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 SP02 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 ait/oxygen mixtures and/or manual ventilation to the infant.

For professional use only, by trained clinicians.

Device Description

The Ohmeda Medical 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.

Infant radiant warmers may incorporate other features, such as tilting of the bed. elevating base, and data output to remote monitors or nurse call systems. Infant radiant warmers may also allow use with or attachment of an independent phototherapy device or other accessories.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Giraffe and Panda Warmer:

The provided document, K070377, is a 510(k) Premarket Notification for the Giraffe and Panda Warmer. It focuses on demonstrating substantial equivalence to predicate devices and conformance to recognized consensus standards through bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Standard	Reported Device Performance
Conformance to all applicable clauses of the recognized consensus standard for infant radiant warmers	"The conformance of the Giraffe and Panda Warmers to performance specifications and to multiple recognized performance standards is being established through bench testing." (The specific standards are not listed in the provided text, but such standards typically cover aspects like temperature accuracy, alarm thresholds, safety features, electromagnetic compatibility, and mechanical integrity.)
Performance specifications (for the device itself)	"The conformance of the Giraffe and Panda Warmers to performance specifications and to multiple recognized performance standards is being established through bench testing." (Specific performance metrics are not detailed in the provided text, but would ideally include temperature control range and accuracy, alarm functioning, and SpO2 monitoring accuracy if applicable.)

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

The document explicitly states: "animal or clinical testing to support safety and effectiveness is not necessary." Therefore, there is no test set of clinical data (human or animal) to analyze for sample size or provenance. The evaluation was entirely based on bench testing.

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

Not applicable. As stated above, no clinical test set was used, and therefore no experts were required to establish ground truth for such a set. The ground truth for bench testing refers to the calibrated reference instruments and defined test conditions.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe any MRMC comparative effectiveness study. The evaluation focused on the device's standalone performance against engineering and safety standards, not its impact on human reader performance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, in spirit, but not in the context of an algorithm. The evaluation focuses solely on the device itself and its components' performance as a medical device, independent of human interaction beyond normal operation. While there isn't an "algorithm" in the typical sense (e.g., for image analysis), the "standalone performance" was assessed in terms of the warmer's ability to meet its technical specifications and regulatory standards through bench testing.

7. Type of Ground Truth Used

The ground truth for this device's evaluation was based on:

Engineering specifications and design requirements: How the device was designed to function.
Recognized consensus standards for infant radiant warmers: These standards (e.g., ISO, ASTM, IEC) define specific performance criteria, safety requirements, and test methods that the device must meet.
Calibration standards: For instruments used in bench testing to measure temperature, power output, SpO2 accuracy (if applicable), etc.

Essentially, the ground truth was derived from established technical and regulatory benchmarks for medical devices of this type.

8. Sample Size for the Training Set

Not applicable. This device is a hardware medical device; it does not involve machine learning or AI models that require a "training set" of data in the conventional sense. The "training" for such a device is its design and manufacturing process, guided by engineering principles and regulatory standards.

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

Not applicable. As there is no training set as understood in AI/ML, there's no ground truth established for one. The design and development process for the device relies on fundamental engineering principles, material science, and established medical device design controls, all validated against recognized standards and internal specifications to ensure it performs as intended.

Summary

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K070377

1863

Submitter Information and Date Prepared

Agata Smieja GE Healthcare 8880 Gorman Road Laurel, MD 20723 USA

410-888-5218

Prepared June 18, 2007

Device Identification

Proprietary Name:	Giraffe and Panda Warmer
Common Name:	Infant Radiant Warmer
Classification Name:	Warmer, Infant Radiant (21 CFR 880.5130)

Predicate Device Information

The Giraffe and Panda Warmer is substantially equivalent to the following predicate devices:

Predicate Devices	510(k) Number
Ohmeda Medical Infant Warmer System (IWS) Model 4300	K963058
Ohmeda Medical OmniBed (in open mode)	K993407
Masimo SET technology SpO2	K033296
Atom Infa Warmer V505	K002355
Giraffe and Panda T-piece Resuscitation System	K070210
Giraffe and Panda Bag and Mask Resuscitation System	K070247

Intended Use Statement

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<207007>
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SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 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 ait/oxygen mixtures and/or manual ventilation to the infant.

For professional use only, by trained clinicians.

Functional Description and Technological Characteristics

Performance Data

Because care of infants in infant radiant warmers is a well established clinical practice and because the Giraffe and Panda Warmer will comply with all applicable clauses of the recognized consensus standard for infant radiant

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K070377

3 of 1

warmers, animal or clinical testing to support safety and effectiveness is not necessary. The conformance of the Giraffe and Panda Warmers to performance specifications and to multiple recognized performance standards is being established through bench testing.

Prepared by:
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Date
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 1 2007

Ms. Agata Smieja Global Compliance Leader Ohmeda Medical, a Division of Datex Ohmeda 8880 Gorman Road Laurel, Maryland 20723

Re: K070377

Trade/Device Name: Giraffe and Panda Warmer Regulation Number: 21 CFR 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: II Product Code: FMT Dated: July 2, 2007 Received: July 3, 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.

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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 (OS) 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) 276-0115. 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,

Clas

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): K070377

Device Name: Giraffe and Panda Warmer

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 SpO2 monitoring feature may be used for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 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.

For professional use only, by trained clinicians.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

John Q. Lee
Len Churlin
(Division Sign Off)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Depirige 1 of 1

510(k) Number: K070375

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.