(104 days)
The GE Datex-Ohmeda Aptaér Heliox delivery system is designed to deliver heliox from a source gas cylinder to spontaneously breathing patients via a facemask using pressure support. A built-in nebulizer, the Aerogen Aeroneb Pro (K021175) is provided for adding nebulized medication to the delivered heliox. The system is designed for facility use and should only be used under the orders of a clinician. The Aptaér Heliox Delivery System is not intended as a life support device and is not intended for intubated patients.
The GE Datex-Ohmeda Aptaér Heliox delivery system is designed to deliver heliox from a source gas cylinder to spontaneously breathing patients via a facemask using pressure support. A built-in nebulizer, the Aerogen Aeroneb Pro (K021175) is provided for adding nebulized medication to the delivered heliox. The system is designed for facility use and should only be used under the orders of a clinician. The Aptaér Heliox Delivery System is not intended as a life support device and is not intended for intubated patients.
The provided document is a 510(k) summary for the GE Datex-Ohmeda Aptaér Heliox Delivery System. This type of regulatory document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of the device's performance against specific acceptance criteria in a clinical or AI context.
Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/algorithm performance, detailed study design, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document primarily focuses on:
- Identifying the device and its regulatory classification.
- Stating its intended use (delivering heliox to spontaneously breathing patients via a facemask).
- Claiming substantial equivalence to two predicate devices (Viasys Avea Ventilator and Puritan Bennett 7200 Series Ventilator).
- Listing voluntary standards the device was designed to comply with (e.g., UL 2601, ASTM F100, EN/IEC 60601-1).
- Stating that the device has been "validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Aptaér Heliox Delivery System to the standards listed above."
This statement about "rigorous testing" is a general claim of validation for a medical device's physical and functional aspects, not an AI or algorithm performance study with specific metrics as requested.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).