(197 days)
To provide fluid path connection and flow regulation from fluid delivery set to venipuncture device.
The device is a sterile, nonpyrogenic, single use, I.V. extension set which has flexible tubing that connects to a fluid delivery system by a Luer lock connector, a flow regulator, and flexible tubing that connects to a venipuncture device by a Luer lock connector. A Y-site on the lower length of tubing allows for infusion of medication below the regulator.
The provided document describes the Medcorp Flow I.V. Regulator Extension Set and its substantial equivalence to a predicate device. However, it does not contain the specific details required to fully address all parts of your request, especially regarding a study proving acceptance criteria in the context of an AI/ML device. This document is a 510(k) summary for a traditional medical device, not an AI/ML product.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Flow Rates: Equivalent to predicate device's calibrations | Flow rates are equivalent to those indicated by the calibrations for the predicate device. |
| Toxicity: Nontoxic after manufacturing and sterilization | Toxicity testing indicates the device, after manufacturing and sterilization, is nontoxic. |
| Pyrogenicity: Absence of pyrogens | Pyrogenicity testing supports the claim for the device, which is the same as the claim for the predicate device. |
| Tensile Strength: Acceptable static tensile strength of fittings | Physical testing (static tensile strength of fittings) performed. (No specific threshold or value given, but implied as meeting equivalence) |
Missing Information: Specific numerical thresholds for flow rates, toxicity, pyrogenicity, or tensile strength are not provided in this summary.
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 mentions "physical testing (flow rates and static tensile strength of fittings), toxicity testing, and pyrogenicity testing" were performed.
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
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 is not applicable to this type of device and study. The testing described (flow rates, toxicity, pyrogenicity, static tensile strength) does not involve expert readers or ground truth in the way it would for an AI/ML diagnostic device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable as there is no expert adjudication process for these types of physical and biological 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
Not applicable. This is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed can be considered as follows:
- Flow Rates: Measurable physical properties against calibrated standards (likely factory specifications or a reference device).
- Toxicity: Laboratory assays demonstrating non-toxicity according to established standards (e.g., ISO biocompatibility standards).
- Pyrogenicity: Laboratory assays demonstrating absence of pyrogens according to established standards.
- Static Tensile Strength: Measurable physical properties against engineering specifications or established safety limits.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no concept of a "training set." The device is evaluated based on its physical and biological performance directly.
9. How the ground truth for the training set was established
Not applicable.
Summary of Limitations:
The provided document describes a traditional medical device (I.V. extension set) undergoing a 510(k) clearance process. The performance evaluation focuses on physical characteristics (flow rates, tensile strength) and biocompatibility (toxicity, pyrogenicity) compared to a predicate device. This is fundamentally different from the evaluation criteria and study types (e.g., MRMC, standalone algorithm performance, expert consensus on ground truth) typically associated with AI/ML-powered medical devices. Therefore, many of the requested points are not applicable or cannot be answered with the given text.
§ 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.