AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER

K041418 · Cardinalhealth · CAF · Jun 10, 2004 · Anesthesiology

Device Facts

• Record ID: K041418
• Device Name: AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
• Applicant: Cardinalhealth
• Product Code: CAF · Anesthesiology
• Decision Date: Jun 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

This device is intended to be used to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Continuous Large Volume Nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used under medical supervision in hospitals, nursing homes, extended care facilities or outpatient clinics.

Device Story

Airlife Misty Finity is a single-patient-use, non-sterile, large-volume continuous nebulizer. Device connects to an external compressed air source via flexible tubing. Liquid medication is placed in the reservoir; gas stream shatters liquid into particles; particles impact a baffle to reduce size. Larger particles return to liquid state via gravity/inertia; smaller particles are inhaled by patient. Used in hospitals, nursing homes, and clinics under physician/healthcare professional supervision. Provides continuous aerosolized medication delivery to assist in respiratory treatment.

Clinical Evidence

Bench testing only. Performance evaluated via cascade impaction at 28.3 L/min flow rate to measure MMAD, GSD, and deposited drug mass (0.4–4.7 microns). Tested with beta-agonist bronchodilators, anti-cholinergic bronchodilators, and anti-inflammatory drugs. Results demonstrated performance substantially equivalent to the predicate device.

Technological Characteristics

Disposable, non-sterile, single-patient-use nebulizer. Materials: Thermoplastics. Principle: Pneumatic nebulization via gas-liquid contact and baffle impaction. Flow rate: 10 lpm. Capacity: 240 ml. Compatible with compressed air systems. No software or electronic components.

Indications for Use

Indicated for infant, pediatric, and adult patients requiring administration of medical aerosol products via continuous large volume nebulization in clinical settings (hospitals, nursing homes, extended care facilities, outpatient clinics).

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

• Westmed Heart Continuous Large Volume Nebulizer (K963910)

Submission Summary (Full Text)

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K041418

(JUN 1 0 2004

Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of several curved lines, and the text "CardinalHealth" is written in a simple, sans-serif font.

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

### SMDA REQUIREMENTS

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Airlife™ Misty Finity™ Large Volume Continuous Nebulizer

| Manufacturer: | Cardinal Health Corporation<br>1300 Waukegan Road<br>McGaw Park, IL 60085 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Lavenia Ford<br>1500 Waukegan Road MPWM<br>McGaw Park, IL 60085 |
| Telephone: | [phone] |
| Date Summary Prepared: | March, 2004 |
| Trade Name: | Airlife™ Misty Finity™ Large Volume Continuous Nebulizer |
| Classification: | Class II per 21CFR § 868.5630 |
| Classification Name: | Nebulizer |
| Predicate Device: | Westmed Heart Continuous Large Volume Nebulizer |
| Description: | The nebulizer is a single patient use device, which is<br>filled with a fluid, typically respiratory medication and<br>connected to an air source via flexible tubing. The<br>nebulizer works by having the fluid come into contact<br>with the steam of gas. The gas shatters the liquid into<br>small particles. These particles then impact a baffle that<br>further reduces the size of the particles. The majority of<br>the larger particles settle inside the nebulizer as a result<br>of gravity and inertia, returning the mist to liquid to<br>repeat the nebulization process. The smaller particles<br>are then administered as the patient inhales. The<br>treatment is completed when the majority of fluid is<br>nebulized. |

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Image /page/1/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic of several curved lines above the company name. The text "CardinalHealth" is written in a simple, sans-serif font.

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

### SMDA REQUIREMENTS (continued)

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Airlife™ Misty Finity™ Large Volume Continuous Nebulizer

This device is intended to be used to spray liquids in Intended Use: aeroso! form into gases that are delivered directly to the patient for breathing. It's use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using the Airlife™ Misty Finity™ Large Volume Continuous Nebulizer. This product is a single patient use, nonsterile prescriptive device and is designed to be used in either a hospital, nursing homes, extended care facilities or outpatient clinics.

Substantial Equivalence: Airlife™ Misty Finity™ Large Volume Continuous Nebulizer is substantially equivalent to the Westmed Heart Continuous Large Volume Nebulizer All materials used in the fabrication of the Airlife™ Misty Summary of testing: Finity™ Large Volume Continuous Nebulizer were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices"and were found similar to the predicate. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use. Note Table below:

| Characteristic | (Proposed Cardinal) AirLife Misty Finity Large Volume Continuous Nebulizer | (Predicate WestMed) Heart Large Volume Continuous Nebulizer K963910 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Intended Use | This device is intended to be used to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing | Same |
| Type of Device | Disposable, Sold Non-Sterile, Single Patient Use | Same |
| Type of Air Source | Compatible with compressed air systems | Same |
| Nebulizer Flow Rates | 10 lpm | 10 or 15 lpm |
| Maximum Fill Capacity | 240 ml | Same |
| Patient Population | Infant, Pediatric and Adult | Same |
| Accessories | Aerosol Masks, Tubing | Same |
| Materials | Thermo Plastics | Same |
| Manufacturing Process | Plastic Molding | Same |

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#### SMDA REQUIREMENTS (continued)

Summary of Testing:

"Performance evaluation of the proposed and predicated devices consisted of cascade impaction and output rate testing. Cascade impaction was conducted at a flow rate of 28.3 L/min, evaluating MMAD, GSD and deposited drug masses (total within impactor, at each stage and between 0.4 - 4.7 microns). Three different drug classes were tested; beta-agonist bronchodilator. anti-cholinergic bronchodilator and anti-inflammatory drugs. Test results found the performance of the Misty Finity substantially equivalent to the predicate device."

Test Description and Performance Summary - Particle Size "%0.4 - 4.7 microns was calculated by summing the drug masses deposited onto stages 3-7 and dividing by the total mass collected in the impactor."

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three horizontal lines that curve and merge into a single line at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### (JUN 1 0 2004

Cardinal Health C/O Mr. Ned Devine Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K041418

Trade/Device Name: Airlife Misty Finity Large Volume Continuous Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated on Submission: May 27, 2004 Date Received in ODE: May 27, 2004

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 Eederal Register.

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Page 2 - Mr. Devine

Please be advised that FDA's issuance of a substantial equivalence determination does not Flease be auvrsod that I Dr. o tosmination that your device complies with other requirements Incall that I DA nas made a deceminations administered by other Federal agencies. of the Act of any I ederal bates and squirements, including, but not limited to: registration You must comply with and the reseling (21 CFR Part 801); good manufacturing practice allu listing (21 CF R Part 807), abstitus (QS) regulation (21 CFR Part 820); and if requirements as set form in the quadistion control provisions (Sections 531-542 of the Act); applications and cleculity letter will allow you to begin marketing your device as described 21 CFR 1000-1030. This leaser manufication. The FDA finding of substantial equivalence in your bection 916(i) 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), If you desire specificatives for your 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 may overnit our 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,

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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## Indications for Use

K041418 510(k) Number (if known)

Device Name: Misty Finity™ Large Volume Continuous Nebulizer

Indications for Use:

This device is intended to be used to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Its use is indicated whenever a physician or healthcare professional administers or inaloutu medical aerosol products to a patient using a Continuous Large Volume Nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used under medical supervision in hospitals, nursing homes, extended care facilities or outpatient clinics.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

| 510(k) Number: | K041418 |
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