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510(k) Data Aggregation
(264 days)
The SuperNO2VA Et™ Device is a nasal mask that creates a seal when positioned over a patient's nose to direct anesthesia gas, air, and / or oxygen to the upper airway during the continuum of anesthesia care.
It has a means for sampling expired gases from the patient's exhaled breath from the oral / nasal areas.
The SuperNO2VA Et™ Device is intended for short-term (30 kg.). It is a single patient use, disposable.
The SuperNO2VA Et™ Device is contraindicated for use in long-term ventilation conditions and treatment of sleep apnea.
To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure.
The SuperNO2VA Et™ Device is a nasal mask with a sampling port for the nasal portion and a sampling "hood" for over the mouth.
The subject device is similar to an anesthesia or oxygen mask with gas sampling port. Instead of covering the full face the SuperNO2VA Et™ Device design is to allow the clinician to have access to the oral cavity during a procedure but still be able to provide air, oxygen or anesthesia gases to the patient while also sampling expired gases from the nasal or oral areas.
The design incorporates the standard 15 mm male circuit connector, luer fitting for the gas sampling line and a slip-fit port for pressure monitoring or oxygen if the mask is used with a manual resuscitator or hyperinflation bag.
The mask is not considered a long-term use device as it would only be used from pre- to postoperative care. This would be similar to the standard anesthesia mask.
It is not for use in long-term ventilation conditions or the treatment of sleep apnea.
Here's a breakdown of the acceptance criteria and study information for the SuperNO2VA Et™ Device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than explicitly stating pre-defined acceptance criteria for each tested parameter. However, we can infer some criteria from the comparative testing and performance values presented. The "Proposed SuperNO2VA EtTM Device" column shows the reported performance.
| Feature | Acceptance Criteria (Inferred from Predicate/Equivalence) | Reported Device Performance (SuperNO2VA Et™ Device) |
|---|---|---|
| Mechanical Performance | ||
| Internal Volume (Nasal mask only) | Comparable to K163277 (Medium – 53 ml, Large – 87 ml) | Medium – 53 ml, Large - 87 ml |
| Pressure to maintain a seal | Comparable to K163277 (Up to 30 cmH2O) | Up to 30 cmH2O |
| Resistance to flow | Comparable to K163277 (0.46 cmH2O @ 50 lpm, 1.8 cmH2O @ 100 lpm) & Medline (30 lpm – 0.13 cmH2O, 60 lpm – 0.25 cmH2O, 90 lpm – 0.51 cmH2O) | 0.46 cmH2O @ 50 lpm, 1.8 cmH2O @ 100 lpm |
| Leak rate under pressure | Comparable to K163277 (0.8 Lpm @ 20 cmH2O) | 0.8 Lpm @ 20 cmH2O |
| Dead space (Nasal mask only) | Comparable to K163277 (Medium – 53 ml, Large – 87 ml) | Medium – 53 ml, Large – 87 ml |
| Pressure / Leakage (General) | Maintain pressure > 20 cmH2O with 10 lbs. force, Leakage 20 cmH2O with 10 lbs. force, Leakage |
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