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 (SpO2) and pulse rate (measured by an 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.

The proposed modification of the Giraffe and Panda Warmers is the addition of the Giraffe Shuttle accessory. The Giraffe and Panda Warmers can be used with the Giraffe Shuttle, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the Warmers. The Shuttle has two primary active functions: Locking to a bed and providing transportable power to the bed and accessories. The internal power source of the Shuttle consists of two 12 volt 42 amp hour lead acid batteries. The Shuttle contains two sensor systems: One system detects an interference condition. The other system determines the attaching status of the device. The Shuttle features an LED Display Board, which contains the battery runtime indicator and the battery health indicator.

AI/ML Overview

This document describes a Special 510(k) Premarket Notification Submission for the addition of the Giraffe Shuttle accessory to the existing Giraffe and Panda Warmers. The submission argues that the modified device is substantially equivalent to the legally marketed predicate devices and does not require clinical studies.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria or performance metrics for the Giraffe Shuttle. Instead, it relies on a general statement of compliance with voluntary standards and a series of quality assurance measures.

Acceptance Criteria (Quantitative/Qualitative)	Reported Device Performance
Not specified quantitatively	"The Giraffe and Panda Warmers and their applications with the Giraffe Shuttle, comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission."
Functional: Locking to a bed	"Attaching the Shuttle to a bed is accomplished by guiding the Shuttle between the legs of the bed and stepping on the Lock pedal. This effectively locks the Shuttle and bed together as one unit."
Functional: Providing transportable power	"The Shuttle is configured to attach to the Giraffe and Panda Warmers and provide electrical power to the bed and selected accessories." "The internal power source of the Shuttle consists of two 12 volt 42 amp hour lead acid batteries. The batteries are high capacity, sealed, no-maintenance batteries and are connected in series to provide a nominal 24 volts supply to the power generation module."
Safety: Interference detection	"One system [sensor] detects an interference condition."
Functional: Attaching status detection	"The other system [sensor] determines the attaching status of the device."
Battery runtime indication (visual)	"The Shuttle features an LED Display Board, which contains the battery runtime indicator..."
Battery health indication (visual)	"...and the battery health indicator."
No change in primary device indications for use	"The UPS does not change the indications for use, control mechanisms, operating principles, performance specifications, or other features of the Giraffe and Panda Warmers." (This also applies to the Shuttle, as it's an accessory with similar functionality to the UPS in terms of power provision.) "The intended use of the legally marketed device and the proposed modified device is identica!."
Non-clinical testing	"Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), Usability testing (Validation), Biocompatibility testing."

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Clinical Tests: The subject of this premarket submission, Giraffe and Panda Warmers, used with Shuttle, did not require clinical studies to support substantial equivalence."

Therefore, there is no test set in the traditional sense of a clinical study, and thus no sample size for a test set, nor data provenance (country of origin, retrospective/prospective). The evaluation was based on non-clinical testing and comparison to predicate devices, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

As no clinical studies were performed, there was no "ground truth" established by external experts for a test set in the context of device performance on patients. The ground truth for the non-clinical testing referenced would have been established by internal GE Healthcare engineers and quality assurance personnel, following their defined testing protocols and design specifications. Their qualifications are not specified but would typically include relevant engineering and technical expertise.

4. Adjudication Method for the Test Set

Since no clinical test set was used, there was no adjudication method for a test set of clinical outcomes.

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

No MRMC comparative effectiveness study was done. This device is an infant warmer accessory (mobile power source), not an image analysis or diagnostic AI device that would involve human readers or AI assistance in interpretation.

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

This question is not applicable as the device is a medical accessory (mobile power source for an infant warmer) and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

For the non-clinical tests conducted (e.g., performance, safety, usability, biocompatibility), the "ground truth" would be established by:

Design Specifications: The device was tested against its own design requirements and specifications.
Voluntary Standards: Compliance with relevant industry and safety standards (as mentioned in "Section 9, 11 and 17" of the submission, though not detailed in the provided text).
Engineering Measurement and QA: Direct measurement and verification by engineers and quality assurance teams during the development and testing phases.

8. The Sample Size for the Training Set

This question is not applicable as the device does not employ machine learning or AI, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the same reason as above.

Summary

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GE Healthcare Special 510(k) Premarket Notification Submission JUL 21 2010

510(k) Summary

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

June 23, 2010 Date:

Company

Ohmeda Medical, a Division of Datex-Ohmeda, Inc., A General Electric Submitter:

Primary Contact Person:

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

Secondary Contact Person:

8880 Gorman Rd. Laurel, MD 20723 Tel: 410-888-5332

Andrew Ahn

Fax: 410 888 0544

Giraffe and Panda Warmers

Device: Trade Name:

Common/Usual Name: Infant Warmer

Warmer, Infant Radiant Classification Names:

Product Code: FMT 880.5130

Description:

Predicate Device(s): Giraffe and Panda Warmers Legally Marketed Device Device and Change

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

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and there are decorative swirls or flourishes around the letters, adding to the logo's distinctive appearance.

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Special 510(k) Premarket Notification Submission technology or a T-piece technology.

The Giraffe and Panda Uninterruptible Power Supply (UPS) provides a short term source of electrical power to the Warmers, thus aiding their intra hospital mobility. The power cord of the Giraffe and Panda Warmer devices is plugged into Giraffe and Panda UPS, and, in turn, the power cord of the UPS is then connected to the wall receptacle. When disconnected from wall power, the parent device continues receiving the power that it needs to operate, but the energy is supplied by the UPS rather than the distribution line.

The UPS does not change the indications for use, control mechanisms, operating principles, performance specifications, or other features of the Giraffe and Panda Warmers. The UPS serves as an extension to the Warmers by providing uninterrupted electric power to the device. The UPS comprises a medical grade battery and a shelf.

When used with the UPS, the Giraffe and Panda Warmers are not intended for use as transport incubator or to be taken outside of the hospital building.

Description of Device Modification

The proposed modification of the Giraffe and Panda Warmers is the addition of the Giraffe Shuttle accessory.

The Giraffe and Panda Warmers can be used with the Giraffe Shuttle, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the Warmers. These areas include, but are not limited to Labor and Delivery, NICU, Radiology, and Operating Room.

This eliminates the need to transfer the infant to and from a transport incubator for transport within the hospital building, reducing the potential for clinical problems associated with patient touch, handling and movement. The patient can instead be moved within the hospital in a single device. This reduces the potential for clinical problems associated with intra-hospital transport that result from interrupted patient thermal regulation.

Similarly to the UPS accessory, the Shuttle facilitates the mobility of the Giraffe and Panda Warmers within the hospital building. The Warmers, when used with the UPS or with the Shuttle are not a transport incubator and are not intended to be used outside of the

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Special 510(k) Premarket Notification Submission hospital building.

The Shuttle has two primary active functions: Locking to a bed and providing transportable power to the bed and accessories.

Attaching the Shuttle to a bed is accomplished by guiding the Shuttle between the legs of the bed and stepping on the Lock pedal. This effectively locks the Shuttle and bed together as one unit.

To detach the Shuttle from the bed, the locking arms are rotated back to their unlocked position by stepping on the Unlock pedal. Once unlocked, the Shuttle can be moved away from the bed.

The internal power source of the Shuttle consists of two 12 volt 42 amp hour lead acid batteries. The batteries are high capacity, sealed, no-maintenance batteries and are connected in series to provide a nominal 24 volts supply to the power generation module.

Legally Marketed Device Intended Use:

The intended use of the legally marketed device and the proposed modified device is identica!. The intended use is as follows:

The Giraffe Shuttle is a transportable power source that is an Device Modification accessory to the Giraffe and Panda Warmers. The Shuttle connects to Technology: the Warmer and provides electrical power to the bed and other auxiliary equipment, required for patient care during transport.

The Shuttle is configured to attach to the Giraffe and Panda Warmers and provide electrical power to the bed and selected accessories. The Shuttle makes it possible to deliver continuous baby care during

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Special 510(k) Premarket Notification Submission transport from one hospital area to another (e.g. from L&D to NICU).

The Shuttle is designed to accept all Shuttle-specific accessories from GE Healthcare, including: the cord wrap bracket and gas cylinder holder.

The Shuttle has two primary active functions: Locking to a bed and providing transportable power to the bed and accessories.

The Shuttle contains two sensor systems:

One system detects an interference condition.
The other system determines the attaching status of the device.

The Shuttle features an LED Display Board, which contains the battery runtime indicator and the battery health indicator.

Determination of Substantial Summary of Non-Clinical Tests: Equivalence:

The Giraffe and Panda Warmers and their applications with the Giraffe Shuttle, 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
Requirements Reviews .
. Design Reviews
. Testing on unit level (Module verification)
. Integration testing (System verification)
. Performance testing (Verification)
. Safety testing (Verification)
. Usability testing (Validation)
Biocompatibility testing

Clinical Tests:

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

GE Healthcare considers the modified Giraffe and Panda Warmers, Conclusion: used with the Giraffe Shuttle accessory to be as safe, and effective,

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUL 2-1 2010

Ms. Agata Smieja Regulatory Affairs Director OHMEDA Medical, a Division of Datex-OHMEDA, Incorporated, A General Electric Company 8880 Gorman Road Laurel, Maryland 20723

Re: K101804

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: June 23, 2010 Received: June 28, 2010

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. 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.

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Page 2- Mr. 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); 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/CDRHQffices/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.

for

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 'G' and 'E' intertwined within a circular border. The design is simple and recognizable, representing the company's brand identity.

Special 510(k) Premarket Notification Submission

510(k) Number (if known):

K101804

Device Name: Giraffe and Panda Warmers

Indications 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 to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated Spa 2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) 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.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K101604

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.