(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 ( |
§ 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).