AIRLIFE

• K Number: K123527
• Device Name: AIRLIFE
• Manufacturer: CAREFUSION
• Date Cleared: 2013-04-25 ( 160 days)
• Product Code: CAF
• Regulation Number: 868.5630

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 Description

Pneumatic jet nebulizer that aerosolizes medication by driving a high pressure gas through the jet stem across the one piece jet immersed in the solution.

Predicate Devices

K023602, K962879

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and aerosolization properties of a pneumatic jet nebulizer, with no mention of AI or ML.

Therapeutic

Yes
The device is intended to aerosolize liquid medication for breathing, delivering therapeutic agents directly to the patient's respiratory system for treatment.

Diagnostic

No

The device is described as a pneumatic jet nebulizer intended to aerosolize liquid medication for delivery to the patient for breathing. Its purpose is to administer medication, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "Pneumatic jet nebulizer" which is a hardware device used to aerosolize medication. The performance studies also focus on physical characteristics and performance of the nebulizer hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The device is intended to aerosolize liquid medication for direct delivery to the patient for breathing. This is a therapeutic function, not a diagnostic one.
• Device Description: It's a pneumatic jet nebulizer, which is a medical device used for drug delivery.
• Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition based on such analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

CAF

Device Description

Pneumatic jet nebulizer that aerosolizes medication by driving a high pressure gas through the jet stem across the one piece jet immersed in the solution.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adults, pediatrics, and infants

Intended User / Care Setting

hospital setting.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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. Aerosol Characterization: Performance data using Cascade Impactor (NGI) per USP 34 chilled to 5 °C with an extraction flow of 15 lpm for three common aerosolized medications (Albuterol Sulfate, Budesonide Suspension, Cromolyn Sodium). Treatment time was defined as onset of audible sputtering plus one minute. Values represent the Mean and 95% confidence interval of the mean. Key metrics include MMAD, GSD, extra-fine particles ( 5 µm), respirable particles (1-5 µm), total mass of drug (in nebulizer), total delivered mass of aerosol, and average treatment time.

No clinical tests were conducted for this submission.

Conclusions: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

MMAD, GSD, Extra-fine particles ( 5 µm), Respirable particles (1-5 µm), Total mass of drug (in nebulizer), Total Delivered Mass of Aerosol, Average Treatment Time (minutes).

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K023602, K962879

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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
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
K962879: NebuTech HDN
Device description	Pneumatic jet nebulizer that aerosolizes medication by driving a
high pressure gas through the jet stem across the one piece jet
immersed in the solution.
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 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

PREDICATE DEVICE
	Proposed Device	Predicate Device
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.	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 Misty Max 10
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.
Indications for Use	This device is intended to be used
to aerosolize liquid medication into
gases that are delivered directly to
the patient for breathing. Its use is
indicated when a licensed
healthcare professional prescribes
or administers medical aerosols to
a patient using a small volume
nebulizer. The patient population
includes adults, pediatrics, and
infants that are spontaneously
breathing. The product is a single-
patient; non-sterile, disposable,
prescriptive device intended to be
used in hospital setting.	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. Its use is indicated whenever
a physician or healthcare professional
administer 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.
Patient Population	adult, pediatric, infant	Same
Type of Device	Disposable
Non-Sterile
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
(Adrenergic
Bronchodilator,
Beta-2
agonist).
Typical dose
2.5 mg/3 ml
(0.083% by
volume) or 2500 µg
of drug
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 ( 5 µm)4	48 ± 2%
547 ± 31 µg	41 ± 1%
438 ± 23 µg	36 ± 2%
354 ± 17 µg
	Respirable particles (1-5 µm)4	46 ± 2%
515 ± 24 µg	52 ± 1%
551 ± 12 µg	56 ± 2%
545 ± 23 µg
	Total mass of drug (in nebulizer)5	2500 µg	2500 µg	2500 µg
	Total Delivered Mass of Aerosol6	45 ± 2%
1129 ± 38 µg	42 ± 1%
1064 ± 25 µg	39 ± 1%
973 ± 23 µg
	Average Treatment Time (minutes)7	3.4 ± 0.1	3.0 ± 0.1	2.7 ± 0.1
Budesonide
Suspension
(Corticosteroid).
Typical dose
0.50 mg/2 ml or
500 µg of drug
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 ( 5 µm)4	61 ± 2%
134 ± 10 µg	55 ± 2%
112 ± 8 µg	50 ± 3%
95 ± 8 µg
	Respirable particles (1-5 µm)4	35 ± 2%
78 ± 6 µg	41 ± 1%
83 ± 2 µg	43 ± 2%
80 ± 23 µg
	Total mass of drug (in nebulizer)5	500 µg	500 µg	500 µg
	Total Delivered Mass of Aerosol6	44 ± 2%
222 ± 14 µg	41 ± 2%
205 ± 9 µg	38 ± 1%
188 ± 7 µg
	Average Treatment Time (minutes)7	1.9 ± 0.1	1.9 ± 0.1	1.7 ± 0.1
Cromolyn Sodium
(Nonsteroidal
Anti-asthma
Medication).
Typical dose
20 mg/2 ml or
20000 µg of
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 ( 5 µm)4	50 ± 2%
3220 ± 290 µg	42 ± 1%
2360 ± 140 µg	36 ± 3%
1900 ± 250 µg
	Respirable particles (1-5 µm)4	40 ± 1%
2550 ± 150 µg	47 ± 1%
2660 ± 120 µg	51 ± 2%
2640 ± 190 µg
	Total mass of drug (in nebulizer)5	20000 µg	20000 µg	20000 µg
	Total Delivered Mass of Aerosol6	32 ± 2%
6380 ± 390 µg	28 ± 2%
5680 ± 240 µg	26 ± 2%
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 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: