(171 days)
The Giraffe OmniBed Carestation 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%).
The Giraffe OmniBed Carestation is an updated version of the cleared predicate Giraffe OmniBed. The Giraffe OmniBed Carestation is a combination device that can function as an incubator (with the canopy closed) or as an infant radiant warmer (with the canopy open) based on the user's selection.
Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. With the canopy closed, the bed functions as an incubator, maintaining the infant's temperature by circulating heated air within the enclosed bed compartment. The operator may select either the air or skin temperature control method. Depending on the control method selected, heat is regulated based on either the air temperature or the infant's skin temperature compared to the operated selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors.
With the canopy opened, this bed operates like a conventional open, radiantly heated infant bed. Radiant heat from an infrared heat source is focused onto the bed to warm the patient.
The Giraffe OmniBed Carestation incorporates an optional weighing scale, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.
The proposed modification of the Giraffe OmniBed is referred to as the Giraffe OmniBed Carestation.
The Giraffe OmniBed Carestation updates the graphical monochrome display user interface (UI) on the predicate to a digital touchscreen UI, with the required software changes to support the new format and layout. The main system control software was not changed; however the software for the UI was updated because of the UI format change. The modified Giraffe OmniBed Carestation maintains the predicate Giraffe OmniBed functionality, performance, and clinical workflows. The changes also include a modified device visual indicator light and the capability for Hands Free Alarm Silencing (HFAS).
Other modifications being made for the Giraffe OmniBed Carestation include upgrading the power supply from 75W to 120W to support the increased power requirements of the touchscreen and associated electronics.
There is no change in the indications for use or intended use of the system. There are no changes to the patient contacting materials of the device, and they remain identical to the predicate. The changes made do not affect the function, performance, safety, or clinical use of the device.
This document is a marketing submission (510(k) summary) for a medical device, specifically a neonatal incubator/warmer, and not a study proving a device meets acceptance criteria. Therefore, the detailed information requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document, as it does not contain the specifics of a performance study with defined acceptance criteria and results.
The document states: "The subject of this premarket submission, Giraffe OmniBed Carestation, did not require clinical studies to support substantial equivalence." This means that the manufacturer is claiming substantial equivalence based on non-clinical tests (such as electrical safety, performance verification against standards, software testing) and the device's technological similarity to previously cleared predicate devices, rather than through a comparative clinical study.
Here's what can be inferred and what cannot, based on the provided text:
What Can Be Inferred/Extracted (to some extent):
- Device Name: Giraffe OmniBed Carestation CS1 (K152814)
- Device Type: Combination infant incubator and infant warmer.
- Indication for Use: To provide heat in a controlled manner to neonates unable to thermoregulate. Can operate as an incubator (closed canopy) or radiant warmer (open canopy). May incorporate a Servo Controlled Oxygen Delivery System for stable oxygen concentration (21-65%).
- Predicate Device(s): Giraffe OmniBed (K101788, K071175, K020543, K993407)
- Key Modification: Updates the graphical monochrome display user interface (UI) to a digital touchscreen UI, with associated software changes. Also, an upgraded power supply (75W to 120W) and updated visual indicator light and Hands Free Alarm Silencing (HFAS) capability.
- Determination of Substantial Equivalence: Based on non-clinical tests and technological similarity to predicates.
- Non-Clinical Tests Mentioned (examples of types of tests, not specific results or acceptance criteria):
- Risk Analysis
- Design Reviews
- Unit level testing (Module verification)
- Integration testing (System verification)
- Software testing (Verification and Validation, IEC 62304:2006)
- Performance testing (Verification of performance specifications, including IEC 60601-2-21:2009 for warmers, IEC 60601-2-19:2009 for incubators)
- Safety and EMC testing (Verification ES 60601-1:2005+A1 2012, IEC60601-1-2:2007)
- Usability testing (Validation IEC 62366: 2014)
What Cannot Be Extracted (because the document is not a study report):
- A table of acceptance criteria and the reported device performance: This document lists types of tests performed (e.g., performance testing against standards), but it does not provide the specific numerical acceptance criteria (e.g., "temperature stability must be within +/- 0.5°C") nor the measured device performance against those criteria.
- Sample sizes used for the test set and the data provenance: Not applicable as it's not a clinical study. The non-clinical tests would have involved specific test units, but the "sample size" of patients/data as in a clinical study is not relevant here.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable as no clinical ground truth was established for "testing" in the sense of patient data. Usability testing might involve experts, but details are not provided.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: No, the document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." An MRMC study would be a clinical study.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is electro-mechanical, not AI-driven in the sense of an algorithm interpreting data to generate a finding.
- The type of ground truth used: Not applicable. Ground truth for clinical studies would be, for example, pathology results for a lesion, or confirmed diagnosis; here, "ground truth" would be the engineering specifications and performance standards.
- The sample size for the training set: Not applicable. This device is not an AI/ML device that requires a training set of data.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text is a regulatory submission demonstrating substantial equivalence of a medical device based on non-clinical testing and comparison to predicate devices, not a report of a study designed to prove the device meets specific clinical acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 17, 2016
Ohmeda Medical A Division of Datex-ohmeda, Inc., A GE Company Mr. Kenny Bello Regulatory Affairs Leader 8880 Gorman Road Laurel, Maryland 20723
Re: K152814
Trade/Device Name: Giraffe Omnibed Carestation CS1 Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ, FMT Dated: February 18, 2016 Received: February 19, 2016
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.
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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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -S
for Erin I. Keith, M.S. 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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Indications for Use
510(k) Number (if known) K152814
Device Name Giraffe Omnibed Carestation CS1
Indications for Use (Describe)
The Giraffe OmniBed Carestation 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%).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a circular frame. The frame is adorned with decorative flourishes, resembling water droplets or stylized leaves, surrounding the circle. The logo is presented in a blue color scheme.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 18 FEB 2016 |
|---|---|
| Submitter: | Ohmeda Medical, a Division of Datex-Ohmeda, Inc., A General ElectricCompany |
| 8800 Gorman Road | |
| Laurel, MD 20723 USA | |
| Tel: (410)888-5200 | |
| Fax: (410)888-0544 | |
| Primary Contact Person: | Kenny M Bello |
| Regulatory Affairs Leader | |
| Ohmeda Medical, a Division of Datex-Ohmeda, Inc., A General ElectricCompany | |
| Tel: (410)888-5393 | |
| Fax: (410)888-0544 | |
| Secondary Contact Person: | Monica Morrison |
| Regulatory Affairs Director | |
| Ohmeda Medical, a Division of Datex-Ohmeda, Inc., A General ElectricCompany | |
| Device Trade Name: | Giraffe OmniBed Carestation CS1 |
| Common/Usual Name: | Incubator / Warmer |
| Classification Names: | Incubator, Neonatal: (880.5400) |
| Regulatory Class | II |
| Product Code: | FMZ, FMT |
| Predicate Device(s): | Giraffe OmniBed, K101788, K071175 K020543, K993407 |
| Device Description: | The Giraffe OmniBed Carestation is an updated version of the clearedpredicate Giraffe OmniBed. The Giraffe OmniBed Carestation is acombination device that can function as an incubator (with the canopy closed)or as an infant radiant warmer (with the canopy open) based on the user'sselection.Incubators and warmers provide heat in a controlled manner to neonates whoare unable to thermo-regulate based on their own physiology. With the canopyclosed, the bed functions as an incubator, maintaining the infant's temperatureby circulating heated air within the enclosed bed compartment. The operatormay select either the air or skin temperature control method. Depending on thecontrol method selected, heat is regulated based on either the air temperature |
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Image /page/4/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" intertwined in a stylized script. The letters are white and stand out against the blue background. The logo is simple and recognizable, and it is associated with a well-known and established company.
or the infant's skin temperature compared to the operated selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors.
With the canopy opened, this bed operates like a conventional open, radiantly heated infant bed. Radiant heat from an infrared heat source is focused onto the bed to warm the patient.
The Giraffe OmniBed Carestation incorporates an optional weighing scale, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.
Description of Device The proposed modification of the Giraffe OmniBed is referred to as the Modification Giraffe OmniBed Carestation.
The Giraffe OmniBed Carestation updates the graphical monochrome display user interface (UI) on the predicate to a digital touchscreen UI, with the required software changes to support the new format and layout. The main system control software was not changed; however the software for the UI was updated because of the UI format change. The modified Giraffe OmniBed Carestation maintains the predicate Giraffe OmniBed functionality, performance, and clinical workflows. The changes also include a modified device visual indicator light and the capability for Hands Free Alarm Silencing (HFAS).
Other modifications being made for the Giraffe OmniBed Carestation include upgrading the power supply from 75W to 120W to support the increased power requirements of the touchscreen and associated electronics.
There is no change in the indications for use or intended use of the system. There are no changes to the patient contacting materials of the device, and they remain identical to the predicate. The changes made do not affect the function, performance, safety, or clinical use of the device.
Indication for Use: The Giraffe OmniBed Carestation 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%).
Device Modification The Giraffe OmniBed Carestation employs the same fundamental scientific Technology: technology as its predicate device.
The Giraffe OmniBed Carestation replaces the Graphic Display of the current
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Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular shape. The logo is in blue and has a white background.
Giraffe OmniBed (GOB) with a new design based on a Single Board Computer (SBC), color LCD, and touch screen. The Graphical User Interface (GUI) incorporates graphical elements that are compatible with current Giraffe functionality and workflow. The information displayed to the user and the device functionality/features are equivalent, with a different layout and touch screen functionality.
The existing 75W power supply was replaced with a 120W part because the new interface has a higher power requirement than the predicate unit's graphical monochrome display interface.
The Giraffe OmniBed Carestation also introduces an updated device Indicator light and Hands Free Alarm Silence (HFAS) capability.
Determination of Substantial Equivalence and performance Data:
Summary of Non-Clinical Tests:
The Giraffe OmniBed Carestation is an updated version of the cleared predicate Giraffe OmniBed; K101788, K071175, K020543, K993407. It complies with voluntary standards and 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) ●
- Software testing (Verification and Validation, IEC 62304:2006 -Medical Device Software - Software life cycle processes )
- Performance testing (Verification of performance specifications, ● including IEC 60601-2-21:2009 - Particular requirements for the safety of infant radiant warmers , IEC 60601-2-19:2009 - Particular requirements for the safety of incubators)
- Safety and EMC testing (Verification ES 60601-1:2005+A1 2012 -General Requirements for Safety, IEC60601-1-2:2007 -Electromagnetic compatibility - Requirements and tests))
- . Usability testing (Validation IEC 62366: 2014 - Application of usability engineering to medical devices)
The testing performed to support these modifications was based on the risk assessment and design controls, and summary level data was provided in the 510(k) for the testing described above.
Summary of Clinical Tests:
The subject of this premarket submission, Giraffe OmniBed Carestation, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the Giraffe OmniBed Carestation to be as safe, as Conclusion: effective, and the performance to be substantially equivalent to the predicate device.
§ 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).