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510(k) Data Aggregation
(144 days)
The Sleepnet Moio 2 and Veraseal 3 Non-Vented and AAV Non-Vented Full Face Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.
Veraseal 3 - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional)
Mojo 2 - Single patient, multi-use (home or hospital/institutional)
The Sleepnet Mojo 2 and Veraseal 3 are full face mask used with non0invasive ventilation. They are available in multiple sizes and in a Non-Vented style with an elbow and Non-Vented with elbow and anti-asphyxia (AAV) valve.
The subject of this submission is:
- . Slight redesign of the shape of the masks but no appreciable differences as the elbow is identical to the predicate
- Add an anti-asphyxia valve (AAV) option .
- Add an additional size, ex-large, mask to the product line ●
Veraseal 3 is intended as a Disposable single use (hospital/institutional) and as a Single patient, multi-use up to 7 days (hospital/institutional)
Mojo 2 is intended as a Single patient, multi-use (home or hospital/institutional)
The provided FDA 510(k) summary (K190533) describes the acceptance criteria and supporting studies for the Sleepnet Mojo 2 and Veraseal 3 Full Face Non-Vented Masks.
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to a predicate device (K063806 - Sleepnet Mojo Full Face mask) and reference devices (K101129 – Respironics - AF531 SE Full Face Mask, K121692 - MiniMe 2 nasal) through non-clinical bench testing. The acceptance criteria are implicitly based on being "similar" to the predicate or reference device, or meeting specific ISO standards.
| Acceptance Criteria / Attribute | Reported Device Performance (Subject Device) | Predicate/Reference Device Performance | Explanation of Differences / Compliance |
|---|---|---|---|
| Indications for Use | The Sleepnet Mojo 2 and Veraseal 3 Non-Vented and AAV Non-Vented Full Face Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multi-use version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation. Veraseal 3: Disposable single use (hospital/institutional); Single patient, multi-use up to 7 days (hospital/institutional). Mojo 2: Single patient, multi-use (home or hospital/institutional). | The Sleepnet Mojo-NV Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation. (Standard version): For homecare applications, the Sleepnet Mojo-NV Full Face Mask, Non-vented may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients. (Disposable version): The Sleepnet Mojo-NV Full Face Mask, Non-vented Disposable is a single patient, single use interface. | Similar. The subject devices maintain the same core intended use and patient population as the predicate, with expanded specific use cases for the new models (Veraseal 3 disposable/multi-use, Mojo 2 multi-use). |
| Patient Population | Adult (>30 kg) | Adult (>30 kg) | Identical. |
| Environment of Use | The masks are intended for use in the home or hospital/institutional environment. | The masks are intended for use in the home or hospital/institutional environment. | Identical for each model. |
| Duration of Use | Veraseal 3: Disposable, single patient use; Single patient, multi-use up to 7 days. Mojo 2: Single patient, multi-use. | Mojo: Single patient, multi-use; Multi-patient, multi-use. | Added Veraseal 3 model, which has similar durations of use to the predicate. The overall duration intent is similar or further defined. |
| Useful Life | Veraseal 3: Single use disposable; Up to 7 days. Mojo 2: Expected useful life - 6 months. | Mojo: Expected useful life - 6 months. | Performance testing was done to support this length of use. The products are all still single patient, multi-use. This indicates that the new devices' useful life meets the predicate's established useful life where applicable, or has been validated. |
| Biocompatibility | Materials in patient contact are identical to predicate device, evaluated as permanent duration. Meets ISO 10993 for biocompatibility via Material Certification. | Materials in patient contact (for predicate) also meet ISO 10993-1 categories for surface contact, intact skin, externally communicating, tissue, and permanent duration of use. | Identical safety profile. This implies the new materials are either identical to the predicate or have been tested to the same standard (ISO 10993) and deemed safe for the specified contact and duration. |
| Internal Volume / Dead space | Veraseal 3 w/o AAV: 180 ml, 193 ml, 203 ml, 215 ml. Veraseal 3 w/AAV: 180 ml, 194 ml, 203 ml, 213 ml. Mojo 2 w/o AAV: 177 ml, 194 ml, 209 ml, 216 ml. Mojo 2 w/AAV: 176 ml, 193 ml, 206 ml, 220 ml. | Mojo w/o AAV: 180 ml, 220 ml, 255 ml. (Reference K101129): 308 ml, 423 ml, 469 ml. | Less than reference and similar to the predicate Mojo. The acceptance criterion is likely to maintain dead space within clinically acceptable ranges, often implying values no greater than the predicate or established safe limits. The subject devices demonstrate lower or comparable dead space to the predicate and significantly lower than the reference. |
| Anti-asphyxia valve (AAV) Pressure Opening / Closing | Mojo 2: Opening - 1.15 cm H2O; Closing - 1.55 cm H2O. Veraseal 3: Opening - 1.2 cm H2O; Closing - 1.5 cm H2O. | (Reference K101129 – Respironics): |
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