(71 days)
The HLIC Needle-Less Valve is intended to allow access to IV administration sets, medication vials, blood donor collection bags, and solution bags with one convenient device without the use of needles or blunt cannulas.
The HLIC Needle-Less Valve is a needle free valve that allows the user to add medication into IV sets without the use of a needle. When the valve is in the closed position, it has a flat, smooth surface for cleaning. When the male connector of a syringe or secondary line is pushed into the valve, the silicone stem opens in the middle creating a fluid path. When the male connector is removed from the valve, the body of the valve forces the stem shut and maintains a sealed fluid path. A cap is not required to seal the valve or to maintain sterility.
The provided text describes a 510(k) Premarket Notification for the HLIC Needle-Less Valve, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to establish diagnostic performance against specific acceptance criteria like those common for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not directly applicable to this SSEA (Summary of Safety and Effectiveness Analysis) for a non-diagnostic, non-AI medical device.
However, I can extract the relevant information pertaining to the device's performance testing and the conclusion regarding its safety and effectiveness.
Here's a breakdown based on the provided text, indicating where information is not available or not applicable for this type of device submission:
1. A table of acceptance criteria and the reported device performance
The document states that the device "met all established acceptance criteria for performance testing and design verification testing." While the specific acceptance criteria are not detailed in this public summary, the device passed them.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance Testing | Met all established criteria |
| Design Verification Testing | Met all established criteria |
| Biocompatibility | Met requirements according to ISO-10993 for externally communicating, blood path, indirect, limited contact duration ( |
§ 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.