(86 days)
The Horizon Outlook™ with DoseCom™ is an electrical, external volumetric infusion pump intended to provide infusions of parenteral fluids. Parenteral fluids may include all standard fluids and/or medications indicated for infusion as well as blood and blood products. Adjustable occlusion pressure settings allow arterial, epidural and intrathecal infusions. The system created by using dedicated cassettes is intended to provide accurate and continuous flow of these fluids to the patient.
The Horizon Outlook™ with DoseCom™ is intended to provide a way to automate the rnogramming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.
The Horizon Outlook™ with DoseCom™ is intended for but not limited to use in the hospital, and/or nursing home (extended care) settings. The Horizon Outlook™ with DoseCom™ is intended for use by trained healthcare providers in accordance with the instructions provided in the Operation Manual.
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical Inc. intends to introduce into interstate commerce the Horizon Outlook™ with DoseCom™ Infusion Pump. The Outlook™ with DoseCom™ is an external volumetric infusion pump that is suitable for dispensing liquids indicated for use with infusion therapy. The system created by using dedicated cassettes is intended to provide accurate and continuous flow of these fluids to the patient. The pump is software controlled and operates using volumetric displacement with a stepper-motor mechanism.
The infusion pump contains the following hardware assemblies: volumetric displacement / stepper motor pumping mechanism assembly, power supply assembly, pole clamp assembly, display assembly, electronics assembly and a wireless PCMCIA network card. The battery power supply consists of rechargeable 12 volt battery. The display subassembly contains an LCD display and a keypad used to input data into the pump as well as to present pump status and information to the user.
The electronics subassembly contains all of the electronics in the pump, including the microprocessors that run the software. The electronics subassembly also contains communications electronics that will allow the pump to transmit and receive messages to and from external devices, including personal computers, personal digital assistants (PDA), hospital monitoring systems and hospital information management systems (HIMS).
The software provides communication capabilities from the pump to external communication devices. This includes transmission of the following information: Operation / Alarm Log, pump status and pump configuration / calibration data. The software also provides the ability to customize pump features by downloading from external devices to the pump. This feature is only accessible by a trained Biomedical Technician.
The provided text is a 510(k) summary for the Horizon Outlook™ with DoseCom™ Infusion Pump. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary focuses on establishing substantial equivalence to a predicate device (Horizon Outlook™ with DoseScan™) based on similarities in design, materials, manufacturing process, intended use, and labeling. It lists various documents submitted to support this claim, such as descriptions of devices, comparison tables, hazard analyses, requirements, and test plans, but it does not provide the results of any performance tests or studies against specific acceptance criteria.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, or training set details, as this information is not present in the provided document.
§ 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).