(217 days)
The Disetronic Multifuse Pump with its accessories is intended for the controlled delivery of parenteral fluids, including patient controlled analgesia (PCA), in both the hospital and home care environments.
The Disetronic Multifuse pump is a small, battery-operated peristaltic infusion pump that is suited for ambulatory hospital and home use. The pump is extremely versatile. It has been designed to allow the health provider program the pump to provide one of several types of infusion therapies. The pump can be configured as a continuous rate infusion pump with demand bolus capability, a variable rate infusion pump with demand bolus capability, a Patient Controlled Analgesia (PCA) pump, a Total Parenteral Nutrition (TPN) pump or an intermittent infusion pump. The health provider can further customize the pump for a specific patient by allowing or excluding optional programming steps, limiting allowable ranges, adjusting the rate at which boluses are infused and adjusting alarm and display features. These control functions can only be performed by using the Multifuse Computer Software. This proprietary control software runs on IBM compatible personal computers in the Windows® environment and communicates with the pump through an optical interface. The pump can be re-programmed as required for different patients. This versatility enables the health care provider minimize the different types of pumps and still provide for almost all infusion therapies.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Disetronic Multifuse Pump System.
The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to currently marketed devices rather than presenting a detailed de novo clinical study with specific acceptance criteria and detailed study results as one might expect for a novel AI device. Therefore, much of the requested information, particularly around AI-specific testing, ground truth, and expert involvement, is not applicable or not present in this document.
Summary of Device Acceptance Criteria and Performance (Based on provided text):
The document doesn't explicitly list "acceptance criteria" in the format typically seen for AI device performance. Instead, it refers to regulatory and engineering standards. The reported device performance is primarily described through its functional equivalence to predicate devices and adherence to relevant standards.
| Acceptance Criterion (Inferred/Standard) | Reported Device Performance |
|---|---|
| Functional Equivalence | Functionally equivalent to Disetronic Panomat and Dolomat Infusion Pumps, and SIMS Deltec CADD-PLUS, CADD-PCA and CADD-TPN. |
| Safety - IEC 601-2-24 | Designed and tested in accordance with IEC 601-2-24 (Particular requirements for safety of infusion pumps and controllers). |
| General Safety - IEC 601-1 | Incorporates requirements of IEC 601-1, including IEC 801-2 and 801-3 for EMI and ESD. |
| Software Performance | All test results demonstrate that the system specifications and functional requirements were met. |
| Biocompatibility | Drug contact materials are either used in legally marketed devices for similar uses or comply with ISO 10993-1: 1992 (E) for externally communicating devices, blood path - indirect, prolonged use ( |
§ 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).