(160 days)
The Perfusor® compact is a transportable syringe infusion pump that provides infusions of parenteral and enteral fluids. The system created by using syringes validated for use with the Perfusor® compact is intended to provide accurate and continuous flow of parenteral and enteral fluids to the patient. The syringe interacts with the pump so that the size of the syringe is detected. The pump is software controlled and operates using a drive mechanism.
The Perfusor® compact is intended for but not limited to use in the hospital, home care and/or nursing home (extended care) settings. The Perfusor® compact is intended for use by trained healthcare providers in accordance with the instructions provided in the Operation Manual. All data entry and validation of the Perfusor® compact is performed by the trained healthcare provider per a physician's order.
The Perfusor® compact is a transportable syringe pump that is suitable for dispensing liquids in nutritional and infusion therapy.
The infusion pump contains the following hardware assemblies: swivel-drive pumping mechanism assembly, power supply assembly, pole clamp assembly, display assembly, and electronics assembly. The power supply cord is able to be mounted and removed from a receptacle in the rear of the pump. The battery power supply consists of four AA alkaline batteries. 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 and hospital monitoring systems.
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 communication abilities from external devices to the pump. This feature is only accessible by a trained Biomedical Technician. Programming of the pump is only performed by trained biomedical professionals. The pump's software does not allow for the capability to control rate, volume or therapy information from external devices.
This document describes the Perfusor® compact Infusion Pump, a medical device. However, the provided text does not contain acceptance criteria for its performance, nor does it detail a study that proves the device meets such criteria.
The 510(k) submission primarily focuses on establishing "substantial equivalence" to a predicate device (the BD 360 Infuser). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing new clinical or performance study data to meet specific acceptance criteria.
The submission mentions that substantial equivalence is supported by information and data including:
- Description of subject and predicate devices.
- Intended use.
- Material composition.
- Labels and labeling.
- Comparison tables of attributes and specifications.
- Subject device customer functional specification.
- Subject device system and software hazard analysis.
- Subject device system and software requirements.
- Subject device system and software test plans.
- Subject device system and software test protocols.
- Subject device system and software test matrix.
While "test plans" and "test protocols" are listed, the document does not provide any specific acceptance criteria or the reported device performance from these tests. It also does not include information on sample size, data provenance, expert involvement for ground truth, or adjudication methods, which are typically found in studies designed to demonstrate performance against acceptance criteria.
Therefore, I cannot populate the requested tables and information based on the provided text. The document acts as a summary for regulatory clearance based on substantial equivalence, not a detailed performance study.
§ 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).