(88 days)
No
The device description focuses on mechanical components and standard clinical practices for infant resuscitation, with no mention of AI or ML.
Yes
The device is described as providing "pulmonary resuscitation" and delivering "oxygen or air/oxygen mixtures and/or manual ventilation to the infant," which are interventions aimed at treating a medical condition (failure to establish adequate breathing patterns).
No
Explanation: The device is described as a "T-piece Resuscitation System" for "pulmonary resuscitation of infants," providing tools for ventilation and airway management. Its purpose is to deliver therapy (oxygen, air/oxygen mixtures, manual ventilation) and monitor physical parameters like pressure, not to diagnose a medical condition.
No
The device description clearly outlines multiple hardware components including a suction device, flowmeters, an airway pressure manometer, and an optional air/oxygen blender.
Based on the provided information, 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 respiratory support and clearing airways. This is a direct medical intervention on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is a system for delivering gases and pressure to the infant's lungs. It includes components like flowmeters, a manometer, and a T-piece circuit. These are all involved in providing physical support to the respiratory system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device is used for treatment and support, not for diagnosing a condition based on in vitro testing.
Therefore, this device falls under the category of a medical device used for direct patient care and intervention, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The T-piece 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
BTL
Device Description
The T-piece Resuscitation System incorporates the following features for the practice of infant resuscitation: a suction device for clearance of the trachea and nasal passages; two medical gas flowmeters to deliver oxygen or air/oxygen mixtures to the infant requiring such therapy; and an airway pressure manometer. An optional air/oxygen blender including high-pressure yokes may be included with the system which allows the clinician to adjust FiO2 % from 21-100%.
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.
Positive End Expiratory Pressure (PEEP) can be set using the adjustable PEEP valve located on the T-piece patient circuit.
The T-piece resuscitation system is intended for use only with GE Healthcare T-piece resuscitation circuits.
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
For 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 T-piece 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)
K971243, K892885, K003335, K002355
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator 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
070210
510(k) Summary
Submitter Information and Date Prepared
APR 2 0 2007
Mary Dadone GE Healthcare 8880 Gorman Road Laurel, MD 20723 USA
410-888-5327
Prepared January 20, 2007
Device Identification
Proprietary Name: Giraffe and Panda T-piece Resuscitation System Common Name: Powered Emergency Ventilator (Resuscitator) Classification Name: Powered emergency ventilator (21 CFR 868.5925)
Predicate Device Information
The Giraffe and Panda T-piece Resuscitation System is substantially equivalent to the following predicate devices:
| Predicate Device | Last 510(k) Number |
|---|---|
| Ohmeda Medical Infant Resuscitation System | K971243 |
| Fisher & Paykel Neopuff Infant Resuscitator | K892885 |
| AirShields Resuscitaire | K003335 |
| Atom InfaWarmer V505 | K002355 |
Intended Use Statement
The T-piece 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 T-piece Resuscitation System incorporates the following features for the practice of infant resuscitation: a suction device for clearance of the trachea and nasal passages; two medical gas flowmeters to deliver oxygen or air/oxygen mixtures to the infant requiring such therapy; and an airway pressure manometer. An optional air/oxygen blender including high-pressure yokes may be included with the system which allows the clinician to adjust FiO2 % from 21-100%.
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.
Positive End Expiratory Pressure (PEEP) can be set using the adjustable PEEP valve located on the T-piece patient circuit.
The T-piece resuscitation system is intended for use only with GE Healthcare Tpiece resuscitation circuits.
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 T-piece Resuscitation System to performance specifications and to multiple recognized performance standards is being established through bench testing.
Prepared by: Mary Osborne and the following is the response:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Agata Smieja Global Compliance Leader Maternal Infant Care, Clinical Systems, GE Healthcare 8880 Gorman Road Laurel, Maryland 20723
APR 2 0 2007
Re: K070210
Trade/Device Name: Giraffe and Panda T-Piece Resuscitation System Regulation Number: 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: March 29, 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 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.
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Aryite y. Michael Dms.
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):
Giraffe and Panda T-piece Resuscitation System Device Name:
Indications for Use:
The T-piece 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, 54 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)
Chullo
cinesiology, General Hosp. 3. Contral Demost Kuvices
S(K) Number: K070210
A - 1