(30 days)
Not Found
No
The summary describes a standard infant radiant warmer with optional monitoring and resuscitation features. There is no mention of AI or ML in the intended use, device description, or any other section.
Yes
The device is described as providing infrared heat to neonates for thermoregulation and includes optional features for SpO2 monitoring and resuscitation, all of which are interventions intended to manage or improve a patient's health condition.
No
The device is primarily a radiant warmer for neonates to maintain thermal balance. While it has an optional SpO2 monitoring feature, the core function described is therapeutic/supportive (heating, resuscitation) rather than diagnostic. The SpO2 monitoring is for "continuous noninvasive monitoring" (a measurement), not explicitly for diagnosing a condition.
No
The device description clearly outlines hardware components such as a radiant heating source, an optional integrated SpO2 monitoring feature with an SP02 sensor, and an optional integrated resuscitation system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device's function is to provide radiant heat to neonates for thermoregulation. It also mentions optional features for SpO2 monitoring and resuscitation. These are all direct patient care functions, not laboratory testing of samples.
- Intended Use: The intended use is to provide a controlled environment and facilitate the neonate's transition, along with optional monitoring and resuscitation. This does not involve analyzing biological samples.
The device is a therapeutic and monitoring device used directly on the patient, not a diagnostic device used to analyze samples in a laboratory setting.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
FMT
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. Infant radiant warmers provide infrared heat in a controlled . Intended Use: 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 air/oxygen mixtures and/or manual ventilation to the infant.
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
professional use only, by trained clinicians
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)
The subject of this premarket submission, Giraffe and Panda Warmers, 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.
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.
0
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
March 16, 2009 Date: Ohmeda Medical/GE Healthcare Submitter: 8880 Gorman Rd Laurel, MD 20723, USA Primary Contact Person: Agata Smieja Regulatory Affairs Manager Ohmeda Medical/GE Healthcare APR 1 6 2009 Tel: 410 456 0329 Fax: 410 888 0544 Andrew Ahn Secondary Contact Person: GE Healthcare Regulatory Affairs Leader Ohmeda Medical/GE Healthcare Tel: 410 888 5332 Fax: 410 888 0544 Giraffe and Panda Warmer Device: Trade Name: Infant radiant warmers Common/Usual Name: 21 CFR 880.5130 Classification Names: FMT Product Code: Giraffe and Panda Warmers (K072157, K070377) Predicate Device(s): The Ohmeda Medical Giraffe and Panda Warmers are devices Device Description: 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. Infant radiant warmers provide infrared heat in a controlled . Intended Use: 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 air/oxygen mixtures and/or manual ventilation to the infant.
1
For professional use only, by trained clinicians.
Technology:
The Giraffe and Panda Warmers employ the same fundamental scientific technology as its predicate devices.
Determination of Substantial Equivalence:
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Summary of Non-Clinical Tests:
The Giraffe and Panda Warmer and its applications comply with voluntary standards as detailed in this premarket submission. The following quality assurance measures were applied to the development of the system:
- � Risk Analysis
- . Requirements Review
- o Integration testing (System verification)
- Performance testing (Verification) .
- . Safety testing (Verification)
Summary of Clinical Tests:
The subject of this premarket submission, Giraffe and Panda Warmers, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the Giraffe and Panda Warmers to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device(s).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Agata Smieja Regulatory Affairs Manager Ohmeda Medical/GE Healthcare 8880 Gorman Road Laurel, Maryland 20723
APR 1 6 2009
Re: K090697
Trade/Device Name: Giraffe and Panda Warmers Regulation Number: 21 CFR 880.5130 Regulatory Class: II Product Code: FMT Dated: March 16, 2009 Received: March 17, 2009
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 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.
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Page 2- Ms. Smieja
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Anthony D. Martin for
Susan Runner, D.D.S., MA Acting 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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510(k) Number (if known):
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 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 X (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)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Fied Alum For ABC Scott Callarin 04/15/09
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _K090692