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K Number
K041845
Device Name
NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4
Manufacturer
NEXUS MEDICAL, LLC
Date Cleared
2004-08-24

(47 days)

Product Code
FPA
Regulation Number
880.5440
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Nexus PAV TM Luer Lock (NIS-4) is to be used for the delivery of drugs and fluids as an accessory to intravascular administration sets. The Nexus PAV TM Luer Lock Device (NIS-4) may aid in the prevention of needle stick injuries.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a 510(k) premarket notification letter from the FDA to Nexus Medical, LLC regarding their Nexus PAV™ Luer Lock Device (NIS-4). It confirms that the device has been found substantially equivalent to legally marketed predicate devices. The letter also includes an "Indications For Use Statement" for the device.

However, it does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Details on sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for any test set.
  3. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
  4. The type of ground truth used, training set sample size, or how ground truth for the training set was established.

This document is a regulatory approval letter, not a scientific study report or clinical trial summary.

§ 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.