(50 days)
For administration of intravenous fluids to a patient's vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. The needleless safety feature may aid in the prevention of needlestick injury.
Sterile single use, non-pyrogenic intravenous fluid administration set: 85 in. (216 cm) long, multiport IV manifold with integrated back check valves, pre-attached needleless injection sites, drip chamber, roller clamps.
The provided text describes the 510(k) summary for the Quest Medical Multiport® Manifold I.V. Set with Swabable Valves. It states that the device is substantially equivalent to a predicate device (Baxter Continu-Flo Solution Set, 2C8930, K003225) based on non-clinical testing.
Here's an analysis of the requested information based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions "acceptable performance of the device" based on "laboratory testing (design verification) using the FDA guidance for Intravascular Administration Sets." However, specific acceptance criteria and detailed quantitative performance metrics are not provided in the given text. The summary only states a qualitative conclusion.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functions as intended for intravenous fluid administration. | "acceptable performance of the device" |
| Meets standards outlined in FDA guidance for Intravascular Administration Sets. | Device successfully underwent "laboratory testing (design verification) using the FDA guidance for Intravascular Administration Sets." |
| Substantially equivalent to predicate device (Baxter Continu-Flo). | "The technological characteristics of the Multiport IV Set do not differ significantly from the currently marketed Baxter Continu-Flo set. The devices use the same fundamental scientific technology and have the same intended use." |
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "laboratory testing (design verification)." The specific sample size (N) used for this testing is not mentioned. The data provenance is also not specified beyond being "laboratory testing." It is non-clinical testing, so it's not real-world patient data (retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is a non-clinical device test. There is no mention of experts being used to establish ground truth in the context of clinical interpretation or diagnosis. The "ground truth" would be the engineering specifications and performance standards defined by the FDA guidance and internal design requirements.
4. Adjudication Method for the Test Set:
As this is non-clinical laboratory testing, adjudication methods typically associated with clinical studies (like 2+1 or 3+1) are not applicable or mentioned. The "adjudication" would refer to the successful meeting of engineering and performance standards during testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document describes a non-clinical assessment of substantial equivalence, not a clinical study involving human readers or comparative effectiveness with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable to the device described. The Multiport® Manifold I.V. Set is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" in this context is irrelevant.
7. The Type of Ground Truth Used:
For this non-clinical device, the "ground truth" would be the engineering specifications, performance standards, and safety requirements outlined in the FDA guidance for Intravascular Administration Sets and the device's own design documentation. It is not expert consensus, pathology, or outcomes data, as these are related to clinical findings or diagnoses.
8. The Sample Size for the Training Set:
This question is not applicable as the device is a physical medical device and not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
This question is not applicable for the same reasons as #8.
§ 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.