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The Plum Duo Infusion System is intended for parenteral fluids and medications through clinically acceptable routes (limited to intravenous, intra-arterial, and subcutaneous therapies).

The Plum Duo Infusion System is intended for use in clinical environments in the hospital environment and other outpatient healthcare facilities by licensed healthcare professionals are trained in the use of the infusion pump and the administration of therapies consistent with the intended use.

The Plum Duo Infusion System is intended for adult, pediatric (including infants and children), and neonatal patient populations.

The Plum Duo™ Infusion System is the next generation of the Plum™ family of devices that is based on the fundamental technology of the Plum 360™ Infusion System cleared under K161469. The pump design incorporates state-of-the-art features such as dual channel functionality, touch screen display, and lithium iron phosphate battery technology. The pump uses the same volumetric piston type technology with a plunger stepper motor to deliver fluids to a patient as the predicate Plum 360™ Infusion System.
Plum Duo™ Infusion System is a large volume pump (LVP) with two independent pump channels that can deliver fluid to a patient on up to 4 lines and is designed so that it is possible to use one channel only. In addition, although the channels can operate independently, patient parameters can be shared across the channels to aid in the speed of programming. Each channel accepts a cassette that is part of a PlumSet™ administration set and can connect to a primary and/or secondary container.

The provided document is a 510(k) Summary for the Plum Duo™ Infusion System, which is an infusion pump. It demonstrates substantial equivalence to a predicate device. This type of regulatory submission focuses on engineering and performance validation rather than clinical studies involving patient data or human interpretation of medical images.

Therefore, the document does not contain the information requested regarding acceptance criteria and study details for an AI/ML-enabled medical device that typically involves:

• A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, AUC, etc., which are common for diagnostic or AI algorithms).
• Sample size for a test set based on patient data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication methods for test sets.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance.
• Type of ground truth (pathology, outcomes data, expert consensus).
• Sample size for the training set and how its ground truth was established.

This document describes a more traditional medical device submission, focusing on the mechanical, electrical, and software safety and performance of an infusion pump. The "Summary of Non-Clinical Testing" section lists various engineering tests (e.g., flow rate accuracy, air in line performance, alarm testing, electrical safety, reliability testing, human factors validation), which are typical for infusion pumps to ensure their safe and effective operation, but these do not align with the criteria for evaluating an AI/ML model for diagnostic or predictive purposes.

The statement "Clinical evaluation is not required for this submission to support substantial equivalence" further confirms that the type of studies and data provenance you are asking about (which often involve clinical data and human interpretation) were not part of this specific submission.

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