(86 days)
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes; intravenous, arterial, subcutaneous, epidural or irrigation of fluid space. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient care environments such as, but not limited to hospitals and outpatient care areas.
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming, thereby helping to reduce errors. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used by trained healthcare professionals.
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is a large volume infusion pump system that provides for safe and effective delivery of fluids into a patient in a controlled manner, as identified in 21 CFR, 880.5725. The pump is a software controlled, electromechanical device used for the infusion of pharmaceutical drugs, blood, blood products and mixtures of required patient therapy through administration sets at user selectable rates and volumes. The feedback-controlled, motorized pumping mechanism is of linear peristaltic design and uses inlet and outlet valves for flow control. The pump utilizes a primary and secondary processor to assure safe operation while providing infusion pump capabilities for a wide range of applications.
The pump is specifically manufactured and calibrated for the application of a manufacturer's brand of standard gravity administration sets, as indicated in the device labeling. For use, the administration set is loaded into the infusion pump. After acceptance of program parameters, the pump is started and fluid is propelled by the peristaltic action of the pumping mechanism against the outside surface of the administration set tubing. The pump is controlled to create smooth fluid dynamics, precision volumetric accuracy and uniformity of flow rate. None of the pump materials contact the administration set's fluid path.
The infusion pump is small in comparison to the traditional Large Volume Parenteral (LVP) infusion pumps currently on the market. It is designed to be used in a variety of patient care environments such as, but not limited to hospitals and outpatient care areas using an IV pole mounted configuration.
The Master Drug Library (MDL) Editor is a software application that allows the generation, configuration and management of a downloadable drug library into a SIGMA Spectrum infusion pump.
The drug library can be loaded directly into the SIGMA Spectrum infusion pump through a wireless network host or through an Infrared Data Association (IrDA) device. The MDL Editor software operates on a Microsoft Windows® platform.
Using the MDL Editor software application, a facility can provide preprogrammed delivery profiles, advisories and limits for a corresponding drug that is intended for a specific use classification or clinical care area, thus reducing the risk of medication errors.
The MDL Editor software application allows the ability to generate both standard or customized drug and fluid reports by clinical care area. The MDL Editor software application also provides a feature to restrict/limit the access of data to only appropriate personnel, providing additional security and rights to specific users.
The provided text is a 510(k) summary for the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library. Its purpose is to demonstrate substantial equivalence to a predicate device, not to detail the full acceptance criteria and study proving its performance.
The document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to AI or a clinical effectiveness study.
Instead, the document focuses on:
- Identifying the device and its predicate.
- Describing the device's function as an infusion pump.
- Stating its indications for use.
- Explaining that the specific 510(k) notification is to "update the algorithm and labeling related to the upstream occlusion alarm of the pump" and that "Performance testing for the software was completed."
Therefore, I cannot provide the requested information based on the given text. The prompt asks for details that would typically be found in a detailed validation report or clinical study summary, which is not present in this 510(k) 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).