(45 days)
The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, dedicated administration sets, and pump accessories. The system is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments.
The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, dedicated administration sets, and pump accessories. The Infusomat® Space is a 12V DC or battery powered external, transportable, volumetric infusion pump. The Infusomat® Space utilizes a linear peristaltic pumping mechanism and is intended to provide infusions of parenteral and enteral fluids. The Infusomat® Space is intended for but not limited to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments. A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting. The system created by using the administration sets with the Infusomat® Space is intended to provide intermittent or continuous flow of parenteral and enteral fluids to the patient. Parenteral fluids may include all standard fluids and/or medications indicated for infusion as well as blood and blood products.
Here's an analysis of the provided text regarding the acceptance criteria and study for the B. Braun Infusomat® Space Volumetric Infusion Pump System, based on the requested categories.
It's important to note that the provided 510(k) summary focuses heavily on demonstrating substantial equivalence to predicate devices and describes the device's components and intended use. It does not contain specific acceptance criteria, detailed study designs, or performance metrics in a quantitative manner that would be typically found in a full efficacy study report. Therefore, many sections of your request cannot be fully answered from this document.
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the given 510(k) summary. The document focuses on demonstrating that the device is "substantially equivalent" to existing predicate devices, implying that its performance meets the generally accepted safety and effectiveness standards for infusion pumps. However, no specific quantitative acceptance criteria (e.g., flow rate accuracy within X%, duration of battery life, etc.) or corresponding performance data are listed.
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the document. The 510(k) summary does not describe any specific clinical or performance testing that would involve a "test set" in the context of efficacy or diagnostic accuracy. The substantial equivalence argument relies on comparing features and intended use with predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable/provided. As there's no described "test set" for performance evaluation against a ground truth in the document, there's no mention of experts or their qualifications for establishing such truth.
4. Adjudication Method for the Test Set
This information is not applicable/provided. No "test set" or adjudication method is described.
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
This information is not applicable. The device described is a volumetric infusion pump, not an AI-assisted diagnostic or interpretation system. Therefore, an MRMC study related to human reading improvement with AI is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The Infusomat® Space is a physical medical device (an infusion pump), not an algorithm that performs standalone analysis. Its performance is inherent in its electromechanical function.
7. The Type of Ground Truth Used
This information is not applicable/provided. No specific ground truth, in the context of diagnostic accuracy or similar, is described as being used for performance evaluation in this 510(k) summary. The "ground truth" for an infusion pump would typically be its physical accuracy and safety parameters, which are assessed through engineering and bench testing, but specifics are not detailed here.
8. The Sample Size for the Training Set
This information is not applicable/provided. The document does not describe the use of machine learning or AI, and therefore, there is no "training set" in this context. The pump's design and engineering would be based on established medical device standards and principles, not statistical data training sets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided. As there is no training set for an AI/ML algorithm described, the method for establishing its ground truth is also not mentioned.
§ 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).