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510(k) Data Aggregation
(212 days)
The Hard Shell Vented Nasal Mask is intended to provide an interface for application of positive airway pressure therapy, such as CPAP or bi-level.
The mask is intended for:
- Single use, disposable .
- . Single patient, multi-use in the home setting
- . Multi-patient, multi- use in the hospital or institutional settings
- Single patient, short-term use (up to 7 days) in the hospital or institutional settings ●
The masks are to be used on adult patients (>66 lbs. />30 kg) for whom CPAP or bi-level therapy has been prescribed.
The SleepNet Innova Nasal Vented Mask is similar to other CPAP mask. The Innova Nasal Vented mask is nearly identical to our iQ Nasal mask, K102317, except for the following changes:
- Slightly different indications for use, but the predicate is Respironics ComfortGel Blue . Nasal mask, K092835.
- . A range of durations of use for marketing purposes only
- o single use, disposable
- single patient, multi-use up to 7 days o
- single patient, multi-use in home setting o
- o multi-patent, multi-use in institutional settings
- . material for shell, hard vs. soft
- a new exhaust elbow design .
Here's an analysis of the provided 510(k) summary for the SleepNet Innova Nasal Vented Mask, addressing your specific questions:
Device Name: Innova Nasal Vented Mask (also referred to as Hard Shell Vented Nasal Mask)
510(k) Number: K121321
Predicate Device: Respironics ComfortGel Blue Nasal Mask (K092835)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Innova Nasal Vented Mask are based on demonstrating equivalence or being "well within" the established limits of the predicate device (Respironics ComfortGel Blue Nasal Mask, K092835) or relevant ISO standards.
| Acceptance Criteria / Performance Aspect | Acceptance Criteria | Reported Device Performance (Innova Nasal Vented Mask) | Discussion/Conclusion |
|---|---|---|---|
| CO2 Washout | Per ISO 17510-2: changes in CO2 at various pressures to be |
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(151 days)
The MiniMe 2 Nasal mask is intended to provide a patient interface for application of positive pressure therapy. The mask is to be used as an accessory to CPAP or Bi-level positive pressure systems. It is intended for patients >2 years old and
The MiniMe 2 Nasal mask is intended to provide a patient interface for application of positive pressure therapy. The mask is to be used as an accessory to CPAP or Bi-level positive pressure systems. It is intended for patients >2 years old and
The provided text describes a 510(k) summary for a medical device, the MiniMe 2 Nasal Mask, seeking substantial equivalence to predicate devices. It does not describe an AI/ML device or a study involving human readers or ground truth established by experts/pathology/outcomes data. Therefore, much of the requested information (like sample sizes for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, and how ground truth was established for training) is not applicable or cannot be extracted from this document.
The document primarily focuses on demonstrating that the MiniMe 2 Nasal Mask is substantially equivalent to existing predicate devices (SleepNet MiniMe pediatric nasal mask and ResMed Kidsta Pediatric Mask) through comparative performance testing and material biocompatibility.
Here's the information that can be extracted based on the provided text, adapted to the questions where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate devices in various performance aspects. The "reported device performance" are the actual measurements for the MiniMe 2 Nasal Mask, which are then compared to the predicates.
| Acceptance Criteria (Implicitly, Equivalence to Predicate) | MiniMe 2 Nasal Mask Performance | SleepNet MiniMe Nasal Mask (K090935) Performance (Predicate 1) | ResMed Kidsta (K060105) Performance (Predicate 2) |
|---|---|---|---|
| Indications for Use: Provide patient interface for positive pressure therapy, accessory to CPAP/Bi-level, for patients >2 yo and 2 yo to 7 yo and up (MiniMe 2 aligns with SleepNet MiniMe) | |||
| Environment of Use: Home or hospital/institutional | Identical | Identical | Identical |
| Durations of Use: Single use, disposable; Single patient, multi-use (home); Single patient, short-term (up to 7 days). | Matched or represented as shorter duration which is acceptable. | Single patient, multi-use (home); Single patient, short-term (up to 7 days). | Single patient, multi-use (home); Single patient, short-term (up to 7 days). |
| Prescriptive: Yes | Yes | Yes | Yes |
| Cleaning: Soap and water | Soap and water | Soap and water | Soap and water |
| Exhalation Port: Incorporates exhalation port with multiple holes | Yes | Yes | Yes |
| Non-vented elbow: Configuration used with circuit with integrated exhalation valve | Yes | Yes | N/A |
| Delivered Pressure Range: | 4-20 cm H2O | 3-20 cm H2O | >4 cm H2O |
| CO2 washout profile (ETCO2% at mask at various pressures): Should be comparable to predicates/not excessively high. Testing done per ISO 17510-2 (largest size tested, worst case). | 4 cm H2O: 5.3 (6%) | ||
| 5 cm H2O: 5.2 (4%) | |||
| 10 cm H2O: 5.1 (3%) | |||
| Occluded: 5.3 (7%) | 4 cm H2O: 5.3 (6%) | ||
| 5 cm H2O: 5.2 (4%) | |||
| 10 cm H2O: 5.1 (3%) | |||
| Occluded: 5.3 (7%) | 4 cm H2O: 5.8 (14%) | ||
| 5 cm H2O: 5.7 (12%) | |||
| 10 cm H2O: 5.5 (7%) | |||
| Occluded: 6.8 (34%) | |||
| Dead Space: Small volume. | Small | ||
| 25 ml (Small size) | |||
| 40 ml (Large size) | Small | ||
| 21 ml (Small size) | Small | ||
| 81 ml (Large size) | |||
| Exhaust - pressure / flow: Comparable flow rates at given pressures. | 4 cmH2O: 17.1 lpm | ||
| 12 cmH2O: 33.5 lpm | |||
| 20 cmH2O: 43.6 lpm | 4 cmH2O: 19.1 lpm | ||
| 12 cmH2O: 34.8 lpm | |||
| 20 cmH2O: 45.8 lpm | 4 cmH2O: 19.5 lpm | ||
| 12 cmH2O: 36.2 lpm | |||
| 20 cmH2O: 48.7 lpm | |||
| Resistance to Flow: Acceptable resistance to flow values at various flow rates. | 30 lpm: 0.22 cm H2O | ||
| 50 lpm: 0.72 cm H2O | |||
| 60 lpm: 1.03 cm H2O | |||
| 100 lpm: 3.09 cm H2O | 30 lpm: 0.10 cm H2O | ||
| 50 lpm: 0.36 cm H2O | |||
| 60 lpm: 0.54 cm H2O | |||
| 100 lpm: 1.71 cm H2O | 30 lpm: 0.12 cm H2O | ||
| 50 lpm: 0.44 cm H2O | |||
| 60 lpm: 0.67 cm H2O | |||
| 100 lpm: 2.10 cm H2O | |||
| Biocompatibility: Materials in patient contact are identical to predicate or tested per ISO 10993. | Materials are either identical to predicate SleepNet masks or tested per ISO 10993 for specific contact types (e.g., skin and gas pathway, permanent duration) and passed respective ISO 10993 tests (e.g., Cytotoxicity, Sensitization, Genotoxicity, Implantation, Intracutaneous, Systemic Toxicity for tubing). | Defined by the predicate devices. | Not explicitly detailed for this predicate. |
| Mechanical Testing: Drop Test | Performed, but results not detailed in the summary. | Not detailed. | Not detailed. |
| Cleaning Validation: | Performed, but results not detailed in the summary. | Not detailed. | Not detailed. |
| Environmental Testing: | Performed, but results not detailed in the summary. | Not detailed. | Not detailed. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "test set" in terms of subject count. The testing performed is laboratory-based comparative performance testing (e.g., pressure-flow, CO2 washout, dead space, resistance to flow) comparing the device's physical properties to those of predicate devices.
- Data Provenance: The data is generated from laboratory testing of the physical device, not from human subject data or retrospective/prospective clinical studies. The origin is stated implicitly as SleepNet Corporation facilities (Hampton, NH, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical device performance and biocompatibility study, not one requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication by experts 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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of expert ground truth. The "ground truth" for the device's performance is established by standardized engineering tests and measurements (e.g., flow meters, pressure sensors for exhaust/resistance, CO2 sensors for washout) and adherence to material standards (ISO 10993). In terms of regulatory "ground truth" for substantial equivalence, it's defined by the performance characteristics of the legally marketed predicate devices.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
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