(41 days)
The infusion/blood warmer model ANIMEC AM-2S is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated in intravenous administration sets for intermittent use and low flow rate applications at 1 to 12ml/min. The AM-2S is available in two sizes: 4mm channel for I.V. administration sets and a 5mm channel for blood administration sets.
The infusion/blood warmer model ANIMEC AM-2S is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated in intravenous administration sets for intermittent use and low flow rate applications at 1 to 12ml/min. The AM-2S is available in two sizes: 4mm channel for I.V. administration sets and a 5mm channel for blood administration sets.
The provided document describes an FDA 510(k) premarket notification for infusion/blood warmers (Animec, Models AM-2S-4 and AM-2S-5). It establishes substantial equivalence to a predicate device but does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a more comprehensive technical document for a medical device.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study details (effect size).
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is primarily an FDA clearance letter and an "Indications For Use" statement, not a scientific or clinical study report.
§ 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).