Search Results

The Tiara Medical Systems SNAPP is intended to be used with continuous positive airway pressure devices (CPAP), operating at or above 3 cmH20 for the treatment of obstructive sleep apnea. The SNAPP is intended for single patient use and can be used in the home or in a hospital/institutional environment. The SNAPP is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed.

The Tiara Medical Systems SNAPP Soft Nasal Accessory for Positive Pressure is a nasal cannula with inserts intended to be used with positive anway pressure devices such as CPAP (Continuous Possure). It provides a seal such that positive pressure from a positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with mild soap and water. The cleaning process does not require disassembly.

The device consists of latex-free silicone air delivery tubes connecting a polycarbonate Wye adapter / swivel with a latex-free silicone soft, resilient nasal inserts which form a seal with the nostrils.

The device connects to a conventional air delivery hose between itself and the positive airway pressure source via a standard 22 mm polycarbonate fitting on the combination Wye adapter / swivel. The built in vent slots are molded into the underside of the nasal insert body to direct air away from the patient's face and chest, and eliminate the need for a separate exhalation device. The vent slots may be visually checked for obstruction prior to use. The SNAPP Headgear is available in three sizes to fit a broad range of facial structures, and attaches to the SNAPP via slots molded into the nasal insert body.

The provided text is a 510(k) summary for the Tiara Medical Systems SNAPP Soft Nasal Accessory for Positive Pressure, a nasal cannula for use with CPAP devices. It details the device's description, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain the specific information requested regarding acceptance criteria or a detailed study proving the device meets said criteria.

The document states that "bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the Tiara Medical Systems SNAPP Soft Nasal Accessory for Positive Pressure and the specified predicate devices." This is a general statement of equivalence, not a report of a specific study against predefined acceptance criteria.

Therefore, I cannot provide the requested table or detailed answers to questions 1-9 as the necessary information is not present in the provided text. The document focuses on establishing substantial equivalence based on overall comparison to predicate devices rather than reporting on a study with explicit acceptance criteria for the new device.

Ask a specific question about this device