(142 days)
The Innova™ Nasal Non-Vented Mask is intended to be used as an accessory to CPAP/bi-level positive pressure systems containing exhalation valves. This product is indicated for use with CPAP/BI-LEVEL systems that have adequate alarins for positive pressure delivery failure. The mask is ingle patient, multi-use in the home, hospital or institutional environment on adult patients (>30kg/66 lbs.).
The Sleepnet Innova™ Non-Vented Nasal mask is a patient interface for use with positive pressure equipment.
There are 2 labeled versions:
- Single patient, multi-use (home or hospital/institutional) up to 6 months .
- Single patient, multi-use up to 7 days (hospital/institutional) .
The Sleepnet Innova™ Nasal Non-Vented Mask is evaluated for substantial equivalence to the predicate device, K102317 - Sleepnet iQ Ventilation Nasal Mask. The evaluation relies on non-clinical bench testing to demonstrate similar performance characteristics.
1. Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Predicate: iQ Ventilation Nasal Mask) | Reported Device Performance (Subject: Innova Nasal Non-Vented Mask) | Explanation of Differences |
|---|---|---|---|
| Dead Space (ml) | 120 ml | Small/Medium size – 78 ml; Medium/Large size - 100 ml | The dead space of both sizes of the subject device is lower than the predicate device. |
| Resistance to Flow (Pressure Drop) (cm H2O) | @ 30 lpm - 0.31 cm H2O; @ 60 lpm - 1.28 cm H2O | @ 30 lpm - 0.10 cm H2O; @ 50 lpm - 0.33 cm H2O; @ 60 lpm - 0.46 cm H2O; @ 100 lpm - 1.42 cm H2O | The subject device has a lower pressure drop compared to the predicate. No specific performance requirements for pressure drop, but disclosed in labeling consistent with ISO 17510:2015. |
| Unintentional Leak (lpm) | @ 5 cm H2O - 3.2 lpm; @ 10 cm H2O - 5.6 lpm; @ 15 cm H2O - 9.0 lpm; @ 20 cm H2O - 10.8 lpm; @ 25 cm H2O - 12.5 lpm; @ 30 cm H2O - 14.3 lpm | @ 5 cm H2O - 4.86 lpm; @ 10 cm H2O - 9.20 lpm; @ 15 cm H2O - 11.43 lpm; @ 20 cm H2O - 14.70 lpm; @ 25 cm H2O - 17.53 lpm; @ 30 cm H2O - 20.33 lpm | The subject device has a higher unintentional leak than the predicate. However, it is stated that so long as the unintentional leak is lower than 50 lpm (the leak compensation capability of positive pressure ventilators), it does not cause any loss of therapy. The maximum reported leak (20.33 lpm) is below this threshold, implying acceptance. |
2. Sample Size and Data Provenance:
The provided document does not specify a distinct sample size for a test set. The data presented are reported performance characteristics of the Innova Nasal Non-Vented Mask, which are compared against known performance characteristics of the predicate device. The information is derived from non-clinical bench testing. The country of origin of the data is not specified, but the submission is to the US FDA, implying compliance with US regulatory standards. The data is prospective, generated from tests on the subject device.
3. Number of Experts and Qualifications:
Not applicable. The study involves non-clinical bench testing and performance measurements, not expert evaluation of medical cases or images.
4. Adjudication Method:
Not applicable. The study involves non-clinical bench testing and performance measurements, not expert evaluation of medical cases or images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a MRMC comparative effectiveness study was not done. This submission pertains to a medical device (nasal mask) and its performance characteristics through bench testing, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone Performance Study:
Yes, a standalone performance study in the form of non-clinical bench testing was done for the device. This includes measurements for:
- Pressure drop
- Unintentional leak
- Internal Volume / Dead space
- Mechanical drop test
- Cleaning validation
- Shelf-life via Accelerated aging per ASTM F1980:16
- Biocompatibility testing in accordance with ISO 10993-1:2018 and ISO 18562-1:2017 (for mask materials) and ISO 10993-5:2009 and ISO 10993-10:2010 (for headgear material).
- Testing following ISO 17510:2015
7. Type of Ground Truth Used:
The "ground truth" for the non-clinical bench testing is established through standardized testing methodologies and physical measurements, and comparison against the performance of a predicate device. For example, dead space is a direct measurement, resistance to flow is measured using specific flow rates, and unintentional leak is measured at different pressures. The predicate device's performance data serves as the comparative "truth" for demonstrating substantial equivalence.
8. Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI algorithm, and therefore there is no "training set." The performance data is based on physical testing of the device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).