Cleared · 510(k)
Nellcor pulse oximetry system with Nell-EQ intelligent processor
Medtronic · Pulmonology
- Type
- Imaging or monitoring
- FDA route
- 510(k) clearance
- Used by
- Clinicians
Bottom line for your practice
50s read
Clinicians will have a Nellcor system designed for more consistent SpO2 readings across skin tones, with sales expected in the upcoming months. The release gives no performance numbers, so the size of any improvement cannot be judged from it.
- What it is
- A pulse oximetry system with a new processor that uses patient-specific and sensor-specific signal characteristics to interpret optical signals into SpO2 values. It also supports Perfusion Index and Heart Rate Variability.
- Indicated for
- Patients who need oxygen saturation (SpO2) and pulse rate monitoring across clinical care settings; the release does not give the full indications for use.
- What changes
- Medtronic says pulse oximetry performance has historically varied with clinical conditions, patient physiology and skin tone. The release does not report a comparison against other devices for the Nell-EQ system.
- Evidence
- Performance testingStudy not named in the releaseThe release gives no result figures. It says clinical studies for the Nell-EQ system included participants across the full range of skin tones and refers to positive verification study results announced earlier in the year.Accuracy, bench or analytical testing. The source reports no clinical outcome trial, which is common for cleared devices.
- Watch for
- Medtronic states these products should not be used as the sole basis for diagnosis or therapy and are intended only as an adjunct in patient assessment. Oxygen saturation accuracy can be affected by certain environmental, equipment and patient physiologic conditions.
- Training
- Medtronic plans to support the rollout with clinician education and training resources.
- FDA decision
- 510(k)Cleared
- De NovoGranted
- PMAApproved