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| Name | Class |
|---|---|
| Clinimark, LLC | OTHER |
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Data will be collected with the MultiSense® pulse oximetry system during non-motion conditions over the range of 70-100%. A Clinimark reference system, previously correlated to arterial blood CO-Oximetry will be the basis for comparison. A minimum of fifteen (15) up to fifty (50) healthy adult subjects, ranging in pigmentation from light to dark, with at least six (6) subjects with dark pigmentation (Fitzpatrick 5-6), will be enrolled in the study to meet the study design requirements defined by ISO 80601-2-61 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). SpO2 data will be evaluated during non-motion conditions. SpO2 data will be evaluated during stable step plateaus of induced hypoxic levels. The investigational device will be placed on the thorax of the subjects (patch on the upper back and external electrode on the right pectoral). Simultaneous data collection will be set up for the reference and the systems under test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controled Hypoxia - Healthy volunteer | Other | Male and female subjects, ranging in pigmentation from light to dark |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse Oximeter, Respiratory Rate, Heart Rate | Device | Measurement of physiological parameters |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the quality of measurements of arterial blood saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with a reference Pulse Oximetry System, in terms of accuracy. | Accuracy is defined as an average measurement variation less than 3.5% of the mean value to the reference standard. Reference Pulse Oximetry Systems, previously compared to Reference CO-Oximetry will be used as the basis for comparison. The study population will include 15 to 50 subjects. The data for analysis will be equally distributed across the range of 70-100%. All data will be used for the analysis unless identified as unstable by the control oximeter. Data that is found to be unstable will be removed prior to the comparative analysis. | from device placement to device removal, assessed up to 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinimark LLC | Louisville | Colorado | 80027 | United States |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D056152 | Respiratory Rate |
| D006339 | Heart Rate |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D012119 |
| Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |