AIRLIFE

K123527 · Care Fusion · CAF · Apr 25, 2013 · Anesthesiology

Device Facts

• Record ID: K123527
• Device Name: AIRLIFE
• Applicant: Care Fusion
• Product Code: CAF · Anesthesiology
• Decision Date: Apr 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

This device is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing. The patient population includes adults, pediatrics, and infants that are spontaneously breathing. The product is a prescriptive device intended to be used in hospital setting.

Device Story

Pneumatic jet nebulizer; aerosolizes liquid medication for inhalation. Input: high-pressure gas (compressed air or oxygen) and liquid medication. Operation: high-pressure gas drives through jet stem across one-piece jet immersed in solution; creates aerosol. Output: aerosolized medication delivered to patient. Used in hospital setting; operated by healthcare professionals. Benefits: enables targeted delivery of aerosolized drugs to respiratory tract. Device is disposable, non-sterile, single-patient use.

Clinical Evidence

No clinical data. Bench testing only. Performance characterized using Next Generation Impactor (NGI) per USP 34 <1601> at 15 LPM flow, testing three medications (Albuterol, Budesonide, Cromolyn Sodium) at 7, 8, and 9 LPM drive flow. Metrics included MMAD, GSD, particle size distribution (extra-fine, fine, coarse, respirable), and total delivered mass.

Technological Characteristics

Pneumatic jet nebulizer; disposable, non-sterile, single-patient use. Drive flow rate: 8 ± 1 LPM. Max fill capacity: 10 mL. Gas source: compressed air or oxygen. Biocompatibility per ISO 10993-1 (cytotoxicity, sensitization, irritation).

Indications for Use

Indicated for spontaneously breathing adults, pediatrics, and infants requiring aerosolized liquid medication delivery in a hospital setting.

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 Max 10 Nebulizer (K023602)
• NebuTech HDN (K962879)

Submission Summary (Full Text)

{0}------------------------------------------------

K 123527

Image /page/0/Picture/1 description: The image shows the logo for CareFusion. The logo consists of a circular emblem on the left and the word "CareFusion" on the right. The emblem contains a stylized image of two figures embracing within a shield-like shape.

# ک(۵ (κ) Summary of Safety and Effectiveness

APR 2 5 2013

Summary of 510(k) safety and effectiveness in accordance with 21 CFR 807.92.

## SUBMITTER INFORMATION

| Name | CareFusion | | | | |
|--------------------------------------|---------------------------------------------------|--|--|--|--|
| Address | 1500 Waukegan Road MPWM, McGaw Park, IL 60085 USA | | | | |
| Phone number | [phone] | | | | |
| Fax number | [phone] | | | | |
| Establishment<br>Registration Number | 8030673 | | | | |
| Name of contact person | Erika Fernandez | | | | |
| Date prepared | November 14, 2012 | | | | |

## NAME OF DEVICE

| Trade or proprietary name | AirLife Small Volume Nebulizer |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or usual name | Small Volume Nebulizer |
| Classification name | Nebulizer |
| Classification panel | 73 Anesthesiology |
| Regulation | Class II per 21CFR §868.5630, Product code CAF |
| Legally marketed device(s) to which equivalence is claimed | K023602: AirLife Misty Max 10 Nebulizer<br>K962879: NebuTech HDN |
| Device description | Pneumatic jet nebulizer that aerosolizes medication by driving a<br>high pressure gas through the jet stem across the one piece jet<br>immersed in the solution. |
| Intended use | This device is intended to be used to aerosolize liquid medication<br>into gases that are delivered directly to the patient for breathing.<br>The patient population includes adults, pediatrics, and infants<br>that are spontaneously breathing. The product is a prescriptive<br>device intended to be used in a hospital setting. |

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for CareFusion. The logo consists of a circular icon on the left and the word "CareFusion" on the right. The icon contains a stylized image of a shield with a heart inside of it.

| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE<br>PREDICATE DEVICE | | |
|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed Device | Predicate Device |
| Intended Use | This device is intended to be used<br>to aerosolize liquid medication into<br>gases that are delivered directly to<br>the patient for breathing.<br>The patient population includes<br>adults, pediatrics, and infants that<br>are spontaneously breathing. | This device is intended to be used to<br>spray liquids in aerosol form into<br>gases that are delivered directly to the<br>patient for breathing. Its use is<br>indicated whenever a physician or<br>healthcare professional administers or<br>prescribes medical aerosol products to<br>a patient using a Misty Max 10<br>nebulizer. This product is a single<br>patient use, non-sterile prescriptive<br>device and is designed to be used in<br>either a hospital or homecare<br>environment. |
| Indications for Use | This device is intended to be used<br>to aerosolize liquid medication into<br>gases that are delivered directly to<br>the patient for breathing. Its use is<br>indicated when a licensed<br>healthcare professional prescribes<br>or administers medical aerosols to<br>a patient using a small volume<br>nebulizer. The patient population<br>includes adults, pediatrics, and<br>infants that are spontaneously<br>breathing. The product is a single-<br>patient; non-sterile, disposable,<br>prescriptive device intended to be<br>used in hospital setting. | The AirLife Misty Nebulizer is a<br>pneumatic nebulizer which nebulizes<br>specific drugs for inhalation by a<br>patient. The patient population<br>includes infant, pediatric and adult<br>patients. Its use is indicated whenever<br>a physician or healthcare professional<br>administer or prescribes medical<br>aerosol products to a patient using a<br>small volume nebulizer. This product<br>is a single patient use, non-sterile<br>prescriptive device and is designed to<br>be used in either a hospital or<br>homecare environment. |
| Patient Population | adult, pediatric, infant | Same |
| Type of Device | Disposable<br>Non-Sterile<br>Single-Patient Use | Same |
| Core Technology | Pneumatic Jet | Same |
| Type of Gas Source | Compressed Air or Oxygen | Same |
| Nebulizer drive flow rates (LPM) | $8 \pm 1$ LPM | 6-10 LPM |
| Maximum Fill Capacity (mL) | 10 mL | Same |

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the CareFusion logo. The logo consists of a circular icon on the left and the word "CareFusion" on the right. The icon contains a stylized image of two arms embracing a shield. The text is in a bold, sans-serif font.

#### Performance Data

Summary of non-clinical tests conducted for determination of substantial equivalence

## Performance Test Summary

#### 1. Biocompatibility

.

.

Biocompatibility tests on the finished product were performed according to ISO 10993-1. Cytotoxicity, Sensitization and Irritation studies were concluded with satisfactory results.

## 2. Simulated Life-Time

No performance degradation was observed for at least 50 treatments

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for CareFusion. The logo consists of a circular icon to the left and the word "CareFusion" to the right. The icon contains a shield-like shape within a circle. The text "CareFusion" is in a bold, sans-serif font.

| Drug Description | Aerosol Characteristic | Recommended Nebulizer Set Flow Rate 8 ± 1 LPM | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------|----------------------------|--------------------------|
| | | 7 LPM | 8 LPM | 9 LPM |
| Albuterol Sulfate<br>(Adrenergic<br>Bronchodilator,<br>Beta-2<br>agonist).<br>Typical dose<br>2.5 mg/3 ml<br>(0.083% by<br>volume) or 2500 µg<br>of drug<br>substance. | MMAD (µm)2 | 4.5 ± 0.1 µ | 3.8 ± 0.1 µ | 3.5 ± 0.1 µ |
| | GSD3 | 2.1 ± 0.04 | 2.1 ± 0.02 | 2.1 ± 0.05 |
| | Extra-fine particles (< 1 µm)4 | 5.9 ± 0.3%<br>67 ± 5 µg | 7.1 ± 0.3%<br>75 ± 2 µg | 7.6 ± 0.4%<br>74 ± 4 µg |
| | Fine particles (< 5 µm)4 | 52 ± 2%<br>582 ± 27 µg | 59 ± 1%<br>626 ± 12 µg | 64 ± 2%<br>619 ± 24 µg |
| | Coarse particles (> 5 µm)4 | 48 ± 2%<br>547 ± 31 µg | 41 ± 1%<br>438 ± 23 µg | 36 ± 2%<br>354 ± 17 µg |
| | Respirable particles (1-5 µm)4 | 46 ± 2%<br>515 ± 24 µg | 52 ± 1%<br>551 ± 12 µg | 56 ± 2%<br>545 ± 23 µg |
| | Total mass of drug (in nebulizer)5 | 2500 µg | 2500 µg | 2500 µg |
| | Total Delivered Mass of Aerosol6 | 45 ± 2%<br>1129 ± 38 µg | 42 ± 1%<br>1064 ± 25 µg | 39 ± 1%<br>973 ± 23 µg |
| | Average Treatment Time (minutes)7 | 3.4 ± 0.1 | 3.0 ± 0.1 | 2.7 ± 0.1 |
| Budesonide<br>Suspension<br>(Corticosteroid).<br>Typical dose<br>0.50 mg/2 ml or<br>500 µg of drug<br>substance. | MMAD (µm)2 | 5.6 ± 0.1 µ | 5.1 ± 0.1 µ | 4.7 ± 0.2 µ |
| | GSD3 | 1.9 ± 0.03 | 1.9 ± 0.04 | 1.9 ± 0.1 |
| | Extra-fine particles (< 1 µm)4 | 4.8 ± 1.6%<br>11 ± 4 µg | 4.7 ± 0.6%<br>9.4 ± 1.1 µg | 7.0 ± 1.1%<br>13 ± 2 µg |
| | Fine particles (< 5 µm)4 | 39 ± 2%<br>87 ± 6 µg | 45 ± 2%<br>92 ± 2 µg | 50 ± 3%<br>93 ± 3 µg |
| | Coarse particles (> 5 µm)4 | 61 ± 2%<br>134 ± 10 µg | 55 ± 2%<br>112 ± 8 µg | 50 ± 3%<br>95 ± 8 µg |
| | Respirable particles (1-5 µm)4 | 35 ± 2%<br>78 ± 6 µg | 41 ± 1%<br>83 ± 2 µg | 43 ± 2%<br>80 ± 23 µg |
| | Total mass of drug (in nebulizer)5 | 500 µg | 500 µg | 500 µg |
| | Total Delivered Mass of Aerosol6 | 44 ± 2%<br>222 ± 14 µg | 41 ± 2%<br>205 ± 9 µg | 38 ± 1%<br>188 ± 7 µg |
| | Average Treatment Time (minutes)7 | 1.9 ± 0.1 | 1.9 ± 0.1 | 1.7 ± 0.1 |
| Cromolyn Sodium<br>(Nonsteroidal<br>Anti-asthma<br>Medication).<br>Typical dose<br>20 mg/2 ml or<br>20000 µg of<br>drug substance. | MMAD (µm)2 | 4.7 ± 0.2 µ | 3.9 ± 0.1 µ | 3.5 ± 0.1 µ |
| | GSD3 | 2.0 ± 0.02 | 2.0 ± 0.02 | 2.0 ± 0.02 |
| | Extra-fine particles (< 1 µm)4 | 9.7 ± 1%<br>617 ± 57 µg | 11 ± 1%<br>648 ± 31 µg | 13 ± 1%<br>675 ± 49 µg |
| | Fine particles (< 5 µm)4 | 50 ± 2%<br>3170 ± 180 µg | 58 ± 1%<br>3320 ± 150 µg | 64 ± 3%<br>3310 ± 220 µg |
| | Coarse particles (> 5 µm)4 | 50 ± 2%<br>3220 ± 290 µg | 42 ± 1%<br>2360 ± 140 µg | 36 ± 3%<br>1900 ± 250 µg |
| | Respirable particles (1-5 µm)4 | 40 ± 1%<br>2550 ± 150 µg | 47 ± 1%<br>2660 ± 120 µg | 51 ± 2%<br>2640 ± 190 µg |
| | Total mass of drug (in nebulizer)5 | 20000 µg | 20000 µg | 20000 µg |
| | Total Delivered Mass of Aerosol6 | 32 ± 2%<br>6380 ± 390 µg | 28 ± 2%<br>5680 ± 240 µg | 26 ± 2%<br>5220 ± 400 µg |
| | Average Treatment Time (minutes)7 | 3.1 ± 0.1 | 1.7 ± 0.1 | 1.6 ± 0.1 |

#### 3. Aerosol Characterization

³ Performance data using Cascade Impactor (NGI) per USP 34 <1601> chilled to 5 °C with an extraction flow of 15 lpm for three common aerosolized medications. Treatment time was defined as onset of audible sputtering plus one minute. Values represent the Mean and 95% confidence interval of the mean.

2 MMAD Is Mass Median Aerodynamic Diameter.

3 GSD is the Geometric Standard Deviation.

4 Values are the mass of drug substance delivered in the specified size range of aerosol particles and the mass represented as a percentage of the Total Delivered Mass of Aerosol.

5 Total mass of drug in nebulizer is the mass of drug substance placed in the nebulizer cup for typical dose listed.

6 The total delivered mass of aerosol is the mass of drug substance recovered from the cascade impactor after treatment time. The mass is stated in micrograms of drug substance and as a percentage of the total mass of drug substance placed in the nebulizer.

- 7 Treatment time, defined as onset of sputtering plus one minute, to deliver the aerosol masses starting with the initial mass of drug listed.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the CareFusion logo. The logo consists of a circular icon on the left and the word "CareFusion" on the right. The icon contains a stylized shield shape within a circle. The text "CareFusion" is in a bold, sans-serif font.

#### Results and Conclusion

Based upon the information provided the proposed device is substantially equivalent to the predicate devices, and raises no new issues of safety and effectiveness

Summary of clinical tests conducted for determination of substantial equivalence and/or of clinical information

N/A - No clinical tests were conducted for this submission

Conclusions drawn from non-clinical and clinical data

The results of the non-clinical tests show that the small volume nebulizer meets all performance requirements, and is substantially equivalent to the predicate devices.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three wave-like lines, and the text is in all caps.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## April 25, 2013

Ms. Erika Silva Fernandez Manager, Regulatory Affairs CareFusion 1500 Waukegan Road WAUKEGAN IL 60060

Re: K123527

Trade/Device Name: Small Volume Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: March 21, 2013 Received: March 26, 2013

Dear Ms. Fernandez:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{6}------------------------------------------------

Page 2 - Ms. Fernandez

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): medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kwame O. Ulmer -S for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image contains the logo for CareFusion. The logo consists of a circular graphic on the left and the word "CareFusion" on the right. The graphic appears to be a stylized representation of a person or figure within a circular border. The text "CareFusion" is written in a bold, sans-serif font.

## Indication for Use

K123527

510(k) Number (if known):

Device Name:

Indications for Use:

Small Volume Nebulizer

or

Unknown at this time

This device is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing. The patient population includes adults, pediatrics, and infants that are spontaneously breathing. The product is a prescriptive device intended to be used in hospital setting.

Prescription Use X_

Over-The Counter Use _

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chan O. Lee -S
2013.04.24
16:11:51 -04'00' For LS

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

510(k) Number: