HUMIDIFIER

K945782 · Respironics, Inc. · BTT · Mar 1, 1996 · Anesthesiology

Device Facts

• Record ID: K945782
• Device Name: HUMIDIFIER
• Applicant: Respironics, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: Mar 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

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 and absorb water by evaporation into the airstream.

Device Story

Passover humidifier; adds moisture to airstream of BiPAP/CPAP systems. Input: airstream from CPAP/BiPAP; Output: humidified air. Device consists of transparent plastic tank (425 ml capacity) with 22 mm OD ports. Placed between CPAP/BiPAP outlet and patient tubing. User monitors water level visually via transparent tank. Benefits: increases relative humidity of inspired air for patient comfort. Decontamination: daily low-level process using 50% vinegar solution or quaternary ammonia compound.

Clinical Evidence

Bench testing only. Performance testing evaluated relative humidity output at 30 LPM and flow rates <50 LPM. Impact testing confirmed structural integrity after 30-inch drop. Decontamination efficacy testing showed bacterial reduction from 1.7 x 10^6/ml to 2.7/ml using 50% vinegar solution.

Technological Characteristics

Passover-style humidifier; transparent plastic tank; 425 ml water capacity; 22 mm OD connector ports; optional mounting stand. Passive evaporation mechanism; no external energy source required for humidification. Non-sterile.

Indications for Use

Indicated for patients requiring humidification of the airstream during use of Respironics BiPAP or CPAP systems. No specific age or gender restrictions provided.

Regulatory Classification

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.

Submission Summary (Full Text)

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K945782

RE

SECTION 4, Summary of Safety and Effectiveness

MAR - 1 1996

# Summary of Safety and Effectiveness

Device Name: Humidifier

Distributor: Respironics Inc.
1001 Murry Ridge Drive
Murrysville, Pa. 15668
Phone: [phone]

## 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 and absorb 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.

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. 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 filling 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 90°F and 25 % relative humidity, and a nominal patient air flow of 30 LPM. Humidifier has a capacity of approximately 425 ml. of water.

1001 Murry Ridge Drive, Murrysville, PA 15668-8550

412/733-0200 Fax [phone]

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Section 4, Summary of Safety and Effectiveness

An optional stand is available for the Humidifier which allows the Humidifier to be mounted beneath the BiPAP or CPAP systems.

## 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 satisfactorily withstand a drop from $30^{\circ}$ 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 $1.7 \times 10^{6} / \mathrm{ml}$ to $2.7 / \mathrm{ml}$ bacterial concentration.

An alternate method of low level decontamination can be achieved by using a quaternary 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.

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