Search Results

The DripAssist Plus is a device intended to be used with gravity infusions as a supplementary monitor the flow of fluid through a compatible drip chamber. The device is intended to be used with single-use intravascular administration sets uniquely identified as "compatible with DripAssist Plus." Sensors measure the flow rate and calculations are performed to convert the drip rate to mL/hr measurement and total volume. An alarm is available to alert the user if the drip rate deviates from the set infusion rate setting controlled through the IV administration set.

The DripAssist Plus device is intended to be used as a supplementary monitoring system for monitoring the flow rate of intravenous fluids. DripAssist Plus is a passive device. It does not control the flow rate of fluids passing through a drip chamber. The device operates by monitoring the drops through the drip chamber of a compatible single-use intravascular administration set that is inserted into a mechanical attachment mechanism on the DripAssist Plus. By tracking the intervals between drops, the device calculates the flow rate through the chamber and displays the flow rate on an LCD screen. The device operates by tracking drops using an infrared emitter and detector positioned on opposite sides of a well wherein the drip chamber is situated. There is an alarm functionality that can be activated once a desired flow rate, or "set point," is reached. The alarm, when activated, will sound when the flow rate deviates a fixed percentage from the "set point." The device can be used with compatible drip sets of 10, 15, 20, or 60 gtt/mL. The device is powered by one AA battery. The device can display the flow rate in drops per minute or mL per hour. The unit of measurement being displayed can be changed while the device operates. The device can also display the total volume that has dispensed through the drip chamber. The device is designed to be used with drip rates slow enough to be calculated by the human eye; a steady stream of fluid is outside the operating parameters.

The provided document describes the DripAssist Plus, a device intended to be a supplementary monitor for gravity infusions, and its substantial equivalence to the predicate device, DripAssist (K150687). The document primarily focuses on demonstrating that the DripAssist Plus meets its specifications and is substantially equivalent to the predicate device.

Here's an analysis of the acceptance criteria and the study performance based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly provide a "table of acceptance criteria" with specific pass/fail thresholds for each test, nor does it present the "reported device performance" in a granular, quantitative manner for all parameters. Instead, it describes general performance characteristics and states that "Predefined acceptance criteria were met" and "results were acceptable for all testing."

However, we can infer some performance characteristics and the device's claimed adherence to them:

Inferred Acceptance Criteria and Reported Performance for DripAssist Plus (compared to DripAssist Predicate)

Ask a specific question about this device