(85 days)
No
The description focuses on mechanical components and standard clinical practices, with no mention of AI or ML.
Yes
The device is used for pulmonary resuscitation, which involves providing oxygen/air and/or manual ventilation to infants to address respiratory issues and improve tissue oxygen demands. These actions directly treat a physiological condition, making it a therapeutic device.
No
The device is designed for therapeutic interventions like providing oxygen/air mixtures and manual ventilation, and for clearing airways, not for diagnosing conditions. While it includes an airway pressure manometer, this is described as for adjusting pressure during ventilation, not for diagnostic purposes.
No
The device description clearly outlines multiple hardware components including a suction device, air/oxygen blender, flowmeters, and an airway pressure manometer.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "pulmonary resuscitation of infants," which involves providing manual ventilation, oxygen, and clearing airways. This is a direct intervention on the patient's respiratory system.
- Device Description: The device components (suction device, air/oxygen blender, flowmeters, manometer, PIP knob) are all designed for delivering therapy and monitoring physiological parameters in vivo (within the living body).
- Lack of Diagnostic Function: The device does not perform any tests on biological samples (blood, urine, tissue, etc.) to diagnose a condition or provide information about a patient's health status. It is a therapeutic and monitoring device.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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 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.
Product codes
BTM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Infants
Intended User / Care Setting
professional use only, by trained clinicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5915 Manual emergency ventilator.
(a)
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.(b)
Classification. Class II (performance standards).
0
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. *
1
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
2
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.
3
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
4
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
chillo
on Control, Services
A - 001