📋 FDA Reference
Oximetry Interface Kit
Philips Respironics
Summary: The oximetry interface kit by Philips Respironics is a medical device used to monitor oxygen saturation levels in patients. It is primarily used by healthcare professionals in various clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K111378 ↗
Decision Date ?
October 4, 2011
Product Code ?
MNS
Device Class ?
Class 2
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on October 4, 2011. It is manufactured by Philips Respironics and classified as a Class 2 medical device.
What It Is
The oximetry interface kit is a medical device designed to measure and monitor oxygen saturation levels in the blood. It functions by using sensors that detect the amount of oxygen carried by hemoglobin in the blood. This information is crucial for assessing a patient's respiratory function and is commonly used in conjunction with other vital sign monitoring systems.
FDA-Cleared Indications
- Used with compatible monitoring equipment to measure and display arterial oxygen saturation and pulse rate.
- Intended for noninvasive monitoring of oxygen saturation in patients when pulse oximetry is clinically indicated.
- May be used for spot-check or continuous monitoring, depending on the compatible monitor, sensor, and labeling.
Clinical Applications
- Monitoring oxygen saturation and pulse rate during evaluation or treatment of patients with suspected or known respiratory problems.
- Monitoring oxygenation during anesthesia, recovery, or other supervised clinical care when the compatible monitoring system is indicated.
- Continuous or intermittent pulse-oximetry monitoring in hospital, outpatient, or home-care settings when prescribed and configured according to labeling.
- Use as an interface between compatible pulse-oximetry sensors and monitoring equipment.
Practical Considerations
- Compatibility depends on the specific Philips Respironics monitor, interface, cable, and pulse-oximetry sensor; verify the product labeling before connection.
- Correct sensor placement, adequate circulation, and secure cable connections are needed for reliable readings. Motion, poor perfusion, nail products, ambient light, and some skin characteristics can affect accuracy.
- This device provides oxygen-saturation measurements; it does not diagnose the cause of low oxygen levels or replace clinical assessment and blood-gas testing when indicated.
- The available interface and sensor configurations determine patient size and application site, such as adult, pediatric, or neonatal use and finger, toe, or other approved sites.
- MRI compatibility is configuration-specific. Do not bring the kit or connected components into an MRI environment unless the exact components are labeled MR Safe or MR Conditional and the stated conditions are followed.
Related Literature
The linked study describes a web-based vital sign telemonitor that includes the use of an oximetry development kit for monitoring oxygen saturation. The study highlights the system's ability to acquire and display vital signs over the internet, making it useful for telemedicine applications. However, the study's design was limited to a prototype system and did not include clinical trials to validate its effectiveness in real-world settings.
Frequently Asked Questions
What is the oximetry interface kit used for?
It is used to monitor and measure oxygen saturation levels in patients' blood, providing crucial information for assessing respiratory function.
What specialties typically use this device?
Specialties such as pulmonology, critical care, anesthesiology, and home healthcare commonly use this device.
What are the FDA-cleared indications?
The device is cleared for monitoring oxygen saturation levels in patients, useful for those with respiratory conditions or undergoing surgery.
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.