(297 days)
The Biegler BW385L Blood and Infusion Warmer has the same intended use as several devices now marketed in the U.S. The DW1000, Baxter, the HotlineR1, Level 1; the FloTemR2, DataChem and the FenwalR3, Baxter are all used to heat infusate.
The Biegler BW385L Blood & Infusion Warmer is designed to reduce complications associated with the infusion of blood and other liquids that are cooler than normal body temperature. The BW385L warms the fluid by means of a metal Heat Exchanger which is adjacent to an I.V. Tubing Extension Set through which the fluid to be heated flows. The cylindrical Heat Exchanger has a series of grooves; the Extension Set tubing is 'wrapped' around the Exchanger and into these grooves. The BW385L operates on a 120 volt (or where required 220 Volt) A.C. power source and is controlled by an on-off switch on the plastic face of the instrument. Above the on-off switch is an LED temperature monitor. The BW385L Blood & Infusion Warmer weighs 2.5 Kg. and is equipped with a dual knob clamp at the back of the instrument for I.V. pole attachment. The infusate is warmed to approximate body temperature as it travels a path around the constantly monitored and regulated Heat Exchanger. The BW385L is UL / C-UL approved and units placed to date have received special CSA inspection certification.
The provided text is a 510(K) Summary for the Biegler BW385L Blood & Infusion Warmer. It describes the device, its intended use, and compares it to other similar devices on the market. However, it does not contain the detailed information required to fill out the requested table and answer all questions about acceptance criteria and a study proving those criteria are met.
Specifically, the document states: "Data compiled by Biegler G.m.b.H. using the BW385L Blood & Infusion Warmer with Biegler Extension Sets, ambient temperature of 21 oC., with liquids at initial temperatures of both 18 oC. and 07 oC. indicate that at moderate infusion rates (to 6 litres / hour) the BW385L adds sufficient heat to the liquid medium to claim substantial equivalence to the warmers mentioned above."
While this snippet hints at a study and performance, it does not provide:
- Explicit acceptance criteria: It only mentions "sufficient heat to the liquid medium to claim substantial equivalence." It does not define what "sufficient heat" means in terms of specific temperature ranges or deviations from body temperature, nor does it quantify "substantial equivalence."
- Specific performance metrics: No actual temperature values achieved by the device are reported.
- Details about the study design: No information on sample size, data provenance, ground truth establishment, expert involvement, or statistical methods.
Therefore, many of the requested fields cannot be filled from the given text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of numerical targets. The document states the device should "add sufficient heat to the liquid medium to claim substantial equivalence" to predicate devices. | The BW385L adds "sufficient heat to the liquid medium" for liquids initially at 18°C and 7°C, at infusion rates up to 6 litres/hour, with an ambient temperature of 21°C. Specific final temperatures or temperature deltas are not reported. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The text only mentions "Data compiled by Biegler G.m.b.H."
- Data provenance: "Biegler G.m.b.H." (presumably Germany, as "G.m.b.H." is a German corporate designation). The nature of the study (retrospective or prospective) is not stated, but it implies a prospective test setting given the controlled variables (ambient temp, initial liquid temp, infusion rates).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not mentioned. This device is a blood/infusion warmer; its performance is measured by physical parameters (temperature), not by expert interpretation of medical images or symptoms.
4. Adjudication method for the test set
- Not applicable/Not mentioned. See point 3.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not an algorithm. The "study" described directly measures the device's physical performance.
7. The type of ground truth used
- The "ground truth" (or more accurately, the measurement standard) would be accurate temperature readings of the infusate, as verified by calibrated temperature sensors. This falls under physical measurements/engineering performance data.
8. The sample size for the training set
- Not applicable. The concept of a "training set" is relevant for machine learning algorithms, which this device is not. The "Data compiled by Biegler G.m.b.H." would serve as performance verification data, not training data.
9. How the ground truth for the training set was established
- Not applicable. See 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).