(30 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 Veraseal 3, V3 and Mojo 2 Full Face Vented masks are identical to the predicate Veraseal 3, V3, and Mojo 2 Full Face Vented masks (K190254).
The subject of this submission is:
- Addition of a contraindication related to magnets on the Mojo 2 Full Face Vented mask .
- . Update to the warning related to magnets on the Mojo 2 Full Face Vented mask
The provided text describes a 510(k) premarket notification for a medical device, specifically full face vented masks (Mojo 2, Veraseal 3, V3 Full Face Vented Mask). This submission seeks to establish substantial equivalence to a predicate device (K190254). Crucially, the document explicitly states that no performance testing was conducted on the subject device because its design is identical to the predicate device. The only changes are the addition of a contraindication and an updated warning related to magnets, prompted by a prior recall.
Therefore, the information required to answer your query regarding acceptance criteria and the study proving the device meets those criteria (e.g., test set sample size, expert ground truth establishment, MRMC studies, standalone performance, ground truth type for training/test sets) is not present in the provided document. This document primarily focuses on demonstrating substantial equivalence based on identical design and leveraged predicate data, rather than new performance studies.
However, I can extract the specifications and comparison tables, which can be interpreted as the implicit "acceptance criteria" through their demonstration of identical characteristics to the predicate device. The "reported device performance" is then the stated performance of these identical characteristics.
Here's a breakdown of what can be inferred from the document, acknowledging the missing information about new performance studies:
A. Acceptance Criteria and Reported Device Performance (Inferred from Predicate Equivalence)
Since the subject device is identical to the predicate device (K190254) in design and performance, the "acceptance criteria" are effectively that the subject device's specifications match those of the predicate. The "reported device performance" is therefore the reported performance of the predicate device, which the subject device is stated to replicate.
| Acceptance Criteria Category | Specific Criteria (from Predicate) | Reported Device Performance (for Subject Device, stated as Identical to Predicate) |
|---|---|---|
| General | Identical design to predicate K190254 except for labeling changes. | Identical design. |
| Indications for Use | Intended to be used with positive airway pressure devices (CPAP/bi-level) operating at or above 3 cm H2O for adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. | Identical. |
| Patient Population | Adult (>30 kg) | Identical. |
| Patient Type | Patients prescribed non-invasive pressure therapy (CPAP or bi-level) | Identical. |
| Prescriptive | Yes | Identical. |
| Principle of Operation | Provides seal around nose and mouth for air delivery; includes exhalation port and anti-asphyxia valve. Passive until connected to CPAP blower. | Identical. |
| Therapy Pressure | Typically 3 to 25 cm H2O (determined by attached equipment) | Identical. |
| Anatomical Site | Face (seals around nose and mouth) | Identical. |
| Environment of Use | Home or hospital/institutional environment. | Identical. |
| Duration of Use | Veraseal 3: Disposable single patient use / Single patient, multi-use up to 7 days. Mojo 2 & V3: Single patient, multi-use. | Identical. |
| Useful Life | Veraseal 3: Disposable, up to 7 days. V3 & Mojo 2: Single patient use - 6 months. | Identical. |
| Sterility | Non-sterile | Identical. |
| Cleaning Methods | Mild Soap (such as Ivory) and water; Isopropyl alcohol. | Identical. |
| Available Sizes | 4 | Identical. |
| Shape | Identical to predicate | Identical. |
| Incorporates Exhaust Elbow | Yes | Identical. |
| Components | Mask shell (soft/rigid), Gel bladder, Exhalation elbow with Anti-asphyxia valve, 4-point headgear. | Identical. |
| Shell Design | Veraseal 3/V3: Rigid; Mojo 2: Soft. | Identical. |
| Patient Contact (ISO 10993-1) | Surface contact, skin; Externally Communicating, Tissue; Permanent Duration of Use. | Identical safety profile and materials. |
| CO2 Washout Profile (ISO 17510:2015) | At 3 cmH2O: 6.0 (15 %); At 5 cmH2O: 6.0 (15 %); At 10 cmH2O: 5.8 (12 %); SingleFault1: 6.3 (21 %); SingleFault2: 7.7 (48 %). | Identical. |
| Dead Space (nominal ml) | Mojo 2: S: 179, M: 190, L: 207, XL: 220. Veraseal 3 / V3: 184, 193, 209, 220. | Identical. |
| Exhaust - Pressure / Flow | Mojo 2: 3cmH2O/20.50lpm, 10cmH2O/36.30lpm, 20cmH2O/52.80lpm. Veraseal 3/V3: 3cmH2O/21.50lpm, 10cmH2O/36.80lpm, 20cmH2O/54.40lpm. | Identical. |
| Pressure AAV Opening / Closing | Mojo 2: Opening 1.35cmH2O, Closing 1.72cmH2O. Veraseal 3/V3: Opening 1.45cmH2O, Closing 1.80cmH2O. | Identical. |
| AAV Inspiratory/Expiratory Resistance in Single Fault Condition | Mojo 2: Inspiratory 0.8cmH2O, Expiratory 0.8cmH2O. Veraseal 3/V3: Inspiratory 0.8cmH2O, Expiratory 0.8cmH2O. | Identical. |
| Resistance to Flow | Mojo 2: 50 lpm - 0.25 cm H2O, 100 lpm - 0.50 cm H2O. Veraseal 3/V3: 50 lpm - 0.23 cm H2O, 100 lpm - 0.48 cm H2O. | Identical. |
| Sound Pressure and Sound Power Level | Mojo 2: Sound Pressure - 30.07 dBA, Sound Power - 33.09 dBA. Veraseal 3/V3: Sound Pressure - 29.98 dBA, Sound Power - 32.99 dBA. | Identical. |
| Contraindications | New contraindication for Mojo 2 related to strong magnets and proximity to active/metallic implants. | New contraindication added. |
| Warnings | Updated warning for Mojo 2 related to magnetic field strength (380 mT) and safe distance (6 inches) from implants. | Updated warning added. |
B. Study Details (Not Applicable/Information Not Provided)
- Sample size used for the test set and the data provenance: Not applicable. No new performance testing was conducted for this submission. The device design is identical to the predicate.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new performance testing was conducted.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new performance testing was conducted.
- 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 face mask, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a face mask, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No new performance testing was conducted.
- The sample size for the training set: Not applicable. No new performance testing was conducted, and this is a physical device, not a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study Proving Acceptance Criteria:
The "study" proving the device meets the acceptance criteria is the demonstration of substantial equivalence to a previously cleared predicate device (K190254). The manufacturer asserts that the subject devices (Mojo 2, Veraseal 3, V3 Full Face Vented Mask) are identical in design, indications for use, technology, principle of operation, environment of use, patient population, and performance characteristics to the predicate.
The only modifications are to the labeling, specifically the addition of a new contraindication and an updated warning statement for the Mojo 2 mask related to magnets. These changes were a proactive measure following a voluntary recall and information from post-market surveillance.
Therefore, the evidence for meeting acceptance criteria relies entirely on the prior clearance of the predicate device (K190254) and the assertion that the new device is functionally identical, with only labeling changes to address safety information not present in the original predicate's labeling. No new performance data, clinical trials, or expert consensus studies were performed or presented for this specific 510(k) submission.
§ 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).