(14 days)
The Baxa Corporation MicroFuse™Dual Rate Infuser is intended to be used for the intermittent administration of I.V. medication.
The Baxa Corporation MicroFuse Dual Rate Infuser, is a battery powered, portable device that automates the injection of the contents of a syringe into a patient. Each MicroFuse has two pre-determined rates that are be preset at the manufacturing facility. These preset rates can not be modified by the user or patient. The MicroFuse is used with a sterile administration set for injecting the medication into a patient. It depresses the plunger of the syringe at a controlled, pre determined rate, delivering the dose in the syringe over an extended period of time. The MicroFuse is offered in a standard dual rate model. Some custom dual rate models with the only difference being the pre-determined infusion rates are also offered.
The MicroFuse System consists of the MicroFuse Dual Rate Infuser and a syringe and administration set. Both syringe and administration sets are sterile and disposable. Since only the accessory syringes and administration sets are in the fluid path, the MicroFuse has no patient contact materials. This also means the device is not provided sterile, nor is it sterilized in the field. The accessories have been previously cleared with the predicate device in K933506.
Here's the analysis of the provided text regarding the Baxa MicroFuse™ Dual Rate Infuser, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the Baxa MicroFuse™ Dual Rate Infuser was tested to and met "all applicable requirements of ANSI/AAMI ID26-1992. Standard for Infusion Devices."
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI ID26-1992 requirements (Standard for Infusion Devices) | Met all applicable requirements of the Standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific details on:
- The exact sample size used for testing in relation to the ANSI/AAMI ID26-1992 standard.
- The data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing appears to be based on engineering performance against a recognized standard rather than an assessment of clinical outcomes by experts.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of testing against an engineering standard, a formal adjudication method by experts is unlikely to have been part of this specific safety and effectiveness summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device and adherence to an engineering standard.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical infusion pump, not an AI algorithm. The performance described is "standalone" in the sense that it's the device's inherent operation.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the device's performance was the ANSI/AAMI ID26-1992 Standard for Infusion Devices. Performance was assessed against the technical specifications and requirements outlined in this standard.
8. The Sample Size for the Training Set
This question is not applicable. The Baxa MicroFuse™ Dual Rate Infuser is a hardware device, not an AI system. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above; there is no training set for a hardware device.
Summary of Key Findings from the Document:
The acceptance criteria for the Baxa MicroFuse™ Dual Rate Infuser were compliance with the ANSI/AAMI ID26-1992 Standard for Infusion Devices. The study (or testing) performed demonstrated that the device "met all the applicable requirements of the Standard." The document does not elaborate on the specifics of this testing, such as sample sizes, expert involvement, or adjudication methods, as it primarily serves as a summary for a 510(k) submission focused on substantial equivalence to a predicate device (Baxa Syringe Infuser 510(k) K933506).
§ 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).