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510(k) Data Aggregation
(163 days)
The SleepNet Mojo and Veraseal masks 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 (>30kg) for whom positive airway pressure therapy has been prescribed. Veraseal - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional) Mojo - Single patient, multi-use (home or hospital/institutional)
The SleepNet Mojo and Veraseal Full Face mask are modifications of the SleepNet Mojo Full Face mask cleared under K060273. The modifications to the cleared Mojo Full Face mask are: - different durations of use - o single use, disposable (Hospital/Institutional) Veraseal - o single patient, multi-use up to 7 days (Hospital/Institutional) Veraseal - o single patient, multi-use (Home or Hospital/Institutional) MoJo - a change in materials . - updated design of the exhaust elbow used with the mask As a result of these modifications we have established two (2) product tradenames to help distinguish them. Veraseal model has 2 durations of use - single use, disposable or single patient, multi-use up to 7 days in the hospital. Mojo model is single patient, multi-use (typically more than 7 days) for use in the home or hospital.
Here's a breakdown of the acceptance criteria and study information for the SleepNet Mojo and Veraseal Full Face Mask, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to predicate devices using comparative performance testing, rather than explicit acceptance criteria with numerical targets for each attribute. However, the "Comparative Performance" section and the "Table of Comparison to Predicates" implicitly serve this purpose by showing that the modified devices perform similarly to or better than the predicates.
| Test / Performance Metric | Acceptance Criteria (Implicit - based on predicate performance) | Reported Device Performance (Modified Mojo and Veraseal) | Predicate Device Performance (Mojo K060273) | Predicate Device Performance (ResMed Mirage Quattro K063122) |
|---|---|---|---|---|
| CO2 washout (per ISO 17510-2) | Results demonstrating substantial equivalence to predicates. | Demonstrated substantial equivalence to predicates. | Performed. | Performed. |
| ETCO2% at mask (increase) | Similar to or lower than predicates. | |||
| - 3 cm H₂O | ≤ 5.9 (15%) | Mojo: 6.1 (17%) | ||
| Veraseal: N/A (not explicitly listed for Veraseal at this pressure) | 5.9 (15%) | Implicitly not tested for this predicate | ||
| - 5 cm H₂O | ≤ 5.8 (14%) | Mojo: 5.9 (14%) | ||
| Veraseal: N/A (not explicitly listed for Veraseal at this pressure) | 5.8 (14%) | Implicitly not tested for this predicate | ||
| - 10 cm H₂O | ≤ 5.6 (9%) | Mojo: 5.8 (12%) | ||
| Veraseal: N/A (not explicitly listed for Veraseal at this pressure) | 5.6 (9%) | Implicitly not tested for this predicate | ||
| - Occluded (Mojo) | ≤ 6.0 (17%) | 6.3 (21%) | 6.0 (17%) | Implicitly not tested for this predicate |
| Deadspace | Similar to or lower than predicates. | |||
| - Small (Mojo) | ≤ 200 ml | 160 ml | 200 ml | N/A (varies by cushion size) |
| - Medium (Mojo) | ≤ 245 ml | 185 ml | 245 ml | N/A (varies by cushion size) |
| - Large (Mojo) | ≤ 295 ml or similar to ResMed (242ml) | 205 ml | 295 ml | 242 ml |
| Exhaust - pressure / flow | Similar flow characteristics to predicates for given pressures. | |||
| - 3 cm H₂O | Mojo: ~32.00 lpm | |||
| Veraseal: N/A | Mojo: 21.20 lpm | |||
| Veraseal: 21.10 lpm | 32.00 lpm | N/A | ||
| - 10 cm H₂O | Mojo: ~43.00 lpm | |||
| Veraseal: N/A | Mojo: 37.20 lpm | |||
| Veraseal: 36.40 lpm | 43.00 lpm | 8 cm H₂O: 32 lpm | ||
| - 20 cm H₂O | Mojo: ~55.00 lpm | |||
| Veraseal: N/A | Mojo: 53.10 lpm | |||
| Veraseal: 53.00 lpm | 55.00 lpm | 20 cm H₂O: 54 lpm | ||
| Pressure AAV (Anti-asphyxia valve) | Opening/closing pressures similar to predicate (Mojo K060273). | Mojo: Opening - 1.10 cm H₂O, Closing - 1.60 cm H₂O | ||
| Veraseal: Opening - 1.29 cm H₂O, Closing - 1.45 cm H₂O | Opening - 0.65 cm H₂O, Closing - 1.38 cm H₂O | Not disclosed | ||
| Resistance to Flow | Pass / Fail criteria is |
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