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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 (<24 hours) use on adult patients (>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 < 2 Lpm | Can maintain pressure of > 20 cmH2O with 10 lbs. force, Leakage < 2 Lpm |
| Pressure Drop Acceptance | < 5 cmH2O @ 60 Lpm (from predicate RMD SuperNO2VA) | 30 lpm – 0.13 cmH2O, 60 lpm – 0.38 cmH2O, 90 lpm – 1.15 cmH2O |
| Biocompatibility | ISO 10993-1 compliance for externally communicating tissue, surface contact (skin/mucosal), limited duration (<24 hours) | ISO 10993-1 compliant, externally communicating tissue, surface contact (skin/mucosal), limited duration (<24 hours). Testing included: Cytotoxicity, Sensitization, Irritation. |
| O2 / CO2 Performance | Comparable to K011050 (Oridion - Capnostream) for nasal and oral sampling. Also comparable to Exempt Medline Anesthesia mask for both nasal/oral sampling under positive pressure. Note: The exact delta for "comparable" isn't quantified. | Nasal Sampling (Adult, CO2 1%, O2 Flow 1 lpm): Ave. - 1.00% Nasal Sampling (Adult, CO2 1%, O2 Flow 5 lpm): Ave. - 4.93% Nasal Sampling (Adult, CO2 5%, O2 Flow 1 lpm): Ave. - 0.94% Nasal Sampling (Adult, CO2 5%, O2 Flow 5 lpm): Ave. - 4.92% Oral Sampling (Adult, CO2 1%, O2 Flow 1 lpm): Ave. - 0.98% Oral Sampling (Adult, CO2 1%, O2 Flow 5 lpm): Ave. - 4.95% Oral Sampling (Adult, CO2 5%, O2 Flow 1 lpm): Ave. - 0.90% Oral Sampling (Adult, CO2 5%, O2 Flow 5 lpm): Ave. - 4.46% |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each test in terms of number of physical devices or runs, but it refers to "testing" and provides average values. For the O2/CO2 performance, the values are "Ave." suggesting multiple measurements were taken for each condition (Adult/Pediatric, CO2%, O2 Flow).
- Data Provenance: The document explicitly states "Bench Testing" and refers to the device's internal performance tests. This implies a controlled laboratory environment. There is no information provided regarding country of origin of the data or whether it was retrospective or prospective in a clinical setting. It solely refers to non-clinical (bench) testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
There is no mention of experts being used to establish a "ground truth" for the test set. The testing described is bench testing against specified parameters or compared to predicate device performance under simulated conditions. This type of engineering performance evaluation typically does not involve human expert adjudication of results but rather objective measurements.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this was bench testing based on objective measurements and comparisons to predicate device specifications, not a study requiring human adjudication (like image interpretation or clinical outcomes).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes a 510(k) submission for a medical device (a nasal mask with gas sampling), which is typically supported by bench testing and comparison to predicate devices, not MRMC studies. MRMC studies are generally relevant for AI/radiology devices where human interpretation is a key component.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. The SuperNO2VA Et™ Device is a physical medical device (a mask) with technical specifications, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for the testing described is primarily based on objective physical measurements and engineering specifications, which are then compared to the performance of legally marketed predicate devices and established standards (e.g., ISO 10993-1). For the O2/CO2 performance, the "ground truth" would be the known CO2 concentrations and O2 flow rates created in the simulated breathing setup.
8. Sample Size for the Training Set
Not applicable. As stated, this is a physical medical device, not a machine learning or AI algorithm, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as above.
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