The Giraffe Incubator Carestation is an Infant Incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment to the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

Device Description

The Giraffe Incubator Carestation is an updated version of the cleared predicate Giraffe Incubator. The Giraffe Incubator Carestation is an enclosed infant bed, which provides thermal support for infants who are unable to provide for their own heat requirements. The device maintains the infant's temperature by circulating heated air within the closed 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 operator selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. The Giraffe Incubator Carestation incorporates an optional weighing scale, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Giraffe Incubator Carestation CS1", which is an updated version of a predicate device, the "Giraffe Incubator". The focus of the modifications is primarily on updating the user interface from a graphical monochrome display to a digital touchscreen.

Based on the provided document, the device in question does not involve AI or machine learning algorithms, and therefore, the acceptance criteria and study information related to those aspects are not applicable. The device is a neonatal incubator, and the modifications are related to its hardware and user interface.

Consequently, many of the requested points regarding AI/ML device performance and studies cannot be answered from this document.

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with detailed performance metrics in the way one would for an AI/ML diagnostic device with quantifiable sensitivity, specificity, etc. Instead, it refers to compliance with voluntary standards and quality assurance measures for the modified device to demonstrate substantial equivalence to the predicate device.

The "reported device performance" is essentially the device's adherence to these standards and the successful verification and validation activities.

Acceptance Criteria / Performance Aspect	Reported Device Performance
Risk Analysis	Complies with ISO 14971
Design Reviews	Complies with OSR, ISO 13485
Unit Level Testing	Module verification performed
Integration Testing	System verification performed
Software Testing	Verification and Validation according to IEC 62304 ("moderate" level of concern)
Performance Testing	Verification of performance specifications, including IEC 60601-2-19
Safety and EMC Testing	Verification per ES 60601-1, IEC60601-1-2
Usability Testing	Validation per IEC 62366
Main System Control Software	Not changed from predicate
UI Functionality/Workflow	Graphical User Interface incorporates graphical elements compatible with current Giraffe functionality and workflow. Information displayed and device functionality/features are equivalent, with a different layout and touch screen functionality.
Power Supply	Upgraded from 75W to 120W to support new interface power requirements.
Device Visual Indicator Light	Updated
Hands Free Alarm Silencing (HFAS)	Capability introduced
Indications for Use & Intended Use	No change from predicate
Patient Contacting Materials	Identical to predicate
Function, Performance, Safety, Clinical Use	Unaffected by changes

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as it is not an AI/ML study. The testing described is verification and validation of hardware and software components, not a clinical trial on a 'test set' of patient data in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided and is not applicable for a device that is not an AI/ML diagnostic tool. Validation activities would involve engineers and testers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is an incubator, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the hardware and software modifications, the "ground truth" would be engineering specifications, established medical device safety and performance standards (like IEC 60601-2-19), and the functional requirements derived from the predicate device. These are verified through various testing methodologies described (module verification, system verification, etc.). It's not a clinical 'ground truth' in the diagnostic sense.

8. The sample size for the training set

This information is not applicable as there is no mention of a training set, the device is not an AI/ML product.

9. How the ground truth for the training set was established

This information is not applicable as there is no mention of a training set, the device is not an AI/ML product.

In summary, the provided document describes a 510(k) submission for an updated medical device (a neonatal incubator) with hardware and user interface modifications, not an AI/ML-driven device. Therefore, most of the detailed questions related to AI/ML study design and performance metrics found in your request are not addressed by this document. The safety and effectiveness are established through compliance with existing standards and verification/validation testing against the predicate device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 31, 2015

Ohmeda Medical, A Division Of Datex-ohmeda, Inc. Mr. Kenny Bello Regulatory Affairs Leader, Product 8880 Gorman Road Laurel, Maryland 20723

Re: K152809

Trade/Device Name: Giraffe Incubator Carestation CS1 Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ Dated: November 25, 2015 Received: November 27, 2015

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 (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.

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) K152809

Device Name Giraffe Incubator Carestation CSI

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	23 DEC 2015
Submitter:	Ohmeda Medical, a Division of Datex-Ohmeda, Inc., A General ElectricCompany
	8800 Gorman Road
	Laurel, MD 20723
	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 Incubator Carestation CS1
Common/Usual Name:	Incubator
Classification Names:	Incubator, Neonatal: (880.5400)
Regulatory Class	II
Product Code:	FMZ
Predicate Device(s):	Giraffe Incubator; K101778, K072512, K020547, K010222
Device Description:	The Giraffe Incubator Carestation is an updated version of the clearedpredicate Giraffe Incubator. The Giraffe Incubator Carestation is anenclosed infant bed, which provides thermal support for infants who areunable to provide for their own heat requirements. The device maintainsthe infant's temperature by circulating heated air within the closed bedcompartment. The operator may select either the air or skin temperaturecontrol method. Depending on the control method selected, heat isregulated based on either the air temperature or the infant's skin
	temperature compared to the operator selected control temperature.Physical access to the patient is obtained through the side portholes orby opening one of the side doors. The Giraffe Incubator Carestationincorporates an optional weighing scale, Uninterruptible Power Supply(UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storagedrawers.
Description of DeviceModification	The proposed modification of the Giraffe Incubator is referred to as theGiraffe Incubator Carestation.
	The Giraffe Incubator Carestation updates the graphical monochromedisplay user interface (UI) on the predicate to a digital touchscreen UI,with the required software changes to support the new format andlayout. The main system control software was not changed; however thesoftware for the UI was updated because of the UI format change. Themodified Giraffe Incubator Carestation maintains the predicate GiraffeIncubator functionality, performance, and clinical workflows. Thechanges also include a modified device visual indicator light and thecapability for Hands Free Alarm Silencing (HFAS).
	Other modifications being made for the Giraffe Incubator Carestationinclude upgrading the power supply from 75W to 120W to support theincreased power requirements of the touchscreen and associatedelectronics.
	There is no change in the indications for use or intended use of thesystem. There are no changes to the patient contacting materials of thedevice, and they remain identical to the predicate. The changes made donot affect the function, performance, safety, or clinical use of the device.
Indication for Use:	The Giraffe Incubator Carestation is an Infant Incubator. Incubatorsprovide heat in a controlled manner to neonates who are unable tothermo-regulate based on their own physiology. They achieve this byproviding an enclosed temperature controlled environment to the infant.This device may incorporate a Servo Controlled Oxygen DeliverySystem. This is indicated to provide a stable oxygen concentrationwithin the infant compartment at the value set by the operator (21-65%).
Device ModificationTechnology:	The Giraffe Incubator Carestation employs the same fundamentalscientific technology as its predicate devices.
	The Giraffe Incubator Carestation replaces the Graphic Display of thecurrent Giraffe Incubator (GINC) with a new design based on a SingleBoard Computer (SBC), color LCD, and touch screen. The GraphicalUser Interface (GUI) incorporates graphical elements that arecompatible with current Giraffe functionality and workflow. Theinformation displayed to the user and the device functionality/featuresare equivalent, with a different layout and touch screen functionality.
	The existing 75W power supply was replaced with a 120W part becausethe new interface have a higher power budget than the predicate unit's

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graphical monochrome display interface.

The Giraffe Incubator 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 Incubator Carestation is an updated version of the cleared predicate Giraffe Incubator; K101778, K072512, K020547, K010222. It complies with voluntary standards and the following quality assurance measures were applied to the development of the system:

Risk Analysis (ISO 14971)
Design Reviews (OSR, ISO 13485)
Testing on unit level (Module verification)
· Integration testing (System verification)
Software testing (Verification and Validation IEC 62304, "moderate" level of concern)
Performance testing (Verification of performance specifications, including IEC 60601-2-19)
" Safety and EMC testing (Verification ES 60601-1, IEC60601-1-2)
Usability testing (Validation IEC 62366)

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 Incubator Carestation, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the Giraffe Incubator Carestation to be as safe, as effective, and the performance to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).