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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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(148 days)
The Sleepnet Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H₂O.
The masks are to be used on adult patients (>30 kg.) for whom positive airway pressure therapy has been prescribed.
Veraseal 3: Disposable single use (hospital/institutional), Single patient, multi-use up to 7 days (hospital/institutional)
V3: Single patient, multi-use (home)
Mojo 2: Single patient, multi-use (home or hospital/institutional)
The Sleepnet Mojo 2, Veraseal 3 and V3 Full Face mask are provided with an exhalation 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 identical exhalation elbow and anti-asphyxia valve (AAV)
- Add an additional size, ex-large, mask to the product line
- Support useful life of the V3 and Mojo 2 up to 6 months as a single patient, multi-use mask
Veraseal 3 is intended as a Disposable single use (hospital/institutional) and as a Single patient, multi-use up to 7 days (hospital/institutional)
V3 is intended as a Single patient, multi-use (home)
Mojo 2 is intended as a Single patient, multi-use (home or hospital/institutional
The provided document, a 510(k) summary for certain full face vented masks, focuses on demonstrating substantial equivalence to predicate devices rather than detailing a study that proves the device meets specific acceptance criteria through novel performance data. The core of this submission is about showing that the new masks are as safe and effective as pre-existing, legally marketed devices.
Therefore, many of the requested details, such as sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set information (which are typical for AI/ML device submissions or devices requiring extensive clinical performance testing), are not applicable to this 510(k) for a respiratory mask.
However, based on the principle of demonstrating substantial equivalence, we can infer the "acceptance criteria" and "device performance" relate to meeting the standards of the predicate device and relevant international standards.
Here's an interpretation of the available information in the context of the prompt:
Acceptance Criteria and Reported Device Performance
The document states that the performance of the new masks was "compared" to predicate devices and that the new masks "Meets ISO 17510 testing". This indicates that the acceptance criteria are adherence to established performance benchmarks (likely from ISO 17510) and performance comparable to the predicate device.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility: Materials in patient contact are safe and compatible. | "The materials in patient contact are identical to predicate devices." This implies that the biocompatibility of the new device is accepted if it uses materials already proven to be safe in the predicate device. |
| Internal Volume / Dead Space: Must be within acceptable limits. | "Compared performance for: Internal Volume / Dead space." (Implied: Met accepted limits, likely comparable to predicate and/or within ISO 17510). |
| Pressure Drop: Must be within acceptable limits for proper function. | "Compared performance for: Pressure drop." (Implied: Met accepted limits, likely comparable to predicate and/or within ISO 17510). |
| Anti-asphyxia valve pressure testing: AAV must function correctly. | "Compared performance for: Anti-asphyxia valve pressure testing." (Implied: Met accepted limits, likely comparable to predicate and/or within ISO 17510). |
| CO2 Washout: CO2 clearance must be adequate. | "Compared performance for: CO2 washout." (Implied: Met accepted limits, likely comparable to predicate and/or within ISO 17510). |
| Simulated Life Testing Post-Cleaning: Device must maintain performance after simulated use/cleaning. | "Compared performance for: Simulated life testing post-cleaning." (Implied: Met accepted limits for useful life duration, e.g., 6 months for V3 and Mojo 2, 7 days for Veraseal 3 hospital multi-use). |
| Mechanical Drop Test: Device must withstand typical handling/drops. | "Compared performance for: Mechanical drop test." (Implied: Met accepted limits). |
| Meets ISO 17510 testing: Adherence to the international standard for respiratory equipment. | "Meets ISO 17510 testing." This is a direct statement of compliance with a recognized standard, which defines numerous performance and safety criteria for respiratory masks (e.g., breathing resistance, leakage, dead space, strength, durability, material safety). This single statement encompasses a broad range of acceptance criteria. |
| No New Safety Concerns: The design changes do not introduce new risks. | "There are no differences between the proposed devices which would raise new safety concerns." This is a critical overall acceptance criterion for a 510(k) submission based on substantial equivalence. |
Study Details (as inferable from a 510(k) for a medical device)
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of patients or cases but rather as a series of bench tests on device samples. For physical device testing (like pressure drop, CO2 washout, mechanical drop), typically multiple units of the device are tested to ensure consistency and reliability. The specific number of units tested for each benchmark is not provided in this summary.
- Data Provenance: The data are generated from bench testing (laboratory-based performance evaluations) rather than clinical studies with patient data. The country of origin of the data is not specified but would be where the manufacturer (Sleepnet Corporation, Hampton, NH, USA) conducts its testing or where a contracted testing facility is located. The tests are prospective in the sense that they are conducted specifically for this submission to demonstrate performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For mechanical/performance bench testing of a device like a mask, "ground truth" is established through physical measurements and adherence to engineering specifications and international standards (like ISO 17510), rather than expert consensus on medical images or clinical outcomes. The "experts" would be the engineers and technicians performing and verifying the tests, ensuring compliance with established protocols and standards.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical data (e.g., radiology reads) where subjective interpretation might vary. For bench testing, test results are typically objective measurements compared against predefined pass/fail criteria or reference values.
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
- Not Applicable. This is a physical medical device (mask), not an AI/ML diagnostic or assistive device that involves "human readers" or "AI assistance."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. Same as above, not an AI/ML algorithm.
7. The type of ground truth used
- The "ground truth" for the bench tests is defined by engineering specifications, international standards (specifically ISO 17510), and the performance characteristics of the legally marketed predicate devices. For example, the acceptable range for CO2 washout is defined by ISO standards, and the performance of the predicate device serves as a comparative benchmark.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a "training set" for model development.
9. How the ground truth for the training set was established
- Not Applicable. (See point 8).
In summary, this 510(k) relies heavily on demonstrating that the new mask designs maintain the same essential safety and performance characteristics as the previously cleared predicate device, and that they meet relevant international standards through various bench tests. The "study" here is a series of engineering and performance evaluations designed to prove this equivalence, rather than a clinical trial or AI model validation study.
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