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 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 Description

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 has a color touchscreen user interface (UI) and includes a Hands-Free Alarm Silence (HFAS) feature. The incubator includes a mattress for patient comfort. The Giraffe Incubator Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

AI/ML Overview

The provided document describes the Giraffe Incubator Carestation CS1, a medical device. The submission focuses on modifications to the porthole and wall latches of an existing predicate device (K152809). The document does not describe the device's main performance in terms of medical outcomes but rather the safety and functionality of the latch modifications.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria for the overall medical device performance (e.g., temperature control accuracy, humidity control). Instead, it focuses on demonstrating that the modified latch mechanisms continue to meet existing safety and performance standards, and that their functionality is equivalent or improved compared to the predicate without introducing new risks.

However, the document lists system performance specifications that are identical to the predicate device, implying these are the baseline acceptance criteria for the overall incubator function. For the latch modifications, the acceptance criteria are demonstrated through successful completion of various tests.

Acceptance Criteria (Implied from "Identical" or "Meets all performance and standards requirements") and Reported Performance for the General Device:

Characteristic	Acceptance Criteria (from Predicate Device K152809)	Reported Device Performance (Proposed Device)
Temp Control Accuracy	± 1.0℃ (Control Temp vs. Avg. Incubator Temp)	Identical to Predicate
Temp Variability	± 0.5℃ (Incubator Temp vs. Avg. Incubator Temp)	Identical to Predicate
Warm-up time	< 50 min. (Time to reach 39°C control temp from cold Start)	Identical to Predicate
Patient Temp Accuracy	± 0.3°C @ 30°C to 42°C	Identical to Predicate
Air Velocity	<10 cm/sec	Identical to Predicate
CO2 Level	0.3% Maximum CO2 level measured per IEC 60601-2-19	Identical to Predicate
Sound Level	< 50 dBA	Identical to Predicate
Humidity Servo Acc.	± 10 %	Identical to Predicate
Humidity Ramp-up time	<50 minutes	Identical to Predicate
Humidity Oper. w/o refill	>12 hours	Identical to Predicate
Porthole Latch Action	User action: Press to open. Push to close.	User action: Rotate to open. Turn to close.
Wall Latch Function	Two latches, one latching point, pinch to open.	North side latches: Two latching points (primary and secondary), pinch to open. South side unchanged.
Latch Functionality	Ensure proper securing of panels, allow operation, meet performance and standards (IEC 60601-2-19 Clause 201.9.8.3.101)	Meets all performance and standards requirements.
Usability	No new risks or use-related issues.	No findings from summative usability testing that led to changes or new risks.

2. Sample size used for the test set and the data provenance

The document describes non-clinical testing which includes various functional and reliability bench tests for the modified latches, as well as summative usability testing.

Test Set Sample Size: The document does not specify a numerical sample size for the bench tests (e.g., number of latches tested, number of cycles for reliability). It lists the types of tests performed. For the "Summative Usability Testing," the sample size of participants is not provided.
Data Provenance: The testing appears to be prospective and conducted by GE Healthcare (the submitter) in their own labs, as part of their quality system. The country of origin of the data is not explicitly stated but can be inferred to be internally generated by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified for the bench tests. For the "Summative Usability Testing," the number of participants is not provided, and whether these participants are considered "experts" (e.g., clinicians) or typical end-users is not detailed.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert opinions (e.g., for image interpretation). The testing involves physical and functional evaluation against established standards and internal quality criteria. For usability, the findings are reported, implying evaluation against predefined usability metrics and safety outcomes.

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

Not applicable. This submission is for an infant incubator with modified latches, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not applicable. This device does not have an "algorithm only" component that would require standalone performance evaluation typical of AI/ML software.

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

For the latch modifications, the "ground truth" is defined by:

Compliance with Voluntary Standards: IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-19.
Engineering Specifications: Internal design requirements for load, torque, cycles, and physical dimensions that ensure safety and functionality.
Risk Analysis: Identification and mitigation of potential risks associated with the changes.
Usability Objectives: Ensuring the modified latches do not introduce new use errors or significantly alter the user experience negatively.

8. The sample size for the training set

Not applicable. This device submission does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set mentioned or relevant for this device, there is no ground truth established for one.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

March 2, 2022

Datex Ohmeda Inc. Shiwani Zalpuri Regulatory Affairs Leader 9900 Innovation Drive Wauwatosa, Wisconsin 53226

Re: K213551

Trade/Device Name: Giraffe Omnibed Carestation CS1 Regulation Number: 21 CFR 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: Class II Product Code: FMT, FMZ Dated: January 28, 2022 Received: January 31, 2022

Dear Shiwani Zalpuri:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Gang Peng for Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name Giraffe Omnibed Carestation CS1

Indications for Use (Describe)

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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	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	02-March-2022
Submitter:	Datex-Ohmeda, Inc.9900 Innovation DriveWauwatosa, WI 53226
Primary ContactPerson:	Shiwani ZalpuriRegulatory Affairs LeaderGE HealthcarePhone: +91 9871090801Email: shiwani.zalpuri@ge.com
Secondary ContactPerson:	Lee BushRegulatory Affairs DirectorGE HealthcarePhone: 262-309-9429Email: Lee.Bush@ge.com
Device Trade Name:	Giraffe Incubator Carestation CS1
Common/Usual Name:	Neonatal Incubator
Classification Names:	Neonatal Incubator
Regulation	21 CFR 880.5400 Neonatal Incubator
Classification	II
Product Code:	FMZ
Predicate Device:	Giraffe Incubator (K152809)
Indications for Use:	The Giraffe Incubator Carestation is an Infant Incubator.Incubators provide heat in a controlled manner to neonateswho are unable to thermo-regulate based on their ownphysiology. They achieve this by providing an enclosedtemperature-controlled environment to the infant. This devicemay incorporate a Servo Controlled Oxygen Delivery System.This is indicated to provide a stable oxygen concentrationwithin the infant compartment at the value set by the operator(21-65%).

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5.1 Device Description:

5.2 Comparison of Technological Characteristics with the Predicate Device

The Porthole Latch design has been modified to change the latch action from "press to open" to "turn to open". The design of the latch mounting part was modified to accommodate the redesigned latch. There were no impacts to form, fit or function of the Porthole Door of incubator aside from the latch.

The design of the Wall Latches and latch receptacles on the North side of the device have been modified. A secondary "catch" was added to address the situation where users leave the door vertical/up with the primary latches not engaged. The receptacles and back plates used to secure the latches on the NE and NW side of the wall have also been modified to accommodate the changes to the wall latches. There were no impacts to form, fit or function of the wall of the incubator aside from the latches. See detailed comparison of the proposed device relative to the predicate device in the table below.

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Product Comparison with Predicate Device (K152809)

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Image /page/9/Picture/0 description: The image shows the logo of General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by a series of curved lines, resembling water droplets or waves, which give the logo a dynamic and fluid appearance. The overall design is simple, clean, and recognizable, reflecting GE's brand identity.

GE Healthcare 510(k) Premarket Notification Submission

5.3 Determination of Substantial Equivalence:

Summary of Non-Clinical Testing:

The following performance data was provided in support of the substantial equivalence determination:

Compliance with Voluntary Standards

The Giraffe Incubator Carestation CS1 was designed and tested for compliance with the following standards as was the predicate Giraffe Incubator Carestation CS1 (K152809):

1. AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
1. AAMI / ANSI / IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment --Part 1-2: General Requirements For Basic Safety And Essential Performance --Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
1. IEC 60601-2-19 Edition 2.1 2016-04. CONSOLIDATED VERSION Medical Electrical Equipment - Part 2-19: Particular Requirements For The Basic Safety And Essential Performance Of Infant Incubators

The Giraffe Incubator Carestation CS1 was designed and is manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485 and the following quality assurance measures were applied to the development of subject features:

Risk Analysis
Requirements Reviews
. Design Reviews
Performance Testing (Verification) .
Safety/Reliability Testing (Verification) •
. Summative Usability Testing (Validation)

Verification and Validation Testing

The proposed device has successfully completed all testing per our quality system.

Non-Clinical Testing

Evaluations of safety and effectiveness of the modified wall and porthole latches used controlled performance and reliability testing to substantiate the performance of the new latches in worst-case conditions. The specific tests and verification methods are summarized in the table below.

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Image /page/10/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. There are white swirls around the outside of the circle. The logo is simple and recognizable.

GE Healthcare 510(k) Premarket Notification Submission

Test Name	VerificationMethod
Rough Handling Testing as per IEC60601-1 Cl 15.3.5a and IEC60601-2-19 - Ascending Step Shock	Test
Rough Handling Testing as per IEC60601-1 Cl 15.3.5b and IEC60601-2-19 - Descending Step Shock	Test
Rough Handling Testing as per IEC60601-1 Cl 15.3.5c and IEC60601-2-19 - Door Frame Shock	Test
Check for Rough surfaces, sharp corners and edges (IEC 60601-1Clause 9.3)	Test
Humidifier Operating Time	Test
Air Velocity	Test
Opening and Closing of E/W Doors and South Wall	Test
Opening of Doors and Portholes	Test
E/W Doors latch mechanism and N/S Walls as Barriers (IEC 60601-2-19 Clause 201.9.8.3.101)	Test
Porthole latch mechanism as Barriers (IEC 60601-2-19 Clause201.9.8.3.101)	Test
Removing of E/W Doors and infant compartment design	Test
Maximum sidewall upright angle	Test
Porthole Latch: Over Torque Test	Reliability Test
Wall Latch and Porthole Latch: Vibration / Reliability ThresholdTest	Reliability Test
Porthole Latch: Push Load	Reliability Test
Porthole Latch: Pull Load for Cleaning	Reliability Test
Porthole Latch: Open Close Cycles of Knob Latch	Reliability Test
Porthole Latch: Cleaning Pull Cycles of Knob Latch	Reliability Test
Wall Latch: Handling Load Test	Reliability Test
Wall Latch: Pull and Push Loads with chemical exposure	Reliability Test
Wall Latch: Handling Load on Snap	Reliability Test
Wall Latch: Pinch Action Open Close Cycles	Reliability Test
Wall Latch: Push Close Cycles (Push to Close from SecondaryLatch Position to Primary Latch Position)	Reliability Test

Table 5.1 – Functional Bench Tests Performed on Modified Latches

Animal Study

The Giraffe Incubator Carestation CS1 did not require animal tests to support substantial equivalence.

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Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. There are also some white water droplet shapes around the circle.

GE Healthcare 510(k) Premarket Notification Submission

Clinical Studies

The Giraffe Incubator Carestation CS1 did not require clinical tests to support substantial equivalence.

Human Factors Analysis

The Giraffe Incubator Carestation CS1 successfully completed a summative usability study of the modified wall and porthole latches and their instructions for use. There were no findings from the summative usability testing that led to changes in wall latches, porthole latches, or on-product labeling. The latch modifications did not introduce any new risks or use-related issues.

Conclusion:

The modifications associated with Giraffe Incubator Carestation CS1 do not change the Indications for Use or intended use from the predicate, and represent equivalent technological characteristics, with no impact on energy type, operating principles, or primary control mechanisms.

Design verification, along with bench testing demonstrate the proposed incubator system is substantially equivalent and as safe and as effective as the legally marketed predicate device. Clinical data was not required to demonstrate substantial equivalence. GE Healthcare's quality system's design, verification, validation, and risk management processes did not identify any new hazards, unexpected results, or adverse effects stemming from the changes to the predicate. The modified system continues to meet all applicable IEC 60601-1 series of standards.

Based on development under GE Healthcare's quality system, the successful verification. engineering bench testing, and usability testing, GE Healthcare believes that the Giraffe Incubator Carestation CS is substantially equivalent to the predicate device (K152809). The summary above demonstrates that there are no new questions of safety or effectiveness for the Giraffe Incubator Carestation.

Regulation Number and Section

§ 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.

Specification	Predicate Device (K152809)	Proposed Device	Discussion of Differences
	Giraffe Incubator Carestation	Giraffe Incubator Carestation
	CS1	CS1
Indications for Use	The Giraffe Incubator Carestation is an InfantIncubator. Incubators provide heat in acontrolled manner to neonates who areunable to thermo-regulate based on their ownphysiology. They achieve this by providingan enclosed temperature controlledenvironment to the infant. This device mayincorporate a Servo Controlled OxygenDelivery System. This is indicated to providea stable oxygen concentration within theinfant compartment at the value set by theoperator (21-65%).	The Giraffe Incubator Carestation is an InfantIncubator. Incubators provide heat in acontrolled manner to neonates who areunable to thermo-regulate based on their ownphysiology. They achieve this by providingan enclosed temperature controlledenvironment to the infant. This device mayincorporate a Servo Controlled OxygenDelivery System. This is indicated to providea stable oxygen concentration within theinfant compartment at the value set by theoperator (21-65%).	Identical
Sterility	non-sterile device	non-sterile device	Identical
DisplayManual Control	10.4" Color LCD10.4" Touch Screen	10.4" Color LCD10.4" Touch Screen	Identical
Alarm Silence	Two Options:· Touch Screen Silence· Hands free Alarm silence (HFAS)	Two Options:· Touch Screen Silence· Hands free Alarm silence (HFAS)	Identical
Device Indicators	White Device Indicator lightUpdates to alarm display (enhancedpresentation on the touch screen, colors) andsounds (tones, volumes, and frequencies) incompliance with IEC 60601-1-8Power Fail Indicator LED	White Device Indicator lightUpdates to alarm display (enhancedpresentation on the touch screen, colors) andsounds (tones, volumes, and frequencies) incompliance with IEC 60601-1-8Power Fail Indicator LED	Identical
Environment of use	Labor and Delivery, NICU, Radiology, andOperating Room.	Labor and Delivery, NICU, Radiology, andOperating Room.	Identical
Dimensions	Weight: 138 ± 1 kgMattress Size: 48.8cm x 64.8cm Height: 152cmWidth: 66 cmDepth: 114 cm	Weight: 138 ± 1 kgMattress Size: 48.8cm x 64.8cm Height: 152cmWidth: 66 cmDepth: 114 cm	Identical
Bed Tilt	Mattress tilt angle: 12°	Mattress tilt angle: 12°	Identical
Specification	Predicate Device (K152809)Giraffe Incubator CarestationCS1	Proposed DeviceGiraffe Incubator CarestationCS1	Discussion of Differences
Electrical Power ratingsRequirements	11.5 @ 100V ~ 50/60 Hz9.5A @ 115V ~ 50/60 Hz5.5A @ 220/230/240V ~ 50/60 Hz	11.5 @ 100V ~ 50/60 Hz9.5A @ 115V ~ 50/60 Hz5.5A @ 220/230/240V ~ 50/60 Hz	Identical
Primary Electrical SafetyStandards	IEC 60601-1IEC 60601-2-19IEC 60601-1-2	IEC 60601-1IEC 60601-2-19IEC 60601-1-2	Identical
Humidity	Servo control accuracy: ± 10 % Ramp-uptime: <50 minutesOperating time without refill: >12 hours	Servo control accuracy: ± 10 % Ramp-uptime: <50 minutesOperating time without refill: >12 hours	Identical
System Performance	Temp Control accuracy: ± 1.0℃ (ControlTemp vs. Avg. Incubator Temp)Variability: ± 0.5℃ (Incubator Temp vs.Avg. Incubator Temp) Warm-up time: < 50min. (Time toreach 39°C control temp from coldStart)Patient temp measurement accuracy: ± 0.3°C@ 30°C to 42°C (Accuracy of patienttemperature Measurement)Air Velocity: <10 cm/secCO2 level: 0.3% Maximum CO2level measured per IEC60601-2-19Sound level < 50 dbAAlarms associated with key performanceitems	Temp Control accuracy: ± 1.0℃ (ControlTemp vs. Avg. Incubator Temp)Variability: ± 0.5℃ (Incubator Temp vs.Avg. Incubator Temp) Warm-up time: < 50min. (Time toreach 39°C control temp from coldStart)Patient temp measurement accuracy: ± 0.3°C@ 30°C to 42°C (Accuracy of patienttemperature Measurement)Air Velocity: <10 cm/secCO2 level: 0.3% Maximum CO2level measured per IEC60601-2-19Sound level < 50 dbAAlarms associated with key performanceitems	Identical
User Control Settings	• Patient control temperature 35- 37.5℃ in0.1º increments• Air control temperature 20-39°C in 0.1increments• Humidity Servo - % relativehumidity 30-95% in 5% increments	• Patient control temperature 35- 37.5℃ in0.1° increments• Air control temperature 20-39°C in 0.1increments• Humidity Servo - % relativehumidity 30-95% in 5% increments	Identical
Specification	Predicate Device (K152809)Giraffe Incubator Carestation	Proposed DeviceGiraffe Incubator Carestation	Discussion of Differences
	CS1	CS1
Port Hole Latches	User action is to Press the Latch toward theincubator to open the Port hole door.The Latch design allows clinical user to pushthe door closed.	User action to open the Port hole door is toRotate the Knob Clockwise orCounterclockwise.The Latch design allows user to turn the PortHole Latch or Knob to close the Port HoleDoor.	Different. The porthole latch nowutilizes rotate to open action instead ofpress to open. The Port holefunctionality and device performanceremains the same and does not raisedifferent questions of safety andeffectiveness.
Wall Latches	East Side Wall & West Side wall have twowall latches, one on South side and one onNorth side.The Wall latch assembly is common for all 4side North East Side, North West Side, SouthEast Side, and South West Side. Each Latchassembly contains one Latching point whichis operated via pinch to open mechanism.	East Side Wall & West Side wall have twoWall latches, one on South side and one onNorth side.The South side wall latches are common andunchanged from the predicate. North sidelatches each have two latching points, aprimary latch and secondary latch. All latchesare operated via pinch to open mechanismwhich is unchanged from the predicate.	Similar. The secondary latchingmechanism provides additionalsecondary catch mechanism. Thefunctionality of the latches to securethe side panels and the pinch to openoperation remain unchanged and meetall performance and standardsrequirements.
Operating Environment	Temperature: 20° to 30° CHumidity: 10 to 95% RH (non- condensing)Air Velocity: Up to 0.3 m/sec	Temperature: 20° to 30° CHumidity: 10 to 95% RH (non- condensing)Air Velocity: Up to 0.3 m/sec	Identical
Mattress Cover Material	• Polyurethane Laminated Fabric• Silkscreened GE branding logo ink type	• Polyurethane Laminated Fabric• Silkscreened GE branding logo ink type	Identical
Latch Materials	Plastic	Plastic	Identical
Accessories	Disposable patient probe, Reusable patientprobe, Heat reflecting patch, Giraffe In-BedScales Gravity Zone Specific, Corner trays,Giraffe monitor shelf, Swivel instrumentshelf, High frequency vent porthole cover,Giraffe tubing management arm, Giraffe silosupport, Patient restraint, Giraffe pressurediffusing mattress and sheet, Dovetail basketassembly, Dovetail rail extension, Ventilatormounting pole, IV pump mounting post, IVpoles, Utility post, Dovetail handle, Cord wrap holders, Retaining clips, Giraffe	Disposable patient probe, Reusable patientprobe, Heat reflecting patch, Giraffe In-BedScales Gravity Zone Specific, Corner trays,Giraffe monitor shelf, Swivel instrumentshelf, High frequency vent porthole cover,Giraffe tubing management arm, Giraffe silosupport, Patient restraint, Giraffe pressurediffusing mattress and sheet, Dovetail basketassembly, Dovetail rail extension, Ventilatormounting pole, IV pump mounting post, IV Identical
Specification	Predicate Device (K152809)Giraffe Incubator CarestationCS1	Proposed DeviceGiraffe Incubator CarestationCS1	Discussion of Differences
	Incubator Hood Cover, Giraffe OmniBedHood Cover, Articulating arm formonitor/display mount, Resuscitation bagand mask holder, Cylinder Holders, GiraffeStand-Alone Resuscitation System T-Piece orBag & Mask, Giraffe Exam light, GiraffeBlue Spot PT Lite, BiliSoft PhototherapyLight, Giraffe Shuttle	Incubator Hood Cover, Giraffe OmniBedHood Cover, Articulating arm formonitor/display mount, Resuscitation bagand mask holder, Cylinder Holders, GiraffeStand-Alone Resuscitation System T-Piece orBag & Mask, Giraffe Exam light, GiraffeBlue Spot PT Lite, BiliSoft PhototherapyLight, Giraffe Shuttle
Biocompatibility	ISO 10993-1	ISO 10993-1	Identical