Accuracy Validation of Belun Oxygen Saturation Pulse Oximeter FDA Submission Study

NCT03439306 | Completed FDA Device

• 1 other identifier: PR-2016-207
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (2)

• Collect SpO2 data for accuracy statistical analysis by 11 subjects

  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.

  3 days

• Accuracy data analysis

  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)

  3 days

Study Arms (1)

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

Interventions

Pulse Oximeter DEVICE

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.

healthy adult volunteer

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Belun Technology Company Limited: lead
• Clinimark, LLC: collaborator

Study Sites (1)

Clinimark, LLC

Louisville, Colorado, 80027, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arthur Ruiz Cabrera, M.D.

  Clinimark, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: February 20, 2018
• Study Start: March 15, 2017
• Primary Completion: March 17, 2017
• Study Completion: March 17, 2017
• Last Updated: February 20, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)