(14 days)
This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities.
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.
These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms (that contain the tube and solid state detector), x-ray generator and a patient table.
The provided text is a 510(k) premarket notification summary for the Toshiba INFX-8000C, an x-ray angiography system. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data for a new AI or diagnostic algorithm.
Therefore, the document does not contain the detailed information required to fully answer your request, specifically:
- Acceptance criteria and reported device performance: There is no table of specific performance metrics or acceptance criteria for a new device function, nor is there any presented performance data. The submission is for a model number change and demonstrates equivalence.
- Sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, ground truth types, training set size, or ground truth establishment for a study. These elements are typically found in a clinical study report or a more detailed technical submission for a novel diagnostic device or AI algorithm, which is not what this 510(k) summary provides.
Based on the available information, here is what can be inferred or directly stated, noting the significant lack of the requested study details:
1. A table of acceptance criteria and the reported device performance
Not applicable/Not provided in the document.
This 510(k) submission is for a model number change and asserts substantial equivalence to predicate devices, rather than presenting specific performance data against predefined acceptance criteria for a new diagnostic capability or algorithm. The document emphasizes meeting safety standards and having similar technological characteristics and intended use as the predicates.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided in the document.
No clinical study with a test set is described. The submission focuses on demonstrating substantial equivalence for a device with a model number change.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable/Not provided in the document.
No clinical study requiring expert ground truth establishment for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not provided in the document.
No clinical study with a test set requiring adjudication 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 in the document.
This submission is for an x-ray angiography system, not specifically an AI-powered diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided in the document.
This submission is for an x-ray system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided in the document.
No ground truth data is discussed as no specific diagnostic performance study is presented.
8. The sample size for the training set
Not applicable/Not provided in the document.
No training set is discussed as no machine learning or AI algorithm development is described.
9. How the ground truth for the training set was established
Not applicable/Not provided in the document.
No training set or associated ground truth establishment is described.
Summary of Device and 510(k) Basis:
The Toshiba INFX-8000C, Infinix-CCi, and Infinix-VCi systems are described as digital x-ray systems for diagnostic and interventional angiography of blood vessels in the heart, brain, abdomen, and lower extremities.
The 510(k) submission (K081621) is primarily for a model number change and asserts substantial equivalence to existing predicate devices (GE Innova 4100; K052412 and Toshiba DFP-8000D/FPD; K052884). The basis for equivalence rests on:
- Similar intended uses.
- Similar technological characteristics, employing x-rays to generate fluoroscopic and radiographic images.
- Compliance with relevant safety and performance standards (Quality System Regulations, Federal Diagnostic Equipment Standard, IEC 60601-1, IEC 60601-2-32, IEC 60601-2-28).
No specific clinical performance study with acceptance criteria and measured performance data, as would be expected for a novel diagnostic device or AI algorithm, is detailed in this 510(k) summary. The approval is based on demonstrating that the new model number represents a device that is safe and effective because it is substantially equivalent to already cleared devices, not because it has met specific, new performance thresholds in a clinical trial.
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K081621
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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for INFX-8000C
510(k) Summary
| Date: | June 3, 2008 |
|---|---|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,Tustin, CA 92781-2068 |
| Submitter's Contact: | Paul Biggins, Director Regulatory Affairs(714)730-5000 |
| Establishment RegistrationNumber: | 2020563 |
| Device Proprietary Name: | INFX-8000C (Infinix CCi and Infinix VCi) |
| Common Name: | Electrostatic Fluoroscopic x-ray System)[Fed. Reg. No. 892.1650, Pro. Code: 90MQB] |
| Regulatory Class: | II (per 21 CFR 892.1650) |
| Performance Standard: | 21 CFR Subchapter J,Federal Diagnostic X-ray Equipment Standard |
| Predicate Device(s): | GE Innova 4100; 510(k) Control # K052412Toshiba DFP-8000D/FPD; 510(k) Control # K052884 |
| Reason For Submission | Model Number Change |
Description of this Device:
These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms (that contain the tube and solid state detector), x-ray generator and a patient table.
Summary of Intended Uses:
This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities.
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K081621
Pg. 2 of 2
Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for INFX-8000C
Technological Characteristics:
This device employs similar materials and processes as found in the predicate device. The device produces ionizing radiation that is employed to generate fluorosonois. and radiographic images of the anatomy.
Safety and Effectiveness Concerns:
This device is designed and manufactured under the Quality System Regulations as All requirements of the Federal Diagnostic Equipment outlined in 21 CFR § 820. Standard, as outlined in 21 CFR § 1020,that apply to this device, will be met and reported via an initial report. Additionally this system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32, and IEC 60601-2-28. - Medical Device Safety standards.
Substantial Equivalence:
r
The INFX-8000V is of comparable type and substantially equivalent to:
GE Innova 4100; 510(k) Control # K052412 Toshiba DFP-8000D/FPD; 510(k) Control # K052884
Therefore 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 Department of Health and Human Services. The logo includes the department's seal on the left, which features an abstract design of human figures. To the right of the seal, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
AUG 2 1 2013
Re: K081621
Trade/Device Name: INFX-8000C; Infinix-CCí and Infinix-VCí Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA and MOB Dated: June 6. 2008 Received: June 9, 2008
Dear Mr. Job:
This letter corrects our substantially equivalent letter of June 23, 2008.
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 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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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for INFX-8000C
Indications for Use
108162 510(k) Number (if known):
INFX-8000C; Infinix-CCi and Infinix- VCi Device Name:
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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Aoni In Whang
(Division Sign-Off)
Division of Reproductive, Abdominal, an Radiological Devices 510(k) Number
§ 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.