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The Nellcor Pulse Oximetry Monitor Interface Cable
Summary: The Nellcor Pulse Oximetry Monitor Interface Cable by Covidien is used for monitoring oxygen saturation and heart rate. It is FDA 510k cleared and supported by 15 studies, highlighting its efficacy in neonatal and postoperative care.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K172482 ↗
Decision Date ?
December 15, 2017
Product Code ?
DQA
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510k pathway on December 15, 2017. Manufactured by Covidien, it is classified as a Class 2 medical device under product code DQA.
What It Is
The Nellcor Pulse Oximetry Monitor Interface Cable is designed to connect pulse oximeters to sensors, facilitating the measurement of oxygen saturation and heart rate. It is primarily used in clinical settings for continuous monitoring of patients.
FDA-Cleared Indications
- For use with compatible Nellcor pulse oximetry sensors and monitors to measure functional oxygen saturation of arterial hemoglobin.
- For monitoring pulse rate derived from the pulse oximetry signal.
- Intended for use in clinical patient-monitoring settings when used with compatible Nellcor equipment.
Clinical Applications
- Continuous oxygen-saturation and pulse-rate monitoring in hospitalized patients.
- Monitoring during postoperative care.
- Monitoring newborn and neonatal patients when used with compatible labeled sensors and monitors.
- Connecting a compatible pulse oximetry sensor to a Nellcor monitor during routine clinical observation.
Evidence Summary
The available literature includes 15 studies, ranging from randomized controlled trials to retrospective analyses, conducted between 1997 and 2012. These studies focus on the device's application in neonatal and surgical contexts.
Reported Outcomes
Published studies report that the Nellcor Pulse Oximetry Monitor Interface Cable provides reliable and accurate readings of oxygen saturation and heart rate. It has been shown to be effective in both neonatal and postoperative settings, with studies highlighting its role in improving monitoring performance.
Safety Profile
Reported complications include occasional inaccuracies in readings during motion or low perfusion states. However, the device is generally considered safe with no significant adverse events reported in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes in some studies and the lack of recent data. Further research is needed to explore long-term outcomes and performance in diverse patient populations.
Practical Considerations
- Compatibility depends on the specific Nellcor monitor, sensor connector and cable model; confirm the equipment labeling before use.
- The interface cable is not itself a pulse oximeter or patient sensor and does not measure oxygen saturation without compatible monitoring equipment.
- Inspect the cable, connectors and insulation before use. Do not use damaged, visibly contaminated or malfunctioning components.
- Follow the manufacturer’s cleaning, disinfection, storage and cable-handling instructions; avoid excessive bending, pulling or tight coiling.
- MRI compatibility is not established from the 510(k) record alone. Confirm the complete monitor, cable and sensor configuration in the manufacturer’s MRI labeling before entering an MRI environment.
Frequently Asked Questions
What are the clinical indications for the Nellcor Pulse Oximetry Monitor Interface Cable?
The device is indicated for monitoring oxygen saturation and heart rate in clinical settings, particularly in neonatal and postoperative care.
What outcomes have been reported in clinical studies?
Studies have reported reliable and accurate readings of oxygen saturation and heart rate, with improved monitoring performance in challenging conditions.
What complications have been reported?
Reported complications include occasional inaccuracies during motion or low perfusion, but no significant adverse events have been documented.
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.