(201 days)
The Infusomat® Space Volumetric Infusion Pump System is an electrical, external, volumetric infusion pump system indicated for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.
The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic infusion pump and pump accessories. The Infusomat® Space utilizes a linear peristaltic pumping mechanism and is intended to provide infusions of parenteral fluids. The system is intended to provide intermittent or continuous flow of parenteral fluids to the patient. Parenteral fluids may include standard fluids and/or medications indicated for infusion as well as blood and blood products. The Infusomat® Space Volumetric Infusion Pump System must be housed in a SpaceStation that has SpaceCom software installed in order to accomplish the advanced features of bar coding and out-bound wireless data transmission. The subject device is a computer- controlled electrical, external, lineal peristaltic infusion pump composed of injection molded thermoplastic components.
The provided 510(k) summary for the B. Braun Infusomat® Space Volumetric Infusion Pump System (K083689) does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm.
This document is a premarket notification for an infusion pump system, focusing on its substantial equivalence to previously cleared devices and new functionalities like barcode scanning, wireless data transmission, and PCA. The performance aspects discussed generally relate to the device's mechanical operation and its ability to administer fluids, blood, and medications, as expected from an infusion pump.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not detail specific, quantifiable acceptance criteria (e.g., accuracy percentages, error rates) for new features like barcode reading or wireless data transmission, nor does it present the results of a primary study demonstrating performance against such criteria. The submission largely relies on predicate device equivalence for demonstrating safety and effectiveness.
- Sample size used for the test set and the data provenance: Not applicable as no such study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 document pertains to a medical device (infusion pump), not an AI/ML diagnostic or assistive tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Performance (as inferred from the document's purpose):
The document asserts the device's performance through:
- Substantial Equivalence: The Infusomat® Space Volumetric Infusion Pump System is considered substantially equivalent to the original cleared Infusomat® Space (K062700). Its new features (barcode, wireless, PCA) are deemed substantially equivalent to the B. Braun Outlook® Safety Infusion System (K011975) and the MEDLEY™ PCA Module (K032233). This implies that the performance of the new features is expected to be comparable to these cleared predicate devices.
- Intended Use: The device is intended to provide infusions of parenteral fluids/medications, blood, and blood products with accuracy and control, as would be expected from any volumetric infusion pump.
- Error Reduction: The document highlights that the barcode, wireless, and PCA features are designed to "enhance the administration of infusions" and are "tools in the development of medication error reduction programs while ensuring the validity of transferred data." This is a goal and intended outcome rather than a quantified performance metric from a study within the document.
- Customization: The system can be customized to meet institutional needs (e.g., enabling/disabling features, assigning dose/rate limits). This speaks to its flexibility and control rather than a specific performance metric.
- Mechanical Integrity: "The mechanics of the Infusomat Space have not changed since the original submission," implying its core pumping mechanism maintains its established performance.
In conclusion, this 510(k) summary describes a traditional medical device and its enhanced functionalities through substantial equivalence arguments, rather than presenting a performance study with detailed acceptance criteria that would typically be found for an AI/ML-based device.
§ 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).