(195 days)
This breathing set is an accessory to the F&P 950 Respiratory Humidifier to be used within the limits of its stated technical specifications.
It is intended for delivery of heated humidified high flow respiratory gases to adult patients in a hospital.
This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after setup.
This product is for use by appropriately qualified healthcare professionals who perform anesthesia care and airway management.
The Fisher & Paykel Healthcare (F&P) Optiflow™ Oxygen Kit is a multiple-patient use breathing tube kit. This F&P Optiflow™ Oxygen Kit is presented as the AA451J.
The kit consists of a dry line, water bag, humidification chamber, inspiratory limb, tubing clips and datechange stickers.
The flow source delivers gas through a dryline to a humidification chamber that sits on a humidifier. As the gas passes through the chamber, it is heated and humidified. The gas then flows through the inspiratory limb, through a hydrophobic filter and then through a patient interface into the patients' upper airway via the nose.
The AA451J kit delivers humidified respiratory gases at flows from 5 to 70 L/min. When used with an FDAcleared hydrophobic filter, the AA451J kit can be used on multiple patients. The kit is reprocessed between each patient. The kit can be exposed to a maximum of 30 reprocessing cycles and used for a maximum of 24 hours after setup.
The scope of this 510(k) submission is limited to the AA451J, F&P Optiflow™ Oxygen Kit. The flow source, humidifier, hydrophobic filter and interface are not in the scope of this submission.
The provided text does not contain information about the acceptance criteria or a study proving that a software device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a physical medical device, the "F&P Optiflow Oxygen Kit (AA451J)," which is a breathing set accessory for a respiratory humidifier.
The sections titled "PERFORMANCE DATA" (Section VII) and "CONCLUSION" (Section VIII) discuss performance testing, but this refers to non-clinical tests for the physical device's safety and effectiveness, such as biological evaluation, electrical safety, and respiratory humidifying equipment standards (e.g., ISO 10993-1, ISO 80601-2-74, IEC 60601-1). These tests are typically laboratory-based and relate to the device's physical properties, material compatibility, and functional performance (e.g., flow rates, humidification).
Therefore, I cannot provide the requested information regarding acceptance criteria for a software device based on the given input, as the document pertains to a hardware medical device.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).