(174 days)
The Cedic srl Intravenous Gravity Set is used for IV fluid administration. This device serves as a connection between the IV fluid container and an indwelling catheter.
The Cedic srl Intravenous Gravity Set is a universal non-DEHP tubing set that allows IV solutions to be infused into the patient in conjunction with an indwelling catheter. The drip chamber fiker precludes passage of gross particle potentially generated during spiking of the IV solution container. The vent filter is 3u aerosol microbial barrier . The device consists of a spike, drip chamber with disk filter (15 um approx.), roller clamp, latex free flash bulb injection site, and male luer slip connector (Cedie product code: F 00010) or male luer lock connector (Cedic product code: F 00027).
This document pertains to the 510(k) premarket notification for a medical device, specifically an Intravenous Gravity Set, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI/ML performance evaluation is not applicable.
The document discusses the substantial equivalence of the Cedic srl Intravenous Gravity Set to legally marketed predicate devices. The "safety and effectiveness summary" in the original document outlines the following:
1. A table of acceptance criteria and the reported device performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Solvent Bond Pull test | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
| Leak/Occlusion test | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
| Roller/Clamp functionality | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
| Leak test (for F 00010) | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
| Filter Integrity | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
| Retainer Adhesive Inspection | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
| ISO luer test (594:172) | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
| Check Valve performance | Meets functional requirements for intended use | Indicates device meets or exceeds functional requirements. |
Note: The document broadly states "All testing of the Intravenous Gravity Set indicates that the device meets or exceeds the functional requirements for the device's intended use," without specific numerical values for acceptance criteria or detailed test results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The filing focuses on substantial equivalence based on design, components, and manufacturing processes rather than a detailed clinical trial or performance study with a specified sample size.
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 as this is a medical device (intravenous gravity set) and not an AI/ML diagnostic tool requiring expert ground truth for image or data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. The performance is assessed through various engineering and functional tests as listed above. The "ground truth" for this type of device is its ability to perform its intended mechanical and fluid delivery functions without issues like leaks, occlusions, or component failures.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
§ 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.