(84 days)
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The subject of this submission is the Millipore 0.22 micron filter which Baxter intends to incorporate into various configurations of solution sets for the administration of intravenous solutions. The filter is manufactured by Millipore and has been recently cleared for marketing in Abbott solution administration sets covered by K960466. Baxter will purchase the 0.22 micron filter from Millipore and incorporate it into currently marketed solution administration sets. Baxter is making no changes to the design, components or materials of the Millipore filter.
This 510(k) summary describes a new solution administration set incorporating a 0.22 micron filter manufactured by Millipore, intended for use with intravenous solutions. The submission focuses on the filter itself, as Baxter will be integrating it into their existing solution administration set designs. The predicate devices are Abbott and Baxter solution sets, both incorporating 0.22 micron filters.
Here's an analysis of the provided information based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Performance | Met or exceeded all functional requirements. |
| Reverse Pressure Filter Integrity | Met (implied by "meets or exceeds all functional requirements"). |
| Unit Venting | Met (implied by "meets or exceeds all functional requirements"). |
| Gravity Flow | Met (implied by "meets or exceeds all functional requirements"). |
| Inlet Axial Stress | Met (implied by "meets or exceeds all functional requirements"). |
| Housing Integrity/Female Luer Fitment | Met (implied by "meets or exceeds all functional requirements"). |
| Forward Pressure Filter Integrity | Met (implied by "meets or exceeds all functional requirements"). |
| Downstream Particle Count | Met (implied by "meets or exceeds all functional requirements"). |
| Accelerated Endurance | Met (implied by "meets or exceeds all functional requirements"). |
| Outlet Deflection Stress | Met (implied by "meets or exceeds all functional requirements"). |
| In-Line Filter Wettability | Met (implied by "meets or exceeds all functional requirements"). |
| Biocompatibility | Met or exceeded all functional requirements (this usually encompasses biocompatibility testing). |
| Bacterial Endotoxins | Met (implied by "functional, microbiological, and drug compatibility data indicate that the proposed filter meets or exceeds all functional requirements"). |
| Bioburden Evaluation | Met (implied by "functional, microbiological, and drug compatibility data indicate that the proposed filter meets or exceeds all functional requirements"). |
| Structural Integrity | Met or exceeded all functional requirements. |
| Burst Strength | Met (implied by "meets or exceeds all functional requirements"). |
| MVI Resistance | Met (implied by "meets or exceeds all functional requirements"). |
| Drug Compatibility | Met (explicitly stated: "drug compatibility data indicate that the proposed filter meets or exceeds all functional requirements"). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The summary mentions "Data regarding the functional performance [...] were generated by Millipore," but does not specify the number of units tested for each criterion.
- Data Provenance: The data was generated by Millipore, the manufacturer of the 0.22 micron filter. It is not specified whether the data is retrospective or prospective, nor the country of origin, though given the context of a US 510(k) submission, it's highly likely to be considered within a US regulatory framework.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of medical device submission. This refers to clinical studies where expert consensus or diagnostic interpretation is required for ground truth. For a filter, the "ground truth" is typically defined by standardized physical, chemical, and microbiological tests.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials or diagnostic studies to resolve discrepancies between multiple expert readers. For a filter, objective measurements are taken, and results are compared against predefined acceptance limits.
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
This is not applicable. This submission is for a physical medical device (a filter), not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. As mentioned above, this is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective, quantitative measurements obtained from established test methods for filter performance, biocompatibility, and structural integrity. This includes:
- Physical measurements (e.g., burst strength, flow rates).
- Chemical purity assessments (e.g., bacterial endotoxins, particle counts).
- Microbiological testing (e.g., bioburden evaluation) demonstrating sterile filtration capabilities.
- Drug compatibility studies.
These "ground truths" are derived from validated test procedures and industry standards relevant to medical filters.
8. The Sample Size for the Training Set
This is not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for a physical filter device.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.