SpO2 Accuracy Comparison of Medline ReNewal Sensors to Arterial Blood CO-Oximetry
Condition: Arterial Oxygen Saturation; Healthy
Study type: Interventional

Summary: 
      The purpose of this clinical study is to validate the SpO2 accuracy of the Medline ReNewal
      pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as
      compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide
      supporting documentation for the SpO2 accuracy validation of the ReNewal sensors.

      It is required that the Accuracy Root Mean Square (ARMS) performance of the ReNewal pulse
      oximetry sensors will meet a specification of 3 or better in non-motion conditions for the
      range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance
      specification.
    

Detailed description: 
      An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and
      to measure the blood oxygen saturation based on the amount of reflected or scattered
      radiation. Pulse oximetry monitoring is considered a standard physiological measurement and
      is used by clinicians in everyday situations to estimate arterial oxygen saturation. Because
      an arterial sample of blood is not required to make the measurement, the pulse oximeter can
      provide non-invasive real time information. The clinical use of pulse oximeters has reduced
      the frequency and necessity of invasive arterial blood sampling and has helped to improve
      patient safety by providing continuous information to clinicians about patients' oxygenation
      status.

      The Medline ReNewal Reprocessed pulse oximeter sensors are indicated for single patient use
      when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are
      required. Following clinical use, each sensor is returned to Medline ReNewal where it is
      cleaned, disinfected, and packaged for an additional clinical use. Each sensor is tracked
      through the reprocessing cycle to monitor the number of times the sensor has been
      reprocessed. The purpose of this study will be to test the accuracy of the SpO2 component of
      the devices.

      The SpO2 accuracy performance of ReNewal pulse oximetry sensors will be evaluated during
      non-motion conditions over the range of 70-100% SaO2 and compared to arterial blood samples
      assessed by CO-Oximetry. A minimum of 10 healthy adult subjects, ranging in pigmentation from
      light to dark, will be enrolled in the study to meet the study design requirements defined by
      International Organization for Standardization (ISO) 80601-2-61:2011 and by the FDA's
      Guidance for Pulse Oximeters (March 4, 2013). The subjects will have an arterial catheter
      placed in the radial artery to allow for simultaneous blood samples during stable plateaus of
      induced hypoxic levels. The investigational devices will be placed on the fingers of both
      hands for the test sites per the instructions for use. Simultaneous data collection will be
      set up for each of the systems under test. For the data analysis, the control oximeter will
      be used to assess the stability of each data point. Data that is found to be unstable will be
      removed prior to the comparative analysis. Next the CO-Oximeter data will be reviewed to make
      sure it does not contain any anomalous values such as elevated, low or inconsistent
      carboxyhemoglobin (COHb), methemoglobin (MetHb), or total hemoglobin (tHb) data. Anomalous
      values will be removed from the analysis prior to pairing of the SpO2 and SaO2 data. The
      Accuracy Root Mean Square (ARMS) calculation is used to determine the SpO2 accuracy
      performance. Success will be achieved with an ARMS of 3 or better showing equivalence to the
      Gold Standard Reference CO-Oximetry providing documentation to support SpO2 accuracy claims
      for the investigational device(s).

      The study population will include 10-15 healthy non-smoking (or has refrained from smoking
      for 2 days) competent adults 18-50 years of age. The subject selection will be an equitable
      distribution of males and females of any race with varying skin tones including at least 2
      darkly pigmented subjects or 15% of the subject pool, whichever is larger. Data collection
      will occur over a 2-5 day period for this study population. Follow-up with each subject will
      be conducted within 5 days following participation in the study and will be conducted via
      telephone, text or email.
    

Intervention name(s): MEDLINE RENEWAL PULSE OXIMETRY SENSORS; CO-OXIMETRY SENSORS
Intervention type(s): Device; Device
Intervention description(s): An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information.; A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will recline for the study. Reference sensors will be placed on each subject to evaluate the SpO2 accuracy and performance. Shield material may be used between any adjacent finger sensors to prevent optical crosstalk. Simultaneous data collection will be set up for devices under test. The data from the test devices will be collected by the sponsor or trained Clinimark Study staff. Data will be collected for 1 second intervals data analysis. The SpO2 accuracy of the test devices will be evaluated over the oxygen saturation range between 70-100%.
Masking: None (Open Label)
Primary purpose: Device Feasibility