-8000C [Infinix-CCi]
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- COMMON NAME: Solid State X-ray System, Interventional
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- DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1650)
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- PRODUCT CODE / DESCRIPTION: MQB - solid state x-ray imager (flat panel/digital imager)
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- PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
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- PREDICATE DEVICE: INFX-8000C (K081621)
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- REASON FOR SUBMISSION:
Modification of a cleared device
12. DEVICE DESCRIPTION:
This device in 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 , that is equipped with
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an x-ray tube, beam limiter and x-ray receptor, x-ray controller, computers with system and processing software, and a patient radiographic table.
13. SUMMARY OF INTENDED USES:
This device is intended to perform interventional studies of the head, body, heart and lower extremities in an anqiographic situation.
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional anqiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
14. SUBSTANTIAL EQUIVALENCE:
The modification to this device is to provide improved workflow and reduce radiation exposure to the patient and operator(s). The modification allows for the auto-collimation to a smaller field of few that the operator sets on the last image displays (LIH). The materials, hardware, method of operation, base software and manufacturing processes remain unchanged from the cleared device; INFX-8000C (K081621).
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 an initial report.
16. CONCLUSION
The INFX-8000C with Spot Fluoro Option, is substantially equivalent to the predicate device in that the modification is an improvement in the operation of the existing system. There are no other significant changes to the hardware of this device. Safety is assured through a risk management process and manufacturing is in compliance with the Quality System Regulations.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the wings and body of the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Toshiba Medical Systems Corporation, Japan Mr. Paul Biggins Director Regulatory Affairs/US Agent % Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
NOV 222 2011
Re: K113052
Trade/Device Name: INFX-8000C w/Spot Fluoroscopy Option [Infinix-CCi] Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MOB Dated: November 9, 2011 Received: November 10, 2011
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Pastel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): y 113052
Device Name: INFX-8000C w/Spot Fluoroscopy Option [Infinix-CCi]
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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
MudDOHam
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113052
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§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.