(67 days)
This device is a digital radiography/iluoroscopy system used in a diagnostic anglography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
3D Road-mapping function to assist in the planning and execution of interventional procedures
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 (either one or two), x-ray generator and a patient table.
The 3D Road-mapping function is an extension of the already existing 2D Road-mapping function both of which overlay the fluoroscopic image on the DSA image on the system monitor.
The provided text describes a 510(k) premarket notification for the Toshiba INFX-8000V with 3D Road-mapping, but does not contain information regarding
acceptance criteria, a specific study proving the device meets those criteria, or details such as sample sizes, expert qualifications, or ground truth establishment.
The document focuses on:
- Device Description: A digital x-ray system for fluoroscopy and radiography, with the 3D Road-mapping function being an extension of existing 2D Road-mapping to overlay fluoroscopic images on DSA images.
- Intended Use: Diagnostic and interventional procedures for blood vessels in the heart, brain, abdomen, and lower extremities.
- Technological Characteristics: Similar materials and processes to predicate devices, producing ionizing radiation.
- Safety and Effectiveness Concerns: Adherence to Quality System Regulations (21 CFR § 820), Federal Diagnostic Equipment Standard (21 CFR § 1020), and medical device safety standards (IEC 60601 series). Risk management processes are also mentioned.
- Substantial Equivalence: Comparison to predicate devices (Toshiba INFX-8000V, GE Innova series, Siemens In Space 3D Option).
Therefore, I cannot populate the requested table or provide answers to the specific questions regarding acceptance criteria and performance studies because this information is not present in the provided text.
The document is a submission for substantial equivalence based on a comparison to predicate devices, focusing on regulatory compliance and similar intended use, rather than presenting a performance study with specific acceptance criteria and results.
§ 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.