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To administer IV fluids/medication to a patient's vascular system.

The Victus I.V. Administration and Extension Sets are single use, sterile, non-pyrogenic devices used to administer filtered intravenous solutions and/or nutritional solution to a patient's vascular system via a catheter venous site under gravity-controlled flow. When used, the purpose of the filter is for filtering solution during intravascular administration. The device may include a needle-free valve injection site/connector which eliminates the use of needle to access the set during IV administration and aids in the prevention of needlestick injuries.

This document describes a 510(k) premarket notification for Victus Intravascular (I.V.) Administration Sets and Victus I.V. Extension Sets. The submission details changes and additions to the product line, including substituting a Flow Regulator for a Roller Clamp, replacing PVC tubing, substituting a Needle-Free connector, and adding a filter and check valve to some configurations. The document asserts that these changes do not affect the safety and effectiveness of the devices.

The information provided is primarily focused on the declaration of substantial equivalence to predicate devices and the scope of the device's intended use. It does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the format requested. The only mention of testing is "The VICTUS IV Extension Set and IV Administration Set have undergone Mechanical testing to verify performance," without detailing the tests, criteria, or results.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be extracted based on the provided text, with significant gaps for the unavailable information:

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

Unfortunately, the provided text does not contain a table of acceptance criteria or specific reported device performance metrics beyond the statement "The VICTUS IV Extension Set and IV Administration Set have undergone Mechanical testing to verify performance." No quantitative results or predefined thresholds are mentioned.

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

The document does not specify the sample size used for any mechanical testing or the data provenance.

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 and not present as this is a mechanical medical device, not an AI or diagnostic imaging device.

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

This information is not applicable and not present. No adjudication method is mentioned for any testing.

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 as this is a mechanical medical device and not an AI-assisted diagnostic device.

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

This information is not applicable as this is a mechanical medical device and does not involve an algorithm.

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

For mechanical devices, "ground truth" typically refers to established engineering standards or regulatory requirements that the device must meet (e.g., flow rate, tensile strength, sterility). The document states that the devices underwent "Mechanical testing to verify performance" and that the "Technological characteristics of the Victus Sets are substantially equivalent to the referenced predicates." This implies that the performance was compared to established standards for similar predicate devices, though the specific 'ground truth' metrics are not detailed.

8. The sample size for the training set

This information is not applicable and not present as this is a mechanical medical device, not an AI or machine learning device.

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

This information is not applicable and not present as this is a mechanical medical device, not an AI or machine learning device.

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To administer IV fluids/medication to the patient's vascular system through a needle-free system that aids in the elimination of needle-stick injury.

The Victus I.V. Administration Sets are single use, sterile, non-pyrogenic devices used to administer I.V. fluids/medication to a patient's vascular system via gravity control.

The provided text describes a 510(k) premarket notification for the Victus IV Administration Sets. However, it does not contain the detailed acceptance criteria, study design, or performance data that you've requested regarding device performance. The document explicitly states:

"The Victus I.V. Administration Sets have undergone performance and safety testing to verify mechanical properties and biocompatibility using FDA recognised standards."

This indicates that testing was performed, but the results of that testing (i.e., acceptance criteria and reported performance) are not included in this document. Instead, this document is a summary for a 510(k) submission, confirming that the device is substantially equivalent to predicate devices. Substantial equivalence means it has the same intended use and similar technological characteristics, and any differences don't raise new questions of safety or effectiveness.

Therefore, I cannot populate the table or answer the specific questions about "the study that proves the device meets the acceptance criteria" using the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical or performance study report.

Here's what I can extract based on the limited information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not provided. The document states "performance and safety testing" was done, but gives no details about the sample size, type of test set, or data provenance.

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/Not provided. This type of information is relevant for studies involving human interpretation (e.g., medical imaging AI). For an IV administration set, "ground truth" would typically be established through engineering specifications, material science testing, and biological assays, not expert consensus on interpretations. No details on specific experts or their qualifications are mentioned.

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

• Not applicable/Not provided. Adjudication methods are typically used when multiple human experts provide opinions that need to be reconciled, such as in clinical studies evaluating diagnostic accuracy. This is not mentioned or relevant for the type of device and testing described.

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:

• No. This is not an AI device. It is a traditional medical device (IV administration set).

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

• Not applicable. This is not an algorithm or AI device.

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

• Inferred: For this type of device, ground truth would be established by engineering specifications, material properties, biocompatibility standards, and functional performance benchmarks (e.g., flow rates, leak integrity, particulate matter, pyrogenicity). The document mentions "FDA recognised standards" were used, implying these types of criteria formed the "ground truth." Specific details are not provided.

8. The sample size for the training set:

• Not applicable/Not provided. This is not an AI device that requires a training set.

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

• Not applicable. This is not an AI device.

In summary: The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to pre-existing devices, rather than a detailed scientific study report outlining specific performance criteria and test results. It confirms that "performance and safety testing" was conducted using "FDA recognized standards," but the specifics of those tests and their outcomes are not included in this document.

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To administer IV fluids/medication to the patient's vascular system.

The Victus Administration Sets are single use, sterile, non-pyrogenic devices used to administer IV fluids/medication to a patient's vascular system via gravity control.

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this is for a physical medical device (I.V. Administration Set) and not an AI/software device, so many of the requested fields are not applicable:

Acceptance Criteria and Device Performance

Study Details (Relevant to K023469 - Victus IV Administration Sets)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document mentions "performance and safety testing" and "biocompatibility testing," but does not specify the sample size for these tests or the data provenance (e.g., country, retrospective/prospective). This information is typically found in detailed testing reports, which are not included in the provided 510(k) summary.

2. 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. This device is a physical IV administration set. Ground truth establishment by medical experts (like radiologists) is relevant for diagnostic or image-based AI devices, not for the functional testing of a physical product like this. Testing would involve engineering, microbiology, and biocompatibility specialists.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. This refers to consensus methods for establishing ground truth, typically in the context of expert review of images or data for AI studies. For a physical device, testing outcomes are objective (e.g., pass/fail for sterility, flow rate, material strength).

4. 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:
   No. This device is an IV Administration Set, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   No. This device is a physical medical product, not an algorithm or AI. Standalone performance refers to the accuracy of a digital algorithm on its own.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" for this device would be established through:

   • Engineering specifications and standards: Verification that the device meets defined physical, mechanical, and functional requirements (e.g., flow rates, connection integrity, material strength).
   • Microbiological testing: Confirmation of sterility.
   • Biocompatibility testing: Verification that materials are non-toxic and do not induce adverse biological responses, often following standards like ISO 10993.
   • Comparison to predicate device: The fundamental "ground truth" for FDA clearance here is substantial equivalence to a legally marketed predicate device (BBraun-McGaw IV Administration Sets), implying that if it performs comparably to a safe and effective predicate, it too is considered safe and effective.

7. The sample size for the training set:
   Not applicable. This is not an AI/machine learning device that requires a training set.

8. How the ground truth for the training set was established:
   Not applicable. As above, this is not an AI/machine learning device.

Summary of the Study:

The provided document describes a 510(k) premarket notification for the Victus IV Administration Set. The study primarily involves demonstrating substantial equivalence to existing predicate devices (BBraun-McGaw IV Administration Sets).

The evidence for this substantial equivalence is based on:

• Technological characteristics: The Victus IV Administration Sets have the "same technological characteristics" as the predicate device.
• Performance and safety testing: The device "undergone performance and safety testing to verify mechanical properties and biocompatibility using FDA recognised standards, where applicable." This testing would rigorously assess physical integrity, flow rates, sterility, material safety, and other critical performance attributes against established standards and the performance profile of the predicate device.

The FDA's decision to clear the device (K023469) signifies that they found the data presented by Victus, Inc. sufficient to demonstrate that the Victus IV Administration Set is as safe and effective as the predicate device already on the market. The specific details of the individual tests (e.g., how many units were tested for sterility, details of biocompatibility studies) are not in the provided summary but would have been part of the full 510(k) submission.

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