AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER

K051226 · Cardinalhealth · BZD · Nov 17, 2005 · Anesthesiology

Device Facts

• Record ID: K051226
• Device Name: AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER
• Applicant: Cardinalhealth
• Product Code: BZD · Anesthesiology
• Decision Date: Nov 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or are recovering from RDS.

Device Story

AirLife™ nCPAP System Driver is a hardware device used in hospital settings to deliver a mixture of air and oxygen to newborns and infants. The system functions by providing a prescribed level of continuous positive airway pressure (CPAP) through a circuit and generator. A patient interface, consisting of either a nasal prong or mask, is attached to the generator and secured to the infant's nose via a fixation device. The device is operated by clinical staff to support respiratory function in patients with RDS or those in recovery. It provides mechanical respiratory support to assist patient breathing and improve clinical outcomes.

Clinical Evidence

Bench testing only. Materials were evaluated for biological safety per ISO 10993 Part-1 and tested in accordance with industry-recognized methods to confirm suitability for the intended use.

Technological Characteristics

Hardware-based CPAP delivery system. Materials evaluated per ISO 10993-1. System includes a driver, circuit, generator, and patient interface (prong or mask) with a fixation device. Operates by delivering air/oxygen mixture to provide positive airway pressure. No software or electronic algorithm described.

Indications for Use

Indicated for newborns and infants with Respiratory Distress Syndrome (RDS) or those recovering from RDS requiring CPAP therapy in a hospital setting.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• EME Infant Flow System Driver

Submission Summary (Full Text)

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K 051226

NOV 1 7 2005

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

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™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver

| Sponsor: | Cardinal Health 1430 Waukegan Road MPWM McGaw Park, IL 60085 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Nichols |
| Telephone: | [phone] |
| Date Summary Prepared: | April 2005 |
| Common Name: | AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver |
| Classification: | Class II per 21CFR § 868.5905 |
| Predicate Device: | EME Infant Flow System Driver |
| Description: | The AirLife™ nCPAP System Driver (hardware) delivers a mixture of air and oxygen to provide the prescribed level of CPAP through a circuit and generator. Either a prong or mask is attached to the generator as a patient interface. The generator is held to the infant's nose by a fixation device. |

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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 above the company name. The graphic is made up of several curved lines that intersect each other. The text "CardinalHealth" is written in a bold, sans-serif font.

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

## SMDA REQUIREMENTS (continued)

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

AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver

Intended Use: The AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or are recovering from RDS. Substantial Equivalence: AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver is substantially equivalent to the EME Infant Flow System Driver 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™ Infant Nasal Continuous Positive Airway Pressure (nCPAP) Driver 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or ribbons, which are meant to represent the human services provided by the department. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 2005

Ms. Sharon Nichols Regulatory Affairs Manager Cardinal Health 1430 Waukegan Road, WM McGaw Park, Illinois 60085

Re: K051226

Trade/Device Name: AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 8, 2005 Received: November 9, 2005

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/industry/support/index.html.

Sincerely yours,

Susan Ruane

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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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Image /page/4/Picture/0 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 that resemble a bird in flight. The text "CardinalHealth" is written in a simple, sans-serif font.

Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847,578,6610 AX: 847.785.2506

#### Indication for Use

510(k) Number (if known):

Device Name:

Indications For Use:

K051226

AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver

The AirLife™ Nasal Continuous Positive Airway Pressure (nCPAP) System Driver is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or are recovering from RDS.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aim Sarlson

(Division Sign-Off)
Division of Anesihesiology, General Hospital,
Division Ocentral Devices (Jivision Sign-C Division of Anesthesionaly)
Dental Devices Infection Control. Dental Devices

510(k) Number:***_***_

000011