(413 days)
The Agilia VP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medications, blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous and intraosseous using dedicated administration sets.
The Agilia VP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, and subcutaneous using dedicated administration sets.
It is intended for use by trained healthcare professionals in healthcare facilities.
The Agilia VP Infusion System includes the Agilia VP MC WiFi Volumetric Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with Volumat Line administration sets and optional accessories. The optional accessories are identified as follows:
- Agilia Link 4, 6 and 8 Stacking rack system intended to power and organize 4, 6 or 8 pumps at the patient bedside.
- Agilia Duo two-channel accessory designed to power two Agilia infusion pumps.
- Agilia USB Cable - intended to connect the Agilia VP infusion pump to a PC for serial communication.
The provided document is a 510(k) summary for the Fresenius Kabi Agilia VP Infusion System. This document focuses on demonstrating substantial equivalence to a predicate device (Agilia Infusion System (K121613)), rather than proving the device meets specific acceptance criteria based on a clinical study evaluating its diagnostic or therapeutic performance (like an AI/CADe device).
Therefore, the requested details specific to a study that proves the device meets acceptance criteria (especially for AI/CADe devices, such as sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) are not applicable (N/A) in this context.
This submission relies on non-clinical testing and comparison to a predicate device to establish safety and effectiveness.
Here's an analysis of the document regarding acceptance criteria and the methods used to prove substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantitative acceptance criteria with reported numerical performance values in the way one would for a diagnostic AI device (e.g., sensitivity, specificity thresholds). Instead, it relies on demonstrating similarity to a predicate device and showing conformance to industry standards and internal design verification/validation testing.
The "acceptance criteria" are implied by:
- Substantial Equivalence: The primary "acceptance criterion" for a 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.
- Conformance to Standards: Meeting the requirements of relevant electrical safety, EMC, and usability standards (e.g., IEC 60601-1, IEC 62366-1).
- Verification and Validation Testing: This implicitly means the device performs according to its design specifications.
- Reliability Goals: The device met its internal reliability goals.
Implied Acceptance Criteria and Reported Performance (from comparison table and non-clinical testing section):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Infusion Accuracy | Agilia VP Infusion System: ± 5% under most conditions. (Stated as "Similar" to predicate which also had ± 5%). Detailed flow rate accuracy disclosed in labeling. Flow rate and bolus accuracy testing conducted per AAMI TIR101 2021. |
| Safety (Electrical & EMC) | Agilia VP Infusion System: Complies with IEC 60601-1: 2005 +A1:2012 (3rd edition) for Electrical Safety and IEC 60601-1-2: 2014 for EMC testing. ("Similar" due to application of state-of-the-art standards). |
| Usability/ Human Factors | Agilia VP Infusion System: Human factors evaluation conducted to validate effectiveness of use-related features/functionality and use error-related mitigations, following IEC 62366-1 Edition 1.0 2015. ("Passing results"). |
| Software Verification & Validation | Agilia VP Infusion System: Performed per FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). |
| Cybersecurity | Agilia VP Infusion System: Cybersecurity testing performed confirmed the system is effective in addressing cybersecurity threats, referencing FDA guidances (Management of Cybersecurity, Oct 2014; Postmarket Management of Cybersecurity, Dec 2016). |
| Reliability | Agilia VP Infusion System: Device reliability activities, testing and statistical analysis confirmed the system met its reliability goal at the system, device subsystem, and subsystem component levels. |
| Risk Assessment | Agilia VP Infusion System: Residual risks analyzed and determined to be acceptably low using industry-standard risk analysis practices and regulatory guidance. |
| Performance of New Features (Ramp-up/down, Sequential modes, WIFI, auto-restart) | Agilia VP Infusion System: Performance testing demonstrates these additional modes/features do not introduce any new issues of safety or effectiveness. ("Similar" or "Similar" in comments of Table 2). The document states: "Results of verification and validation activities demonstrate that the Agilia VP Infusion System is substantially equivalent to the predicate Agilia Infusion System (K121613)." and "Design verification and validation testing confirmed the Agilia VP Infusion System met user needs and design inputs. Testing results conformed with acceptance criteria." |
The following points are N/A for this type of 510(k) submission which is for an infusion pump, not an AI/CADe device.
2. Sample size used for the test set and the data provenance: N/A (No clinical test set for diagnostic performance)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth establishment for diagnostic performance)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A
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: N/A
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (Ground truth in this context would refer to engineering specifications and performance measurements against those specifications, rather than clinical ground truth for diagnostic accuracy)
8. The sample size for the training set: N/A (Not an AI/ML device in the context of diagnostic algorithms; "training set" would relate to internal engineering development and testing, not a formal clinical data training set for an AI model)
9. How the ground truth for the training set was established: N/A
§ 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).