(19 days)
The intended use of the Perfusor® compact with fm system is to provide accurate and continuous flow of parenteral, including blood, and enteral fluids to the patient. The addition of the fm system extends the abilities of the Perfusor® compact and creates a versatile system that will enhance the administration and management of infusion therapy. The fm system may be used in a variety of configurations depending on the level of needs of the healthcare facility.
The new incorporation of a barcode reader and programmable dosing limits are intended to aid in medication error reduction by decreasing the steps necessary to program an infusion and to alert the clinician when dose amounts are not within facility defined parameters.
The Perfusor@compact with fm system is intended for but not limited to use in the hospital and/or other healthcare facilities. The Operation Manual is intended to reinforce the teaching given to the user by a trained healthcare professional or an authorized B. Braun Medical Inc. representative. A trained Biomedical Technician must perform a full set-up of the pump and system before use in a clinical setting
The Perfusor® compact is a battery and AC powered transportable syringe delivery system intended to provide infusion of parenteral and enteral fluids. The addition of the fm system will enhance the use of the Perfusor® compact by allowing the user greater flexibilty in the administering and monitoring of a patients infusion status. Used as a complete system the Perfusor® compact with fm system introduces some additional features to aid the clinician in fluid delivery and maintenance.
These features include the addition of a barcode reader to minimize the potential for programming errors, an external power source to reduce the number of electrical outlets required at the bedside, and the convenience of a large interactive monitor that displays the status of all Perfusor compacts being used on one particular patient. This monitor also incorporates the use of a drug library, makes calculations based on user input. In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Inc. intends to introduce into interstate commerce the Perfusor® compact with fm system.
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 can 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 provided 510(k) summary for the Perfusor® compact with fm system does not contain information regarding a standalone study with acceptance criteria and a detailed analysis of device performance.
This 510(k) is a submission for substantial equivalence to predicate devices (Horizon Outlook™ and Alaris Medley™ Patient Care System) and focuses on demonstrating that the new device does not raise new issues of safety or effectiveness. The general approach for this type of submission is to compare the new device's characteristics and intended use to those of already cleared devices, rather than conducting new, detailed performance studies against specific acceptance criteria for a novel technology.
The document lists "Subject device system and software test plans" and "Subject device system and software hazard analysis," which indicate that testing was performed. However, it does not provide the results of these tests or the specific acceptance criteria used for them in this public summary.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample sized used for the test set and the data provenance: This information is not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is described.
- Adjudication method: Not applicable as no such study is described.
- 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: Not applicable. This device is an infusion pump, not an AI-powered diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No detailed standalone performance study is described in this summary.
- The type of ground truth used: Not applicable as no such study is described.
- The sample size for the training set: Not applicable as no AI training set is mentioned for this device.
- How the ground truth for the training set was established: Not applicable as no AI training set is mentioned.
Summary of available information related to performance (implicit in 510(k) process):
The submission asserts that the differences between the subject device and the predicate devices "do not raise new issues of safety and effectiveness." This implies that any internal testing or validation performed by B. Braun Medical Inc. confirmed that the device performs as intended and is safe, similar to the predicate devices. However, the specific details of that testing and the acceptance criteria are not included in this 510(k) summary.
§ 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).