(11 days)
The intended use of the Infusor LV and Infusor SV Devices includes the slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications. It may also include the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management.
The modified Infusion Pumps can be utilized for slow, continuous delivery though clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications. In addition, the intended use of the devices includes continuous infusion of medications directly into an intraoperative site or subcutaneously for post operative pain management.
A modified design is being added to Baxter's Infusor line of Elastomeric Infusion Devices.
This document is a 510(k) premarket notification for a medical device called "Infusor LV and Infusor SV". It does not describe a study involving AI or algorithmic performance, but rather a modification to an existing elastomeric infusion device.
Therefore, many of the requested categories are not applicable to the provided text. However, I can extract the relevant information presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a detailed table of acceptance criteria with specific numerical targets. It states:
| Criterion | Reported Performance |
|---|---|
| Flow Rate Performance (for modified design) | "Standard flow rate testing was performed to confirm performance characteristics." |
| Flow Rate Performance (routine manufacturing) | "Routine testing in manufacturing includes 100% testing for flow rates and pressure." |
| Pressure Performance (routine manufacturing) | "Routine testing in manufacturing includes 100% testing for flow rates and pressure." |
Explanation: The document indicates that the modification to the Infusor line required "standard flow rate testing" to confirm its performance characteristics. For ongoing manufacturing, both flow rates and pressure are 100% tested, implying these are critical performance criteria. However, explicit quantitative acceptance limits or detailed results of these tests are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified. The document only mentions "Standard flow rate testing" was performed.
- Data provenance: Not specified.
3. 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. This device is an infusion pump, and its performance is assessed through objective engineering tests (flow rate, pressure) rather than expert interpretation of data or images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Performance is based on objective measurements, not expert adjudication.
5. 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 describes a physical medical device (infusion pump), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance would be the direct, objective measurement of flow rates and pressure using calibrated instruments, compared against pre-defined engineering specifications. It's not based on subjective assessment or biological outcomes in the context of this 510(k) summary for device modification.
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This document describes a physical medical device, not a machine learning model.
§ 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).