Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer
Phase: NA
Conditions: Healthy
Sponsor: BioSerenity

RESUME_STUDY 
Clinical study EOXY 
BIOSERENITY_80601-2-61 
 
 
 
 
 
Abstract_EOXY                                                                                                                           Page 1 on 4 
Title 
Clinical Trial testing the BioSerenity Pulse Oximeter (EOXY) efficacy, 
performance and safety in healthy volunteer 
 
NCT 
NCT03614416 
Document date 
05 june 2017 
 
Objectives 
 
Primary objective: evaluate the SpO2 and HR accuracy of the Bioserenity 
pulse oximeter (EOXY), evaluating the performance of the device 
compared to invasive method blood sampling (SaO2) by CO-Oximeter, 
and compared to a pulse oximeter gold standard. 
 
Secondary objective 1: measurement of the variation of the fraction of 
inspired oxygen (FiO2).  
 
Secondary objective 2: validation of the algorithm for data review and 
analysis of signal. 
 
Type of the investigational  
medical device 
 
Type: 
Wireless non-invasive and reflectance-based pulse oximeter developed 
by Bioserenity 
 
Description: 
 As opposed to transmittance oximeters, the photodiodes of reflectance-
based oximeters collect the light emitted by the LEDs and reflected (as 
opposed to crossing light) by the bones, tissues and muscles. The 
reflectance type pulse oximeters can perform measurement from various 
sites of the body, excluding the limitation of measurement position [1]. 
 
Using of the device for the study: 
Intended to be used to acquire and transmit recorded data from adults. 
The EOXY permits non-invasive, continuous acquisition and monitoring 
of the pulse rate (PR) and of the oxygen saturation level in the blood 
(SpO2) of adults. For the study, it is intended to be used on different body 
site as the forehead, the chest or the back.  
 

RESUME_STUDY 
Clinical study EOXY 
BIOSERENITY_80601-2-61 
 
 
 
 
 
Abstract_EOXY                                                                                                                           Page 2 on 4 
Method 
According to the European standard ISO 80601-2-61:2011, clinical 
investigation is conducted in order to assess the performance and safety 
of pulse oximeters, comparing the measured EOXY SpO2 values to SaO2 
values collected by invasive methods using blood sampling, and 
comparing the EOXY heart rate values to goldstandard heart rate.  
 
The EOXY SPO2 and HR measurements, is performed in O2 saturation 
conditions up to 100% and then in different desaturation plateaus, 
ranging from 100 % to 70%. Three EOXY pulse oximeters record the SpO2 
and HR at the same time in 3 different body areas : chest, back-torso, 
forehead. Different body areas are tested in order to assess separately 
the safety and performance of the EOXY device on these areas. The EOXY 
SpO2 values is simultaneously compared to SaO2 measures providing 
from invasive blood sampling taken from an indwelling arterial catheter. 
The EOXY heart rate measures is compared to a gold standard oximeter 
CE-marked. The controlled desaturation is performed in five progressive 
plateaus from 100% to 70%. As the example given in the ISO standard, 
we choose to do the test on the 70-100% desaturation range, with 5 
plateaus (100%-97%; 97%-92%; 92%-85%; 84%-78%; 77%-70%). 5 SPO2 
values, 5 SaO2 values (blood samples) and 5 heart rate measures are 
collected per plateau, for each of 13 subjects.  
The desaturation plateaus are reached using controlled FiO2 levels 
performed by a device. It permits to bring subjects near target levels of 
desaturation plateaus and to maintain them at the target plateau during 
the 5 blood samples.  
 
A number of inclusions of 13 was chosen to have at least 10 subjects, in 
case of drop-outs or analysis exclusions. ISO 80601-2-61:2011 standard 
advices to collect 200 pairs of data. 
 
 
Medical conditions and criteria of 
inclusion/exclusion 
 
Medical conditions:  
13 Healthy subjects 
Target population defined in accordance  
 
Specific population: 
☒yes  ☐non 
Description:  among the healthy subjects, at least two must have a dark 
skin pigmentation as required by 80601-2-61:2011 standard and FDA 
guidance  
 
Inclusion criteria: 
- Healthy subject (Man/ Women) > 18 years old 
- Subject signed informed consent prior to any screening procedure 
- Subject in good health (COHb < 3%, MetHb < 2%, CtHb > 10mg/dL). This 
criterion is assessed by a finger-prick blood test 
- Healthy adult capable of undergoing controlled hypoxemia to the level 
called for in the protocol with minimal medical risk 
 
 
 

RESUME_STUDY 
Clinical study EOXY 
BIOSERENITY_80601-2-61 
 
 
 
 
 
Abstract_EOXY                                                                                                                           Page 3 on 4 
 
Exclusion criteria: 
- Smokers or individuals exposed to high levels of carbon monoxide that 
result in elevation of carboxy hemoglobin levels 
- Individual subject to conditions that result in elevated levels of 
methemoglobin 
- Subject who would be placed at undue medical risk associated with any 
procedure called for in the protocol 
- Subject with open wounds 
- Pregnant woman (negative pregnancy test needed) 
- Subject allergic to silicon, polyamide and silver yarn 
- Subject with cardiorespiratory disorders likely to worsen with thoracic 
pressure applied by the textile band 
- Subject with mental or motor impairment preventing him from 
expressing pain 
- Subject with blood or skin disorder that may impacting results 
- Subject with behavioral disorders, too agitated or too aggressive 
- Subject with sensorial disorders, insensible to skin pain 
- Subject susceptible to tension/pressure-based headaches 
 
No vulnerable subject is enrolled on this study. 
 
Duration of participation and follow-up 
Participation duration: 2 days (3 days for subjects of phase 1) 
No follow-up visit planned 
 
End point criteria 
Primary objective : 
-For performance: Collection of 5 different values of SpO2, SaO2 and HR 
after each desaturation plateau. These values are used for the analysis of 
the performance of the EOXY device and the performance of the gold 
standard, following the ISO 80601-2-61:2011 standard. 
-For safety: Monitoring of vital sign: heart rate (HR) continuously, blood 
pressure and temperature between each desaturation plateau. Also, 
adverse events are collected during the study. 
 
Secondary objective 1 : 
FiO2 is assessed to bring subjects near target levels of desaturation 
plateau. No analysis is performed on these data. 
 
Secondary objective 2 : 
Assessment thanks to the signal analysis. No data analysis performed 
 
Statistical method 
The clinical performance analysis for this study is assessed by the 
Accuracy Root-Mean square (ARMs) (calculated by the difference 
between the investigational pulse oximeter SpO2 measurement and the 
co-oximeter’s SaO2 measurements) and is assessed by the Bland-Altman 
plot visualizing the difference between SpO2 and SaO2. 

RESUME_STUDY 
Clinical study EOXY 
BIOSERENITY_80601-2-61 
 
 
 
 
 
Abstract_EOXY                                                                                                                           Page 4 on 4 
ARMS is a representation of the combination of systematic and random 
error. It is defined as the accuracy root-mean-square error difference 
between the measured value and the truth value calculated as below, 
where “n” is the number of observations, and both SpO2 and SaO2 are 
defined as: 
 
According to the ISO 80601-2-61:2011 standard, the accuracy of the 
SpO2 of the oximeter under test, should have an average root mean 
square deviation ARMS, equal to or less than 4.0%, over a SaO2 range 
between 70% and 100%.  
In the same way, the accuracy of the pulse rate (HR) must have an 
average root mean square deviation equal to or less than 4.0% over the 
70-100% range. It is also possible to claim specific accuracies on segments 
of this range. 
 
Safety assessment 
Assessment of the number of undesirable effects 
 
References 
[1] Marcus Kramer, Aaron Lobbestael et al. Wearable Pulse Oximetry 
Measurements on the Torso, Arms, and Legs: A Proof of Concept ; 
Military medicine 182(S1):92-98 · March 2017