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The PRESTIGE CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). It is intended for use at home.

The PRESTIGE CPAP System is similar to the predicate devices, (S8 Prime and S7 Elite CPAP System with H2i) with a new and improved micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHo as required to maintain an "air splint" for effective treatment of OSA. The system comprises the Flow Generator, patient tubing, mask (patient interface) and humidifier.

The provided text describes a 510(k) premarket notification for the RESMED PRESTIGE CPAP System. It states that "Design and Verification activities were performed on the PRESTIGE CPAP System as a result of the risk analysis and product requirements. All tests confirmed the product met the acceptance criteria." However, it does not provide any specific acceptance criteria or details about the studies performed to demonstrate that the device meets these criteria.

The document mainly focuses on establishing substantial equivalence to predicate devices (S8 Prime and S7 Elite) based on similar intended use, operating principles, technologies, and manufacturing processes. It confirms that the new device has "not altered the safety and effectiveness of CPAP treatment."

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The submission is a regulatory filing focused on equivalence, not a detailed report of performance studies with specific statistical outcomes or methodologies.

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