(104 days)
Not Found
No
The description focuses on traditional radiant heating technology and optional integrated modules using existing technology. There is no mention of AI or ML.
Yes.
The device provides a controlled environment to facilitate the neonate's transition and maintain thermal balance, which are non-diagnostic, non-preventative, and address a health condition (thermoregulation). The optional integrated resuscitation system also directly provides therapy.
No
Explanation: The device is primarily an infant radiant warmer for thermal management. While it has an optional SpO2 monitoring feature, which is a diagnostic function, the core purpose of the device as described is therapeutic/supportive (providing heat), not diagnostic. The SpO2 monitoring is an "optional integrated feature," suggesting it's not the primary diagnostic purpose of the device itself.
No
The device description clearly details hardware components such as a radiant heating source, bed, SpO2 sensor, and resuscitation modules (bag-and-mask or T-piece technology). While there may be software controlling these components, the device itself is a physical medical device with integrated hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that the Giraffe and Panda Warmers provide infrared heat to neonates to help them regulate their body temperature. They are external devices that interact with the patient's body directly, not with specimens taken from the body.
- Optional Features: While the optional SpO2 monitoring and resuscitation systems are medical functions, they are also not IVD functions. SpO2 monitoring measures oxygen saturation in the blood in vivo (within the body), and resuscitation involves providing respiratory support in vivo.
The device's primary function and its optional features are all related to providing direct medical support and monitoring to the infant patient, not to analyzing biological samples.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
FMT 880.5130
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. The 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 UPS, 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 proposed modification to Panda branded configuration of the Giraffe and Panda Warmer product line is the expansion of the current product line to offer additional configurations which are identified as Freestanding and Wall Mount. These configurations remove the bed from the predicate Panda branded configuration of the Giraffe and Panda Warmer product line allowing use in commercially available bassinets. The Freestanding and Wall Mount configurations of the Giraffe and Panda warmers product line are non-bedded with one mounting directly to a wall and the other freestanding on a wheeled base. The two new configurations provide heat to a patient using the same patient temperature control algorithm previously cleared per 510(k) K090697. The Maximum heater output has been reduced to support use of tall bassinets. The predicate resuscitation system will not be available for the Wall Mount configuration. The indication for use of the legally marketed device will remain unchanged with the addition of Freestanding and Wall Mount configurations to the current Giraffe and Panda Warmers product line.
The Freestanding and Wall Mount warmer configurations will utilize the existing Panda branded Warmer head, operator interface display, pulse oximetry technologies and resuscitation (Freestanding only). The fundamental technologies in use in the warmer have not been changed by the proposed modification. Device Modifications include software and mechanical changes. Software was changed to support these configurations in two basic areas. First is scaling back the actual heater power at any given input level to comply with standards requirements for surface touch temperatures at maximum altitude (10,000 ft.), maximum ambient operating temperature (30 ℃) and with the tallest specified bassinet (39" from floor to bed surface). The second software change is the adoption of a proportional heater control algorithm described in the Giraffe and Panda warmer 510k (K090697). Mechanical changes include new rails and new wheeled base for the Freestanding unit. The Wall Mount unit requires new rails, a wall mounting bracket, and a new filler plate between the probe panel and the display.
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
neonates, infants
Intended User / Care Setting
hospitals
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)
Summary of Non-Clinical Tests:
The Giraffe and Panda Warmers product line and its applications comply with voluntary standards. 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)
Summary of Clinical Tests:
The subject of this premarket submission, the Freestanding and Wallmount configurations of the Giraffe and Panda Warmers product line, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K122267, K101804, K090697, K072157, K070377
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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FEB 0 5 2013
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
October 23, 2012 Date:
Submitter: Ohmeda Medical, a Division of Datex-Ohmeda, Inc., A General Electric Company 8880 Gorman Rd. Laurel, MD 20723
Agata Anthony Primary Contact Person: 8880 Gorman Rd. Laurel, MD 20723 Tel: 410-456-0329
Secondary Contact Person:
Kenny M Bello 8880 Gorman Rd. Laurel, MD 20723 Tel: 410-888-5393 Fax: 410 888 0544
Giraffe and Panda Warmers
Fax: 410 888 0544
Device: Trade Name: Common/Usual Name:
Infant Warmer
Classification Names: Warmer, Infant Radiant
Product Code: FMT 880.5130
Predicate Device(s):
Giraffe and Panda Warmers; K122267, K101804, K090697, K072157, K070377
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. The units also feature optional integrated SpO2 and Resuscitation modules. The Resuscitation Module may feature either
1
Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are solid black, creating a high-contrast image.
GE Healthcare
510(k) Premarket Notification Submission
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 UPS, 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 to Panda branded configuration of the Giraffe and Panda Warmer product line is the expansion of the current product line to offer additional configurations which are identified as Freestanding and Wall Mount. These configurations remove the bed from the predicate Panda branded configuration of the Giraffe and Panda Warmer product line allowing use in commercially available bassinets.
Warmer and the Wall Mount Warmer Freestanding The configurations of the Giraffe and Panda warmers product line are non-bedded with one mounting directly to a wall and the other freestanding on a wheeled base. The two new configurations provide heat to a patient using the same patient temperature control algorithm previously cleared per 510(k) K090697. The Maximum heater output has been reduced to support use of tall bassinets. The predicate resuscitation system will not be available for the Wall Mount configuration. The indication for use of the legally marketed device will remain unchanged with the addition of Freestanding and Wall Mount configurations to the current Giraffe and Panda Warmers product line.
Infant radiant warmers provide infrared heat in a controlled manner Indication for Use: 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.
The Freestanding and Wall Mount warmer configurations will Device Modification
.
2
Image /page/2/Picture/1 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. The logo is black and white.
GE Healthcare
510(k) Premarket Notification Submission
utilize the existing Panda branded Warmer head, operator interface Technology: display, pulse oximetry technologies and resuscitation (Freestanding . only). The fundamental technologies in use in the warmer have not been changed by the proposed modification
Device Modifications include software and mechanical changes.
Software was changed to support these configurations in two basic areas. First is scaling back the actual heater power at any given input level to comply with standards requirements for surface touch temperatures at maximum altitude (10,000 ft.), maximum ambient operating temperature (30 ℃) and with the tallest specified bassinet (39" from floor to bed surface). The second software change is the adoption of a proportional heater control algorithm described in the Giraffe and Panda warmer 510k (K090697).
Mechanical changes include new rails and new wheeled base for the Freestanding unit. The Wall Mount unit requires new rails, a wall mounting bracket, and a new filler plate between the probe panel and the display.
The proposed modification does not change the indication for use of the legally marketed product.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The Giraffe and Panda Warmers product line and its applications comply with voluntary standards. 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) .
Summary of Clinical Tests:
The subject of this premarket submission, the Freestanding and Wallmount configurations of the Giraffe and Panda Warmers product line, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the Freestanding and Wallmount Conclusion: configurations of the Giraffe and Panda Warmers product line to be as safe, as effective, and equivalent in performance to the predicate
device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2013
Mr. Kenny M. Bello Regulatory Affairs Leader Ohmeda Medical Division of Datex-Ohmeda, Incorporated General Electric Healthcare Company 8880 Gorman Road Laurel, Maryland 20723
Re: K123309
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: January 7, 2013 Received: January 9, 2013
Dear Mr. Bello:
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.
4
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 of medical devicerelated 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 vours.
Nori
Harshita
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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GE Healthcare 510(k) Premarket Notification Submission
510(k) Number (if known): K 123309
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 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.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by Richard C. Chapman Date: 2013.02.01 14:41:50 -05'00'
(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
510(k) Number: K123309