(66 days)
The Alaris® PC Unit is the main user interface unit and power supply of the Alaris® System, a modular system to be used with Alaris® System modules (aka Medley™ System modules) intended for use in today's growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Alario® System module is specified in its respective submission.
The Alaris® System is a modular system that consists of a point-of-care unit (PC Unit) that provides the main user interface and power supply for the associated infusion and monitoring modules. The enhanced PC Unit will include a faster processor, increased memory, and a color screen. This update is only for the Alaris® PC Unit and does not require any change to the associated modules, systems, or accessories of the Alaris® System.
This document is a 510(k) premarket notification for an Alaris® PC Unit (Models 8000 and 8015). It details the device, its intended use, and its substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes a device modification for the Alaris® PC Unit, specifically including "a faster processor, increased memory, and a color screen." The submission's core argument is one of substantial equivalence to a previously cleared predicate device (Alaris® PC Unit K051641).
Therefore, the "acceptance criteria" are implicitly met by demonstrating that the modified device "is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered." This means the device is expected to perform at least as well as the predicate device in its intended function.
Since this is a 510(k) for a device modification and not a new diagnostic algorithm or AI, there are no specific performance metrics like sensitivity, specificity, or AUC mentioned in the provided text. The performance is assessed by comparison to the predicate.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Substantial Equivalence to Predicate Device (K051641) | "With the exception of the device modification presented in this submission, the Alaris® PC Unit is essentially the same as the originally submitted predicate device. The intended use, principles of operation, fundamental scientific technology, method of manufacture, and application are essentially the same." and "The results of this comparison demonstrate that the modified Alaris® PC Unit is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered." |
| No change in intended use | "The intended use of this device has not changed from the original submissions in terms of content or intent." |
| Continued safety and effectiveness for infusion pump function | (Implicit, as the core function remains unchanged and the modifications are enhancements to the user interface/processor, not the core infusion mechanism) |
2. Sample Size Used for the Test Set and Data Provenance:
This document is for a medical device modification (an infusion pump's control unit), not an AI/ML diagnostic or prognostic algorithm. Therefore, the concepts of "test set sample size" and "data provenance" in the context of clinical studies (e.g., patient data, images) are not applicable here. The evaluation is based on engineering and design changes, and comparison to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. As noted above, this is for a medical device modification, not a clinical diagnostic algorithm requiring expert-established ground truth from a test set of patient cases.
4. Adjudication Method for the Test Set:
Not applicable for the same reasons as points 2 and 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
The "ground truth" here is the performance and characteristics of the previous, cleared predicate device. The modified device's "truth" is established by demonstrating its equivalence to this predicate device in terms of function, safety, and effectiveness, as determined through engineering assessment against established standards and internal testing. No clinical "ground truth" from patient data is established or used in this specific regulatory submission for a device modification.
8. The Sample Size for the Training Set:
Not applicable. This is a hardware modification for an infusion pump control unit, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 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).