(216 days)
The IMED Ambulatory Infusion System is intended for use in a health care facility as well as home health care setting to pump standard IV fluids, medications, blood and blood products into a patient in a controlled manner.
The IMED Ambulatory Infusion System is comprised of a cassette assembly and the pump. The system uses a rotary peristaltic pumping action which physically pumps fluid to the patient when used in conjunction with the dedicated administration sets. Various confiqurations of the IV administration sets are available. The IMED Ambulatory Infusion System incorporate the following features:
- Battery status Indicator; provides estimated remaining battery run time.
- Ease of Use; provides operator queries, visual and audio alarms.
- Flow Rates; range of 0.1-999 mL/hr
- Free Flow Protection; administration set-based protection.
- Occlusion Pressure; provides multiple detection options.
- Secondary Infusion; provides dual rate sequential piggyback infusions.
- Tamper-resistant Mode; provides the ability to lockout kevpad.
- Volume-To Be-Infused; range of 0.1-9999 mL.
This document describes an "IMED Ambulatory Infusion System" (pump and associated administration sets) and its equivalence to predicate devices, but it does not contain the specific detailed information typically found in a study proving a device meets acceptance criteria.
The provided text focuses on:
- Device Description and Intended Use: What the device is and what it's for.
- Predicate Devices: Identifying existing devices it's claimed to be substantially equivalent to.
- Technological Aspects and Equivalence Claim: Stating that its technology and materials are equivalent and that performance data supports this.
- Biocompatibility: Mentioning compliance with biocompatibility standards for the administration sets.
However, the key elements requested in your prompt (acceptance criteria table, specific study details like sample size, ground truth, expert qualifications, etc.) are not present in this document.
The document states: "The performance data resulting from the comparative functional testing also support the substantial equivalence claim to the predicate device." and "The conclusion drawn from the Performance Data demonstrates that the IMED Ambulatory Infusion Pump and Administration Sets are equivalent to legally marketed devices and that they perform as well as or better than the predicate devices."
This indicates that such a study was conducted, but the details of that study are not provided in this summary document.
Therefore, I cannot fulfill your request for the specific details of the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information like sample size, ground truth establishment, expert qualifications, etc., is simply not included in this "Safety and Effectiveness Summary."
§ 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).