GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM

K070247 · Ohmeda Medical · BTM · Apr 20, 2007 · Anesthesiology

Device Facts

• Record ID: K070247
• Device Name: GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
• Applicant: Ohmeda Medical
• Product Code: BTM · Anesthesiology
• Decision Date: Apr 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care. * Resuscitation may be required whenever an infant fails to establish effective, adequate breathing patterns necessary to meet tissue oxygen demands and/or to rid the body of carbon dioxide. For professional use only, by trained clinicians. * As stated in collaborative guidelines written by the American Heart Association (AHA) and the American Academy of Pediatrics (AAP) in the Textbook of Neonatal Resuscitation, 5th Edition.

Device Story

System provides equipment for infant pulmonary resuscitation; includes suction device for airway clearance, optional air/oxygen blender (21-100% FiO2), dual gas flowmeters, and airway pressure manometer. Clinician operates system to establish airway and deliver manual ventilation. Manometer allows visual monitoring of respiratory cycle pressure; PIP knob allows adjustment of maximum delivery pressure. Device does not include manual resuscitator; user supplies patient circuit. Used in clinical settings by trained clinicians to meet infant tissue oxygen demands and CO2 removal. Benefits include standardized, controlled delivery of respiratory support during neonatal resuscitation.

Clinical Evidence

Bench testing only. No clinical or animal data required as pulmonary resuscitation practices are well-established standards of care.

Technological Characteristics

Manual emergency ventilator system. Features: suction device, air/oxygen blender, dual gas flowmeters, airway pressure manometer, PIP adjustment knob. Mechanical/pneumatic operation. No software or electronic components described. Standalone system.

Indications for Use

Indicated for infants failing to establish effective breathing patterns requiring pulmonary resuscitation, airway clearance, oxygen/air-oxygen delivery, or manual ventilation. For professional use by trained clinicians only.

Regulatory Classification

Identification

A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Predicate Devices

• Ohmeda Medical Infant Resuscitation System (K971243)
• AirShields Resuscitaire (K003335)
• Atom InfaWarmer V505 (K002355)

Submission Summary (Full Text)

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# K070247

# 510(k) Summary

Submitter Information and Date Prepared

Mary Dadone GE Healthcare 8880 Gorman Road Laurel, MD 20723 USA

APR 2 0 2007

410-888-5327

Prepared January 24 2007

Device Identification

Proprietary Name:Giraffe and Panda Bag and Mask Resuscitation System Common Name: Manual Emergency Ventilator (Resuscitator) Manual emergency ventilator (21 CFR 868.5915) Classification Name:

# Predicate Device Information

The Giraffe and Panda Bag and Mask Resuscitation System is substantially equivalent to the following predicate devices:

| Predicate Device | Last 510(k) Number |
|--------------------------------------------|--------------------|
| Ohmeda Medical Infant Resuscitation System | K971243 |
| AirShields Resuscitaire | K003335 |
| Atom InfaWarmer V505 | K002355 |

Intended Use Statement

The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care. *

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Resuscitation may be required whenever an infant fails to establish effective, adequate breathing patterns necessary to meet tissue oxygen demands and/or to rid the body of carbon dioxide.

For professional use only, by trained clinicians.

* As stated in collaborative guidelines written by the American Heart Association (AHA) and the American Academy of Pediatrics (AAP) in the Textbook of Neonatal Resuscitation, 5th Edition.

## Functional Description and Technological Characteristics

The Bag and Mask Resuscitation System incorporates the following features for the practice of infant resuscitation: a suction device for clearance of the trachea and nasal passages; an optional air/oxygen blender including high-pressure yokes that allows the clinician to adjust FiO2 % from 21-100%; two medical gas flowmeters to deliver oxygen or air/oxygen mixtures to the infant requiring such therapy; and an airway pressure manometer.

The airway pressure manometer allows a trained clinician to see pressure throughout the respiratory cycle.

Peak Inspiratory Pressure (PIP) is adjusted using the PIP knob located on the front panel of the resuscitation system that allows the clinician to set the maximum pressure being delivered to the infant in order to facilitate adequate pressurization of the lungs.

The Giraffe and Panda Bag and Mask Resuscitation System, like the Ohmeda Medical Infant Resuscitation System, does not include the manual resuscitator. The patient circuit is to be supplied by the user.

#### Performance Data

Pulmonary resuscitation of infants includes well established clinical practices; animal or clinical testing to support safety and effectiveness is not necessary. The conformance of the Giraffe and Panda Bag and Mask Resuscitation System to performance specifications and to multiple recognized performance standards is being established through bench testing.

Prepared by: Mary Durance

Date 24 Jun 2007

**B-002**

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 0 2007

Ms. Agata Smieja Global Compliance Leader Maternal Infant Care, Clinical Systems, GE Healthcare 8880 Gorman Road Laurel, Maryland 20723

Re: K070247

Trade/Device Name: Giraffe and Panda Bag and Mask Resuscitation System Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: March 30, 2007 Received: April 2, 2007

Dear Ms. Smieja:

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 vour 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. Smieja

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,

Sulette Y. Mchlan Dis

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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# Indications for Use

510(k) Number (if known):

Device Name: Giraffe and Panda Bag and Mask Resuscitation System

Indications for Use:

The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or ait/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care. *

Resuscitation may be required whenever an infant fails to establish effective, adequate breathing patterns necessary to meet tissue oxygen demands and/or to rid the body of carbon dioxide.

For professional use only, by trained clinicians.

* As stated in collaborative guidelines written by the American Heart Association (AHA) and the American Academy of Pediatrics (AAP) in the Textbook of Neonatal Resuscitation, 5d Edition.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

chillo

**on Control,** Services

K072247

A - 001