(247 days)
This device is a digital radiography/fluoroscopy system use in a diagnostic interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for 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 describes modifications to an existing X-ray system, the INFX-8000V, and outlines safety and testing procedures to demonstrate substantial equivalence to its predicate device. This document is a 510(k) summary, which typically focuses on demonstrating equivalence rather than establishing new acceptance criteria or conducting extensive clinical trials for new device performance claims.
Based on the provided information, the device is an X-ray system, not an AI/ML-driven diagnostic algorithm. Therefore, many of the requested criteria (e.g., sample sizes for test sets, ground truth establishment for training/test sets, number of experts, MRMC studies, standalone algorithm performance) are not applicable or described in this type of submission for this particular device.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define acceptance criteria in a quantitative table format for specific performance metrics. Instead, it states that the modified device's performance is "equal to or better than" the predicate system. The performance characteristics tested include:
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Spatial Resolution | Equal to or better than predicate |
| Low Contrast Resolution | Equal to or better than predicate |
| Dynamic Range | Equal to or better than predicate |
| DQE (Detective Quantum Efficiency) | Performance enhancement from predicate |
| MTF (Modulation Transfer Function) | Equal to or better than predicate |
| NOS (Noise Overtone Spectrum) | Equal to or better than predicate |
| Conversion Function | Equal to or better than predicate |
| Fluoroscopic Still Image Resolution | Equal to or better than predicate |
| Fluoroscopic Still Image Dynamic Range | Equal to or better than predicate |
| Fluoroscopic Still Image After Image Resolution | Equal to or better than predicate |
| DSA (Digital Subtraction Angiography) Artifacts | Equal to or better than predicate |
| DSA Contrast | Equal to or better than predicate |
| DSA Dynamic Range | Equal to or better than predicate |
| Horizontal Streak Noise | Equal to or better than predicate |
| Focal Spot Resolution | Changes (.3/.6/1 to .4/.6/.9) but evaluated to be equal or better |
Study Proving Acceptance Criteria:
The study involved nonclinical testing using "commercially available phantoms and test objects." This testing was conducted "as prescribed in published and FDA recognized equipment standards" where applicable. The conclusion was that "Based upon the results of the verification testing the performance of the modified device is equal to or better than the predicate device."
2. Sample size(s) used for the test set and the data provenance:
- Sample size: Not applicable/not explicitly stated in terms of patient data. The testing involved "commercially available phantoms and test objects." Since this is a hardware and software modification for an X-ray system, the "test set" refers to the measurements taken from these phantoms and objects.
- Data provenance: The data is generated from controlled laboratory testing using specified phantoms and test objects. It is not patient data from a specific country, nor is it retrospective or prospective in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the "ground truth" for evaluating an X-ray system's physical performance (resolution, DQE, etc.) is established by the known properties of the phantoms and test objects and measured against established engineering and physics standards. There is no mention of human expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as the "test set" is composed of phantom and test object measurements, not cases requiring human interpretation and adjudication.
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:
This is not applicable. The device is an X-ray imaging system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is an integrated X-ray system, not a standalone AI algorithm. The performance testing was for the overall system's imaging capabilities.
7. The type of ground truth used:
The "ground truth" for the performance testing of the X-ray system was based on known physical properties of commercially available phantoms and test objects, measured according to established engineering and physics standards, and compared against the performance of the predicate device.
8. The sample size for the training set:
This is not applicable. The device is an X-ray imaging system, not an AI/ML system that requires a "training set" in the context of machine learning. The software updates mentioned are system software (v5.30) and do not imply an AI learning model.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated in point 8.
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K133535 p. 1 of 3
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) INFX-8000V, v5.30
510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS
JUL 2 3 2014
1. CLASSIFICATION and DEVICE NAME:
| Classification Name: | Solid State X-ray System, Interventional |
|---|---|
| Regulation Number: | 21 CFR 892.1650 – Image-intensified fluoroscopic x-ray system |
| Product Code | OWB (Primary); JAA (Secondary) |
| Trade Proprietary Name: | Infinix - V |
| Model Number: | INFX-8000V, v5.30 |
2. ESTABLISHMENT REGISTRATION: 2020563
3. CONTACT PERSON, U.S. AGENT
Contact Person/U.S. Agent: Paul Biggins Director, Regulatory Affairs (714) 730-5000
Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, Ca. 92780
4. MANUFACTURER
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
Contact Person: Hisayuki Uehara Deputy Manager, X-ray Systems Development Department
5. Date OF SUBMISSION:
November 15, 2013
-
- PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
7. PREDICATE DEVICE:
INFX-8000V w/ 3D Roadmapping (K120073)
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8. REASON FOR SUBMISSION:
Modification of a cleared device
9. SUBMISSION TYPE: Traditional 510(k)
10. 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 an x-ray tube, beam limiter and x-ray receptor, x-ray controller, computers with system and processing software, and a patient radiographic table.
11. SUMMARY OF INTENDED 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.
12. SUMMARY OF CHANGE(S)
- a. New system software (v5.30)
- b. Incremental improvement and model number change of solid state detector
- i. Model #: Old TFP-1200A, New TFP1200A/C
- ii. Scintillator thickness increased
- iii. ADC Bus from 14 to 16 bits
- iv. ASIC improvements
- V. DQE performance enhancement
- c. Modification of X-rav tube
- DRSX-T7345GFS to DSRX-T7445GFS i.
- == Focal spot changes .3/.6/1 to .4/.6/.9
13. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the INFX-8000V w/ 3D Roadmapping K120073, marketed by Toshiba America Medical Systems. INFX-8000V is modified with changes to components and software. The basic system configuration, method of operation, base software and manufacturing process remain unchanged from the cleared device. Nonclinical testing of the modifications demonstrated the device performs the same or better. There are no new indication for use or intended use of the device.
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14. 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; 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.
15. 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, NOS, conversion function, fluoroscopic still image resolution/dynamic range resolution/after image resolution, artifacts/contrast/dynamic range of DSA, horizontal streak noise and focal spot resolution. This testing was conducted with commercially available phantoms and test objects. Where applicable all testing was conducted as prescribed in published and FDA recognized equipment standards.
16. CONCLUSION
Based upon the results of the verification testing the performance of the modified device is equal to or better than the predicate device. The modifications incorporated into the INFX-8000V, do not change the indications for use or the intended use of the device. Safety and effectiveness have been verified via risk management and application of design controls to the modifications. Toshiba concludes that it has demonstrated that the modified INFX-8000V is substantially equivalent to the previous version.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 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 an abstract symbol resembling a stylized eagle or bird with three wing-like shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 23, 2014
Toshiba Medical Systems Corporation % Charlemagne Chua Manager. Regulatory Affairs 2441 Michelle Drive TUSTIN CA 92780
Re: K133535
Trade/Device Name: INFX-8000V Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-rav system Regulatory Class: II Product Code: OWB. JAA Dated: July 3, 2014 Received: July 9, 2014
Dear Charlemagne Chua:
We have reviewed vour 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 warrantics. 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 (OS) 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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Page 2-Charlemagne Chua
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/Salety/ReportalProblem/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/Industrv/default.htm.
Sincerely yours.
Sm-m-7)
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Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name INFX-8000V (Infinix-VFi and Infinix-CFi), v5.30
Indications for Use (Describe)
This device is a digital radiography/fluoroscopy system use in a diagnostic interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for 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)
§ 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.