AIRLIFE NEBULIZER CAP

K072119 · Cardinalhealth · CAF · Aug 10, 2007 · Anesthesiology

Device Facts

• Record ID: K072119
• Device Name: AIRLIFE NEBULIZER CAP
• Applicant: Cardinalhealth
• Product Code: CAF · Anesthesiology
• Decision Date: Aug 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Nebulizer cap is for use with Sterile Water or Saline for Inhalation, USP in 500 ml, 1000 ml, and 1500 ml bottles for inhalation therapy only.

Device Story

Airlife Nebulizer Cap is a mechanical device for inhalation therapy. It attaches to a bottle of sterile water or saline and a 50 psi oxygen source regulated by a flow meter. An integrated air entrainment dial adjusts oxygen concentration. The device generates an aerosol of oxygen, air, and liquid, which is delivered to the patient through 22 mm corrugated tubing. It is intended for clinical use to provide respiratory support. The device functions as a direct patient interface to facilitate the delivery of humidified or medicated aerosolized solutions.

Clinical Evidence

Bench testing only. Materials were evaluated for biological safety per ISO 10993 Part-1. Functional performance testing demonstrated equivalence to the predicate device.

Technological Characteristics

Mechanical nebulizer cap; air entrainment dial for oxygen concentration adjustment; 22 mm outlet port for corrugated tubing; compatible with 500 ml, 1000 ml, and 1500 ml bottles. Materials evaluated per ISO 10993 Part-1.

Indications for Use

Indicated for patients requiring inhalation therapy using sterile water or saline delivered via nebulizer.

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Predicate Devices

• Airlife Nebulizer Cap (K962161)
• Nebulizer with Air Entrainment and Immersion Heater Adapter (K801251)

Submission Summary (Full Text)

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CardinalHealth

AUG 1 0 2007

K072119
page 1 of 2

Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6610 FAX: [phone]

## SMDA REQUIREMENTS

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Airlife Nebulizer Cap

1430 Waukegan Road MPKB

McGaw Park, IL 60085

Sponsor:

Regulatory Affairs: Contact

Sharon Nichols

[phone]

Airlife Nebulizer Cap

Nebulizer (Direct Patient Interface)

Class II per 21CFR §868.5630

Airlife Nebulizer Cap, K962161 Nebulizer with Air Entrainment and Immersion Heater Adapter, K801251

May 2007

Cardinal Health

Telephone:

Date Summary Prepared:

Common Name:

Classification Name:

Classification:

Predicate Device:

Description:

A nebulizer cap deliver an aerosol of oxygen, air, and either water or saline. It consists of a dry device attached to a bottle of sterile solution. In use, the device attaches to a 50 psi source of oxygen. which is regulated by a flow meter. An air entrainment dial regulates airflow to adjust for desired oxygen concentration. The outlet port attaches to 22 mm corrugated tubing, which acts as a conduit for the aerosol to the patient.

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### The Nebulizer cap is for use with Sterile Intended Use: Water or Saline for Inhalation, USP in 500 ml and 1000 ml, and 1500 ml bottles for inhalation therapy only. Substantial Equivalence: The Airlife Nebulizer Cap is substantially equivalent to the Airlife Nebulizer Cap in that: - the intended use is the same - the performance attributes are the same . Summary of Technological Characteristics: The proposed device and the predicate device are composed of the same or similar design, materials and the manufacturing characteristics. Summary of testing: All materials used in the fabrication of the

Non-Clinical Testing:

Airlife Nebulizer Cap were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.

Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed Nebulizer Cap with regard to functional characteristics.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, composed of three curved lines.

AUG 1 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardinal Health C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K072119

Trade/Device Name: Airlife Nebulizer Cap Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: July 31, 2007 Received: August 1, 2007

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 -Mr. Devine

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indication for Use

510(k) Number (if known):

Device Name:

Indications For Use:

Unknown at this time

Airlife Nebulizer Cap

The Nebulizer cap is for use with Sterile Water or Saline for Inhalation, USP in 500 ml, 1000 ml, and 1500 ml bottles for inhalation therapy only.

Prescription Use X (Per 21 CFR 801.109)

Over-The C

Over-The Counter Use

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

or

Concurrence of CDRH, Office of Device Evaluation (ODE)

N.Ch

. Bc Division Sign-Off) actiong BC . Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072119

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