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510(k) Data Aggregation
(29 days)
Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented
The Sleepnet Mojo 2 and Veraseal 3 Full Face Non-Vented and AAV Non-Vented 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 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:
- The Mojo 2 subject devices include a new contradiction and warning, which was not . included in the predicate device - K190533.
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 text describes a 510(k) premarket notification for Sleepnet Corporation's Mojo 2 and Veraseal 3 Full Face Masks. This submission primarily focuses on changes to contraindications and warnings due to a previous recall, rather than new device performance data.
Therefore, the document explicitly states: "No new performance testing was conducted on the subject device, since the device designs are identical to the predicates." This means there is no study described that proves the device meets new acceptance criteria. The acceptance criteria and reported device performance are based on the predicate device (K190533) and its original clearance.
However, I can extract the information related to the device and the comparison to its predicate as requested in your format, noting the absence of new performance data.
Here's the information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since no new performance testing was conducted, there are no new specific acceptance criteria or reported performance data for the subject devices presented in this summary beyond the fact that their design is identical to the predicate. The "acceptance criteria" for this specific 510(k) submission revolve around demonstrating substantial equivalence, especially concerning the updated labeling.
The following table summarizes the key attributes and their comparison to the predicate device, implying that the acceptance for these attributes is "identical" to the predicate, which had presumably met its own performance acceptance criteria during its original clearance (K190533).
| Attributes (Acceptance Criteria by Equivalence) | Reported Device Performance (Identical to Predicate K190533) | Explanation of Differences |
|---|---|---|
| Product Classification | CBK Continuous ventilator | Identical |
| CFR | CFR 868.5895 | Identical |
| List of Devices | Mojo 2 Full Face Non-Vented mask, Mojo 2 Full Face AAV Non-Vented mask, Veraseal 3 Full Face Non-Vented mask, Veraseal 3 Full Face AAV Non-Vented mask | Identical |
| Indications for Use | Provide a patient interface for application of noninvasive ventilation for adult patients (>30 kg) suitable for noninvasive ventilation. Used as an accessory to ventilators with adequate alarms and safety systems for ventilator failure. Offered in disposable and multi-use versions. 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). | Identical |
| Patient Population | Adult (>30 kg) | Identical |
| Patient type | Patients who are appropriate candidates for non-invasive ventilation | Identical |
| Prescriptive | Yes | Identical |
| Environment of Use | Home or hospital/institutional environments | Identical |
| Duration of Use | Veraseal 3: Single patient use disposable - 7 days. Mojo 2: Single patient use - 6 months. | Identical |
| Principle of Operation | Provides a seal over the face (nose and mouth) to allow for delivery of pressurized air from a non-invasive ventilator. Mask used with circuits including an exhalation port. AAV Non-Vented version includes an anti-asphyxia valve for CO2 flushing during fault conditions. Device is passive until connected to the ventilator. | Identical |
| Therapy Pressure | Greater than 3 cm H2O (typically determined by attached equipment) | Identical |
| Anatomical site | Face (seals around nose and mouth) | Identical |
| User Interface to administer therapy | Standard 22mm ID connection (ISO 5356-1 compliant) to 22mm ventilator circuits. | Identical |
| Contraindications | New Contraindication (Mojo 2 only): Do not use if the patient or anyone in close physical contact has an active medical implant or metallic implant that will interact with magnets. Examples include pacemakers, ICDs, neurostimulators, aneurysm clips, etc. | New as per recall event #94169 |
| Warnings | Updated Warning: Magnets are used in the mask and headgear clips with a field strength of 380mT. Except for devices in the contraindication, ensure mask is kept at least 6 inches (approx. 16 cm) away from other medical implants/devices that can be impacted by magnetic fields. Applies to user and anyone in close physical contact. | Unchanged in K190533, but updated with magnetic field information |
| Useful life | Veraseal 3: Single patient use disposable - 7 days. Mojo 2: Single patient use - 6 months. | Identical |
| Non-sterile | Yes | Identical |
| Cleaning methods | Mild Soap (such as Ivory) and water, Isopropyl alcohol | Identical |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
There is no new test set or data provenance information provided in this submission, as "No new performance testing was conducted." The basis of this submission is the identical design to a predicate device and updated labeling.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No new test set and no ground truth establishment for a test set are described. The updated contraindications and warnings were established due to information from post-market surveillance related to a voluntary recall (Event 94169).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set is described.
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 device is a patient interface for ventilation, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical patient interface, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for new data. The primary "ground truth" for the new contraindication/warning was post-market surveillance data leading to a voluntary recall (Event 94169), which indicated potential risks from magnets interacting with medical implants. This implicitly relies on real-world outcomes and expert clinical judgment regarding patient safety.
8. The sample size for the training set
Not applicable. This device is a mechanical patient interface, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a mechanical patient interface, not an AI/ML device.
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(144 days)
Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented
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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