(64 days)
The Venusa, Ltd. Extension Set with Filter is used for IV fluid administration where The Velusa, Do. Dxtention Dot, Mai 22 mirron is desired. Use of the device helps assure the delivery of a bacteria-free product. The device is used in conjunction with an IV administration set and in-dwelling IV catheter.
The device consists of female Luer lock, TOTM (non-DEHP) plasticised PVC tubing, a Millipore 0.22 micron air eliminating filter, an on\off clamp, and a male Luer lock adapter.
This looks like a 510(k) premarket notification for a medical device. The document primarily focuses on establishing "substantial equivalence" to a predicate device rather than detailing de novo acceptance criteria and a study specifically designed to meet them.
Here's an analysis based on the provided text, highlighting what's available and what's missing:
Acceptance Criteria and Device Performance (as stated by the manufacturer for the filter component):
| Acceptance Criteria (Functional Requirements) | Reported Device Performance (Millipore Filter) |
|---|---|
| Reverse Pressure Filter Integrity | "meets or exceeds all functional requirements" |
| Unit Venting | "meets or exceeds all functional requirements" |
| Gravity Flow | "meets or exceeds all functional requirements" |
| Inlet Axial Stress | "meets or exceeds all functional requirements" |
| Forward Pressure Filter Integrity | "meets or exceeds all functional requirements" |
| Downstream Particle Count | "meets or exceeds all functional requirements" |
| Accelerated Endurance | "meets or exceeds all functional requirements" |
| Bioburden Evaluation | "meets or exceeds all functional requirements" |
| Inline Filter Wettability | "meets or exceeds all functional requirements" |
| Burst Strength | "meets or exceeds all functional requirements" |
| MVI Resistance | "meets or exceeds all functional requirements" |
1. A table of acceptance criteria and the reported device performance:
As shown above. The document states that the filter "meets or exceeds all functional requirements" but does not provide specific numerical values for these requirements or the achieved performance. This is typical for a 510(k) where the focus is on equivalence.
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: Not specified for any of the tests. The document only mentions "Millipore generated data."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It only states the data was generated by Millipore, the filter manufacturer.
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 to this type of device and study. The testing described is for the physical and functional performance of a filter, not for diagnostic accuracy or human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as there is no human interpretation or ground truth to be adjudicated in the context of these physical performance tests.
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 information is not applicable. This device is an extension set with a filter, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" here would be defined physical and performance standards for medical filters (e.g., particle count limits, burst pressure thresholds, flow rates). These are established by engineering and regulatory standards rather than medical consensus or pathology. The document implies these standards exist and were met ("meets or exceeds all functional requirements"), but doesn't detail them.
8. The sample size for the training set:
This information is not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established:
This information is not applicable. No training set exists.
Summary of the Study:
The "study" described in the 510(k) document is not a clinical study in the traditional sense, nor is it a study explicitly designed to meet de novo acceptance criteria. Instead, it relies on tests performed by the filter manufacturer (Millipore) to demonstrate that the filter component (which Venusa is incorporating without modification) meets established functional requirements.
The core of the K994429 submission is to claim substantial equivalence to existing predicate devices (Abbott K960466 and Baxter K964850). Venusa's argument for safety and effectiveness is based on:
- Same intended use.
- Similar/identical components (specifically purchasing the 0.22 micron filter from Millipore without changes).
- Similar device configuration (minus a y-injection site).
- Similar/identical raw materials.
- Similar/identical manufacturing processes.
- The fact that the Millipore filter, as a component, has undergone its own functional performance testing and "meets or exceeds all functional requirements."
Therefore, this document does not contain the detailed information typically found in a study designed to establish new acceptance criteria for a novel device, but rather a justification for substantial equivalence based on existing data for its components and similarity to predicate devices.
§ 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.