📋 FDA Reference
Sensmart Model 8006ca Reusable Regional Oximetry Sensor Sensmart Model 8006pi Disposable Patient Interface
Nonin Medical
Summary: The Sensmart Model 8006CA is a reusable regional oximetry sensor, and the Model 8006PI is a disposable patient interface, both used for monitoring tissue oxygenation. They are primarily used by clinicians in settings requiring precise oxygenation monitoring.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K190560 ↗
Decision Date ?
May 2, 2019
Product Code ?
MUD
Device Class ?
Class 2
Evidence ?
0 studies
The Sensmart Model 8006CA and 8006PI were cleared through the FDA 510k pathway on May 2, 2019. Manufactured by Nonin Medical, these devices are classified as Class 2 under product code MUD.
What It Is
The Sensmart Model 8006CA is a reusable sensor designed to measure regional oxygen saturation (rSO2) in tissues, providing clinicians with critical data on tissue oxygenation. The Model 8006PI is a disposable interface that ensures hygienic application of the sensor. These devices utilize near-infrared spectroscopy to non-invasively assess oxygen levels, which is crucial in various medical settings.
FDA-Cleared Indications
- Noninvasive monitoring of regional tissue oxygen saturation (rSO2) in tissue.
- Use with the compatible SenSmart monitoring system during patient care and procedures in which regional tissue oxygenation is monitored.
Clinical Applications
- Monitoring regional tissue oxygenation during surgical procedures.
- Monitoring tissue oxygenation in critical care settings.
- Assessing regional oxygenation when blood flow or oxygen delivery may change during a procedure or treatment.
Practical Considerations
- The Model 8006CA is reusable, while the Model 8006PI is a disposable patient interface intended to provide a hygienic contact layer between the sensor and the patient.
- Verify compatibility with the SenSmart monitor and associated cables before use; the sensor should not be assumed to work with unrelated monitoring systems.
- Correct placement, secure contact and appropriate site preparation are important because movement, poor contact, ambient light and tissue characteristics can affect readings.
- The available FDA record does not establish MRI safety for these components. Confirm MRI labeling with Nonin and the facility's MRI safety team before bringing the sensor or interface into an MRI environment.
- Use and interpretation should follow the manufacturer's instructions. Regional oximetry readings are adjunctive measurements and should be interpreted with the patient's clinical condition and other monitoring data.
Frequently Asked Questions
What is Sensmart Model 8006CA/8006PI used for?
It is used for monitoring regional tissue oxygenation in clinical settings, providing data on tissue perfusion and oxygen delivery.
What specialties typically use this device?
Specialties such as anesthesiology, cardiology, and neurology commonly use these devices, especially in surgical and critical care settings.
What are the FDA-cleared indications?
The device is indicated for monitoring tissue oxygenation in patients undergoing procedures that may impact blood flow or oxygen delivery.
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.