(297 days)
For the delivery of heated, humidified breathing gases to spontaneously breathing adult patients. This breathing set is suitable for use with Fisher & Paykel Healthcare MR850 Humidifiers in hospital and long-term care environments.
The F&P 850 AirSpiral Adult NIV and NHF Circuit Kit (850A61) is designed to provide a gas conduit between respiratory support equipment and a patient interface such as a mask, nasal prongs or tracheostomy interface for a spontaneously breathing Adult patient.
The Inspiratory Limb is an extruded bubble tube design 1.6 metres in length, and is intended to connect the gas path from humidification chamber to the patient interface. Additionally, temperature sensor clips and a gown clip are included to aid in cable management and to affix the circuit to a gown or sheet. The subject device is single use, prescription only and is provided in a non-sterile state.
The Disposable Exhalation Port is an optional accessory for NIV applications. It features a perforated ventilation hole and a 22mm/15mm coaxial taper connectir for connecting to patient interfaces and a 22mm tapered male connector for connecting to the patient end of the Inspiratory Limb. It also features a capped port for connecting to the Pressure Line.
I apologize, but the provided text does not contain information about an AI/ML-based medical device or any study related to its performance and acceptance criteria.
The document is an FDA 510(k) clearance letter for a medical device called the "F&P 850 AirSpiral Adult NIV and NHF Circuit Kit." This device is a heated breathing tube and associated components designed to deliver heated, humidified breathing gases to spontaneously breathing adult patients.
The 510(k) submission describes:
- The device's intended use and indications for use.
- A comparison of its technological characteristics with a predicate device (F&P AirSpiral Heated Breathing Tube K162553) and a secondary predicate (Philips Disposable Exhalation Port K982454).
- A summary of non-clinical tests performed to demonstrate substantial equivalence to the predicate devices. These tests relate to:
- Compliance with various medical device standards (e.g., ISO, IEC).
- Exhalation port equivalence (flow rates).
- Pressure port equivalence (inspired volume).
- Inhalation path equivalence (tidal volumes).
- Human factors evaluation.
There is no mention of artificial intelligence, machine learning, deep learning, or any form of AI-based algorithm doing image analysis, risk prediction, or any other function that would require the kind of performance data usually associated with AI/ML device clearances (e.g., sensitivity, specificity, AUC).
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as the document clearly pertains to a non-AI 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).