(23 days)
The Infusion Pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intra-operative site or subcutaneously for post operative pain management
Baxter's Infusor SV and LV devices are single-use, disposable elastomeric infusion pumps designed to deliver solution at a constant preset flow rate ranging from 0.5mL/hr to 10 mL/hr, depending on device configuration. The modifications made to the Infusor SV and LV devices include replacing the glass restrictor tube and housing used in previous versions of the device with a plastic tubing flow restrictor, a coupler to connect the tubing flow restrictor to the tube set and a Luer lock connector.
The acceptance criteria and study proving device performance are described below based on the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Performance | Reported Device Performance |
|---|---|---|
| Nonclinical Tests | Mechanical Testing | Met acceptance criteria |
| Biocompatibility Testing | Met acceptance criteria | |
| Flow Rate Testing | Met acceptance criteria | |
| Risk Analysis | Based on ISO 14971 (2000) | Appropriate, and modifications verified by testing |
The document states that "All test results meet the acceptance criteria, and prove that the modifications are appropriate." This indicates that for all the testing performed (mechanical, biocompatibility, and flow rate), the device's performance aligned with the predetermined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set. It mentions "Design verification tests...were performed to verify the modifications" and "Testing of the device and components included mechanical, biocompatibility, and flow rate testing." However, no details on the number of units tested are provided. The data provenance (country of origin, retrospective/prospective) is also not mentioned.
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)
This information is not applicable. The device is an elastomeric infusion pump, and the evaluation involved nonclinical tests (mechanical, biocompatibility, flow rate) rather than a diagnostic device relying on expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The device evaluation did not involve human adjudication for a test set in the context of diagnostic interpretation. The testing described is for engineering and material performance.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is typically performed for diagnostic imaging devices involving human readers, which is not relevant to an elastomeric infusion pump.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of an elastomeric infusion pump. The device is a medical product with mechanical, material, and flow rate performance, not an algorithm. Therefore, "standalone" performance for an algorithm is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the nonclinical tests (mechanical, biocompatibility, and flow rate testing), the "ground truth" would be established by predefined engineering specifications, material standards, and target flow rate tolerances. For example, flow rate testing would compare the actual measured flow rate to the pre-set flow rate range (e.g., 0.5mL/hr to 10 mL/hr) for the device. Biocompatibility would be based on established international standards (e.g., ISO 10993). Mechanical testing would likely involve stress, durability, and integrity tests against predetermined specifications.
8. The sample size for the training set
This information is not applicable. The device is an elastomeric infusion pump undergoing nonclinical testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this 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).