(81 days)
Baxter's Infusor SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. It is suitable for use in the hospital or home setting.
A design modification is being made to Baxter's Infusor SV line of Elastomeric Infusion Devices. This modification is being made to facilitate filling and priming the device. The modification involves the relocation of the fill port to the end of the housing and the addition of a piece of coiled tubing to connect the relocated fill port to the volume indicator. Standard flow rate testing was performed to confirm performance characteristics.
This document describes a 510(k) submission for a modified elastomeric infusion device. The information provided is primarily related to the regulatory approval process and device labeling, rather than a detailed study report demonstrating performance against acceptance criteria. Therefore, I cannot fully complete all sections of your request based on the provided text.
However, I can extract the relevant information and indicate where specifics are missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Standard flow rate characteristics maintained | "Standard flow rate testing was performed to confirm performance characteristics." (No specific flow rate values or criteria are provided in the document.) |
Missing Information: The document states that "Standard flow rate testing was performed to confirm performance characteristics," but it does not specify the numerical acceptance criteria for these flow rates (e.g., +/- x% of nominal flow rate) or the actual measured performance values.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "Standard flow rate testing was performed."
- Data Provenance: Not specified. It can be inferred that the testing was conducted by Baxter Healthcare Corporation to support the 510(k) submission, likely in the United States, but this is not explicitly stated as retrospective or prospective or the country of origin of the data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This is not applicable as the study described is a device performance test (flow rate testing), not a diagnostic or clinical study requiring expert ground truth for interpretation of outcomes.
4. Adjudication Method for the Test Set
- Not applicable for a device performance test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No. The document describes a device modification and subsequent standard flow rate testing, not a clinical effectiveness study involving human readers or comparative effectiveness with or without AI assistance.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- The device is a physical elastomeric infusion device, not an algorithm. Therefore, an "algorithm only" standalone performance study is not applicable. The provided text describes physical performance testing of the device.
7. Type of Ground Truth Used
- For the flow rate testing, the "ground truth" would be the expected or designed flow rate of the device, against which the measured flow rates were compared. This is an objective physical measurement, not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as there is no training set for this type of device.
Summary of Device and Study:
The submission describes a design modification to Baxter's Infusor SV line of Elastomeric Infusion Devices. The modification involves relocating the fill port and adding a coiled tubing piece. To demonstrate that this modification does not adversely affect the device's function, "Standard flow rate testing was performed to confirm performance characteristics." The document states that the modified devices have the "same intended use" as the comparison devices.
The document is purely a regulatory submission (510(k)) and does not contain detailed study reports with specific acceptance criteria thresholds or measured performance data. It confirms that the necessary testing was conducted to support substantial equivalence for FDA approval but does not provide the specifics of that testing.
§ 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).