(114 days)
RadiAnalyzer® is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.
RadiAnalyzer® is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.
RADIAnalyzer® is a diagnostic computer designed to compute, record and display information, based on the input from PressureWire® Sensor and an Aortic Pressure Transducer (AO). 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 vicwing software installed such as RADIView® Software. Data includes: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR) and temperature.
This K042628 510(k) submission for the RADIAnalyzer® Xpress does not contain the details of a study with acceptance criteria and reported device performance.
The document is a 510(k) summary and the FDA's clearance letter, which focus on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for the new device.
Therefore, I cannot provide the requested information from the provided text. The submission primarily addresses:
- Device identification: Proprietary name, common name, classification, and predicate device.
- Description of the device: How it functions and what it measures (systolic, diastolic, mean blood pressure, heart rate, FFR, CFR, temperature).
- Intended Use: Diagnosis and treatment of coronary or peripheral artery disease, and its use in catheterization labs.
- Technical Characteristics: Stating it's a smaller/lighter version of the predicate, with equivalent electrical and signal properties.
- FDA Clearance Letter: Confirming substantial equivalence to the predicate device.
§ 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).