(334 days)
The Agilia Infusion System is a transportable equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonates human patients to administer via a single channel or mounted on a multiple channels rack accessory:
· Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but not limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration.
· Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required.
The Agilia Infusion System is composed of the following components:
- · Volumat MC Agilia infusion pump
- · Volumat Lines administration sets
- 16 sterile administration sets, including 2 for transfusions and 1 auxiliary line
- · Link+ Agilia racks, three options:
- Link4+
- Link6+
- · Link8+
- · Vigilant Drug'Lib Agilia: dose error reduction software (DERS)
- · Accessories:
- . Agilia Duo
- Agilia USB cable .
- · Accessories:
- . Link+ Agilia Nurse Call cable
- Agilia RS232 cable
- Link+ Agilia Ethernet cross-over cable .
- Link+ Agilia USB Cable .
The Volumat MC Agilia infusion pump is a peristaltic infusion pump which can be installed on a rail or pole, or on a flat surface. The system is configurable by the user, ranging from a configuration with a single Volumat MC Agilia infusion pump to multiple-pump configurations utilizing Link+ racks connected to a Hospital Information System (HIS). A series of two pumps may be configured using the Agilia DUO accessory, or a series of 4, 6, or 8 pumps may be mounted on the Link+ Agilia rack to centralize power supply and data communication. Vigilant Drug'Lib Agilia dose error reduction software (DERS) (optional) is installed on a PC platform for communication with the pump via a USB cable.
Here's a breakdown of the acceptance criteria and the study information for the Fresenius Kabi Agilia Infusion System (K121613), based on the provided text:
Important Note: This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting de novo acceptance criteria and performance data for a novel device. Therefore, the "acceptance criteria" here are largely implied by the equivalence demonstration to the predicate. The document states that the proposed and predicate devices have "equivalent accuracies and infusion volume capacities, as well as similar rate ranges." However, specific numerical acceptance criteria (e.g., "accuracy must be within ±X%") and directly corresponding reported performance values are not explicitly provided in this document. The provided text primarily summarizes the non-clinical testing performed to support the safety and performance claims by adhering to industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Equivalence & Standards Adherence) | Reported Device Performance |
|---|---|
| Accuracy and Infusion Volume Capacity: Equivalent to predicate device (Infusomat® Space Volumetric Infusion System). | Stated as "equivalent accuracies and infusion volume capacities" to the predicate device. No specific numerical values provided in the summary. |
| Rate Ranges: Similar to predicate device. | Stated as "similar rate ranges" to the predicate device. No specific numerical values provided in the summary. |
| Occlusion Detection: Detects upstream and downstream occlusion. | Both pumps detect upstream and downstream occlusion by means of specific sensors. |
| DERS Safety: Assures safety in an equivalent way to predicate DERS. | Both offer the possibility to limit the same drug parameters in DERS mode and assure safety in an equivalent way. |
| Biocompatibility: Complies with ISO 10993-1, ISO 8536, ISO 594 for Volumat Lines. | Biocompatibility testing performed according to ISO 10993-1, ISO 8536, ISO 594. (Implies compliance) |
| Hardware & Software V&V: Complies with relevant industry standards (e.g., IEC 60601-2-24, ISO 60601-1-8, IEC 62304, ISO 8536, ISO 594). | Hardware and software verification and validation testing performed, including testing to relevant industry standards. (Implies compliance) |
| Electrical Safety & EMC: Complies with IEC 60601-1, IEC 60601-1-2. | Testing to industry standards for electrical safety and electromagnetic compatibility (e.g., IEC 60601-1, IEC 60601-1-2) performed. (Implies compliance) |
| Sterilization Validation, Shelf Life, Packaging & Transport: Validated. | Sterilization validation, shelf life testing, packaging and transport validation performed. (Implies successful validation) |
| Usability: Design optimized for safety and validated usability in simulated use environment (per IEC 62366). | Usability assessments conducted in a simulated use environment in accordance with IEC 62366 to optimize the safety of the device design and validate the usability of the system. (Implies successful validation) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly specify a "test set" in the context of clinical data for performance evaluation. Instead, it refers to:
- Non-clinical testing: This would involve various engineering and laboratory tests on discrete components and the integrated system. Specific sample sizes for these individual tests are not mentioned in this summary.
- Usability Assessments: These were conducted in a simulated use environment. The sample size of participants for these assessments is not specified.
- Data Provenance: The studies are described as "non-clinical testing" and "usability assessments." This implies the data were laboratory-generated or simulated-environment generated, rather than from live patient data. The country of origin for these studies is not explicitly stated, but the submitter (Fresenius Kabi AG) is based in Bad Homburg, Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. For non-clinical and usability testing, "ground truth" would be established by test protocols, established industry standards, and expert engineering judgment, but the report doesn't detail the involvement of specific experts for this purpose beyond general statements about adherence to standards.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods are typically relevant for clinical studies where multiple human readers or evaluators assess patient cases, which was not the primary focus of this submission.
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
No MRMC comparative effectiveness study was done. The device is an infusion pump, not an AI-powered diagnostic or assistive tool for human readers in the traditional sense. The "DERS" (Dose Error Reduction Software) is a safety feature, but its integration is described as equivalent to the predicate, and no study measuring human improvement with or without this specific DERS is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device itself (the infusion pump system) is a standalone piece of medical equipment designed to perform infusions. The performance testing primarily assessed the function of the device itself (e.g., accuracy, occlusion detection) in a non-clinical setting, which can be considered a standalone assessment of the algorithm/hardware's ability to perform its intended function. However, "standalone" in the context of diagnostic AI algorithms usually refers to the algorithm making a decision without human input, which is not directly applicable here.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical testing and usability assessments would be:
- Engineering Specifications and Industry Standards: For performance metrics like accuracy, flow rate, and occlusion detection, the ground truth is defined by the device's design specifications and the requirements of standards like IEC 60601-2-24.
- Simulated Use Environment Outcomes: For usability, the ground truth is established by observing user interaction in a simulated environment and identifying potential use errors or safety concerns according to principles outlined in IEC 62366.
- Biocompatibility Standards: For material safety, compliance with ISO 10993 standards constitutes the ground truth.
8. The Sample Size for the Training Set
The document does not describe the development of an AI algorithm that would require a "training set" in the typical sense (e.g., for machine learning). The DERS software is configurable but its development doesn't appear to be based on a machine learning model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
As no training set (for a machine learning model) is described, this information is not applicable. For the DERS, the "ground truth" for its functionality (e.g., drug limits) would be established by clinical protocols, pharmaceutical guidelines, and expert medical judgment during its configuration for hospital use, but this is not a training set for an algorithm.
§ 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).