(462 days)
This information is not present in the text.
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No
The device description and performance studies focus on the physical properties and humidification function of a "passover" style humidifier, with no mention of AI or ML technologies.
No
The device is intended to add moisture to the airstream provided by BiPAP or CPAP systems, acting as an accessory to improve comfort, not to treat a medical condition directly.
No
Explanation: The device is described as a humidifier intended to add moisture to the airstream provided by CPAP/BiPAP systems. Its function is to modify the air delivered, not to detect, identify, or monitor medical conditions.
No
The device description clearly outlines a physical, hardware-based humidifier with components like a storage tank, connector ports, and markings for water levels. There is no mention of software as a primary component or function.
Based on the provided text, the Respironics Humidifier is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to add moisture to the airstream provided to a patient by a BiPAP or CPAP system. This is a therapeutic function, directly affecting the patient's breathing comfort and potentially preventing dryness in the airways.
- Device Description: The description details a physical device that connects to a breathing machine and contains water for evaporation. It does not describe any components or processes related to testing biological samples (blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
- Measuring biomarkers.
The device's function is to modify the air delivered to the patient, which falls under the category of a medical device used for therapy or support, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Respironics Humidifier is intended to add vapor phase moisture to the airstream provided to the patient by the Respironics BiPAP or CPAP systems. The Humidifier is a "passover" style which increases moisture content of the airstream by allowing the airstream to pass over a tray of water by evaporation into the airstream.
Product codes
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Device Description
The Respironics passover Humidifier is intended to be connected between the outlet port of the Bi-level or CPAP system and the tubing which goes to the patient. Small sections of patient tubing are included with the humidifier to allow the patient to connect the humidifier to the BiPAP.
The Humidifier consists of a transparent plastic storage tank with appropriate 22 mm OD connector ports to allow connection of the patient tubing and the BiPAP of CPAP connector tubing. The transparent structure allows the user to monitor the water level in the humidifier also has appropriate markings to allow the user to determine fill levels. A large opening in the center is designed to allow easy illian and cleaning of the humidifier.
The Humidifier has been designed to increase the relative humidity of the airstream being supplied to the patient. The unit is designed to have a minimum 8 hours capacity of water when operated at 00% and 25 % relative humidity, and a nominal patient air flow of 30 LPM . Humidfier has a capacity of approximately 25 ml. of water. An optional stand is available for the Humidifier which allows the Humidifier to be mounted beneath the BiPAP or CPAP systems.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The above charts depict the results of Humidifier testing. Greater changes in the relative humidity were found at 30 LPM and flow rates of less than 50 LPM. This is within the expected operating ambient and flow demands of BiPAP and CPAP systems for normal breathing.
Impact testing was conducted on the Humidifier which indicates that the Humidifier can satisfactority withstand a drop from 30" height onto concrete flooring without significantly affecting its performance.
Respironics recommends a low level decontamination process on a daily basis to reduce bacterial levels in the humidifier. Testing of the recommended decontamination procedure, soaking the unit in a 50% vinegar solution for 30 minutes, resulted in a bacterial reduction from 1.7 x 10 % ml to 2.7 / ml. bacterial concentration.
An alternate method of low level decontamination can be achieved by using a quatemary ammonia compound as a decontamination agent. The levels of decontamination achievable are consistent with guidelines for low level decontamination as published in the American Journal of Infection Control.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Section 4, Summary of Safety and Effectiveness
Image /page/0/Picture/1 description: The image shows the logo for RESPIRONICS INC. The logo includes a stylized symbol above the company name. To the right of the logo is the text "Section 4, Summary of Safety and Effectiveness".
A
MAR - 1 1996
Summary of Safety and Effectiveness
Device Name: Humidifier
Distributor: Respironics Inc. 1001 Murry Ridge Drive Murrysville, Pa. 15668 Phone: 412 733-0200
Statement of Intended Use:
The Respironics Humidifier is intended to add vapor phase moisture to the airstream provided to the patient by the Respironics BiPAP or CPAP systems. The Humidifier is a "passover" style which increases moisture content of the airstream by allowing the airstream to pass over a tray of water by evaporation into the airstream.
Technical Description and Construction Details:
The Respironics passover Humidifier is intended to be connected between the outlet port of the Bi-level or CPAP system and the tubing which goes to the patient. Small sections of patient tubing are included with the humidifier to allow the patient to connect the humidifier to the BiPAP.
Image /page/0/Figure/11 description: The image shows a diagram of a container with ports, a removable cap, and a fill line. The container has two ports on the top, labeled "Ports". The removable cap is located on the front of the container, and the fill line is located below the cap. The words "OPEN" and "LOCK" are also visible on the container.
Figure 1 - Respironics Humidifier
The Humidifier consists of a transparent plastic storage tank with appropriate 22 mm OD connector ports to allow connection of the patient tubing and the BiPAP of CPAP connector tubing. The transparent structure allows the user to monitor the water level in the humidifier also has appropriate markings to allow the user to determine fill levels. A large opening in the center is designed to allow easy illian and cleaning of the humidifier.
The Humidifier has been designed to increase the relative humidity of the airstream being supplied to the patient. The unit is designed to have a minimum 8 hours capacity of water when operated at 00% and 25 % relative humidity, and a nominal patient air flow of 30 LPM . Humidfier has a capacity of approximately 25 ml. of water. ...
1
An optional stand is available for the Humidifier which allows the Humidifier to be mounted beneath the BiPAP or CPAP systems.
Image /page/1/Figure/3 description: The image contains two line graphs comparing the relative humidity (RH) increase at different inlet RH levels for two different flow rates: 30 LPM and 80 LPM. The graph on the left shows the RH increase at 30 LPM, with the x-axis representing the inlet RH ranging from 19 to 89, and the y-axis representing the RH increase in percentage. The graph on the right shows the RH increase at 80 LPM, with the x-axis representing the inlet RH ranging from 20 to 89, and the y-axis representing the RH increase in percentage. Both graphs show a decreasing trend in RH increase as the inlet RH increases.
Safety and effectiveness data summary:
The above charts depict the results of Humidifier testing. Greater changes in the relative humidity were found at 30 LPM and flow rates of less than 50 LPM. This is within the expected operating ambient and flow demands of BiPAP and CPAP systems for normal breathing.
Impact testing was conducted on the Humidifier which indicates that the Humidifier can satisfactority withstand a drop from 30" height onto concrete flooring without significantly affecting its performance.
Respironics recommends a low level decontamination process on a daily basis to reduce bacterial levels in the humidifier. Testing of the recommended decontamination procedure, soaking the unit in a 50% vinegar
solution for 30 minutes, resulted in a bacterial reduction from 1.7 x 10 % ml to 2.7 / ml. bacterial concentration.
An alternate method of low level decontamination can be achieved by using a quatemary ammonia compound as a decontamination agent. The levels of decontamination achievable are consistent with guidelines for low level decontamination as published in the American Journal of Infection Control.