(58 days)
The 0.2 µ Bacterial Filter can be used with administration sets or extension sets for removal of particulate matter during the administration of fluids or medications.
The purpose of this submission is to offer an 0.2 u Bacterial Filter with standard luer connections for use with administration sets or extension sets used with fluid delivery devices. The subject device is intended to be "added-on" to an administration set or extension set.
The filter is an air-eliminating filter and is circular in shape with a center vent. The inlet of the filter is a standard female luer and the outlet of the filter is a standard male luer. The filter membranes are enclosed within a plastic case which is approximately 1.22 in. (width) x 1.85 in. (length).
The provided 510(k) summary for the 0.2 µ Bacterial Filter by SIMS Deltec, Inc. primarily describes a device comparison rather than a detailed study with acceptance criteria and specific performance metrics in the way a diagnostic AI/ML device would be evaluated. This medical device submission is from 1997, and the regulatory requirements and types of studies for devices like this were different than those for modern AI-driven devices.
Here's an analysis based on the provided text, highlighting the information that is present and noting what is absent:
1. Table of Acceptance Criteria and Reported Device Performance:
The submission does not contain a table with explicit acceptance criteria (e.g., a specific bacterial retention rate or flow rate threshold) and reported device performance results against those criteria. Instead, it makes a general statement about functional testing and biocompatibility.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Filtration of particulate matter (Implied by intended use) | "the filter functions according to specification" |
| Biocompatibility requirements | "the filter meets the biocompatibility requirements" |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document mentions "Functional testing was performed on the filter," but does not provide details on the number of filters tested or the amount of fluid/particulate matter used.
- Data Provenance: Not specified. The testing was presumably conducted by SIMS Deltec, Inc., but the location of the testing or origin of materials is not detailed. It is retrospective, as the testing was completed prior to submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a filter, and its performance is evaluated through physical and biological testing (e.g., filtration efficiency, biocompatibility), not through expert interpretation of data.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this device is not evaluated by human experts interpreting data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The 0.2 µ Bacterial Filter is a physical device, not an interpretative diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is not an AI/ML algorithm. The performance of the filter itself, as a physical object, is what was tested.
7. Type of Ground Truth Used:
The "ground truth" for this device would be established by validated laboratory methods for assessing filtration efficiency (e.g., bacterial retention tests, particulate removal tests) and standardized biocompatibility assays. The document states:
- "Functional testing was performed on the filter to establish its operating parameters."
- "Biocompatibility testing was conducted on the filter."
This implies that the ground truth was based on these specific, objective laboratory measurements.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm, so there is no training set in the conventional sense. The "training" or development of the filter would involve engineering design and material selection, followed by testing.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set. The design of the filter (likely based on material science and fluid dynamics principles) would be iterated and refined through a series of internal tests, but these are not explicitly detailed as "ground truth" establishment for a training set.
Summary of the Study and Device Proof:
The submission outlines that the device meets its intended purpose based on functional testing and biocompatibility testing. The core of the proof is the demonstration that:
- Functional Testing: The filter "functions according to specification," meaning it effectively removes particulate matter as advertised. While specific percentages or particle sizes are not given, the claim of a "0.2 µ Bacterial Filter" implies it can filter particles down to that size, which would have been demonstrated by the functional tests.
- Biocompatibility Testing: The filter "meets the biocompatibility requirements," indicating it is safe for human contact and use without adverse biological reactions.
The submission specifically states: "Clinical studies were not deemed necessary regarding the filter due to its similarity in materials, design and function to current commercially available filters and extension sets with in-line filters." This is a key point, as it allowed SIMS Deltec, Inc. to rely on substantial equivalence to predicate devices rather than conducting extensive clinical trials, which would typically be required for novel device types or those with significant differences in performance or safety. The 510(k) process is fundamentally about demonstrating substantial equivalence to a legally marketed predicate device. By showing similar materials, design, and function, they could leverage the established safety and effectiveness of the predicate.
§ 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.