(588 days)
No
The summary describes a humidification device with an air compressor and oxygen source, focusing on physical processes (humidification by transpiration, heating). There is no mention of AI, ML, data analysis, or any features that would suggest the use of such technologies.
Yes.
It is intended to provide humidified air/oxygen mixtures to patients, which is a therapeutic intervention for respiratory support.
No
The device is described as a humidifier for air/oxygen mixtures, providing warmth and high humidity for patient comfort in various settings. Its function is to alter the air delivered to a patient, not to diagnose a medical condition.
No
The device description clearly details a hardware device that mixes gases, adds heat and moisture, and includes an internal air compressor and external oxygen source connection. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device as mixing air and oxygen, adding heat and moisture, and being used for patients needing high flow supplemental air or air/oxygen mixtures where humidification is beneficial. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the mechanism of humidification and the physical components of the device (internal air compressor, oxygen inlet). It does not mention any interaction with biological samples (blood, urine, tissue, etc.) or the analysis of such samples for diagnostic purposes.
- Lack of IVD Keywords: The document does not contain keywords typically associated with IVD devices, such as "in vitro," "diagnostic," "assay," "test," "sample," "analyte," etc.
- Focus on Patient Treatment: The entire description points towards a device used to treat patients by providing humidified respiratory support.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such function.
N/A
Intended Use / Indications for Use
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.
Product codes
BTT, BTI, BZR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home, Hospital, Sub-acute Institutions
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
MAY 3 0 2003
Vapotherm, Inc. 107 Ridgely Ave. Suite # 9 Annapolis, MD 21401
Summary of Safety and Effectiveness
Non-Confidential Summary of Safety and Effectiveness Page 1 of 4 21-May-03
Vapotherm, Inc.
107 Ridgely Ave., Suite # 9
Annapolis, MD 21401
| | Tel – (410) 974-9255
Fax – (410) 974-9707 |
|----------------------------|--------------------------------------------------------|
| Official Contact: | Robert Storey - President and CEO |
| Proprietary or Trade Name: | Vapotherm 2000h (5000) |
| Common/Usual Name: | Humidifier, Respiratory Gas (Direct Patient Interface) |
| Classification Name: | Humidifier, Respiratory Gas (Direct Patient Interface) |
| Device: | Vapotherm 2000h (5000) |
| Predicate Devices: | Vapotherm 2000i – K000401 |
Device Description:
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.
15
1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 4 21-May-03
| Intended Use: | |
|---|---|
| Indicated Use -- | The Vapotherm 2000h (5000) can mix air with oxygen |
| from an external source and adds heat and moisture to | |
| the gas. | |
| Patient Population -- | For use with any patient utilizing high flow supplemental air or |
| air/oxygen mixtures in which humidification would be | |
| beneficial. | |
| Environment of Use -- | Home, Hospital, Sub-acute Institutions |
| Contraindications -- | None |
Comparison to Predicate Devices:
| | Vapotherm 2000i
Predicate | Vapotherm 2000h (5000)
Proposed |
|---------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Attributes | | |
| Indications for use | To add moisture to and to warm
breathing gases for administration
to a patient | Same |
| 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 |
| Equipment Design | | |
| Dimensions | 11" x 5.5" x 4.5" | 12" x 15" x 10" |
| Weight | Vapotherm -