(740 days)
The Fluido Compact Blood and Fluid Warming System can be used in adult patients that need fluid warming pror to administration of blood, blood products and IV fluids to help prevent hypothermia. The system is intended to be used by healthcare professionals, e.g., nurses, medical specialists, doctors. Only medical professionals shall interact with the system. The devices must only be used on the order of a physician.
The Fluido® Compact System consists of Fluido Compact Warming Module, Fluido Compact Control Module and Fluido Compact Standard Set (disposable).
The Fluido Compact system is designed to supply warm fluids at 39°C set point with flow rates from 5 to 100 ml/min. The sterile disposable set consist of a plastic housing and biocompatible coated aluminum heater plate. Heat from the warming module is transferred through the heat transfer part into the fluids that is circulating through the inner part of the cassette. The disposable is connected to the blood or fluid source (infusate reservoir) and the patient line on the other end. The disposable has standard luer lock fittings on both ends. The Control Module serves as the power supply for the Warming module.
Fluid and blood are warmed during infusion or transfusion. The delivery of heat is done by heat exchange. A warming module exchanges heat to a disposable set, which is connected to the fluid reservoir and the patient line via conduction warming technology The fluid temperature is controlled by closed loop software and guarded by sensors and has a redundant safety module for fluid overtemperature shutoff.
This describes the Fluido Compact Blood and Fluid Warming System, a medical device for warming fluids prior to administration, and outlines the testing performed to demonstrate its substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance) | Reported Device Performance |
|---|---|
| Temperature (Accuracy) | PASS |
| Flow rates (Accuracy) | PASS |
| Alarms (Functionality) | PASS |
| Usability | PASS |
| Heater Safety (per ASTM F2172-02) | PASS |
| Electrical/EMC (per IEC 60601-1) | PASS |
| Electrical/EMC (per IEC 60601-1-2) | PASS |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the individual non-clinical performance tests (Temperature, Flow rates, Alarms, Usability, Heater Safety, Electrical/EMC). Only "Performance testing according to applicable testing met all acceptance criteria" is stated.
The data provenance is from non-clinical bench testing, conducted for the purpose of demonstrating substantial equivalence to a predicate device. No country of origin is explicitly mentioned for the testing itself, but the submitter is based in the Netherlands. The testing is retrospective in the sense that it was conducted after the device design was finalized to meet established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the provided document describes performance testing of a physical medical device (fluid warming system) against technical standards and specified operational parameters, not an AI device requiring expert ground truth for classification or diagnostic accuracy.
4. Adjudication method for the test set
This information is not applicable for the same reason as point 3. The device's performance was measured directly against objective technical criteria and operational specifications, not against human interpretation or a consensus of experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable as the device is not an AI-assisted diagnostic or classification tool for human readers. It is a physical medical device designed to warm fluids.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an AI algorithm. It is a physical medical device.
7. The type of ground truth used
The "ground truth" for this device's performance is established by objective technical standards and predefined operational specifications. For example:
- Temperature accuracy is measured against a set point (e.g., 39°C ± 2°C).
- Flow rates are measured against a specified range (e.g., 5 to 100 ml/min).
- Heater safety is assessed against the requirements of ASTM F2172-02.
- Electrical/EMC performance is assessed against IEC 60601-1 and IEC 60601-1-2.
8. The sample size for the training set
This information is not applicable as the device is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).