(447 days)
Clicky Cros™ is indicated for fluid flow control and for providing access port(s) for administration of solutions in a limited contact duration (24 hours or less). Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids.
Clicky Cross™ is indicated for fluid flow control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids. Yomura Clicky Cross™ is a new medical device using as flow control switch and is developed by Yomura Technologies Inc. Click-release process via one-handed operation Less leakage issue than currently commercial products Stopcock system for I.V. set and other application Suitable for all current pressure infusion system There are two types of fitting end (Barb /Luer) for normal I.V. infusion sets. In order to meet the requirement of I.V. infusion set, here we provide two different types of fitting end (Barb/Luer).
The provided FDA 510(k) summary for the Clicky Cross™ device details its substantial equivalence to a predicate device, the Safeport Manifold™ (K111016). It primarily focuses on demonstrating that the new device is as safe and effective as the predicate.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a table of "acceptance criteria" in a typical quantitative format for algorithmic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating equivalence to a predicate device by meeting established performance and safety standards for medical devices of this type.
The reported device performance is indicated by its compliance with various ISO and ASTM standards relevant to infusion equipment and biocompatibility.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Functional Performance | ISO 8536-4:2019 | Meets standard for Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed |
| ISO 80369-7:2016 | Meets standard for Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications | |
| Biocompatibility | ISO 10993-3 | Meets standard for genotoxicity, carcinogenicity, and reproductive toxicity |
| ISO 10993-5 | Meets standard for irritation and skin sensitization | |
| ISO 10993-11 | Meets standard for systemic toxicity | |
| ISO 10993-12 | Meets standard for sample preparation and reference materials | |
| USP | Meets standard for Particulate Matter in Injection (Particulate testing) | |
| Sterility | ISO 11135:2014 | Meets standard for Sterilization of healthcare products - Ethylene Oxide (Overkill Approach (Half-cycle) validation method; residuals EO |
§ 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.