(27 days)
The FLOSTAR Needleless Connector device is sterile, disposable, needle-less I.V. access valve for use in intravenous administration of fluids to a patient's vascular system. The FLOSTAR Needleless Connector device may aid in the prevention of needle stick injuries.
The FLOSTAR Needleless Connector is a sterile, disposable, needle-less I.V. access valve for use in general intravenous administration of fluids.
The provided text does not contain detailed information about specific acceptance criteria related to device performance (e.g., accuracy, sensitivity, specificity) for an AI/device, nor does it describe a study (including sample sizes, expert ground truth, adjudication methods, or MRMC studies) designed to prove the device meets such criteria.
Instead, the document is a 510(k) premarket notification for the "FLOSTAR Needleless Connector," a medical device, with a focus on demonstrating "substantial equivalence" to a predicate device.
Here's a breakdown of what the document does provide, and what is missing based on your request:
What is present in the document:
- Device Type: FLOSTAR Needleless Connector (not an AI-driven diagnostic or image analysis device).
- Intended Use: Sterile, disposable, needle-less I.V. access valve for intravenous fluid administration and aid in preventing needle stick injuries.
- Predicate Device: Safe-Connect Valve.
- Demonstration of Substantial Equivalence: The document states the FLOSTAR Needleless Connector is substantially equivalent to the Safe-Connect Valve because they:
- have the same intended use.
- use the same operating principle.
- incorporate the same final design configuration.
- are both labeled as single patient use.
- are packaged and labeled using the same materials and processes.
- Summary of Testing (General): "All materials used in the fabrication of this FLOSTAR Needleless Connector were evaluated with the original design through physical testing and biocompatibility testing." This is a general statement about material and design testing, not performance metrics based on clinical data or AI evaluation.
What is missing from the document (as it pertains to your request for AI/device performance criteria and studies):
- A table of acceptance criteria and the reported device performance: This document does not provide specific performance metrics (like accuracy, sensitivity, specificity, etc.) with corresponding acceptance criteria. It primarily focuses on equivalence to a predicate device in terms of design and material.
- Sample size used for the test set and the data provenance: Not applicable, as no such performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
The provided document is a 510(k) notification demonstrating substantial equivalence for a physical medical device (a needleless connector), not an AI-driven device requiring performance evaluation based on clinical data, ground truth establishment, or specific diagnostic metrics as envisioned by your detailed request. Therefore, it does not contain the information needed to fill out the requested table regarding acceptance criteria and study details for an AI-enabled 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.