(41 days)
The system is intended for use in cardiovascular x-ray imaging applications, including diagnostic and interventional procedures (such as PTCA, stent placement, atherectomies), pacemaker implantations, and electrophysiology. It may also be used for other imaging applications at the physician's discretion.
The MIS NewBrid System is the result of integrating new and or refurbished/rebuilt positioners. components and digital imaging systems that are previously cleared by the FDA. Some of the new components will change the original manufacturers specifications and functionality. For example, MIS could remove the original manufacturers Image Intensifier-based imaging chain and replace it with new components or with a solid-state flat panel detector. MIS will integrate its own system interface rack for system control. The image acquisition package with a system purchased from an OEM that has 510[k] approval. The pivoting base will allow for an extend area of patient imaging coverage.
The provided text is a 510(k) summary for the MIS NewBrid System. It outlines the device description, intended use, indications for use, and a comparison to predicate devices, focusing on substantial equivalence for safety and effectiveness.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The submission focuses on demonstrating substantial equivalence to previously cleared devices based on the integration of existing components rather than presenting performance data from a new clinical study.
Therefore, I cannot provide the requested table and information based on the given input, as such data is not present in the document.
The document only states the intended use/indications for use as: "The system is intended for use in cardiovascular x-ray imaging applications, including diagnostic and interventional procedures (such as PTCA, stent placement, atherectomies), pacemaker implantations, and electrophysiology. It may also be used for other imaging applications at the physician's discretion."
The rest of the questions cannot be answered from the provided text.
§ 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.