(116 days)
The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O. The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.
Mojo is intended for Single patient, multi-use in the home or hospital/institutional environment.
Veraseal 2 is intended for Short Term Single Patient use (maximum of 7 days) in the hospital institutional environment.
Innova is intended for Single patient, multi-use in the home or hospital/institutional environment.
Ascend is intended for Single patient, multi-use in the home or hospital/institutional environment.
The Sleepnet Mojo Vented Full Face Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are used with positive pressure devices, such as CPAP and Bi-level.
The modifications to the cleared Mojo Full Face mask (K120463) are:
- Addition of contraindication and updated warning related to presence of magnets
- Change to the headgear material
- Addition of an XL size
The modifications to the cleared Veraseal Full Face mask (K120463) are:
- Modified design, now called the Veraseal 2 Full Face Vented Mask
- . Addition of an XL size
Other modifications include:
- Addition of the Innova Full Face Vented Mask version
- Addition of the Ascend Full Face Vented Mask version
This document does not describe an AI/ML device or a comparative effectiveness study. It is a 510(k) summary for several full face vented masks (Mojo, Veraseal 2, Innova, Ascend) and compares them to a predicate device (Mojo Full Face Mask and Veraseal Full Face Mask, K120463).
The summary focuses on demonstrating substantial equivalence to a previously cleared device through comparisons of indications for use, patient population, environment of use, and technological characteristics. This typically involves performance testing, biocompatibility, transportation, shelf-life, and reprocessing.
Therefore, many of the requested elements for an AI/ML device evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the provided "Table of Comparison to Predicate" and "Non-Clinical Testing Summary" as they relate to these medical masks.
1. Table of Acceptance Criteria and the Reported Device Performance (as applicable to a physical medical device, not AI/ML):
| Acceptance Criteria (Typically based on ISO 17510 and predicate device performance) | Reported Device Performance (Subject Device: Mojo, Veraseal 2, Innova, Ascend Full Face Vented Mask) | Predicate Device Performance (K120463: Mojo, Veraseal Full Face Mask) | Explanation of Differences (and compliance) |
|---|---|---|---|
| Exhaust Flow Characteristics: (Comparison to predicate device) | Mojo: 3cmH2O: 17.88 lpm, 10cmH2O: 32.57 lpm, 20cmH2O: 48.90 lpm | ||
| Veraseal 2: 3cmH2O: 22.08 lpm, 10cmH2O: 38.50 lpm, 20cmH2O: 54.30 lpm | |||
| Innova: 3cmH2O: 22.08 lpm, 10cmH2O: 38.50 lpm, 20cmH2O: 54.30 lpm | |||
| Ascend: 3cmH2O: 26.80 lpm, 10cmH2O: 41.50 lpm, 20cmH2O: 58.00 lpm | Mojo: 3cmH2O: 21.20 lpm, 10cmH2O: 37.20 lpm, 20cmH2O: 53.10 lpm | ||
| Veraseal: 3cmH2O: 21.10 lpm, 10cmH2O: 36.40 lpm, 20cmH2O: 53.00 lpm | Similar. The exhaust flow characteristics of the subject devices are similar to the predicate. | ||
| Anti-Asphyxia Valve (AAV) Opening/Closing Pressure: ( |
§ 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).