(11 days)
The Vapotherm™ 2000h and 2000i are designed to add moisture to and to warm breathing gases for administration to patients, including neonates/infant, pediatrics, and adults. The flow rates may be from 1 to 40 liters per minute via nasal cannula. Environments of use - Home, Hospital, Sub-acute Institutions
The Vapotherm 2000i and Vapotherm 2000h are identical and share the concept of humidification by transpiration of water vapor across a membrane by the use of a low or high flow cartridge with membrane bundles. The difference in the cartridges is only the number of membrane bundles included, fewer in the low flow. Both units and cartridges produce a highly humidified air (relative humidity >95%), virtually free of droplets, at body temperature or above at flow rates from 1 to 40 lpm via a nasal cannula. The water content at 41℃ is 40-50 mg/liter, about fourfold higher than can be achieved by humidification at room temperature. The unique combination of high flow and high vapor-phase humidity allow an unusually wide range of clinical applications. Applications previously considered impractical because of limited patient tolerance for high nasal flow can now be routine because of the comfort provided by warmth and high humidity.
The provided text primarily consists of regulatory summaries and approval letters for the Vapotherm 2000h and 2000i devices. It details the device's function, indications for use, and a comparison to predicate devices. However, it does not contain information about acceptance criteria, specific studies conducted to demonstrate performance against those criteria, sample sizes, expert involvement, or any statistical evaluation of device performance.
Therefore, I cannot directly answer your request based on the provided input. The document focuses on regulatory equivalence rather than an empirical study demonstrating performance against specific acceptance criteria.
To elaborate, the document states:
- Device Description: The Vapotherm 2000i and 2000h produce "a highly humidified air (relative humidity >95%), virtually free of droplets, at body temperature or above at flow rates from 1 to 40 lpm via a nasal cannula. The water content at 41℃ is 40-50 mg/liter..."
- Comparison to Predicate Devices: It highlights "Same" or "No changes" for several attributes when comparing to predicate devices (K000401, K013486, K040862).
These descriptions are technical specifications and comparisons, not acceptance criteria for a validation study. The FDA approval K042245 is based on substantial equivalence to predicate devices, meaning it largely relies on the predicate devices having already met safety and effectiveness standards, rather than requiring extensive new clinical trial data for this specific iteration.
§ 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).