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Neonatal Introducer Kit
Norton Performance Plastics
Summary: The neonatal introducer kit by Norton Performance Plastics is a medical device used primarily for neonatal procedures. It is FDA 510k cleared and linked to studies exploring less traumatic techniques for preterm patients.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K820710 ↗
Decision Date ?
April 1, 1982
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The neonatal introducer kit was cleared via the FDA 510k pathway on April 1, 1982. It is manufactured by Norton Performance Plastics and classified as a Class 2 device under product code DYB.
What It Is
The neonatal introducer kit is designed for use in neonatal medical procedures, particularly in the placement of medical devices in small or preterm infants. It facilitates less invasive access to the vascular system or other body cavities.
FDA-Cleared Indications
- Use as an introducer during medical procedures involving neonates.
- Facilitate placement of another medical device in a neonatal patient.
- Intended for use in small or premature infants when an appropriately sized introducer is required.
Clinical Applications
- Introducing a catheter or similar device during neonatal care.
- Supporting device placement in premature or low-birth-weight infants.
- Providing access for neonatal procedures when a small introducer is clinically appropriate.
Evidence Summary
The available literature includes two studies: one published in 2017 and another with an unknown date. These studies explore techniques and outcomes related to the use of introducer kits in neonatal care.
Reported Outcomes
Published studies report that the neonatal introducer kit is associated with less traumatic outcomes in preterm and small for gestational age patients. The 'Pull-Introducer Technique' has been highlighted as a less invasive alternative to traditional methods.
Safety Profile
Reported complications include potential trauma associated with traditional techniques, which the neonatal introducer kit aims to mitigate. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety data. Further research is needed to explore long-term outcomes and broader clinical applications.
Practical Considerations
- Confirm the kit's available sizes and dimensions before use; neonatal devices must be matched carefully to the infant's size and the target access route.
- Verify compatibility with the catheter, guidewire, or other device being introduced, including inner diameter and working length.
- Use sterile technique and follow the current manufacturer instructions for preparation, insertion, and removal.
- The available FDA record does not establish MRI safety. Confirm MR Safe, MR Conditional, or MR Unsafe status from current labeling before an MRI examination.
- Contraindications and precautions depend on the access site, the device being introduced, infection or bleeding risk, and the infant's clinical condition.
Frequently Asked Questions
What are the clinical indications for neonatal introducer kit?
The neonatal introducer kit is indicated for use in neonatal procedures requiring vascular or cavity access, particularly in preterm or small for gestational age infants.
What outcomes have been reported in clinical studies?
Studies have reported that the kit is associated with less traumatic outcomes in neonatal patients, particularly when using the 'Pull-Introducer Technique'.
What complications have been reported?
Reported complications include trauma associated with traditional techniques, which the neonatal introducer kit aims to reduce.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.