(24 days)
The Harvard 2 provides intravenous, intra-arterial, or epidural delivery of drugs or other parenteral fluids when administered by health care professionals such as physicians and nurses.
The Harvard Pump is intended for the delivery of parenteral fluids. It accommodates syringe sizes from 1 through 60 ml from multiple manufacturers. Its user interface consists of an active matrix color LCD display with two rotary knobs for controling pump peration. The rotary Data Entry knob provides scrolling and selection of data and menu items as well as state Jection. The knob is turned to scroll, and pressed for selection. The rotary Function knob controls the state (Purge, Setup, Stop, Run and Bolus) of the pump. The pump has several microprocessors, one master which controls operation of the device, one pump processor which controls the operation of the motor and sensors specific to the syringe drive mechanism, and one upervisor which monitors the status of the system. The pump has sensors which permit its microprocessors to determine the syringe size loaded, determine if the I ne pain nas securely captured by the pusher block assembly, measure occlusion force and calculate the proper rate and distance the plunger of the syringe must travel to cause an infusion of fluid at a given rate and volume. The pump provides for bidirectional remote communications via an RS232 serial port. The pump may be used with The Harvard Library, an optional computer program which runs on MS Windows based personal computers. The Harvard Library is capable of downloading and uploading drug information in the form of a drug library to and from the pump. After downloading, the drug library is resident in flash memory within the pump, enabling the pump to provide drug specific defaults for drug concentrations, pumping rates, bolus amounts, and bolus times. Barcode versions of the pump provide a laser scanning barcode reader is used to scan a label placed on the syringe which selects a drug from the pump's resident drug library. This allows the pump to retrieve from its internal memory the drug's specific parameters such as concentration, infusion rate etc. in an effort to minimize user input errors.
This document is a 510(k) summary for the Harvard 2 Syringe Pump, indicating its intended use and device description, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document discusses:
- Contact information for the manufacturer.
- Trade name, common name, and classification name of the device.
- Predicate devices (Harvard 1 Syringe Pump).
- Intended Use (intravenous, intra-arterial, or epidural delivery of drugs or parenteral fluids by healthcare professionals).
- Device Description (accommodates syringe sizes, user interface with LCD and rotary knobs, microprocessors for control and monitoring, sensors for syringe size, occlusion force, and rate calculation, RS232 port for communication, optional Harvard Library software for drug information, and barcode versions).
- A letter from the FDA confirming substantial equivalence to legally marketed predicate devices.
- An "Indications for Use Statement."
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets those criteria, as it is not present in the provided text.
§ 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).