(33 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document | Not provided in the document |
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.
§ 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.