(205 days)
For the administration of fluids from a container into the patient's vascular system through a vascular access device.
The proposed devices are single use disposable devices intended for the administration of fluids from a container to the patient's vascular system. The extension sets consist of a combination of the following components: PVC or PE lined PVC tubing, a clamp, female Luer with non-vented cap, male Luer with filter vented cap. The accessories consist of an anti-siphon valve, back check valve, and 1.2 µm Filter. The accessories are used in combination with IV sets to administer solutions directly from a container to a patient's vascular system.
This FDA 510(k) summary describes an intravascular extension set and accessories. The filing primarily focuses on demonstrating substantial equivalence to a predicate device (K192366) and the removal of a caution statement related to body weight. Therefore, the information provided does not detail a study involving AI or complex performance metrics as typically seen for AI/ML-enabled devices.
Based on the provided text, the acceptance criteria and study information are as follows:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Passed (supported the removal of caution statement) |
| Functional Equivalence to Predicate | Established (Same design, material, sterility, chemical properties as predicate. No changes except removal of caution statement). |
| Indications for Use | Equivalent to predicate device. |
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 a "test set" in the context of performance evaluation with a defined sample size for the device itself. The primary testing mentioned is biocompatibility. For biocompatibility, there is no information about sample size or data provenance provided in this summary.
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. This device is a physical medical device (intravascular extension set and accessories), not an AI/ML-enabled device requiring expert ground truth for performance evaluation of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is a physical medical device, not an AI/ML-enabled device requiring adjudication of expert interpretations.
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. No MRMC study was performed as this is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For biocompatibility testing, the "ground truth" would be established by standardized testing methods and international standards (e.g., ISO 10993 series), not expert consensus, pathology, or outcomes data in the context of diagnostic performance.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, there is no ground truth established for a training set.
§ 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.