AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS

K993833 · Allegiance Healthcare Corp. · BZE · Dec 10, 1999 · Anesthesiology

Device Facts

• Record ID: K993833
• Device Name: AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS
• Applicant: Allegiance Healthcare Corp.
• Product Code: BZE · Anesthesiology
• Decision Date: Dec 10, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5270
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Breathing system heaters are defined as a device that is intended to warm breathing gases before they enter a patient's airway.

Device Story

Disposable breathing circuit assembly; includes tubing, connectors, and heating wire. Used in conjunction with breathing system heaters to warm gases delivered to patient airway. Designed for infant, pediatric, and adult patient populations. Operated by clinicians in clinical settings. Device warms gases to prevent heat loss during mechanical ventilation or anesthesia delivery.

Clinical Evidence

Bench testing only. Materials evaluated for biological safety per ISO 10993 Part-1. Materials tested in accordance with industry-recognized methods and found acceptable.

Technological Characteristics

Disposable circuit components including tubing, connectors, and heating wire assemblies. Materials evaluated per ISO 10993-1. Class II device (21 CFR 868.5270).

Indications for Use

Indicated for warming breathing gases prior to entry into the airway of infant, pediatric, and adult patients.

Regulatory Classification

Identification

A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.

Predicate Devices

• Isothermal Heated Ventilator and Anesthesia Breathing Circuits

Submission Summary (Full Text)

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K993833

DEC 1 0 1999

Image /page/0/Picture/2 description: The image shows the word "Allegiance" in a bold, sans-serif 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

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Airlife® Heated Ventilator and Anesthesia Breathing Circuits

| 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: | September, 1999 |
| Common Name: | Airlife® Heated Ventilator and Anesthesia<br>Breathing Circuits |
| Classification: | Class II per 21CFR § 868. 5270 |
| Predicate Device: | Isothermal Heated Ventilator and Anesthesia<br>Breathing Circuits. |
| Description: | The Airlife Heated Ventilator and Anesthesia<br>Breathing Circuits are comprised of disposable<br>connectors, tubing, and heating wire<br>assemblies. The circuits are for infant, pediatric<br>and adults. |

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Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif 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® Heated Ventilator and Anesthesia Breathing Circuits

| Intended Use: | Breathing system heaters are defined as a device<br>that is intended to warm breathing gases before<br>they enter a patient's airway. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Airlife® Heated Ventilator and Anesthesia<br>Breathing Circuits are substantially equivalent to<br>the Isothermal Heated Ventilator and Anesthesia<br>Breathing Circuits in that:<br><br>- 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>Heated Ventilator and Anesthesia Breathing Circuits<br>were evaluated through biological qualification safety<br>tests as outlined in ISO 10993 Part-1 "Biological<br>Evaluation of Medical Devices". These materials<br>also were tested in accordance with industry<br>recognized test methods and were found to be<br>acceptable for the 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 & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird-like symbol with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 1999

Ms. Sharon Robbins Allegiance Heathcare Corporation 1500 Waukegan Road McGaw Park, IL 60085-6787

Re: K993833 Airlife® Heated Ventilator and Anesthesia Breathing Circuits Requlatory Class: II (two) Product Code: 73 BZE November 10, 1999 Dated: Received: November 12, 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 requlatory 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation 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,

Juano H Westerhausen for

elia M. Witten, Ph.D., M.D. Acting 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 bold, stylized font. To the left of the word is a graphic of a plus sign made up of small dots. The word is in all capital letters, and the font is sans-serif.

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 K993833 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Airlife® Heated Ventilator and Anesthesia<br>Breathing Circuits |
| Indications For Use: | Breathing system heaters are defined as a device<br>that is intended to warm breathing gases before<br>they enter a patient's airway. |

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
|--------------------------------------------------------|--|

| Prescription Use (Per 21 CFR 801.109) | X |
|---------------------------------------|----|
| | or |
| Over-The Counter Use | |

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| Division Sign-Off | <img alt="Signature" src="signature.png"/> |
|-------------------------------------------------------------------|--------------------------------------------|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K993833 |