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Accuracy Validation of Belun Oxygen Saturation Pulse Oximeter FDA Submission Study

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ClinicalTrials.gov Identifier: NCT03439306
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : February 20, 2018
Sponsor:
Collaborator:
Clinimark, LLC
Information provided by (Responsible Party):
Belun Technology Company Limited

Brief Summary:
The purpose of this study is to evaluate the oxygen saturation accuracy performance of Belun Ring Oximeter placed on the index fingers during non-motion conditions

Condition or disease Intervention/treatment
Hypoxia Device: Pulse Oximeter

Detailed Description:

The purpose of this study is to evaluate the SpO2 accuracy performance of Belun Ring Oximeter placed on the index fingers during non-motion conditions over the range of 70-100% SaO2, arterial blood samples, assessed by CO-Oximetry. It is expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system will meet the required specification of ARMS of 3.5% or less allowed for reflectance technology in non-motion conditions for the range of 70 - 100% SaO2.

The Clinimark proprietary Desaturation Fixture with Automated Data Collection is a single limb blow by system used to deliver medical grade oxygen and nitrogen gas mixtures to induce various hypoxic levels in subjects at a slow steady rate allowing an automatic marking and collection of the Control or secondary Transfer reference Pulse Oximeter and other pulse oximetry systems at 1 second intervals.

The Control Pulse Oximeter, an FDA cleared device, is used to monitor the oxygen saturation levels real time throughout the study for subject safety and to target stable plateaus. This device is used to assess the stability of the data.

Multi-parameter monitor used during the study to observe a subject's vital signs including ECG tracing, heart rate, respiratory rate, end-tidal CO2 with capnograph, secondary monitor for the oxygen concentration being delivered to the subject.

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.


Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Accuracy Validation of Belun SpO2 Pulse Oximeter FDA Submission Study
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : March 17, 2017
Actual Study Completion Date : March 17, 2017

Group/Cohort Intervention/treatment
healthy adult volunteer

Subject is 18 to 50 years of age.

Subject is a non-smoker or who has not smoked within 2 days prior to the study.

Device: Pulse Oximeter
The Pulse Oximeter are placed on the left and right Index fingers of each subject of the healthy adult volunteer group to evaluate the SpO2 accuracy performance.




Primary Outcome Measures :
  1. Collect SpO2 data for accuracy statistical analysis by 11 subjects [ Time Frame: 3 days ]
    Subjects were given medical grade mixtures of oxygen and nitrogen to induce stable plateaus across the range of 100% to 70%. The stable plateaus allowed data collection in the following SaO2 ranges 95-100, 90-95, 85-90, 80-85, 75-80, 67-75. In general, 4 to 8 discrete points were collected at each of the levels.

  2. Accuracy data analysis [ Time Frame: 3 days ]
    Data analysis follows ISO80601-2-61:2011, Annex EE and Pulse Oximeters - Premarket Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy adult volunteer. The skin pigmentation / tones ranged from light to dark meeting the requirement of at least 2 darkly pigmented or 15 % of the subject pool whichever is larger.
Criteria

Inclusion Criteria:

  • Subject must have the ability to understand and provide written informed consent.
  • Subject is 18 to 50 years of age.
  • Subject must be willing and able to comply with study procedures and duration.
  • Subject is a non-smoker or who has not smoked within 2 days prior to the study.
  • Male or female of any race.
  • Subject demographics include a range of skin pigmentations, including at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger.

Exclusion Criteria:

  • Subject is considered as being morbidly obese (defined as BMI large than 39.5).
  • Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
  • Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study.
  • Subjects with COHb levels larger than 3% as assessed with a Masimo Radical 7 (Rainbow).
  • Subjects with known respiratory conditions such as (self-reported) uncontrolled / severe asthma, flu, pneumonia / bronchitis, shortness of breath / respiratory distress, respiratory or lung surgery, emphysema, COPD, lung disease.
  • Subjects with known heart or cardiovascular conditions such as: (self-reported), except for blood pressure and ECG review) hypertension, have had cardiovascular surgery, Chest pain (angina), heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia, previous heart attack, blocked artery, unexplained shortness of breath, congestive heart failure (CHF), history of stroke, transient ischemic attack, carotid artery disease, myocardial ischemia, myocardial infarction, cardiomyopathy.
  • Self-reported health conditions as identified in the Health Assessment Form (self-reported), diabetes, thyroid disease, kidney disease / chronic renal impairment, history of seizures (except childhood febrile seizures), epilepsy, history of unexplained syncope, recent history of frequent migraine headaches, recent head injury, cancer / chemotherapy.
  • Subjects with known clotting disorders (self-reported) history of bleeding disorders or personal history of prolonged bleeding from injury, history of blood clots, hemophilia, current use of blood thinner: prescription or daily use of aspirin.
  • Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported).
  • Unwillingness or inability to remove colored nail polish from test digits.
  • Other known health condition, should be considered upon disclosure in health assessment form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439306


Locations
United States, Colorado
Clinimark, LLC
Louisville, Colorado, United States, 80027
Sponsors and Collaborators
Belun Technology Company Limited
Clinimark, LLC
Investigators
Principal Investigator: Arthur Ruiz Cabrera, M.D. Clinimark, LLC

Responsible Party: Belun Technology Company Limited
ClinicalTrials.gov Identifier: NCT03439306     History of Changes
Other Study ID Numbers: PR-2016-207
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms