(70 days)
The Hospira MedNet™ Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira Infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters.
The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician's orders.
The Hospira MedNet™ Medication Management Suite (MMS) is an optional software product intended for use in healthcare facilities by trained healthcare professionals to facilitate networked communications (wired or wireless) between MMS compatible hospital information systems and compatible infusion pumps.
The MMS provides healthcare professionals with the capability to send, receive, and store information from infusion pumps. The bi-directional communication includes infusion parameters, pump default configurations, pump location, history, events, trending, alarms and status. The MMS cannot remotely start, modify, or terminate ongoing infusions.
Below is a summary of the acceptance criteria and study information for the Hospira MedNet™ Medication Management Suite:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary focuses on software changes to an existing device and primarily relies on non-clinical performance testing for validation. Therefore, the acceptance criteria are related to meeting design requirements and ensuring safety and effectiveness after software modifications.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Software meets user needs and design inputs | Confirmed through verification and validation activities. |
| New feature design requirements are met | Confirmed through verification and validation testing. |
| Pre-existing design requirements continue to be met | Re-tested and reconfirmed through verification and validation testing. |
| Risk management activities are incorporated and safety demonstrated | Safety Assurance Case generated to demonstrate safety. |
| Effectiveness of use-related error mitigations | Validated through Human Factors studies. |
| Device remains safe and effective after modifications | Demonstrated by results of verification/validation, risk analysis, and Human Factors studies. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of clinical data for a machine learning model. Instead, the validation involved software verification and validation activities and Human Factors studies.
- Sample Size: Not applicable in the traditional sense of a clinical test set. The validation refers to software testing and human factors studies, but specific numbers of test cases or participants are not provided.
- Data Provenance: Not applicable for clinical data. The studies performed were non-clinical (software verification/validation) and human factors studies. The geographical origin of these studies is not specified, but they were conducted by Hospira, Inc.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
This information is not provided. Given that the validation involves software testing and human factors studies for a medical device accessory software, "ground truth" would likely be established by internal engineering and human factors experts, but their number and specific qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies for establishing ground truth from multiple expert interpretations, especially in image analysis. Since no clinical trials or image interpretation tasks were involved, no adjudication method is described or applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical trials have been performed." The device is an infusion pump accessory software for medication management, not a diagnostic imaging device that typically requires MRMC studies.
6. Standalone Performance Study
No standalone performance study in the typical sense of algorithm-only performance without human interaction was conducted. The device is software designed to be used by trained healthcare professionals to facilitate communication and automate programming, meaning human-in-the-loop interaction is inherent to its intended use. The validation focused on the software meeting design requirements and human factors.
7. Type of Ground Truth Used
The "ground truth" for this device's validation was based on:
- Design Specifications and Requirements: The software's performance was evaluated against its pre-defined design inputs and user needs.
- Risk Analysis Outcomes: Demonstrating that identified risks were acceptably mitigated.
- User Performance in Human Factors Studies: Validating the effectiveness of use-related error mitigations during interaction with the software.
8. Sample Size for the Training Set
Not applicable. The document describes a software update to an existing medical device, not a machine learning or AI model that requires a "training set" in the traditional sense. The development likely involved standard software engineering practices and testing, rather than an AI training paradigm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As no training set for a machine learning model was described, there is no information on how its "ground truth" would be established.
§ 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).