(81 days)
Not Found
No
The summary describes a thermal support device for infants with two modes of operation (incubator and warmer) and an optional oxygen delivery system. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on thermal regulation and power supply.
Yes.
The device provides controlled heat to neonates to help them with thermo-regulation, which is a therapeutic function. Additionally, it may incorporate a Servo Controlled Oxygen Delivery System to provide stable oxygen concentration, further supporting therapeutic intervention.
No
The device is an infant incubator and warmer, designed to provide thermal support and controlled oxygen, not to diagnose medical conditions.
No
The device description clearly outlines a physical medical device (infant bed, incubator, warmer) with hardware components (heating elements, enclosure, UPS with battery). It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Function of the OmniBed: The description clearly states that the OmniBed is an infant incubator and warmer. Its primary function is to provide thermal support to neonates and infants who cannot regulate their own body temperature. It does this through controlled heating (either enclosed or radiant).
- No Specimen Analysis: The device description and intended use do not mention the collection, preparation, or analysis of any biological specimens from the patient. It directly interacts with the patient's external environment to provide thermal support.
The device is a therapeutic and supportive medical device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
Product codes (comma separated list FDA assigned to the subject device)
FMZ
Device Description
Giraffe OmniBed is an infant bed, which provides thermal support to infants who are unable to thermo-regulate based on their own physiology. The bed has two modes of operation, enclosed bed operation and open bed operation. In an open mode, the device functions as an incubator and in an enclosed mode it functions as a conventional, infant radiant warmer.
The Giraffe Uninterruptible Power Supply (UPS) is intended to provide a short term source of electrical power Giraffe OmniBed, thus aiding its intra hospital mobility. The Giraffe UPS does not change the indications for use, control mechanisms, operating principles, performance specifications, or other features of the Giraffe Omnibed. The UPS serves as an extension to the Giraffe OmniBed by providing uninterrupted electric power to the device. The UPS comprises a medical grade battery and a shelf.
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
Not Found
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)
Performance of the OmniBed with the addition of UPS has been established by bench testing against product specifications and recognized consensus standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The battery has a life of 15 minutes at 37° C and 70% RH at steady state. The recharge time is 6 hours.
The addition of the UPS to the Giraffe OmniBed reduces the decibel level of the alarm at 3 meters in front of the equipment by less than 1 dB, within the minimum lower level of 50dB as specified by IEC 601-2-21 Amend 1 clause 102.1 and IEC-601-2-19 Amend 1 clause 102.3.
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
§ 880.5400 Neonatal incubator.
(a)
Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.(b)
Classification. Class II (performance standards).
0
K071175
JUL 1-7 2007
510(k) Summary
Submitter Information and Date Prepared
Agata Smieja GE Healthcare 8880 Gorman Road Laurel, MD 20723 USA
Phone: 410 888 5218 Mobile: 410 456 0329
Prepared July 16, 2007
Device Identification
| Proprietary Name: |
|---|
| Common Name: |
Ohmeda Medical Giraffe OmniBed Giraffe OmniBed
Predicate Device Information
| Predicate Device | 510(k) Number |
|---|---|
| Ohmeda Medical Giraffe OmniBed | K993407 |
| Ohmeda Medical Giraffe OmniBed (with optional | |
| Servo Controlled Oxygen Delivery System) | K020543 |
Intended Use Statement
The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same
1
time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment.
This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
Functional Description and Technological Characteristics
Giraffe OmniBed is an infant bed, which provides thermal support to infants who are unable to thermo-regulate based on their own physiology. The bed has two modes of operation, enclosed bed operation and open bed operation. In an open mode, the device functions as an incubator and in an enclosed mode it functions as a conventional, infant radiant warmer.
Functional description of the new features added to the device
The Giraffe Uninterruptible Power Supply (UPS) is intended to provide a short term source of electrical power Giraffe OmniBed, thus aiding its intra hospital mobility. The Giraffe UPS does not change the indications for use, control mechanisms, operating principles, performance specifications, or other features of the Giraffe Omnibed.
The UPS serves as an extension to the Giraffe OmniBed by providing uninterrupted electric power to the device. The UPS comprises a medical grade battery and a shelf.
Performance Data
The battery has a life of 15 minutes at 37° C and 70% RH at steady state. The recharge time is 6 hours.
The addition of the UPS to the Giraffe OmniBed reduces the decibel level of the alarm at 3 meters in front of the equipment by less than 1 dB, within the minimum lower level of 50dB as specified by IEC 601-2-21 Amend 1 clause 102.1 and IEC-601-2-19 Amend 1 clause 102.3.
2
3 8+3
Performance of the OmniBed with the addition of UPS has been established by bench testing against product specifications and recognized consensus standards.
| Prepared by: | |
|---|---|
| Date |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2007
Ms. Agata Smieja Global Compliance Leader Ohmeda Medical, a Division of Datex Ohmeda, a GE Healthcare Company 8880 Gorman Road Laurel, Maryland 20723
Re: K071175
Trade/Device Name: Giraffe OmniBed Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ Dated: June 28, 2007 Received: June 29, 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 (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.
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,
Chiu Lin, Ph.D.
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): K071175
Device Name:
Indications for Use:
The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time.
Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
Prescription Use _ X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
S = 006
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: (