AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006

K991484 · Allegiance Healthcare Corp. · BTT · May 13, 1999 · Anesthesiology

Device Facts

• Record ID: K991484
• Device Name: AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006
• Applicant: Allegiance Healthcare Corp.
• Product Code: BTT · Anesthesiology
• Decision Date: May 13, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Humidifiers are defined as a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient

Device Story

Airlife Bubble Humidifiers consist of polypropylene bottles with high-impact polystyrene caps. Devices are pre-filled with sterile water and connected to an oxygen source. The device functions by bubbling oxygen through the water to add moisture to breathing gases before administration to a patient; heating may also be applied. Used in clinical settings to improve patient comfort and respiratory gas quality.

Clinical Evidence

Bench testing only. Materials evaluated for biocompatibility per ISO 10993 Part-1, including cytotoxicity, skin irritation, and sensitization (guinea pig maximization). Materials confirmed acceptable for intended use via industry-recognized test methods.

Technological Characteristics

Materials: Polypropylene (bottle), high-impact polystyrene (cap). Biocompatibility: ISO 10993 Part-1 compliant. Function: Bubble humidification of breathing gases. Energy: Passive (gas flow driven).

Indications for Use

Indicated for patients requiring supplemental moisture or warming of breathing gases during respiratory therapy.

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.

Predicate Devices

• Airlife® Bubble Humidifiers

Submission Summary (Full Text)

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MAY 1 3 1999

K9914841

Image /page/0/Picture/2 description: The image shows the word "Allegiance" in a stylized, bold, black font. To the left of the word is a symbol resembling a plus sign, but it is made up of many small dots. The word is slightly slanted to the right, giving it a dynamic appearance.

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: [phone]

## SMDA REQUIREMENTS

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Airlife® Bubble Humidifiers

| Manufacturer: | Allegiance Healthcare Corporation<br>1660 Iowa Avenue<br>Riverside, CA 92507 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Robbins<br>1500 Waukegan Road MPWM<br>McGaw Park, IL 60085 |
| Telephone: | [phone] |
| Date Summary Prepared: | March, 1999 |
| Common Name: | Airlife® Bubble Humidifiers |
| Classification: | Class II per 21CFR § 868.5450 |
| Predicate Device: | Airlife® Bubble Humidifiers. |
| Description: | The Airlife Bubble Humidifiers are comprised of<br>polypropylene bottles with caps which are<br>comprised of high impact polystyrene. These<br>humidifiers are filled with sterile water and<br>connected to an oxygen source to add moisture<br>to, and sometimes to warm, the breathing<br>gases for administration to a patient. |

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Image /page/1/Picture/0 description: The image contains the word "Allegiance" in a bold, italicized font. To the left of the word is a graphic of a plus sign made up of small dots. The word is in black and the background is white.

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: [phone]

## SMDA REQUIREMENTS (continued)

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Airlife® Bubble Humidifiers

| Intended Use: | Humidifiers are defined as a device that is<br>intended to add moisture to, and sometimes to<br>warm, the breathing gases for administration to<br>a patient |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Airlife® Bubble Humidifiers are<br>substantially equivalent to the Airlife® Bubble<br>Humidifiers in that: |
| | - the intended use is the same<br>- the performance attributes are the<br>similar |
| Summary of testing: | All materials used in the fabrication of the Airlife®<br>Humidifiers were evaluated through biological<br>qualification safety tests as outlined in ISO 10993<br>Part-1 "Biological Evaluation of Medical Devices".<br>The biocompatibility tests performed were<br>cytotoxicity, skin irritation and sensitization (guinea<br>pig maximization). These materials also were<br>tested in accordance with industry recognized test<br>methods and were found to be acceptable for the<br>intended use. |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 1999

Ms. Sharon Robbins Alleqiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085-6787

Re : K991484 Airlife® Bubble Humidifiers Regulatory Class: II (two) Product Code: 73 BTT Dated: April 26, 1999 Received: April 28, 1999

Dear Ms. Robbins:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Sharon Robbins

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594–4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image contains the word "Allegiance" in a stylized font. To the left of the word is a graphic that resembles a plus sign made up of small dots. The word is in bold, and the font is slightly italicized.

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500
FAX: [phone]

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| 510(k) Number (if known): | Unknown |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Airlife® Bubble Humidifiers |
| Indications For Use: | Humidifiers are defined as a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | <span style="text-decoration: overline;">✓</span> |
| | or |
| Over-The Counter Use | <span style="text-decoration: overline;">_____</span> |

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| (Division Sign-Off) | |
|----------------------------------------------------------------------|---------|
| Division of Cardiovascular, Respiratory,<br>and Neurological Devices | |
| 510(k) Number | K991484 |