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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 < 3 cm H₂O. | Mojo: 50 lpm - 0.40 cm H₂O, 100 lpm - 0.65 cm H₂O Veraseal: 50 lpm - 0.49 cm H₂O, 100 lpm - 0.89 cm H₂O | 50 lpm - 0.38 cm H₂O, 100 lpm - 0.80 cm H₂O | 50 lpm - 0.5 cm H₂O, 100 lpm - 1.6 cm H₂O |
| Biocompatibility | Tested per ISO 10993. | Tested per ISO 10993; materials in patient contact are identical to predicates or tested per ISO 10993. | Yes. | N/A. |
| Cleaning validation | Validated methods for different durations of use. | Performed. | Performed. | Performed. |
| Storage and aging | Evaluated for impact on performance and safety. | Performed. | Performed. | Performed. |
| Dead space | Evaluated. | Performed. | Performed. | Performed. |
| Exhaust Flow | Evaluated. | Performed. | Performed. | Performed. |
| Pressure drop | Evaluated. | Performed. | Performed. | Performed. |
| Anti-asphyxia valve (AAV) pressure testing | Evaluated. | Performed. | Performed. | Performed. |
| Exhaust Elbow Change Performance | Evaluated. | Performed. | Performed. | Performed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set (number of masks tested, number of repetitions for each test). The studies mentioned were "comparative performance testing" pre- and post-cleaning or conditioning. The data provenance is not specified (e.g., country of origin) but is implied to be from internal testing by the manufacturer, SleepNet Corporation, in support of their 510(k) submission. There is no indication whether the data is retrospective or prospective, but for product performance testing, it is typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a medical mask (patient interface), and the "ground truth" for its performance is established through objective engineering and biological safety testing (e.g., CO2 washout, dead space measurements, flow resistance, biocompatibility), not through expert clinical consensus or interpretation of images/data.
4. Adjudication Method for the Test Set
This information is not applicable as the "test set" involves objective performance metrics and not subjective expert judgment, which would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret results (e.g., radiologists reading medical images). The SleepNet Mojo and Veraseal Full Face Mask is a patient interface device that does not involve human interpretation in its function.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies performed were standalone performance tests of the device itself. There is no "algorithm" or "human-in-the-loop" component to this medical mask. The tests measured the physical and biological performance characteristics of the mask in isolation.
7. Type of Ground Truth Used
The "ground truth" for the performance of the device was established through:
- Objective engineering measurements: Such as pressure drop, exhaust flow, AAV pressure, dead space calculation.
- Standardized testing procedures: Like CO2 washout performed per ISO 17510-2, and biocompatibility testing per ISO 10993.
- Comparison to predicate device performance: The primary method for demonstrating substantial equivalence, meaning the performance of the predicate devices served as a de facto "ground truth" for acceptable performance.
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" for this type of device. Training sets are typically used for machine learning algorithms, which are not involved in the design or evaluation of a medical mask.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (no training set).
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