(73 days)
a. For use as a needleless alternative to IV set injection ports. The NIMA™ adapter will replace the conventional Y-site on a primary IV line as a continuous or intermittent connection.
b. For use as part of a program to reduce needle stick injuries and the associated transmission of blood borne pathogens such as HIV and HBV.
C. For use as a replacement to the injection cap (heparin cap) on an I. V. catheter for intermittent injections.
d. For use for injection, as a gravity flow connector, and as an access port for withdrawal of fluids.
e. For use with standard luer taper connections.
f. For single patient use.
The NIMA™ adapter is a two-way valve that permits easy needleless intermittent and continuous access in IV therapy. It can be connected to peripheral or central venous catheters or Y-sites. The normally closed NIMA™ adapter valve is opened by inserting a standard male luer taper, such as on an extension set. IV tubing or syringe to the female end of the NIMA™ adapter. This device does not require the use of hypodermic needles for the infusion of IV solutions. Thus preventing needle stick injuries. The NIMA™ adapter is packaged individually and as attached as part of extension sets
This document is a 510(k) summary for a medical device called the "NIMA™ Needleless Injectionsite Master Adapter and IV Sets." This document does not contain information about acceptance criteria or a study proving that the device meets those criteria.
Instead, it focuses on demonstrating substantial equivalence to a predicate device. It describes:
- Submitter and Contact Information: Critical Device Corporation.
- Device Trade Name: NIMA™ Needleless Injectionsite Master Adapter and IV Sets.
- Common Name: Intravenous (IV) Medication Connector and IV Sets.
- Predicate Device: NIMA™ Needleless Injectionsite Master Adapter and IV Sets (the previous version of the same device).
- Description: A two-way valve for needleless intermittent and continuous IV access, preventing needle stick injuries.
- Intended Use: As a needleless alternative to IV set injection ports, to reduce needle stick injuries, as a replacement for injection caps, for injection/gravity flow/fluid withdrawal, with standard luer taper connections, and for single patient use.
- Technological Comparison: States that the technological characteristics are equivalent to the currently approved predicate device. The key changes are alternate materials and an extended use duration (from 24 to 96 hours).
- Nonclinical Test Summary: New materials meet all performance specifications established for the original device. Tripartite biocompatibility testing shows the new materials are safe and biocompatible.
- Conclusion: The modifications have demonstrated safety and effectiveness and are substantially equivalent to the legally marketed predicate device.
To answer your specific questions, this document does not provide the following information:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or effect size.
- Standalone performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document serves as a regulatory submission demonstrating substantial equivalence based on material changes and extended use duration, primarily relying on nonclinical testing (biocompatibility and performance specification adherence) rather than a clinical trial with acceptance criteria for device performance.
§ 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.