AIRLIFE DEMAND NASAL CANNULA

K023673 · Allegiance Healthcare Corp. · NFB · May 2, 2003 · Anesthesiology

Device Facts

• Record ID: K023673
• Device Name: AIRLIFE DEMAND NASAL CANNULA
• Applicant: Allegiance Healthcare Corp.
• Product Code: NFB · Anesthesiology
• Decision Date: May 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is an adjunct to oxygen therapy with its primary functions being that of a conduit for the delivery of intermittent oxygen upon demand to a patient's lungs and to transmit a patient's breath effort to the oxygen conserver. Oxygen is administered only during the inhalation cycle, conserving oxygen during the exhalation cycle.

Device Story

Airlife Demand Nasal Cannula serves as a conduit for oxygen therapy; connects patient to oxygen conserver device. Device transmits patient's inspiratory effort to conserver; delivers oxygen only during inhalation cycle. Conserves oxygen supply during exhalation. Used in clinical or home settings; operated by patients or caregivers. Output is physical delivery of oxygen; enables efficient oxygen utilization for patients requiring supplemental therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nasal cannula interface; conduit for gas delivery and pressure/flow signal transmission. Mechanical design for integration with oxygen conserver systems. No electronic components or software.

Indications for Use

Indicated for patients requiring supplemental oxygen therapy who utilize an oxygen conserver device. Functions as a conduit for intermittent oxygen delivery and transmission of breath effort signals.

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.

Submission Summary (Full Text)

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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

Ms. Sharon Nichols Regulatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787

Re: K023673

Trade/Device Name: Airlife Demand Nasal Cannula Regulation Number: 21 CFR 868.5905 Regulation Name: Oxygen Conserving Devices Regulatory Class: II Product Code: 73 NFB Dated: February 25, 2003 Received: February 26, 2003

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.

MAY - 2 2003

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.

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

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Page 2 - Ms. Nichols

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/dsma/dsmamain.html

Sincerely yours,

Susan Carson

Susan Runner, DDS, MA Interim 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/2/Picture/0 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a symbol that resembles a plus sign made up of small circles. The word is in bold, and the font is slightly slanted to the right. The overall impression is that of a logo or brand name.

a Cardinal Health company

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

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510(k) Number (if known):

Unknown_ KO23673

Device Name:

Indications For Use:

Airlife Demand Nasal Cannula

This device is an adjunct to oxygen therapy with its primary functions being that of a conduit for the delivery of intermittent oxygen upon demand to a patient's lungs and to transmit a patient's breath effort to the oxygen conserver. Oxygen is administered only during the inhalation cycle, conserving oxygen during the exhalation cycle.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

or

Over-The Counter Use

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Division Sign-Off) vision of Dental, Infection Control, and General Hospital Devices 1023673

510(k) Number.