(55 days)
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
| Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional | Administer IV fluids/medication to the patient's vascular system via gravity control. | Same as legally marketed predicate IV Administrations Sets. |
| Safety | Sterile | Verified through performance and safety testing. |
| Safety | Non-pyrogenic | Verified through performance and safety testing. |
| Mechanical | Mechanical properties and biocompatibility. | Verified through performance and safety testing using FDA recognized standards. |
| Equivalence | Substantially equivalent to legally marketed predicate devices. | Found substantially equivalent by FDA. |
Study Details (Relevant to K023469 - Victus IV Administration Sets)
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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. -
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. -
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). -
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. -
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. -
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.
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The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set. -
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.
§ 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.