(42 days)
The RyMed Technologies InVision-Plus™ Injection Port Systems are intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use.
The RyMed Technologies INVISION-PLUS™ Injection Port Systems are composed of either a Heparin Lock Injection Port, or a Y - Injection Port that contain a specialized two part valve made from medical grade Silicone material. The female luer housing, guide washer, and heparin lock are made from medical grade plastics. The valve provides excellent fluid Flow Rates, low Priming Volumes, and reseals after extended use.
The provided document is a 510(k) premarket notification for a medical device (RyMed Technologies INVISION-PLUS™ Injection Ports), not a study report for an AI/ML device. Therefore, the specific information requested in points 2-9 (related to AI/ML study design) is not applicable or cannot be extracted from this document.
However, I can extract and present the acceptance criteria for the device and its reported performance based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Performance (RyMed InVision-Plus™) |
|---|---|---|
| Fluid reflux |
§ 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.