(87 days)
The AutoMed 3200 ambulatory infusion pump with integrated administration set is intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites. The AutoMed 3200 infusion pump is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.
The AutoMed 3200 infusion pump with integrated administration set and drug reservoir is a rotary peristaltic pump. Associated dedicated administration set, AM 330, and accessories are part of the overall system. The system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
This document describes the AutoMed 3200 infusion pump, a rotary peristaltic pump intended for general infusion use, including patient-controlled infusion. The device is significantly similar to several predicate devices. The information provided does not include acceptance criteria or a study that proves the device meets specific performance criteria. The document is primarily a 510(k) premarket notification summary and an FDA clearance letter for the device, focusing on its intended use and substantial equivalence to existing products.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies demonstrating device performance based on the input text. The text does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Details about experts used for ground truth or adjudication methods.
- Information on multi-reader multi-case (MRMC) studies or effect sizes.
- A standalone algorithm performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth was established for a training set.
§ 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).