(274 days)
The IQ® Ventilation Nasal Mask is to be used as an accessory to CPAP / bi-level positive pressure systems that have adequate alarms and safety systems for positive pressure delivery failure. Use of this product is indicated for use with CPAP / BI-LEVEL POSITIVE PRESSURE SYSTEMS CONTAINING EXHALATION VALVES.
The IQ® Ventilation Nasal mask is intended for single patient, multi-use in the home environment and multiple patients, multi-use in the hospital/institutional environment.
The SleepNet IQ® Ventilation Nasal mask is a standard type nasal mask but with no vent ports in the swivel elbow which allows this mask to be used with CPAP and bi-level positive pressure systems.
The IQ® Ventilation Nasal mask requires that the mask and circuit be connected to a positive pressure (CPAP / bi-level) system with its own exhalation valve having adequate alarms and safety systems for positive pressure delivery failure.
The IQ® Ventilation Nasal mask also utilizes standard headgear, swivel elbow (without vent holes) and a delivery tube.
This document describes a 510(k) submission for the SleepNet IQ® Ventilation Nasal Mask, which is a patient interface intended for use with CPAP/bi-level positive pressure systems containing exhalation valves.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SleepNet IQ® Ventilation Nasal Mask are established by demonstrating substantial equivalence to predicate devices through comparative performance testing. The reported device performance is presented in comparison to these predicate devices. The "acceptance criteria" column reflects the performance of the predicate device that the proposed device aims to be equivalent to or demonstrate comparable performance with.
| Performance Metric | Acceptance Criteria (Predicate: Respironics Contour nasal mask (Deluxe) – K991648 unless specified) | Reported Device Performance (SleepNet IQ® Ventilation Nasal mask) |
|---|---|---|
| Unintentional Leak | ||
| 3 cm H₂O | 2.3 lpm | 1.8 lpm |
| 10 cm H₂O | 5.4 lpm | 4.3 lpm |
| 20 cm H₂O | 9.6 lpm | 7.9 lpm |
| 30 cm H₂O | 15.9 lpm | 13.7 lpm |
| 40 cm H₂O | 25.9 lpm | 22.9 lpm |
| Intentional Leak | ||
| 3 cm H₂O | 1.5 lpm | 1.5 lpm |
| 10 cm H₂O | 3.6 lpm | 3.9 lpm |
| 20 cm H₂O | 5.8 lpm | 6.4 lpm |
| 30 cm H₂O | 7.5 lpm | 8.5 lpm |
| 40 cm H₂O | 9.1 lpm | 10.2 lpm |
| Internal volume / Dead space | 120 ml | 120 ml |
| Pressure Drop | ||
| 0.25 cm H₂O @ 30 lpm | 0.25 cm H₂O @ 30 lpm (Tested with extension tube) | 0.31 cm H₂O @ 30 lpm |
| 1.02 cm H₂O @ 60 lpm | 1.02 cm H₂O @ 60 lpm | 1.28 cm H₂O @ 60 lpm |
| Biocompatibility | Tested to ISO 10993 (Predicate materials) | Tested to ISO 10993 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of human subjects or a clinical study. The performance data presented (e.g., leak rates, pressure drop, internal volume) are results of bench testing (laboratory measurements). Therefore, sample size is not applicable in the human case, and data provenance refers to the laboratory environment where these tests were conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on substantial equivalence through bench testing to established predicate devices, not on human expert ground truth for interpretation of outcomes.
4. Adjudication Method for the Test Set
Not applicable. As this is bench testing, there is no adjudication method in the context of human expert review.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done, as this is a medical device (nasal mask) and not an AI-powered diagnostic or assistive technology. Therefore, effect size related to human reader improvement with AI is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical nasal mask, not an algorithm, so standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on engineering and performance specifications derived from legally marketed predicate devices and international standards (e.g., ISO 10993 for biocompatibility). The claim of substantial equivalence is based on demonstrating comparable physical and functional characteristics.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in that context.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an algorithm, there is no ground truth established for it.
§ 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).