510(k) for Motion Claims

510(k) for Motion Claims

Covidien is the Covidien the first company to receive FDA clearance for a motion-tolerant bedside pulse oximeter.

May 23, 2013
Manufacturing Group
Devices/Implants/Equipment Contract Manufacturing Design/Engineering Industry/Regulations People/Facilities Motion Control

Covidien officials announced that its Nellcor pulse oximetry portfolio, which is used to measure arterial oxygen saturation, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for motion claims. This makes Covidien the first company to receive FDA clearance for a motion-tolerant bedside pulse oximeter portfolio that is also compliant with ISO 80601-2-61 (International Organization for Standardization standards for pulse oximetry).

Devices covered by the action include:

Pulse oximeters provide early warning of dangerous respiratory complications, enabling clinicians to detect and address life-threatening events sooner. Nellcor devices rely on cardiac-based signals to provide a more accurate reading that is closely tied to the patient’s physiology. This drives consistent performance during various challenging conditions, such as patient motion, noise and low perfusion, which can impede the assessment of patient respiratory status.

Motion-tolerant pulse oximetry is critical for ensuring patient safety because patient movement can thwart accurate readings and delay diagnosis of serious respiratory compromise.

“For more than 30 years, clinicians have trusted Nellcor pulse oximetry to monitor their patients,” states Robert J. White, president, Respiratory and Monitoring Solutions, Covidien. “The FDA’s recent clearance of motion-tolerance claims should now give clinicians added comfort that they’re providing the highest standard of patient care.”

Covidien offers comprehensive pulse oximetry training through its new Professional Affairs and Clinical Education Online Platform to support the safe and effective use of motion-tolerant pulse oximeters. For customers, Covidien further offers in-service programs, in-house continuing education programs and field-based technical training tools.

The Nellcor Bedside SpO2 Patient Monitoring System, Bedside Respiratory Patient Monitoring System, and N-600x Pulse Oximetry Monitoring System are indicated for prescription-use only for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. They are intended for neonatal, pediatric, and adult patients, and for well or poorly perfused patients in hospitals, hospital-type facilities, intra-hospital transport and home environments.