Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (measured by a SpO2 sensor). An optional integrated resuscitation system may be used to provide 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.

Device Description

The Giraffe and Panda Warmers are devices with a radiant heating source intended to maintain the thermal balance of an infant patient by direct radiation of energy in the infrared region of the electromagnetic spectrum. The warmers operate similarly to warmers currently in use in hospitals. Radiant heat from an infrared heat source is focused onto the bed to warm the patient. The operator may select either the heater power or skin temperature control method. Depending on the control method selected, the heater is either regulated at the operator selected power level or the heater output is modulated to maintain the patient's temperature at the value selected by the operator. Infant radiant warmers are also used to provide thermal support during surgical procedures and during procedures such as extracorporeal membrane oxygenation, resuscitation, or other procedures requiring open access and thermal support. Both units also feature optional integrated SpO2 and Resuscitation modules. The Resuscitation Module may feature either a traditional bag-and-mask technology or a T-piece technology. Both the SpO2 module and the Resuscitation Modules use existing technology. The Giraffe and Panda Warmers can be used with the Giraffe Shuttle and a UPS module, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the Warmers.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Submission for the GE Healthcare Giraffe and Panda Warmers, specifically concerning the addition of Nellcor pulse oximetry. The document states that no clinical studies were required to support substantial equivalence for this modification. Therefore, it does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.

However, based on the non-clinical information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions compliance with voluntary standards but does not provide a specific table of acceptance criteria with corresponding performance metrics for the Nellcor pulse oximetry addition. It states that the SpO2 performance is "substantially equivalent to the corresponding parameters in the Masimo SET technology," which implies the acceptance criteria would be those met by the predicate Masimo SET technology. Without information on the Masimo SET technology's specific performance criteria, a table cannot be constructed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable, as no clinical human testing was conducted for the Nellcor SpO2 addition to establish performance in a test set. Non-clinical testing was performed, but details on sample sizes for specific non-clinical tests (e.g., number of units tested) are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical human testing requiring expert-established ground truth was reported.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical human testing requiring adjudication was reported.

5. 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:

Not applicable. This device is an infant warmer with integrated pulse oximetry, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies with human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The document implies "standalone" technical performance was assessed during non-clinical testing (e.g., "Testing on unit level (Module verification)", "Integration testing (System verification)", "Performance testing (Verification)"), but specific details on performance metrics for the Nellcor module in isolation are not provided. The key claim is "substantially equivalent to the corresponding parameters in the Masimo SET technology."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical testing, the "ground truth" would likely refer to engineering specifications and established performance standards for pulse oximetry. For example, in performance testing, calibration references or simulated physiological signals would serve as ground truth for accuracy measurements. These details are not explicitly described.

8. The sample size for the training set:

Not applicable. This device is a medical monitoring device, not a machine learning or AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as no training set for an AI algorithm was used.

Summary of Non-Clinical Tests (from the document):

The document states that the following quality assurance measures were applied to the development of the system:

Risk Analysis
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Performance testing (Verification)
Safety testing (Verification)
Simulated use testing (Validation)

These non-clinical tests, along with compliance with voluntary standards (mentioned in Sections 9, 11, and 17, though not included in the provided excerpt), were deemed sufficient to demonstrate substantial equivalence to the predicate device (K101804). The core argument is that the Nellcor pulse oximetry technology is "fundamentally equivalent to Masimo Pulse Oximetry" and its integration technique is "extremely similar" to the previously cleared Masimo SpO2 option.

Summary

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4122267

OCT

2 2012

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized and connected in a cursive-like font. The logo is black and white, with the letters and the circle outline in black and the background in white.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date: July 26, 2012

Ohmeda Medical, a Division of Datex-Ohmeda, Inc., A General Submitter: Electric Company 8880 Gorman Rd.

Primary Contact Person:

Agata Anthony 8880 Gorman Rd. Laurel, MD 20723 Tel: 410-456-0329 Fax: 410 888 0544

Laurel, MD 20723

Secondary Contact Person:

Kenny M Bello 8880 Gorman Rd. Laurel, MD 20723 Tel: 410-888-5393 Fax: 410 888 0544

Infant Warmer

FMT 880.5130

Giraffe and Panda Warmers

Warmer, Infant Radiant

Device: Trade Name: Common/Usual Name: Classification Names: Product Code:

Predicate Device(s): Device Description:

Giraffe and Panda Warmers; K101804

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optional integrated SpO2 and Resuscitation modules. The Resuscitation Module may feature either a traditional bag-andmask technology or a T-piece technology. Both the SpO2 module and the Resuscitation Modules use existing technology. The Giraffe and Panda Warmers can be used with the Giraffe Shuttle and a UPS module, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the Warmers.

Description of Device Modification

The proposed modification of the Giraffe and Panda Warmers is the addition of the Nellcor pulse oximetry to the legally marketed Giraffe and Panda Warmer system. The integrated SpO2 features are substantially equivalent to the corresponding parameters in the Masimo SET technology. The indication for use of the legally marketed device will remain unchanged with the addition of this optional pulse oximetry system.

Indication for Use:

Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used on facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (measured by a SpO2 sensor). An optional integrated resuscitation system may be used to provide 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.

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Device Modification Technology:

Nellcor Pulse Oximetry is an optional technology for Giraffe and Panda Warmers, and provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor) non-invasively via a light signal, which is fundamentally equivalent to Masimo Pulse Oximetry.

The technique used to integrate the Nellcor SpO2 option into the Giraffe and Panda Warmers is extremely similar to the technique used to integrate the current Masimo SpO2 option. This technique provides supplemental electrical isolation of the SpO2 option electronics and patient connection from the rest of the Giraffe and Panda Warmers. Connection of the Nellcor SpO2 option to the Giraffe and Panda Warmers is accomplished through the same cable as used for the Masimo SpO2 option. This cable provides electrical power, ground and RS-232 communications signals. These signals are carried over the isolation barrier using i components providing supplemental electrical isolation.

The Nellcor SpO2 option uses the same module technology as in the predicate device (K101804). The data generated by the module is transferred to the Giraffe and Panda Warmers over the RS-232 serial signals, and contains the pulse rate, saturation and alarm information. The Giraffe and Panda Warmers display this information without change in meaning.

The proposed modification does not change the indication for use of the legally marketed product (K101804).

Summary of Non-Clinical Tests:

The Giraffe and Panda Warmers and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

Risk Analysis .
. Design Reviews
Testing on unit level (Module verification) .
Integration testing (System verification) .
Performance testing (Verification)
Safety testing (Verification
Simulated use testing (Validation)

Determination of Substantial Equivalence:

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized and connected, and the entire logo is in black and white.

Summary of Clinical Tests:

The subject of this premarket submission, Giraffe and Panda Warmers, used with Nellcor Pulse Oximetry did not require clinical studies to support substantial equivalence. :

Conclusion:

GE Healthcare considers the Giraffe and Panda Warmers, used with Nellcor Pulse Oximetry to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ОСТ

Ohmeda Medical, a Division of Datex-Ohmeda, Incorporated,
A General Electric Company
Agata Anthony
Regulatory Affairs Director
8880 Gorman Road
Laurel, Maryland, 20723

Re: K122267

Trade/Device Name: Giraffe and Panda Warmers Regulation Number: 21 CFR 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: II Product Code: FMT Dated: September 4, 2012 Received: September 6, 2012

Dear Ms. Anthony:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

2
2012

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Regulator
Regulator

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Page 2 Ms. Anthony

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ful But

Anthony D. Watson, B.S., M.S., M.B.A. 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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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. There are small, stylized droplets or flourishes extending from the circle at three points. The logo is black and white.

510(k) Number (if known):

Giraffe and Panda Warmers Device Name:

Indications for Use:

Prescription Use_X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

nce of CDRH, Office of Device Evaluation (ODE) Concurre

Robert C. Hogan 10/1/12
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices -

510(k) Number: K122267

Regulation Number and Section

§ 880.5130 Infant radiant warmer.

(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.