(100 days)
The eFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
The Enginivity cFlow™ IV Fluid Warmer consists of a warming device and a single use disposable set. The warmer can be powered by either an AC power adapter supplied by Enginivity LLC or a12-30 volt DC source meeting the requirements listed in the operators' manual. The warmer will deliver infusate to a patient at a temperature of up to 40°C at flow rates of 1 ml/min to a maximum of 200 ml/min.
The sterile disposable cartridge consists of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path.
The document provided is a 510(k) premarket notification for the Enginivity™ eFlow IV Fluid Warmer. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical study with detailed acceptance criteria and performance data like a PMA application would.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document references ASTM F 2172-02 Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers as the performance standard. This standard would contain specific acceptance criteria for fluid warmers. However, the document does not explicitly list the acceptance criteria from this standard or the detailed results of the Enginivity eFlow™ IV Fluid Warmer against them in a table format.
The document states:
- "performance data demonstrate the temperature accuracy of the device at different flow rates."
- "Laboratory evaluations have been conducted to evaluate the hemolytic effect of the eFlow IV Fluid warmer during flows ranging from 10 to 200 ml/min and stopped flow."
Without access to the full submission or the ASTM standard, the specific numerical acceptance criteria and reported performance values cannot be extracted from this document.
| Acceptance Criteria (from ASTM F 2172-02, NOT EXPLICITLY LISTED IN DOC) | Reported Device Performance (from "Discussion of Non-clinical Studies", NOT EXPLICITLY LISTED IN DOC) |
|---|---|
| (e.g., Temperature accuracy within +/- X °C at various flow rates) | "temperature accuracy of the device at different flow rates" (specific values not provided) |
| (e.g., Hemolytic effect below Y threshold) | "evaluate the hemolytic effect of the eFlow IV Fluid warmer during flows ranging from 10 to 200 ml/min and stopped flow" (specific results not provided) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "studies conducted on sterilized eFlow™ Disposable Carticiges" and "Laboratory evaluations." These are non-clinical studies.
- Sample Size for Test Set: Not specified. The document does not provide a number of devices or disposable cartridges tested.
- Data Provenance: The studies were described as "Laboratory evaluations," implying they were conducted in a controlled environment, likely in the US where the company is based. The data would be prospective as it involves testing the device, not analyzing existing patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is an IV fluid warmer, a piece of hardware, not an AI/imaging device requiring expert interpretation for ground truth. Therefore, this question is not applicable to the context of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an imaging or diagnostic device requiring human adjudication of results. The testing would involve objective measurements (e.g., temperature sensors, blood analysis for hemolysis).
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
Not applicable. This is an IV fluid warmer, not a diagnostic device involving human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is geared towards AI/software devices. For this hardware device, the closest equivalent is the standalone performance of the device itself as evaluated in the laboratory studies mentioned (temperature accuracy, hemolytic effect). The document does indicate that such standalone performance (without human input beyond operating it) was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" refers to objective physical and biological measurements obtained through laboratory testing.
- Temperature: Measured by calibrated sensors.
- Hemolysis: Measured through laboratory assays (e.g., spectrophotometry) to quantify free hemoglobin in the blood after passing through the device.
8. The sample size for the training set
Not applicable. This is a hardware device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this hardware device.
§ 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).