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510(k) Data Aggregation
(588 days)
The Vapotherm 2000h (5000) can mix air with oxygen from an external source and adds heat and moisture to the gas. The Vapotherm 2000h (5000) is for use in home, hospital or sub-acute institutional settings.
The Vapotherm 2000i, predicate, and the Vapotherm 2000h (5000) are identical and share the concept of humidification by transpiration of water vapor across a membrane. Both produce a high flow of highly humidified air (relative humidity >95%), virtually free of droplets, at body temperature or above. The water content at 41°C 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 Vapotherm 2000h (5000) is an unmodified Vapotherm 2000i but with an internal air compressor and external oxygen source, wall or cylinder oxygen. There is a single inlet fitting. like the 2000i for connection to an external oxygen source, if desired.
The provided text describes a 510(k) premarket notification for the Vapotherm 2000h (5000), a humidifier for respiratory gas. This submission focuses on demonstrating substantial equivalence to a predicate device (Vapotherm 2000i) rather than presenting a study with specific acceptance criteria and performance data in the context of AI/machine learning.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission and the information provided. This is a medical device, not an AI/ML-based diagnostic system, and thus does not involve "ground truth" derived from expert consensus on images or pathology in the way an AI study would.
Here’s the information that can be extracted and a clear explanation for the N/A categories.
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k), the "acceptance criteria" is demonstrating substantial equivalence to the predicate device (Vapotherm 2000i). The "reported device performance" is essentially a comparison of attributes to show similarity.
| Attribute | Acceptance Criteria (Predicate: Vapotherm 2000i) | Reported Device Performance (Vapotherm 2000h (5000)) |
|---|---|---|
| Indications for use | To add moisture to and to warm breathing gases for administration to a patient | Same (Adds "with an air or air/oxygen mixture" for patent population) |
| Environments of use | Home, Hospital, Sub-acute Institutions, not specified | The same |
| Patient Population | For use with any patient utilizing supplemental oxygen in which humidification would be beneficial | Add - “ with an air or air/oxygen mixture” Otherwise the same. |
| Contraindications | None | The same |
| Dimensions | 11" x 5.5" x 4.5" | 12" x 15" x 10" |
| Weight |
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