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510(k) Data Aggregation
(204 days)
The Whitsundays Mask System has two product variants:
• Whitsundays mask
· Whitsundays SLM (Sleep Lab Mask)
Both masks are intended for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Whitsundays mask is intended for single-patient reuse in the home environment and the Whitsundays SLM is intended for multi-patient reuse in the hospital/institutional environment. The Sleep Lab Mask (SLM) is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.
The Whitsundays Mask System is an accessory to deliver airflow and positive air pressure generated by positive airway pressure (PAP) devices such as CPAP or bi-level flow generator systems to the patient's airway, for the treatment of Obstructive Sleep Apnea (OSA) or ventilatory support (non-life support). It delivers the treatment pressure from the source to the patient's upper airway by providing an air seal between the PAP device and the bottom of the patient's nose.
The Whitsundays mask system has two product variants:
- Whitsundays mask This is the home use variant that is intended for single patient re-use.
- . Whitsundays SLM (Sleep Lab Mask) This is the SLM variant that is intended for multi-patient re-use and must be reprocessed if reused between patients.
The Whitsundays Mask System is made up of 4 main component assemblies: nasal cushion, conduit frame, elbow, and headgear. The nasal cushion and conduit frame are available in various sizes to allow for adequate mask fit in the intended patient population.
The Whitsundays Mask System is a prescription device supplied non- sterile.
The provided text describes the ResMed Whitsundays Mask System and its substantial equivalence to a predicate device, the Scone mask (K180497). The document focuses on non-clinical data and acceptance criteria based on recognized standards.
Here's the breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Design Parameter | Predicate Device Performance (Scone mask) | Reported Device Performance (Whitsundays Mask System) | Acceptance Criteria Comment |
|---|---|---|---|
| Mask Exhaust Flow (Nominal) (ISO 17510:2015 Annex B) | |||
| - Pressure 4 cm H2O | 20 L/min | 20 L/min | Identical |
| - Pressure 9 cm H2O | 31 L/min | 31 L/min | Identical |
| - Pressure 15 cm H2O | 41 L/min | 41 L/min | Identical |
| - Pressure 20 cm H2O | 49 L/min | 49 L/min | Identical |
| - Pressure 25 cm H2O | 55 L/min | 55 L/min | Identical |
| CO2 Re-breathing Performance (ISO 17510:2015 Annex F) | Complies (<20%) | Complies (<20%) | Identical (Acceptance criterion is <20% CO2 re-breathing as per ISO 17510:2015) |
| Physical Dead Space (mL) | |||
| - Frame SML, Cushion S | 109 | 109 | Equivalent (This is a record-only parameter, meaning values are reported rather than needing to meet a specific pass/fail threshold against the predicate, as long as they are comparable) |
| - Frame SML, Cushion SW | 105 | 105 | Equivalent |
| - Frame SML, Cushion M | 113 | 113 | Equivalent |
| - Frame STD, Cushion S | 116 | 116 | Equivalent |
| - Frame STD, Cushion SW | 112 | 112 | Equivalent |
| - Frame STD, Cushion M | 120 | 120 | Equivalent |
| - Frame SML, Cushion L | 119 | 119 | Equivalent |
| - Frame STD, Cushion L | 127 | 127 | Equivalent |
| Resistance to Flow (Pressure drop across mask in cmH2O) (ISO 17510:2015 Annex C) | |||
| - @50 L/min | 0.5 | 0.4 | Resistance to flow values are reported in the instructions for use in accordance with ISO 17510:2015. The subject device has slightly lower resistance, indicating equivalent or improved performance. |
| - @100 L/min | 2.3 | 1.6 | Resistance to flow values are reported in the instructions for use in accordance with ISO 17510:2015. The subject device has significantly lower resistance, indicating equivalent or improved performance. |
| Sound | |||
| - Sound power level | 21 dBA | 24 dBA | Equivalent. While the new device has a slightly higher sound power level (3 dBA increase), this is generally considered a minor difference in acoustic metrics and unlikely to raise new safety or effectiveness concerns, fitting within an "equivalent" assessment for regulatory purposes for this type of device. |
| - Sound pressure level | 14 dBA | 17 dBA | Equivalent. Similar to sound power, a 3 dBA increase in sound pressure is often considered acoustically equivalent or minor in regulatory context for patient comfort if within acceptable ranges, not raising new safety or effectiveness concerns. |
| Biocompatibility | Materials used in predicate | New materials for nasal cushion and conduit frame sleeve | Equivalent. All new materials have been included in previously cleared submissions or underwent biological evaluation as per ISO 10993-1 and ISO 18562-1, meeting the acceptance criteria for biocompatibility. |
| Reprocessing Claims Validation | Single/multi-patient re-use (Scone SLM: 30 cycles) | Single/multi-patient re-use (Whitsundays SLM: 30 cycles) | Identical. Validation performed in accordance with ISO 17664-1 and ISO 17664-2, including cleaning efficacy, disinfection efficacy, residual toxicity, and mechanical integrity testing, ensuring the reprocessing claims are met for the specified use life. |
| Mechanical Integrity | Not explicitly detailed | Met all intended performance requirements | New device completed non-clinical verification and validation testing, including mechanical integrity before and after environmental tests (home cleaning, transportation, storage, operation, free fall, sit test, cleaning, and reprocessing). The acceptance criteria are that the device maintains its mechanical integrity under these conditions. |
2. Sample size used for the test set and the data provenance
The document refers to "non-clinical verification and validation testing" and "bench tests" for performance characteristics. The specific sample sizes for these tests are not provided in the summary.
The data provenance is from bench testing conducted by ResMed Pty Ltd. This is a form of prospective testing, as it involves newly manufactured devices undergoing controlled experiments. The country of origin for the company is Australia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies are primarily engineering and performance tests against recognized standards (e.g., ISO, rather than clinical studies requiring expert ground truth for interpretation like imaging).
4. Adjudication method for the test set
Not applicable. The evaluations are based on quantifiable measurements against established standards (e.g., flow rates, pressure drops, CO2 levels) rather than subjective assessments requiring adjudication.
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
This is not applicable. The device is a medical mask and not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical mask, not an algorithm.
7. The type of ground truth used
The "ground truth" for the non-clinical tests is established by international standards such as ISO 17510:2015, ISO 18562, ISO 10993, and ISO 17664. These standards define the acceptable performance limits and methodologies for testing. For some parameters like physical dead space, the "ground truth" is the measured value of the predicate device, against which the new device's measurements are compared for equivalence.
8. The sample size for the training set
This is not applicable. The device is a physical medical mask, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
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