SMALL VOLUME NEBULIZER

K023602 · Allegiance Healthcare Corporation · CAF · May 1, 2003 · Anesthesiology

Device Facts

• Record ID: K023602
• Device Name: SMALL VOLUME NEBULIZER
• Applicant: Allegiance Healthcare Corporation
• Product Code: CAF · Anesthesiology
• Decision Date: May 1, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Airlife Misty Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. The patient population includes infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used in either a hospital or homecare environment.

Device Story

Pneumatic nebulizer for delivery of respiratory medication; device connects to external air source via flexible tubing. Fluid contacts gas stream, shattering liquid into particles; baffle reduces particle size. Larger particles settle via gravity/inertia, returning to liquid state for re-nebulization; smaller particles inhaled by patient. Single-patient use; intended for hospital or homecare settings. Operated by physician, healthcare professional, or patient. Treatment concludes when majority of fluid nebulized. Benefits patient through targeted aerosolized drug delivery.

Clinical Evidence

Bench testing only. Comparative particle size distribution testing performed against predicate and Pari-LC. Biological qualification safety testing conducted per ISO 10993 Part-1.

Technological Characteristics

Pneumatic nebulizer; single-patient use; non-sterile. Materials evaluated per ISO 10993-1. Operates via gas-stream fluid shattering and baffle-based particle size reduction.

Indications for Use

Indicated for infant, pediatric, and adult patients requiring administration of medical aerosol products via small volume nebulizer. Contraindications not specified.

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 Misty Nebulizer

Reference Devices

• Pari-LC

Submission Summary (Full Text)

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MAY = 1 2003

Image /page/0/Picture/1 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a graphic of a plus sign made up of small circles. The word is in all capital letters and is in bold.

a Cardinal Health company

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500

### SMDA REQUIREMENTS

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESSS

Submitter:

Allegiance Healthcare Corporation 1500 Waukegan Road MPWM McGaw Park, IL 60085

| Regulatory Affairs Contact: | Sharon Nichols |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Date Summary Prepared: | April, 2003 |
| Common Name: | Airlife ® Misty Max 10™ Nebulizer |
| Classification: | Class II per 21CFR § 868.5630 |
| Predicate Device: | Airlife Misty Nebulizer |
| Description: | The nebulizer is a single patient use device which is filled with a fluid, typically respiratory medication, and connected to an air source via flexible tubing. The nebulizer works by having the fluid come into contact with the stream of gas. The gas shatters the liquid into small particles. These particles then impact a baffle that further reduces the size of the particles. The majority of the larger particles settle inside the nebulizer as a result of gravity and inertia, returning the mist to liquid to repeat the nebulization process. The smaller particles are then administered as the patient inhales. The treatment is completed when the majority of fluid is nebulized. |

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Image /page/1/Picture/0 description: The image shows the logo for Allegiance, a Cardinal Health company. The logo features a stylized cross made of small dots to the left of the word "Allegiance" in a bold, italicized font. Below the company name is the text "a Cardinal Health company" in a smaller, non-italicized font.

### SMDA REQUIREMENTS (continued)

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Intended Use: | The Airlife Misty Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. The patient population includes infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used in either a hospital or homecare environment. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | Airlife ® Misty Max 10 ^TM Nebulizer is substantially equivalent to the Airlife® Misty-Neb Nebulizer in that: - the intended use is the same - the performance attributes are similar |
| Summary of testing: | All materials used in the fabrication of the Airlife® Misty Max 10 ^TM Nebulizer were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". Comparative testing was performed using the proposed, predicate and Pari-LC with regards to particle size distribution testing. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use. |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY = 1 2003

Ms. Sharon Nichols Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building WM McGaw Park, Illinois 60085

Re: K023602

Trade/Device Name: Airlife® Misty Max 10™ Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: March 31, 2003 Received: April 1, 2003

Dear Ms. Nichols:

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 - Ms. Nichols

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 (QS) 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/dsma/dsmamain.html

Sincerely vours.

Susa Runner

Susan Runner, DDS, MA Interim 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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Image /page/4/Picture/0 description: The image shows the logo for Allegiance Health. The logo features a stylized cross made of small dots to the left of the word "Allegiance" in a bold, italicized font. The logo is simple and professional, conveying a sense of trust and reliability.

a Cardinal Health company

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):

Device Name:

Indications For Use:

K023602

Airlife®Misty Max 10™ Nebulizer

The Airlife Misty Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. The patient population includes infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used in either a hospital or homecare environment.

(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)

or

Over-The Counter Use

SAHutchinson

n of Anesthesiology, General Hospital,

510(k) Number: K023602