(17 days)
This device is a digital radiography/fluoroscopy system used in a diagnostic angiography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
The main function of this system is to perform fluoroscopy /radiography of the interventional angiography system. Using the fluorescent scintillation effect of X-rays that have passed through the patient's body, image information is obtained for medical diagnosis treatment.
The provided text is a 510(k) summary for the Toshiba America Medical Systems INFX-8000V with 56 inch Monitor. This document is a pre-market notification to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets specific performance acceptance criteria. Therefore, the information requested in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is largely not present in this type of regulatory submission.
The document primarily focuses on:
- Device Description and Intended Use: The system performs fluoroscopy/radiography for interventional angiography, specifically for diagnostic and interventional procedures involving cardiac, abdominal, and lower limb blood vessels.
- Substantial Equivalence: It claims substantial equivalence to its predicate device, the INFX-8000V (K081582). This means it asserts that the new device is as safe and effective as the predicate, which has already been cleared for market.
- Safety Standards: Compliance with Quality System Regulations (21 CFR § 820, ISO 13485) and applicable parts of IEC60601-1 and 21 CFR §1020 is stated.
- Regulatory Clearance: The FDA's letter (K112054) confirms the finding of substantial equivalence.
Therefore, based only on the provided text, I cannot extract the information required to populate the table and answer the specific study-related questions. The document does not describe a performance study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement for the INFX-8000V with 56 inch Monitor. This information would typically be found in a separate performance study report, which is not included here.
However, I can extract what is provided regarding the device and its regulatory clearance.
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the given 510(k) summary. A 510(k) submission generally asserts substantial equivalence to a predicate device based on similar design, intended use, and technological characteristics, rather than presenting a de novo performance study against specific acceptance criteria. The document states compliance with general safety and performance standards (e.g., IEC60601-1, 21 CFR §1020), which serve as a baseline for all such devices, but not specific diagnostic performance metrics or acceptance thresholds for the device itself.
2. Sample size used for the test set and the data provenance:
Not applicable/Not provided. The document does not describe a test set or a performance study involving patient data to demonstrate the device's diagnostic accuracy or performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not provided. As no test set performance study is described, there is no mention of experts establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable/Not provided. No test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable/Not provided. The device is described as a "Solid State X-Ray Imager" and "diagnostic X-ray system," not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant in this context and is not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable/Not provided. The device is a hardware imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable/Not provided. No performance study necessitating ground truth is described.
8. The sample size for the training set:
Not applicable/Not provided. The device is a hardware imaging system and does not mention any machine learning or AI components that would require a "training set."
9. How the ground truth for the training set was established:
Not applicable/Not provided. No training set is described.
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Toshiba America Medical Systems. Pre-Market Notification 510(k) INFX-8000V with 56 inch Monitor
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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- CONTACT PERSON Paul Biggins Director, Regulatory Affairs (714) 730-5000
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- TRADE NAME(S): INFX-8000V with 56 inch Monitor
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- COMMON NAME: Solid State X-Ray Imager (Flat Panel/Digital Imager)
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- DEVICE CLASSIFICATION: Class II (per 21 FR 892.1650)
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- PRODUCT CODE / DESCRIPTION: MQB - Image-Intensified Fluoroscopic X-ray System
8. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
9. DEVICE DESCRIPTION:
The main function of this system is to perform fluoroscopy /radiography of the interventional angiography system. Using the fluorescent scintillation effect of X-rays that have passed through the patient's body, image information is obtained for medical diagnosis treatment.
10. SUMMARY OF INTENDED USES:
This system is a diagnostic X-ray system designed for multidirectional observation of the . flow of the contrast medium injected into the blood vessels of the patient. This system is intended for use in diagnostic and interventional procedures involving the cardiac blood vessels, abdominal blood vessels, and lower limb blood vessels.
Company Confidential
510(k): INFX-8000V with 56 Inch Monitor Page 15 of 736
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11. SUBSTANTIAL EQUIVALENCE:
The INFX-8000V with 56 inch Monitor is of comparable type and is substantially equivalent to the INFX-8000V (K081582).
12. 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.
13. CONCLUSION
The INFX-8000V complies with the same or equivalent standards and has the same intended use as the predicate device.
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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 features a stylized caduceus symbol in blue, with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion.
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 94780
AUG 2 0 2013
Re: K112054
Trade/Device Name: INFX-8000V with 56 inch monitor Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified flouroscopic x-ray system Regulatory Class: II Product Code: JAA and IZI Dated: July 15, 2011 Received: July 19, 2011
Dear Mr. Biggins:
This letter corrects our substantially equivalent letter of August 5, 2011.
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,
Janine M. Morris
Acting 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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ין י
Indications for Use
510(k) Number (if known):
Device Name:
f
INFX-8000V with 56 inch monitor
Indications for Use:
This device is a digital radiography/fluoroscopy system used in a diagnostic angiography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Sposta
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K112054
Page 1 of
Indication for Use Page 1 of 1
Company Confidontial JUL 2011
510(k): INFX-8000V with 56 inch Monitor Page 14 of 738
§ 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.