(74 days)
The 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, and blood products. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, epidural or irrigation of fluid space. The 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 Spectrum IQ Infusion System with Dose IQ Safety Software is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas.
The Spectrum IO Infusion System with Dose IQ Safety Software is intended to reduce operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies. This automation is intended to reduce pump programming errors and increase accuracy of infusion documentation.
The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used by trained healtheare professionals.
The proposed device, Spectrum IQ Infusion System with Dose IQ Safety Software is a large volume infusion system that provides safe and effective delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical pump used for the infusion of pharmaceutical drugs, blood and blood products through intravenous administration sets at user selectable rates and volumes, and a software application that allows the generation, configuration and management of a downloadable drug library into the pump.
The provided text is a 510(k) summary for the Baxter Healthcare Corporation's Spectrum IQ Infusion System with Dose IQ Safety Software. However, it does not contain the acceptance criteria or a study proving the device meets acceptance criteria related to its performance in reducing programming errors or increasing documentation accuracy, which are stated as its intended use.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K173084), whose clearance date was May 11, 2018. The current 510(k) (K220417) is specifically for updating the cleaning instructions for the device.
Therefore, based only on the provided text, I cannot extract the information required to populate the table and answer the study-related questions.
The "Indications for Use" section mentions:
"The Spectrum IQ Infusion System with Dose IO Safety Software is intended to reduce operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies. This automation is intended to reduce pump programming errors and increase accuracy of infusion documentation."
However, the document states in the "DISCUSSION OF NONCLINICAL TESTS" section: "The scope of this notification is to update the cleaning instructions. Performance testing for the cleaning agents was completed. Biocompatibility is not affected by this notification. The intended use and function of the proposed device is the same as the predicate device."
And in the "CONCLUSION" section: "The scope of this notification is to update the cleaning instructions per the performance testing. The intended use and function of the proposed device is equivalent to the predicate 510(k), currently commercialized device."
This explicitly indicates that the current submission (K220417) is not about new performance studies for reducing programming errors or increasing documentation accuracy. It's about cleaning instructions.
To answer your request, a different document that details the original performance study for K173084 (the predicate device) or a subsequent study focusing on the "reduce pump programming errors and increase accuracy of infusion documentation" claim would be needed.
§ 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).