(45 days)
The Perfusor Space Infusion Syringe Pump System includes an external transportable electronic infusion syringe pump and pump accessories. The system is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Perfusor® Space Infusion Syringe Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances).
The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic volumetric infusion pump and pump accessories. The Perfusor® Space is a 12V DC or battery powered external, transportable, infusion syringe pump. The Perfusor® Space utilizes a swivel-drive pumping mechanism is intended to provide infusions of parenteral and enteral fluids. The system is intended to provide intermittent or continuous flow of parenteral and enteral fluids to the patient. Parenteral fluids may include all standard fluids and/or medications indicated for infusion as well as blood and blood products. The Ferfusor Space uses standard, single-use, disposable syringes (with luer-lock connectors) designed for use on syringe pumps and validated on the Perfusor® Space. The B. Braun Space Station is a 12V DC or battery powered flexible docking and communication system for the medical workplace, in particular the intensive medical care. It serves the perspicuous accommodation of the infusion and infusion-syringe pumps Infusomat® Space and Perfusor® Space. SpaceCover Standard or SpaceCover Comfort forms the top of each column. The DrugListEditor Space is a programm to create a drug pool with drug names including the corresponding parameter.
This document is a 510(k) Premarket Notification for the B. Braun Medical Inc. Perfusor® Space Infusion Syringe Pump System. It details the device's description, intended use, and argues for its substantial equivalence to previously cleared predicate devices.
This document describes a medical device, specifically an infusion syringe pump system, and demonstrates its substantial equivalence to existing devices for market clearance. It does NOT contain information about acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics that would typically apply to AI/ML or diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" here implicitly refers to meeting regulatory requirements for substantial equivalence to predicates.
Therefore, I cannot provide a table of acceptance criteria and reported device performance in the format usually requested for AI/ML studies, nor can I answer questions 2 through 9, as they pertain to detailed study design and ground truth establishment for performance evaluation, which are not present in this regulatory submission for a medical pump.
The document's primary "study" is the comparison against predicate devices to establish substantial equivalence under the 510(k) pathway, which is a regulatory assessment, not a performance study in the AI/ML sense.
Here's a breakdown of what can be extracted or inferred based on the provided text's context:
1. Table of "Acceptance Criteria" and "Reported Device Performance" for Substantial Equivalence
| Acceptance Criteria (for Substantial Equivalence to Predicates) | Reported Device Performance (vs. Predicates) |
|---|---|
| Intended Use: Same as predicate devices. | The Perfusor® Space Infusion Syringe Pump System has the "same intended use" as the Perfusor® compact with fm-System (K022575) and MEDLEY™ System with Medication Management System (K030459) together with MEDLEY™ Syringe Pump Module (K023264). Intended for adults, pediatrics, and neonates for intermittent or continuous delivery of parenteral and enteral fluids via various routes (intravenous, intra-arterial, subcutaneous, epidural, irrigation/ablation, enteral). Used by trained HCPs in various environments. |
| Operation & Function: Similar to predicate devices. | The subject device and predicates are all "computer controlled electrical, external, swivel-driven infusion syringe pumps composed of injection molded thermoplastic components." They control infusion rate of parenteral and enteral fluids, use standard, single-use, disposable syringes (with luer-lock connectors) validated with the pumps. Provide possibilities to clean up/organize patient bedside, central power, tubing retainers, transportation, and customization of menu items/drug library. |
| Technology/Design: Similar to predicate devices. | The components of the subject and predicate pumps are "all non solution contact parts." The accessories are similar in offering clinician flexibility and providing filing and communication systems. |
| Safety and Effectiveness: No new questions of safety or effectiveness. | Not explicitly stated in a quantitative manner, but implied by the successful 510(k) clearance, indicating the FDA found no new questions of safety or effectiveness compared to the predicate devices. |
Clarification: In the context of a 510(k) for a medical pump, "acceptance criteria" and "reported device performance" are judged against the predicate devices for establishing substantial equivalence, rather than a specific numerical diagnostic performance for an AI algorithm. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".
The following questions cannot be answered from the provided text as they relate to performance studies, especially those relevant to AI/ML or diagnostic devices, which are not covered in this 510(k) summary for an infusion pump system.
- Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable/Provided. This document does not describe a performance study with a test set in the diagnostic sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable/Provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Provided.
- 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/Provided. This is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/Provided. This is an infusion pump, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Provided.
- The sample size for the training set: Not applicable/Provided.
- How the ground truth for the training set was established: Not applicable/Provided.
§ 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).