AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD

K982722 · Ambu, Inc. · CAF · Apr 12, 1999 · Anesthesiology

Device Facts

• Record ID: K982722
• Device Name: AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD
• Applicant: Ambu, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Apr 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Ambu MediBag Adult Resuscitator is intended for pulmonary resuscitation of adult patients with a body weight of more than 66 lbs (30 kg) and for administration of inhaled B-adrenergic agonist for emergency patients in acute asthma. The resuscitator meets the requirements of the ASTM F920-93 standard except the operation temperature range which is limited to +32 degree - +122 Degree F (0 degree - 50 degree C).

Device Story

Ambu MediBag Adult Resuscitator is a manual resuscitator used for pulmonary resuscitation and delivery of inhaled B-adrenergic agonists. Operated by clinicians in emergency settings; device provides manual ventilation to patients weighing over 66 lbs. Device functions via manual compression of a bag-valve-mask system to deliver air/oxygen to the patient. Benefits include restoration of ventilation and emergency medication delivery in acute asthma cases.

Clinical Evidence

Bench testing only; device meets ASTM F920-93 standards (excluding temperature range).

Technological Characteristics

Manual resuscitator; bag-valve-mask design; meets ASTM F920-93 standard; operating temperature range +32°F to +122°F (0°C to 50°C).

Indications for Use

Indicated for pulmonary resuscitation of adult patients >66 lbs (30 kg) and administration of inhaled B-adrenergic agonists for emergency patients in acute asthma.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 1999

Mr. Sanjay Parikh Ambu, Inc. 611 North Hammonds Ferry Road Linthicum, MD 21090-1356

K982722 Re: Ambu MediBag Adult and Infant/Child Resuscitator Requlatory Class: II (two) Product Code: 73 CAF January 14, 1999 Dated: Received: January 19, 1999

Dear Mr. Parikh:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2 - Mr. Sanjay Parikh

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

sincerely yours,
Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ambu MediBag Adult Resuscitator

Intended Use

## AMBU MEDIBAG ADULT RESUSCITATOR INTENDED USE

The Ambu MediBag Adult Resuscitator is intended for pulmonary resuscitation of adult patients with a body weight of more than 66 lbs (30 kg) and for administration of inhaled B-adrenergic agonist for emergency patients in acute asthma. The resuscitator meets the requirements of the ASTM F920-93 standard except the operation temperature range which is limited to +32 degree - +122 Degree F (0 degree - 50 degree C).

A.A. Carbucci

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K982722

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