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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): < 3 cmH2O. | Similar. Pass / Fail criteria is < 3 cm H2O. The subject device values are well within the acceptable range. |
| Resistance to Flow (cmH2O) | Mojo 2 w/o AAV: 50 lpm – 0.1; 100 lpm – 0.24. Mojo 2 w/AAV: 50 lpm – 0.22; 100 lpm – 0.45. Veraseal 3 w/o AAV: 50 lpm – 0.1; 100 lpm – 0.32. Veraseal 3 w/AAV: 50 lpm – 0.3; 100 lpm – 0.5. | (Reference K101129): 50 lpm - 0.6; 100 lpm - 1.2. The predicate device's resistance to flow values are not explicitly stated, but the "Explanation of Differences" column is empty, implying similarity or better performance compared to the predicate, and definitely better than the reference. | This indicates the resistance to flow is acceptable, presumably meeting or being better than the predicate and certainly better than the reference device. The accepted industry standard or a predicate's performance is the implicit criterion. |
| Resistance of AAV Opening (cmH2O) | Insp: 1.2; Exp: 1.3. | (Reference K101129): Insp – 0.9; Exp – 0.7. ISO 17510 criteria < 10 cmH2O. | The reported values are well below the ISO 17510 criteria of < 10 cmH2O, indicating compliance. |
| Cleaning Validation | Performed. | (Implicitly also performed for multi-use models). The new devices also use "Soap and water" and "Isopropyl alcohol" as cleaning methods, which are similar to the predicate's "Soap and water". | Ensures the device can be effectively cleaned for multi-use applications. |
| Mechanical Drop Test | Performed. | (Implicitly performed for predicate). | Ensures durability and structural integrity. |
| ISO 17510 Testing | Meets ISO 17510 testing. | (Implicitly expected for predicate/reference). | Confirms compliance with the standard for respiratory and anaesthetic equipment – Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment. This provides a comprehensive safety and performance benchmark. |
| Additional Size | 4 available sizes. | 3 available sizes. | Adding a new size (ex-large); this is a difference but not framed as a new safety concern, implying it has been validated to perform similarly to the existing sizes. |
| Anti-asphyxia valve (AAV) inclusion | Elbow – Yes; AAV - Yes. | Elbow – Yes; AAV - No. Reference K101129 (Respironics) includes an AAV. | Predicate has an elbow but the AAV has been added, which is similar to the reference Respironics - K101129. This means the functionality of the AAV is considered substantially equivalent to the reference device. |
| Shell Material | Veraseal 3: Rigid. Mojo 2: Soft. | Mojo: Soft. | Added the rigid shell for the Veraseal model; again, a difference but not raising new safety concerns. |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily describes bench testing for the comparative performance.
- Sample Size: The sample sizes used for each specific bench test (e.g., dead space, pressure drop, AAV pressure, resistance to flow, mechanical drop) are not explicitly stated in this summary. It's implied that sufficient samples were tested to demonstrate compliance and provide the reported performance data.
- Data Provenance: The data is generated from non-clinical bench testing. The country of origin of the data is not specified, but it would typically be generated by the manufacturer or a contracted testing facility. This is retrospective in the sense that the testing was performed on the completed device designs to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the summary focuses on non-clinical bench testing. The "ground truth" for these tests are objective, measurable physical properties (e.g., volume, pressure, resistance) determined by established engineering and testing standards (e.g., ISO, internal methods). Clinical expert review is not typically part of establishing the ground truth for these types of purely technical performance metrics.
4. Adjudication Method for the Test Set
This section is not applicable as the summary describes objective bench testing, which does not involve subjective interpretations requiring adjudication by human experts.
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
This section is not applicable. This is a submission for a patient interface (mask) for non-invasive ventilation, not an AI-powered diagnostic or assistive technology that would require an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. This submission is for a physical medical device (mask), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims in this submission is based on:
- Objective physical measurements determined through standardized bench testing protocols.
- Compliance with international standards such as ISO 10993 (biocompatibility) and ISO 17510 (sleep apnoea breathing therapy equipment).
- Comparison to the performance characteristics of a legally marketed predicate device (K063806) and reference devices (K101129, K121692).
8. The Sample Size for the Training Set
This section is not applicable. This is not a study involving machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reason as above.
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