(87 days)
RadiAnalyzer® Xpress is indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters with Pressure Wire®.
RadiAnalyzer® Xpress is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological and blood flow parameters based on the output from one or more electrodes, transducers or measuring devices.
RadiAnalyzer® Xpress is a diagnostic computer designed to compute, record and display information from Pressure Wire® and other external transducers. The information is displayed as graphs as well as numerical values on the integrated screen and may also be transferred to a cardiac monitor, RadiAnalyzer® Printer and/or PC with external viewing software installed, such as RadiView® or PhysioMon™. Data includes: systolic, diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR). RadiAnalyzer® Xpress can be upgraded with additional software, such as Thermo Option software to enable assessments of invasive temperature, Coronary Flow Reserve (CFR) or other physiological parameters such as first time derivative of pressure (dP/dt).
RadiAnalyzer® Xpress comes with one remote control, two monitor cables, one adapter cable, and one mains cable (standard configuration).
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) summary for the RadiAnalyzer® Xpress, primarily focusing on showing its substantial equivalence to a predicate device. It discusses:
- Device Description: What the RadiAnalyzer® Xpress does and its components.
- Intended Use/Indications for Use: The medical purpose of the device.
- Technical Characteristics: Mentions additions to the device (algorithm for dP/dt and IMR calculation in accessory RadiView®) compared to the predicate.
- Functional/Safety testing: A general statement that "software verification/validation conducted indicate that RadiAnalyzer® Xpress and its accessories PhysioMon™ and RadiView® satisfy safety and performance requirements of the device specifications and do not raise additional safety issues." This is a blanket statement and not a detailed description of acceptance criteria or a specific study.
- Conclusion: Declares substantial equivalence to predicate devices.
- FDA Correspondence: Official letter from the FDA regarding the 510(k) submission.
Therefore, I cannot populate the requested table or answer the specific questions about the study, sample sizes, ground truth, or MRMC results. This type of detailed performance criteria and study summary is typically found in the full 510(k) submission, not usually in the publicly available 510(k) summary document itself, which often focuses on the regulatory aspects and equivalence demonstration.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).