(282 days)
The HVT 2.0 system is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult patients and pediatric patients (5 kg and up). The device is intended to be used in hospital, sub-acute facility, and home-use settings.
The HVT 2.0 system is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult patients and pediatric patients (5 kg and up). The device is intended to be used in hospital, sub-acute facility and home-use settings.
The HVT 2.0 system is intended to be used by qualified medical professionals, such as physicians, nurses, respiratory therapists and by patients in a home-use setting under the supervision of qualified medical professionals.
The HVT 2.0 system consists of the HVT 2.0 main device, a Disposable Patient Circuit (DPC), and a patient interface (nasal cannula). The HVT 2.0 system utilizes an integrated internal blower to deliver warmed and humidified breathing gas at flows up to 45 L/min to spontaneously breathing patients, without the need of wall air or any pressurized air source. The device incorporates a blender and flow sensors that allow the oxygen percentage and total gas flow to be set independently. The addition of an external oxygen source (wall, tank, or oxygen concentrator) enables FiO2 delivery from 21% to 100%, dependent on the oxygen source.
The HVT 2.0 main device contains all the electrical and electronic components including the electronic blender and flow controllers, and remote sensors to monitor the disposable patient circuit. The main device has no water pathways, and the gas pathway only contains dry gas at room temperature, and consequently does not need internal cleaning or disinfection.
The provided text describes the HVT 2.0 respiratory gas humidifier and its review by the FDA for substantial equivalence to a predicate device. However, the document primarily focuses on regulatory approval, device description, and non-clinical performance testing. It does not contain information about acceptance criteria and a study proving the device meets those criteria, particularly within the context of artificial intelligence (AI) or machine learning (ML) performance.
Therefore, I cannot provide the requested table and details because the input text does not contain that information. The document focuses on the HVT 2.0 being "substantially equivalent" to a predicate device based on non-clinical performance testing, not on meeting specific, reported performance metrics with acceptance criteria, especially not in the context of an AI/ML study.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance related to a diagnostic or analytical function. The testing described is for physical characteristics and safety of the humidifier.
- Sample size for a test set, data provenance, ground truth establishment, or expert involvement. These are typically relevant for AI/ML performance studies.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study information.
- Information about standalone (algorithm-only) performance.
- Type of ground truth used (pathology, outcomes data, etc.) relevant to AI/ML or comparative diagnostic performance.
- Sample size for a training set or how ground truth for a training set was established.
§ 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).