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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):

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.

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The Venusa, Ltd. Huber Needle Infusion Set is intended to be used access an implanted port for the purpose of delivering drugs and solutions.
The Venusa, Ltd. Huber Needle Infusion Set is intended to be used to deliver solutions and drugs into vascular implant ports.

The device consists of female Luer lock adapter, Non-DEHP PVC tubing, an onloff clamp, 314 stainless steel Huber point non-coring needle bent to 90 degrees. The device includes a winged hub that surrounds the needle to aid in the insertion, securement, and removal of the device.

This document is a 510(k) premarket notification for a medical device called the "Venusa, Ltd. Huber Needle Infusion Set." It's a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, meaning it's as safe and effective.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving those criteria are met:

The provided text does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way you've described. This is typical for a 510(k) submission that relies on demonstrating substantial equivalence to predicate devices.

Instead of reporting on a new study with defined acceptance criteria for performance, the submission argues that the Venusa, Ltd. Huber Needle Infusion Set is safe and effective because it is substantially equivalent to existing, legally marketed devices.

Let's break down why your specific questions cannot be fully answered by this document and what information is provided:

1. A table of acceptance criteria and the reported device performance

• Not present. The document does not define specific performance acceptance criteria (e.g., flow rate, puncture force, durability) and does not report on performance data against such criteria for the Venusa device itself.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable. There is no "test set" in the context of a performance study described here. The submission uses a comparison to predicate devices, not new performance data.

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)

• Not applicable. No expert ground truth establishment for a test set is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. No adjudication method for a test set is mentioned.

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

• Not applicable. This device is an infusion set, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is an infusion set, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Indirectly, through predicate devices. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices (Pfizer Strato K921674, Douglas Medical Products K932638, and Marquette Medical K884212). The assumption is that because those devices are safe and effective, and the Venusa device is substantially equivalent, then the Venusa device is also safe and effective. No primary ground truth determination for the Venusa device is described.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this type of submission.

9. How the ground truth for the training set was established

• Not applicable. There is no "training set" in the context of this type of submission.

What the document does state in lieu of a performance study against acceptance criteria:

The core of the submission (and the "study" in a loose sense for 510(k)) is the demonstration of substantial equivalence.

• "Acceptance Criteria" (Implicit): The implicit acceptance criterion for a 510(k) is that the new device is substantially equivalent to a legally marketed predicate device(s) in terms of:

  • Intended Use: The Venusa device's intended use ("access an implanted port for the purpose of delivering drugs and solutions" / "to deliver solutions and drugs into vascular implant ports") is identical to that of its predicates.
  • Technological Characteristics: The submission states, "The Venusa, Ltd. Huber Needle Infusion Sets utilize similar and equivalent designs, components, manufacturing processes..." This implies that the materials (Luer lock adapter, Non-DEHP PVC tubing, on/off clamp, 314 stainless steel Huber point non-coring needle, winged hub), design (90-degree bent needle), and manufacturing processes are comparable to the predicates.
  • Performance (Implied): By claiming similar designs, components, and manufacturing processes, the submission implicitly argues that the performance (e.g., integrity, sterility, biocompatibility, flow characteristics, ease of insertion) will be equivalent to the predicates, which are already deemed safe and effective.

• "Study that proves the device meets the acceptance criteria": The "study" here is the substantiation of substantial equivalence through comparative analysis, not a new clinical or laboratory performance trial for the Venusa device itself.

  • The document explicitly states: "The components and the processes used to manufacture these Huber needle infusion sets are substantially equivalent to like products currently legally marketed by Pfizer Strato (K921674), Douglas Medical Products (K932638), and Marquette Medical (K884212)."
  • And concludes: "Based on the fact that the Venusa, Ltd. Huber Needle Infusion Sets utilize similar and equivalent designs, components, manufacturing processes, and have the same intended use as the currently legally marketed products, the Venusa, Ltd. Huber Needle Infusion Sets are safe and effective when used as intended."

In summary, this 510(k) submission for the Venusa, Ltd. Huber Needle Infusion Set relies on establishing substantial equivalence to predicate devices rather than providing detailed performance data from a dedicated study against predefined acceptance criteria.

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