(57 days)
The AutoMed 3300 and 3400 ambulatory infusion pumps and dedicated administration sets and accessories are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-arterial and epidural, and into intraoperative (soft tissue / body cavity) sites. The AutoMed systems are 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 Systems presented in this product notification include the AM 3300 and AM 3400 rotary peristaltic pumps and associated dedicated administration sets (AM 320, AM 330 and AM 340) and accessories. The systems are suitable for use as ambulatory devices and that are intended for use in the hospital, home environment or alternative care sites.
This looks like a 510(k) submission for infusion pumps (AutoMed 3300 and 3400). It focuses on the device description, intended use, and substantial equivalence to predicate devices, rather than a clinical study evaluating specific performance claims or AI integration.
Therefore, the requested information about acceptance criteria, study design, expert involvement, and AI performance cannot be extracted from the provided text because these elements are not present. The document is primarily a regulatory submission demonstrating substantial equivalence, not a clinical performance study.
Here's why the requested information cannot be found in the provided text:
- Acceptance Criteria and Reported Device Performance: This document describes the device and its intended use but does not present specific performance metrics or acceptance criteria that a study would aim to meet.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These are all aspects of a clinical or performance study designed to evaluate a device against specific metrics. This document does not describe such a study.
- Type of Ground Truth: This is relevant for studies where a device's output is compared against a definitive standard. This document does not describe such a comparison.
- Training Set Sample Size and Ground Truth Establishment (Relevant for AI): This document does not mention any artificial intelligence (AI) component in the infusion pumps. Therefore, information about training sets or how ground truth for training was established is not applicable.
In summary, the provided text is a 510(k) premarket notification for infusion pumps, establishing substantial equivalence, and does not contain the details of a performance or clinical study with the elements you've requested.
§ 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).