(211 days)
The Plum A+® Hyperbaric Infusion System with Hospira MedNet® Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
Additionally, the Plum A+ Hyperbaric Infusion System with Hospira MedNet Software can be used under hyperbaric conditions in multiplace and with monoplace (Class A and B) chambers.
The Plum A+ Hyperbaric Infusion System with Hospira MedNet® Software is an electromechanical infusion pump that uses a stepper motor in conjunction with an inline cassette to meter IV fluids through dedicated intravenous administration sets in normal atmospheric Hospital settings and in Hyperbaric conditions. The infusion pump and administration sets are manufactured and distributed by Hospira. Inc. The Plum A+® Hyperbaric Infusion System is a single channel pump.
The subject device is based on modifications of the predicate infusion pumps. The modifications allow for distal pressure increases due to monoplace hyperbaric chamber pressurization and include distinct coloring to identify the purmp as a hyperbaric device.
Additionally, the sets were changed so that they could be used under hyperbaric conditions. The flow regulator is colored green to identify them as hyperbaric administration sets.
In normal atmospheric conditions, both the predicate and the proposed device can be used for standard, piggyback, or concurrent fluid delivery using the dedicated administration sets currently marketed. No changes to these dedicated administration sets have been made or are required in order to be used with the subject devices. However, new sets have been designed for administration with monoplace hyperbaric chambers.
This document is a 510(k) summary for the Plum A+® Hyperbaric Infusion System with Hospira MedNet® Software. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria.
Therefore, much of the requested information (like specific acceptance criteria, detailed study results, sample sizes, expert qualifications, and ground truth methodologies) is not explicitly present in the provided text. The submission describes modifications to an existing device to allow for hyperbaric use and emphasizes the similarities to the predicate device.
However, based on the information provided, here's what can be inferred or stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics. Its primary goal is to establish "substantial equivalence" to a predicate device, meaning its safety and effectiveness are similar to a device already legally marketed.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not specified directly in this summary, as the submission focuses on substantial equivalence to a predicate device. | The modifications allow for distal pressure increases due to monoplace hyperbaric chamber pressurization and include distinct coloring to identify the pump as a hyperbaric device. Additionally, the sets were changed so that they could be used under hyperbaric conditions. The flow regulator is colored green to identify them as hyperbaric administration sets. |
2. Sample Size Used for the Test Set and Data Provenance
No information regarding a "test set" sample size or data provenance (country of origin, retrospective/prospective) is provided. The submission likely relies on engineering testing and comparison to the predicate device's established performance rather than a clinical study with a specific test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable based on the provided text. The document does not describe a "ground truth" establishment process by experts for a test set in the context of clinical performance.
4. Adjudication Method for the Test Set
Not applicable based on the provided text. No test set requiring expert adjudication is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is an infusion pump, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device operates independently, the concept of a "standalone algorithm" performance typically refers to AI/software analysis. This device is an electromechanical infusion pump, and its performance would be assessed through engineering and functional testing rather than a standalone algorithm study in the AI sense. The document does not detail such testing.
7. The Type of Ground Truth Used
No specific "ground truth" (e.g., pathology, outcomes data) is mentioned in relation to the device's performance. The "ground truth" in this context would likely be engineering specifications and established performance characteristics of the predicate device under various conditions, including hyperbaric.
8. The Sample Size for the Training Set
Not applicable. This device is an electromechanical infusion pump and does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for it.
§ 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).