(118 days)
PharmGuard™ Toolbox is intended to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medex Infusion Pumps. The PharmGuard Toolbox collects and downloads operational, infusion, and alarm history events, library usage counts, and PharmGuard™ safety events from motory overner lardly assomment it is intended to provide a rich dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medex Infusion Pumps.
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This document is a 510(k) clearance letter from the FDA for a device called "PharmGuard™ Toolbox." It primarily addresses regulatory aspects and does not contain detailed information about the device's technical acceptance criteria or the specific study details you've requested.
Therefore, I cannot provide the information you've asked for based on the provided text. The document confirms market clearance but does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Information on experts, adjudication methods, or ground truth for a test set.
- Details of a multi-reader multi-case (MRMC) comparative effectiveness study or human-in-the-loop performance.
- Results of a standalone algorithm performance study.
- The type of ground truth used for a study.
- Sample size or ground truth establishment for a training set.
The document describes the device's intended use: "PharmGuard™ Toolbox is intended to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medex Infusion Pumps. The PharmGuard Toolbox collects and downloads operational, infusion, and alarm history events, library usage counts, and PharmGuard™ safety events from motory overner lardly assomment it is intended to provide a rich dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medex Infusion Pumps."
This indicates it's a software tool for managing and configuring infusion pumps and collecting data, rather than a diagnostic device that would typically have the performance metrics you've inquired about.
§ 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).