(28 days)
Florence Medical Ltd. SmartFlow™ is intended for use in coronary and peripheral vasculature in conjunction with pressure measurement devices during and after diagnostic procedures, such as angiography, or interventional procedures, such as angioplasty, to evaluate the hemodynamic status of the diseased arteries and to provide further clinical information in the diagnosis and treatment of both coronary and peripheral artery diseases.
The SmartFlow™ with the Multiple Lesion software is a tool for measuring coronary and peripheral vasculature hemodynamic status patterns during diagnostic and interventional procedures.
The SmartFlow™ is a PC based system comprising of a full color display with a touchscreen for patient data entry and control, and software calculations of the CFR and FFR parameters. The display and touchscreen are mounted in a shielded metal housing.
The SmartFlow™ may be operated through its touchscreen or through an Infrared receiver port which allows the use of a hand-held remote.
There are two defined accessories for use with the device: Monitor interface for standard medical monitors and hand-held Infrared remote control which activates function keys and acts as a mouse.
This document describes the SmartFlow™M device, a diagnostic tool for evaluating the hemodynamic status of coronary and peripheral vasculature. The information provided is from a 510(k) summary, which is a premarket notification for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device.
Note: The provided text does not contain a detailed study report with specific acceptance criteria, sample sizes, and detailed methodology for a clinical or performance study of the SmartFlow™M device itself. Instead, it describes the device, its intended use, and its substantial equivalence to a previously cleared device. Therefore, the response below will extrapolate and make assumptions based on standard FDA 510(k) submissions where such details are usually found in the performance data section, which is missing from this excerpt.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the given 510(k) summary. A 510(k) summary typically includes a table comparing the performance of the new device to the predicate device, often using metrics like accuracy, sensitivity, specificity, and potentially precision or agreement for quantitative measurements such as CFR (Coronary Flow Reserve) and FFR (Fractional Flow Reserve), which the SmartFlow™ calculates.
Since the device "enables analysis of multiple lesion cases as well as single lesion cases," a key performance metric would likely revolve around its ability to accurately measure CFR and FFR for multiple lesions and its agreement with established methods or the predicate device.
Hypothetical Acceptance Criteria (based on common practice in this field, not from the document):
| Performance Metric | Acceptance Criteria (Hypothetical) | Reported Device Performance (Not in document, would be based on studies) |
|---|---|---|
| Agreement for FFR measurement | Mean difference (new vs. predicate/gold standard) within ± 0.02, with 95% limits of agreement within ± 0.05 | Not provided in excerpt |
| Agreement for CFR measurement | Mean difference (new vs. predicate/gold standard) within ± 0.5 units, with 95% limits of agreement within ± 1.0 unit | Not provided in excerpt |
| Accuracy for lesion identification (for multiple lesion cases) | Sensitivity > 90%, Specificity > 85% for identifying relevant lesions in simulated or clinical data | Not provided in excerpt |
| Reproducibility/Precision | Coefficient of Variation (CV) |
§ 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).