(257 days)
The LifeShield™ Infusion Safety Software Suite is a collection of software products that facilitates networked communication between compatible systems. The Infusion Safety Software Suite provides trained healthcare professionals the ability to manage data for compatible infusion pumps. All data entry and validation of infusion parameters on compatible infusion pumps is performed by a trained healthcare professional. LifeShield™ Infusion Safety Software Suite is indicated for use in patients including adult, pediatric and neonate undergoing infusion therapy with connected compatible infusion pumps (as per the indications for use specified for the compatible infusion pump).
The LifeShield™ Drug Library Management (DLM) software product is intended to be used by pharmacists to create, configure, edit, and manage drug library data, including infusion pump settings, for use with compatible infusion pumps. Drug library contents are constructed based on the healthcare provider's defined best practices.
The LifeShield™ Clinical Dashboards & Reports (CDR) software product provides trained healthcare professionals with the capability to view and manage infusion information collected from compatible infusion pumps. Healthcare professionals may choose to use the collected infusion information to support continuous quality improvement programs, or to analyze and trend various aspects of the infusion pumps and therapies used. It is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.
The LifeShield™ Data Flow Management (DFM) software product is intended to facilitate bi-directional communication with compatible infusion pumps, information technology systems, and other LifeShield™ Infusion Safety Software Suite products. LifeShield™ DFM provides a way to automate the programming of infusion parameters, thereby decreasing the number of manual steps necessary to enter infusion data. LifeShield™ DFM forwards infusion-related information received from the infusion pump to compatible information technology systems.
The LifeShield™ Infusion Safety Software Suite is a cloud-based platform provided as a software-as-a-service (SaaS) designed to be compatible with the Plum Duo™ Precision IV infusion pump and Plum Solo™ Precision IV infusion pump. The LifeShield Infusion Safety Software Suite is hosted by Amazon Web Services (AWS) as its cloud provider.
LifeShield™ Infusion Safety Software Suite consists of a collection of software services which, when used together, provide a comprehensive set of data management capabilities for trained healthcare professionals when working with infusion pumps. LifeShield™ Infusion Safety Software Suite does not remotely control or program the infusion pump or provide the ability to remotely manage pump alarms such as real-time monitoring, clearing and silencing alarms.
The LifeShield™ Drug Library Management (DLM) software is used by pharmacists to create approved drug libraries that can be downloaded by the infusion pumps. The latest software version introduces enhancements to its user interface and additional drug library settings for support of Plum Duo™ and Plum Solo™ pumps.
The LifeShield™ Clinical Dashboards & Reports (CDR) software is used by clinical administrators to view infusion or device-related information received from the infusion pumps via the LifeShield™ DFM. The information presented by the software does not create decisions or treatment pathways for patients. The latest version of the software improves the data presented for ongoing infusions and dashboards.
LifeShield™ Data Flow Management (DFM) software facilitates bidirectional communications between the infusion pump and hospital information systems (HIS); it routes pharmacy-validated orders to the connected pumps and infusion-related information to the HIS. The latest software version adds the ability to forward alarms to the HIS.
The provided FDA 510(k) clearance letter for the LifeShield™ Infusion Safety Software Suite (K242117) does not contain the specific details required to construct a table of acceptance criteria with reported device performance, nor does it detail a study that proves the device meets specific performance criteria in terms of accuracy or clinical outcomes.
This document primarily focuses on demonstrating substantial equivalence to a predicate device (K223606) based on non-clinical testing (design verification, design validation, cybersecurity, risk management, and human factors) and software modifications, rather than performance metrics related to clinical accuracy or diagnostic capabilities (which would be more common for AI/ML devices in image analysis, for example).
The submission explicitly states:
- "Summary of Clinical Testing: Not applicable. A clinical study is not required for this submission to support substantial equivalence."
Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. The device is a software suite for managing infusion pump data, not an AI/ML diagnostic or predictive tool that would have performance metrics like sensitivity, specificity, or AUC against a ground truth of disease.
However, I can extract information related to the types of testing performed and what they aimed to prove, which indirectly serve as acceptance criteria for this type of software device.
Analysis of Acceptance Criteria and Study Details based on the Provided Document
Given the nature of the device (infusion safety software suite) and the information provided in the 510(k) summary, the "acceptance criteria" here are aligned with software quality, safety, and functionality, rather than clinical performance metrics typically associated with AI/ML diagnostic tools.
The study proving the device meets acceptance criteria is a comprehensive set of non-clinical tests described below, rather than a single clinical trial.
1. Table of Acceptance Criteria and the Reported Device Performance
Since this is not an AI/ML diagnostic device with performance metrics like accuracy, sensitivity, or specificity against disease presence, the "acceptance criteria" relate to software design, functionality, safety, and usability. The document reports that all these tests "pass established acceptance criteria."
| Acceptance Criteria Category | Specific Criteria (Inferred from testing) | Reported Device Performance |
|---|---|---|
| Design Requirements | Adherence to design specifications; proper function of new features (e.g., UI enhancements, new drug library settings, alarm forwarding). | Passed: "Design verification tests pass established acceptance criteria, confirming the subject device meets design requirements." |
| Software Quality | Conformance to IEC 62304:2015 software development process; reliability. | Passed: "Software verification follows the software development process outlined in IEC 62304:2015." "Verification activities also include software verification, performance, reliability, compatibility, and interoperability tests." |
| Intended User Needs/Use Environment | Device meets all intended users' needs for its intended use and environment. | Passed: "Design validation tests pass established acceptance criteria, confirming the subject device meets all intended users' needs for the device's intended use and intended use environment." |
| Cybersecurity | Reasonable security against threats; protection of data. | Passed: "Cybersecurity evaluation and testing demonstrate that the software is reasonably secure." |
| Risk Management | Identification and mitigation of risks (ISO 14971:2019); effectiveness of mitigations. | Passed: "Risk management activities...concludes that the subject device is reasonably safe." "Mitigations...tested for correct implementation and effectiveness." |
| Human Factors/Usability | Effectiveness of user interface design for new features and critical tasks, per FDA guidance and standards (IEC 62366-1:2020, ANSI/AAMI HE75:2009/(R)2018). | Passed: "Human Factors study demonstrates the effectiveness of the user interface design for additional features and their associated critical tasks." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "sample size" in terms of patient data or clinical cases. For software verification and validation, the "test set" would consist of numerous test cases, simulated use scenarios, and functional tests. These numbers are not detailed in the summary.
- Data Provenance: Not applicable in the traditional sense of patient data. The testing is focused on software functionality, safety, and usability. There is no mention of retrospective or prospective data collection from patients or clinical settings for performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Ground Truth Establishment: For this type of software, "ground truth" isn't established by clinical experts in the same way it would be for a diagnostic image. Instead, it's defined by design specifications, regulatory requirements, industry standards (e.g., IEC 62304, ISO 14971, IEC 62366-1), and best practices in software engineering and cybersecurity.
- Experts: The development team, regulatory affairs, quality assurance, and potentially third-party cybersecurity and human factors experts would define and verify these "ground truths" (i.e., whether the software behaves as intended and safely). The specific number or qualifications of these internal or external experts is not detailed in the provided K summary. The human factors study implies the use of representative users (trained healthcare professionals), but not necessarily "experts" defining a ground truth about a medical condition.
4. Adjudication Method for the Test Set
- Not applicable in the context of clinical expert adjudication of medical cases. Adjudication in software testing would involve bug reporting, resolution, and re-testing processes managed by the development and QA teams, not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not done. The document explicitly states: "Summary of Clinical Testing: Not applicable. A clinical study is not required for this submission to support substantial equivalence." An MRMC study is a type of clinical study often done for diagnostic AI to compare human performance with and without AI assistance. This device is not a diagnostic AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This concept is not directly applicable. The "LifeShield™ Infusion Safety Software Suite" is inherently a human-in-the-loop system designed to assist trained healthcare professionals. It manages data, facilitates communication, and supports drug library management but does not "decide" or "treat" on its own. Its "standalone" performance would pertain to its functional correctness in processing data and facilitating communication, which is covered by the general "design verification" and "performance" testing.
7. The Type of Ground Truth Used
- The "ground truth" for this software pertains to its functional correctness, adherence to specifications, safety requirements, cybersecurity posture, and usability standards. It is not based on clinical "outcomes data" or "pathology" in the medical sense, but rather on:
- Design Specifications: Whether the software performs its programmed functions as intended.
- Regulatory Standards: Compliance with relevant medical device software (IEC 62304), risk management (ISO 14971), and human factors (IEC 62366-1) standards.
- User Needs/Requirements: Whether the software meets the needs of its intended users in its intended environment.
8. The Sample Size for the Training Set
- Not applicable. This device is a software suite, not an AI/ML model that undergoes a "training phase" with a distinct "training set" of data to learn patterns. The software's capabilities are based on explicit programming and configuration, not machine learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for this type of software.
In summary, the FDA 510(k) clearance for the LifeShield™ Infusion Safety Software Suite is based on a demonstration of substantial equivalence to a predicate device through extensive non-clinical software verification and validation, risk management, cybersecurity testing, and human factors analysis. The "acceptance criteria" are related to software quality, safety, and functionality, rather than clinical performance metrics against a medical ground truth or AI model training data.
§ 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).