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 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study based on the provided text, recognizing that it's for a traditional medical device and not AI software, so some requested fields may not be applicable.

Acceptance Criteria and Device Performance

The provided document (K070247) describes a traditional medical device, the "Giraffe and Panda Bag and Mask Resuscitation System," which is a manual emergency ventilator. The acceptance criteria and performance are not presented in a quantitative table as typically seen for AI/software devices with metrics like sensitivity, specificity, etc. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices and conformance to performance specifications and recognized standards through bench testing.

There is no table of acceptance criteria and reported device performance in the provided document. The document states that the device is substantially equivalent to the predicate devices listed.

Study Details

Given that this is a traditional medical device (manual emergency ventilator) intended for a specific clinical practice with well-established guidelines, the nature of the "study" to prove it meets acceptance criteria differs significantly from a study for an AI-powered diagnostic device.

Here's a breakdown of the requested information, with explanations where a direct match isn't present due to the nature of the device:

A table of acceptance criteria and the reported device performance:
- N/A. As mentioned above, a quantitative table of performance metrics (like sensitivity, specificity, accuracy) is not provided or typically required for this type of traditional device. Acceptance is based on substantial equivalence to predicate devices and conformance to recognized performance standards through bench testing.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The document explicitly states: "Pulmonary resuscitation of infants includes well established clinical practices; animal or clinical testing to support safety and effectiveness is not necessary." This means there was no clinical "test set" involving patients or actual clinical data. The testing was limited to bench testing.
- Therefore, there is no "sample size" of patients/data, nor "data provenance" in the context of clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. As no clinical "test set" was used, there was no need for experts to establish ground truth in the context of clinical outcomes or diagnoses. The "ground truth" for this device's performance is compliance with engineering specifications and recognized performance standards for manual emergency ventilators.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No clinical test set. Adjudication methods are not applicable here.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is a manual emergency ventilator, not an AI assistance tool for human readers. Therefore, an MRMC study or AI assistance comparison is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not contain an "algorithm" in the sense of AI or software processing data. It is a mechanical medical device operated by a "trained clinician." Its performance is inherently coupled with human operation, but not in an AI-assisted manner.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's acceptance is based on its conformance to performance specifications and multiple recognized performance standards as established through bench testing. This aligns with engineering and regulatory standards for mechanical medical devices, rather than clinical ground truth from patient data. The "Intended Use Statement" also references "collaborative guidelines written by the American Heart Association (AHA) and the American Academy of Pediatrics (AAP) in the Textbook of Neonatal Resuscitation," which represent the established standard of care that the device supports.
The sample size for the training set:
- N/A. As there was no clinical data and no AI/machine learning model involved, there is no "training set."
How the ground truth for the training set was established:
- N/A. No training set was used.

Summary

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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

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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 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 (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

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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:

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

K072247

A - 001

Regulation Number and Section

§ 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).