(181 days)
The iVolve® Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The iVolve "Mask is: to be used by adult patients (>66lb/30 kg) for whom positive airway pressure has been prescribed. intended for single-patient re-use in the home, hospital, and sub-acute environment.
The iVolve® N2 and Nasal Masks are respiratory nasal mask interfaces that directs airflow from a positive pressure device to the patient's nose. The iVolve® Full-Face Mask is a mask interface that directs air flow from a positive pressure device to the patient's nose or mouth. The iVolve® Mask Series is held in place with adjustable headgear that straps the mask to the face. The iVolve® is safe when used under the conditions and purposes intended as indicated the labeling provided with the product. The iVolve® is a prescription device supplied non-sterile.
The iVolve® Nasal Mask Series (iVolve® Nasal Mask, iVolve® Full Face Mask, iVolve® N2) is a respiratory mask intended to channel airflow non-invasively to patients from a positive airway pressure device. The device was seeking substantial equivalence to existing predicate devices (Mirage Activa LT Nasal Mask (Resmed, K030798), Mirage Quattro Full Face Mask (Resmed, K113127), and Willow Nasal Mask (BMC, K112271)).
Here's an analysis of the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for the iVolve® Mask Series were based on functional performance metrics relative to predicate devices, with the objective for the device to meet intended product specifications and fall within a ±15% range of the predicate devices for key characteristics.
| Test Name | Acceptance Criteria (Objective) | Reported Device Performance (Result/Conclusion) |
|---|---|---|
| Flow/Pressure Curve | a) To meet intended product specifications; b) To compare to range of predicate ±15% | Within limits/pass |
| Pressure Drop/Resistance | a) To meet intended product specifications; b) To compare to range of predicate ±15% | Within limits/pass |
| Dead Space | a) To meet intended product specifications; b) To compare to range of predicate ±15% | Within limits/pass |
Additional Performance Characteristics (Comparison to predicates):
| Characteristic | iVolve® Nasal Mask Performance | Mirage™ Activa LT Nasal Mask (K030798) (Predicate) | Mirage™ Quattro Full Face Mask (K113127) (Predicate) | Willow Nasal Mask (K112271) (Predicate) |
|---|---|---|---|---|
| Dead Space | S: 123.6ml, M: 134ml, L: 145ml (Nasal); S: 220ml, M: 232ml, L: 246ml (Full-Face); S: 123.6ml, M: 129ml, L: 134.1ml (N2) | S: 123.3ml, M: 134.1ml, L: 145.2ml | S: 217ml, M: 228ml, L: 243ml | (N/A – Willow is a nasal pillow mask, direct dead space comparison not provided for all iVolve types) |
| Resistance/Pressure Drop | Nasal Mask: 0.2 cmH2O at 50L/min, 0.7 cmH2O at 100L/min; Full Face Mask: 0.1 cm H2O at 50L/min, 0.5 cm H2O at 100L/min; N2: 0.5 cm H2O at 50L/min, 0.9 cm H2O at 100L/min. | 0.4 cmH2O at 50L/min, 0.9 cmH2O at 100L/min (Nasal); 0.4 cm H2O at 50ml/min (Partial for Full Face equivalence) | 0.2 cmH2O at 50L/min, 0.4 cmH2O at 100L/min (Full Face); 0.9 cm H2O at 100ml/min (Partial for N2 equivalence) | 1.0 cmH2O at 50L/min, 3.1 cmH2O at 100L/min (Willow Nasal) |
| Operating Conditions | +5 to +40°C, 15% to 93% relative humidity, non-condensing | +5 to +40°C, 15% to 95% relative humidity, non-condensing | -41 to 104°F (+5 to +40°C), 15% to 95% relative humidity, non-condensing | +5°C to +40°C, 10%-93 % relative humidity non-condensing |
| Storage Conditions | -20 to +55°C, 10% to 93% relative humidity, non-condensing | -20 to +60°C, up to 95% relative humidity, non-condensing | -4 to 140°F (-20 to +60°C), 15% to 95% relative humidity, non-condensing | -20°C to +55°C, 10%-93 % relative humidity non-condensing |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: For each performance test (Flow/Pressure Curve, Pressure Drop/Resistance, Dead Space), 3 samples of each mask type (iVolve Nasal Mask, iVolve N2 Nasal Mask, iVolve Full-Face Mask) were tested. For Dead Space, all sizes (S, M, L) were tested. For Flow/Pressure Curve and Pressure Drop/Resistance, a medium size (M*) was tested.
- Data Provenance: The document does not specify the country of origin. The data is from non-clinical performance bench testing, implying it's laboratory-generated data rather than patient-derived (retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This study relies on bench testing for physical and mechanical performance, not expert-derived ground truth from clinical images or diagnoses.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods are typically associated with human expert review in clinical studies. This study involved direct measurement against established physical/mechanical parameters and comparison to predicate device specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This submission focuses on non-clinical performance bench testing for substantial equivalence of a medical device (respiratory mask), not on AI-assisted diagnostic or interpretative tasks that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device (a respiratory mask), not an algorithm or AI system. Its performance evaluation is based on its physical characteristics and functionality.
7. The Type of Ground Truth Used:
- The ground truth in this submission is based on intended product specifications and the performance range of legally marketed predicate devices, specifically:
- Biocompatibility Standards: ISO 10993 for materials (cytotoxicity, animal skin irritation, implantation, genotoxicity, Kligman maximization).
- Performance Standards: Internal product specifications for Flow/Pressure, Resistance/Pressure Drop, and Dead Space, and the established ranges of predicate devices (ResMed Mirage Activa LT Nasal Mask (K030798), ResMed Mirage Quattro Full Face Mask (K113127), and BMC Willow Nasal Mask (K112271)).
- Durability: 200 cycles of home cleaning validated the mask's material integrity.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI or machine learning model. There is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
§ 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).