AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM

K050994 · Cardinalhealth · BZD · Aug 3, 2005 · Anesthesiology

Device Facts

• Record ID: K050994
• Device Name: AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
• Applicant: Cardinalhealth
• Product Code: BZD · Anesthesiology
• Decision Date: Aug 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

This device, consisting of a generator, prongs, masks and a headgear/fixation device, is intended to provide continuous positive airway pressure to newborns and infants with compromised respiratory systems while in a hospital environment.

Device Story

Airlife Infant nCPAP system delivers air/oxygen mixture to provide continuous positive airway pressure. Components include generator, prongs, masks, and headgear/fixation device. Used in hospital environments for newborns and infants with compromised respiratory systems. Operated by clinical staff. Device connects to external driver (hardware) via circuit to maintain prescribed pressure levels. Patient interface (prong or mask) secured to infant's nose via headgear. Provides respiratory support to improve patient breathing.

Clinical Evidence

No clinical data. Bench testing only. Materials evaluated via biological qualification safety tests per ISO 10993 Part-1 and industry-recognized test methods.

Technological Characteristics

System includes generator, prongs, masks, and headgear/fixation device. Single patient use, non-sterile. Materials evaluated per ISO 10993-1. Mechanical delivery of air/oxygen mixture via external driver. No software or electronic components described.

Indications for Use

Indicated for newborns and infants with compromised respiratory systems requiring continuous positive airway pressure in a hospital environment.

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

Submission Summary (Full Text)

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K050994

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AUG 3 2005

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 Infant Nasal Continuous Positive Airway Pressure (nCPAP) System

| Sponsor: | Cardinal Health<br>1430 Waukegan Road MPWM<br>McGaw Park, IL 60085 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Nichols |
| Telephone: | [phone] |
| Date Summary Prepared: | April 2005 |
| Common Name: | Airlife Infant Nasal Continuous Positive<br>Airway Pressure (nCPAP) System |
| Classification: | Class II per 21CFR §868.5905 |
| Predicate Device: | EME Infant Flow System |
| Description: | The Cardinal infant nCPAP system<br>consists of a Generator, Prongs, Masks,<br>and a headgear/fixation device. A driver<br>(hardware) delivers a mixture of air and<br>oxygen to provide the prescribed level of<br>CPAP through a circuit and generator.<br>Either a prong or mask is attached to the<br>generator as a patient interface. The<br>generator is held to the infant's nose by<br>straps connected to a headgear/fixation<br>device. This product is a single patient<br>use, non-sterile prescriptive 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 four curved lines that intersect each other. 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 (continued)

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Airlife Infant Nasal Continuous Positive Airway Pressure (nCPAP) System

This device, consisting of a generator, prongs, Intended Use: masks and a headgear/fixation device, is intended to provide continuous positive airway pressure to newborns and infants with compromised respiratory systems while in a hospital environment.

Airlife Infant Nasal Continuous Positive Substantial Equivalence: Airway Pressure (nCPAP) System is substantially equivalent to the EME Infant Flow System in that:

- the intended use is the same

- the performance attributes are similar
All materials used in the fabrication of the Airlife Summary of testing: Infant Nasal Continuous Positive Airway Pressure (nCPAP) System 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.

# 000094

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 - 2005

Ms. Sharon Nichols Regulatory Affairs Manager . . . . Cardinal Health 1430 Waukegan Road, Building KB McGraw Park, Illinois 60085

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Re: K050994

Trade/Device Name: Airlife Infant Nasal Continuous Positive Airway Pressure (nCPAP) System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 7, 2005 Received: July 8, 2005

Dear Ms. Nichols:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed young and have determined the device is substantially equivalent (for the receiced above and not in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mersule commerce prior so prior so been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket the Fouchar I Vou, I vagy ... You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or a 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 (1 WAY), It may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device announcements concernents 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. or are ret or any 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 and insting (2 - set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet forms 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 promative actived 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 dontact 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 maj count 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,

Syritie Y. Michin Oms.

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 FAX: [phone]

تعمل تي ته تع

#### Indications for Use

510(k) Number (if known): K050994 Airlife Infant Nasal Continuous Device Name: Positive Airway Pressure (nCPAP) System This device, consisting of a Indications for Use: generator, prongs, masks and a headgear/fixation device is intended to provide continuous positive airway pressure to newborns and infants with compromised respiratory systems while in a hospital environment.

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

Over-The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cure Muiconi

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

510(k) Number:

000045