Giraffe Incubator Carestation CS1 by Datex Ohmeda Inc.

The Giraffe Incubator Carestation is an Infant 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%).

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 Description

The Giraffe OmniBed Carestation is a device that can function as an incubator (in the closed mode) or as an infant radiant warmer (in the open mode) 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.

In the closed bed mode of operation, the bed functions as an incubator, maintaining the infant's temperature by circulating heated air within the enclosed bed compartment. Warm air is circulated through the closed patient 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.

In the open bed mode, 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, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

AI/ML Overview

This document is a 510(k) premarket notification for the "Giraffe Incubator Carestation CS1" (K213553). The submission seeks to demonstrate substantial equivalence to a legally marketed predicate device, the "Giraffe Omnibed Carestation CS1" (K152814), specifically concerning modifications to porthole and wall latches.

Device Description:
The device, Giraffe OmniBed Carestation CS1, is a combination of an infant incubator and an infant radiant warmer. It provides a temperature-controlled environment for neonates. The modified device primarily features changes to the porthole latch design (from "press to open" to "turn to open") and the wall latches (addition of a secondary "catch" mechanism on the north side). The overall dimensions have also slightly increased in width from 66 cm to 68 cm.

Acceptance Criteria and Reported Device Performance:

The provided document defines acceptance criteria through compliance with voluntary standards and system performance metrics, and the reported device performance is that it meets these criteria.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance and reliability bench tests and a summative usability study.

Compliance with Voluntary Standards:
- The device was designed and tested for compliance with:
  - AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And 1. A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
  - 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
  - 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
  - IEC 60601-2-21 Edition 2.1 2016-04, CONSOLIDATED VERSION Medical Electrical Equipment - Part 2-21: Particular Requirements For The Basic Safety And Essential Performance Of Infant Radiant Warmers [Including: Amendment 1 (2016)]
- Manufactured under Quality System Regulations of 21CFR 820 and ISO 13485, with quality assurance measures including:
  - Risk Analysis
  - Requirements Reviews
  - Design Reviews
  - Performance Testing (Verification)
  - Safety/Reliability Testing (Verification)
  - Summative Usability Testing (Validation)
Verification and Validation Testing (Non-Clinical Testing):
- Evaluations: Safety and effectiveness of the modified wall and porthole latches were evaluated using controlled performance and reliability testing under worst-case conditions.
- Test Methods:
  - Performance Tests: Rough Handling Testing (Ascending Step Shock, Descending Step Shock, Door Frame Shock as per IEC 60601-1 Cl 15.3.5a, 15.3.5b, 15.3.5c and IEC 60601-2-19), Check for Rough surfaces, sharp corners and edges (IEC 60601-1 Clause 9.3), Humidifier Operating Time, Air Velocity, Opening and Closing of E/W Doors and South Wall, Opening of Doors and Portholes, E/W Doors latch mechanism and N/S Walls as Barriers (IEC 60601-2-19 Clause 201.9.8.3.101), Porthole latch mechanism as Barriers (IEC 60601-2-19 Clause 201.9.8.3.101), Removing of E/W Doors and infant compartment design, E/W Doors remains secure even if the North Wall and South Wall receptacle is not latched, Maximum sidewall upright angle.
  - Reliability Tests: Porthole Latch: Over Torque Test; Wall Latch and Porthole Latch: Vibration / Reliability Threshold Test; Porthole Latch: Push Load; Porthole Latch: Pull Load for Cleaning; Porthole Latch: Open Close Cycles of Knob Latch; Porthole Latch: Cleaning Pull Cycles of Knob Latch; Wall Latch: Handling Load Test; Wall Latch: Pull and Push Loads with chemical exposure; Wall Latch: Handling Load on Snap; Wall Latch: Pinch Action Open Close Cycles; Wall Latch: Push Close Cycles (Push to Close from Secondary Latch Position to Primary Latch Position).
- Results: The proposed device "successfully completed all testing per our quality system," and the evaluations "substantiate the performance of the new latches in worst-case conditions."
Human Factors Analysis (Summative Usability Study):
- Study Purpose: To evaluate the modified wall and porthole latches and their instructions for use.
- Results: The study "successfully completed a summative usability study," and "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."

Detailed Information for the Study:

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

Test Set Sample Size: Not explicitly stated for each individual bench or reliability test. The tests were performed on the "modified wall and porthole latches," implying testing on the physical components of the device. For the Summative Usability Study, the sample size of users is not provided in this document.
Data Provenance: The studies are laboratory and human factors evaluations conducted by the manufacturer (GE Healthcare). The data is presumably retrospective in nature, as it's part of the design verification and validation process for a modified existing product. Country of origin for the data is not specified but would be where GE Healthcare conducts its product testing.

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

This information is not provided in the document. For bench/reliability tests, "experts" typically refers to test engineers and quality control personnel, whose qualifications are inherent to their roles in device manufacturing and verification. For the human factors study, the qualifications of the "users" involved are not detailed.

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

Not applicable in the context of engineering bench and reliability testing or human factors usability studies as described. These are objective tests against predefined specifications or assessments of user interaction, not expert consensus for diagnostic interpretation.

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 is not an AI-assisted diagnostic device, and no MRMC study was conducted. The device is a neonatal incubator/warmer; the changes are mechanical (latches) and do not involve "human readers" or "AI assistance."

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

Not applicable. This device is not an algorithm, and its performance involves direct physical interaction and function.

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

Ground truth for the engineering tests was based on objective performance specifications derived from international standards (IEC 60601 series) and internal quality system requirements. For example, "Temp Control accuracy: ± 1.0ºC" is an objective metric.
For the Human Factors Analysis, the ground truth was the observed user interaction and direct feedback regarding the usability and safety of the modified latches. The absence of findings that required design changes indicates that the user experience met safety and usability requirements.

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI models, so there is no "training set."

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

Not applicable for the same reason as above.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

March 2, 2022

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

Re: K213553

Trade/Device Name: Giraffe Incubator Carestation CS1 Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: Class II Product Code: 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)

K213553

Device Name Giraffe Incubator Carestation CS1

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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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The logo is colored in a light blue hue. The circular frame has decorative, wave-like elements surrounding the letters, adding a touch of elegance to the design. The logo is simple, yet recognizable.

K213553

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 Omnibed Carestation CS1
Common/Usual Name:	Incubator/Warmer
Classification Names:	Neonatal Incubator
Regulation	21 CFR 880.5400 Neonatal Incubator
Classification	II
Product Code:	FMZ, FMT
Predicate Device:	Giraffe Omnibed Carestation CS1 (K152814)
Indications for Use:	The Giraffe OmniBed Carestation is a combination of an infantincubator and an infant warmer. The device can be operated asan incubator or as a warmer and can transition from one modeto the other on user's demand. It cannot be operated in bothmodes at the same time. Incubators and warmers provide heatin a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.Incubators provide an enclosed, temperature-controlled
to facilitate the neonate's transition from the uterus to theexternal environment.
This device may incorporate a Servo Controlled OxygenDelivery System. This is indicated to provide stable oxygenconcentration within the infant compartment at the value set bythe operator (21-65%).

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Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script in the center. There are three curved lines emanating from the top and bottom of the circle, resembling water droplets or stylized flames. The logo is simple and recognizable, representing the company's brand identity.

5.1 Device Description:

The Giraffe OmniBed Carestation is a device that can function as an incubator (in the closed mode) or as an infant radiant warmer (in the open mode) 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.

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 Omnibed 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 Omnibed aside from the latches. See detailed comparison of the proposed device relative to the predicate device in the table below.

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Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are water droplet shapes surrounding the circle. The logo is simple and recognizable.

Product Comparison with Predicate Device (K152814)

Specification	PredicateGiraffe OmniBedCarestation CS1(K152814)	Proposed (RedesignedLatches)Giraffe OmniBedCarestation CS1	Discussion of Differences
Indications for Use	The Giraffe OmniBed CarestationCS1 is a combination of an infantincubator and an infant warmer. Thedevice can be operated as anincubator or as a warmer and cantransition from one mode to the otheron user's demand. It cannot beoperated in both modes at the sametime.Incubators and warmers provide heatin a controlled manner to neonateswho are unable to thermo- regulatebased on their own physiology.Incubators provide an enclosed,temperature-controlled environmentand warmers provide infrared heat inan open environment. They may alsobe used for short periods of time tofacilitate the neonate's transition fromthe uterus to the externalenvironment.This device may incorporate a ServoControlled Oxygen Delivery System.This is indicated to provide stableoxygen concentration within theinfant compartment at the value set by	The Giraffe OmniBed CarestationCS1 is a combination of an infantincubator and an infant warmer. Thedevice can be operated as anincubator or as a warmer and cantransition from one mode to the otheron user's demand. It cannot beoperated in both modes at the sametime.Incubators and warmers provide heatin a controlled manner to neonateswho are unable to thermo- regulatebased on their own physiology.Incubators provide an enclosed,temperature-controlled environmentand warmers provide infrared heat inan open environment. They may alsobe used for short periods of time tofacilitate the neonate's transition fromthe uterus to the externalenvironment.This device may incorporate a ServoControlled Oxygen Delivery System.This is indicated to provide stableoxygen concentration within theinfant compartment at the value set by	Identical
Sterility	the operator (21-65%).non-sterile device	the operator (21-65%).non-sterile device	Identical
Specification	Predicate	Proposed (Redesigned	Discussion of Differences
	Giraffe OmniBed	Latches)
	Carestation CS1	Giraffe OmniBed
	(K152814)	Carestation CS1
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) and sounds (tones, volumes,and frequencies) in compliance withIEC 60601-1-8Power Fail Indicator LED	White Device Indicator lightUpdates to alarm display (enhancedpresentation on the touch screen,colors) and sounds (tones, volumes,and frequencies) in compliance withIEC 60601-1-8Power Fail Indicator LED	Identical
Environment of use	Labor and Delivery, NICU,Radiology, and Operating Room.	Labor and Delivery, NICU,Radiology, and Operating Room.	Identical
Dimensions	Weight: $149 \pm 1$ kgMattress Size: 48.8cm x 64.8cmHeight: 152 cm (canopy closed, bedlowered)Width: 66 cmDepth: 114 cm	Weight: $149 \pm 1$ kgMattress Size: 48.8cm x 64.8cmHeight: 152 cm (canopy closed, bedlowered)Width: 66 cmDepth: 114 cm	Different. The proposed change had increased the productdimension in Width. All other dimensions and weightremain the same.Weight: $149 \pm 1$ kgMattress Size: 48.8cm x 64.8cmHeight: 152 cm (canopy closed, bed lowered)Width: 68 cmDepth: 114 cmWith this change, the device performance remains the sameand does not raise different questions of safety andeffectiveness.
Bed Tilt	Mattress tilt angle: 12°	Mattress tilt angle: 12°	Identical
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
Specification	PredicateGiraffe OmniBedCarestation CS1(K152814)	Proposed (RedesignedLatches)Giraffe OmniBedCarestation CS1	Discussion of Differences
Primary Electrical SafetyStandards	IEC 60601-1IEC 60601-2-19IEC 60601-2-21IEC 60601-1-2	IEC 60601-1IEC 60601-2-19IEC 60601-2-21IEC 60601-1-3	Identical
Humidity	Servo control accuracy: ± 10 %Ramp-up time: ≤50 minutesOperating time without refill: >12hours	Servo control accuracy: ± 10 %Ramp-up time: ≤50 minutesOperating time without refill: >12hours	Identical
System Performance	-Temp Control accuracy: ± 1.0ºC(Control Temp vs. Avg. IncubatorTemp)-Variability: ± 0.5°C (Incubator Tempvs. Avg. Incubator Temp)-Warm-up time: < 50 min. (Time toreach 39℃ control temp from coldStart)-Patient temp measurement accuracy:± 0.3°C @ 30°C to 42°C (Accuracyof patient temperature Measurement)-Air Velocity: <10 cm/sec- CO2 level: 0.3% Maximum CO2level measured per IEC60601-2-19- Sound level < 50 dbA-Alarms associated with keyperformance items	-Temp Control accuracy: ± 1.0°C(Control Temp vs. Avg. IncubatorTemp)-Variability: ± 0.5°C (Incubator Tempvs. Avg. Incubator Temp)-Warm-up time: < 50 min. (Time toreach 39℃ control temp from coldStart)-Patient temp measurement accuracy:± 0.3ºC @ 30ºC to 42ºC (Accuracyof patient temperature Measurement)-Air Velocity: <10 cm/sec- CO2 level: 0.3% Maximum CO2level measured per IEC60601-2-19- Sound level < 50 dbA-Alarms associated with keyperformance items	Identical
Specification	PredicateGiraffe OmniBedCarestation CS1(K152814)	Proposed (RedesignedLatches)Giraffe OmniBedCarestation CS1	Discussion of Differences
Port Hole Latches	User action is to press the Latchtoward the omnibed to open the Porthole door.The Latch design allows clinical userto push close the door.	User action to open the Port hole dooris to Rotate the Knob Clockwise orcounter clockwise.The Latch design allows user to turnthe Port hole Latch or Knob to closethe Port hole door.	Different. The porthole latch now utilizes rotate to openaction instead of press to open. The Port hole functionalityand device performance remains the same and does not raisedifferent questions of safety and effectiveness.
Wall Latches	East Side Wall & West Side wallhave two wall latches, one on Southside and one on North side.The Wall latch assembly is commonfor all 4 side North East Side, NorthWest Side, South East side and SouthWest side. Each Latch assemblycontains one Latching point which isoperated via pinch to openmechanism.	East Side Wall & West Side wallhave two Wall latches, one on Southside and one on North side.The South side wall latches arecommon and unchanged from thepredicate. North side latches eachhave two latching points, a primarylatch and secondary latch. All latchesare operated via pinch to openmechanism which is unchanged fromthe predicate.	Similar. The secondary latching mechanism providesadditional secondary catch mechanism. The functionality ofthe latches to secure the side panels and the pinch to openoperation remain unchanged and meet all performance andstandards requirements.
User Control Settings	• Patient control temperature 35-37.5°C in 0.1° increments• Air control temperature 20-39°C in0.1 increments• Radiant heat power 0-100% in 5%increments• Humidity Servo - % relativehumidity 30-95% in 5% increments	• Patient control temperature 35-37.5°C in 0.1° increments• Air control temperature 20-39°C in0.1 increments• Radiant heat power 0-100% in 5%increments• Humidity Servo - % relativehumidity 30-95% in 5% increments	Identical
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
Specification	PredicateGiraffe OmniBedCarestation CS1(K152814)	Proposed (RedesignedLatches)Giraffe OmniBedCarestation CS1	Discussion of Differences
Mattress Cover Material	-Polyurethane Laminated Fabric-Silkscreened GE branding logo inktype	-Polyurethane Laminated Fabric-Silkscreened GE branding logo inktype	Identical
Latch Materials	Plastic	Plastic	Identical
Accessories	Disposable patient probe, Reusablepatient probe, Heat reflecting patch,Giraffe In-Bed Scales Gravity ZoneSpecific, Corner trays, Giraffemonitor shelf, Swivel instrumentshelf, High frequency vent portholecover, Giraffe tubing managementarm, Giraffe silo support, Patientrestraint, Giraffe pressure diffusingmattress, Pressure Diffusing mattresscover sheet, Dovetail basketassembly, Dovetail rail extension,Ventilator mounting pole, IV pumpmounting post, IV poles, Utility post,Dovetail handle, Cord wrap holders,Retaining clips, Giraffe OmniBedRetrofit Kit for Enhanced CanopySeals, Articulating arm for monitor/display Mount, Resuscitation bag andmask holder, Cylinder Holders,Giraffe Stand-Alone ResuscitationSystem T-Piece or Bag & Mask,Giraffe Exam light, Giraffe Blue SpotPT Lite, BiliSoft Phototherapy Light,Giraffe Shuttle	Disposable patient probe, Reusablepatient probe, Heat reflecting patch,Giraffe In-Bed Scales Gravity ZoneSpecific, Corner trays, Giraffemonitor shelf, Swivel instrumentshelf, High frequency vent portholecover, Giraffe tubing managementarm. Giraffe silo support, Patientrestraint. Giraffe pressure diffusingmattress, Pressure Diffusing mattresscover sheet, Dovetail basketassembly, Dovetail rail extension,Ventilator mounting pole, IV pumpmounting post, IV poles, Utility post,Dovetail handle, Cord wrap holders,Retaining clips, Giraffe OmniBedRetrofit Kit for Enhanced CanopySeals, Articulating arm for monitor/display Mount, Resuscitation bag andmask holder, Cylinder Holders,Giraffe Stand-Alone ResuscitationSystem T-Piece or Bag & Mask,Giraffe Exam light, Giraffe Blue SpotPT Lite, BiliSoft Phototherapy Light,Giraffe Shuttle	Identical
Biocompatibility	ISO 10993-1	ISO 10993-1	Identical

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Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. There are also some white water droplet shapes around the circle.

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Image /page/7/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. There are small, curved lines emanating from the circle, giving the impression of movement or energy. The logo is colored in a light blue hue.

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Image /page/8/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. The circle is surrounded by what appear to be stylized water droplets or splashes, giving the logo a dynamic and fluid appearance. The color of the logo is a bright blue, set against a white background.

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Image /page/9/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a blue circle. There are also some white water droplet shapes around the circle.

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Image /page/10/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 three water droplet shapes surrounding the circle. The logo is simple and recognizable.

K213553

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 OmniBed Carestation CS1 was designed and tested for compliance with the following standards as was the predicate Giraffe OmniBed Carestation CS1 (K152814):

AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And 1. 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
IEC 60601-2-19 Edition 2.1 2016-04. CONSOLIDATED VERSION Medical Electrical 3. Equipment - Part 2-19: Particular Requirements For The Basic Safety And Essential Performance Of Infant Incubators
IEC 60601-2-21 Edition 2.1 2016-04, CONSOLIDATED VERSION Medical Electrical 4. Equipment - Part 2-21: Particular Requirements For The Basic Safety And Essential Performance Of Infant Radiant Warmers [Including: Amendment 1 (2016)]

The Giraffe OmniBed 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.

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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.

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
E/W Doors remains secure even if the North Wall and South Wallreceptacle is not latched	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
Test Name	VerificationMethod
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

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Image /page/12/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. There are four stylized water droplets surrounding the circle, one at each cardinal direction. The logo is simple and recognizable, representing the company's brand.

K213553

GE Healthcare 510(k) Premarket Notification Submission

Animal Study

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

Clinical Studies

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

Human Factors Analysis

The Giraffe OmniBed 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 Omnibed 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 Omnibed 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 Omnibed Carestation CS is substantially equivalent to the predicate device (K152814). The summary above demonstrates that there are no new questions of safety or effectiveness for the Giraffe OmniBed Carestation.

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).

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Discussion of Differences
Indications for Use	The Giraffe OmniBed Carestation is a combination of an infant incubator and warmer, providing controlled heat. May incorporate Servo Controlled Oxygen Delivery System (21-65%).	The Giraffe OmniBed Carestation CS1 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%).	Identical
Sterility	non-sterile device	non-sterile device	Identical
Display Manual Control	10.4" Color LCD, 10.4" Touch Screen	10.4" Color LCD, 10.4" 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 light. Updates to alarm display and sounds in compliance with IEC 60601-1-8. Power Fail Indicator LED.	White Device Indicator light. Updates to alarm display (enhanced presentation on the touch screen, colors) and sounds (tones, volumes, and frequencies) in compliance with IEC 60601-1-8. Power Fail Indicator LED.	Identical
Environment of use	Labor and Delivery, NICU, Radiology, and Operating Room.	Labor and Delivery, NICU, Radiology, and Operating Room.	Identical
Dimensions	Weight: $149 \pm 1$ kg. Mattress Size: 48.8cm x 64.8cm. Height: 152 cm (canopy closed, bed lowered). Width: 66 cm. Depth: 114 cm.	Weight: $149 \pm 1$ kg. Mattress Size: 48.8cm x 64.8cm. Height: 152 cm (canopy closed, bed lowered). Width: 68 cm. Depth: 114 cm.	Different. The proposed change increased the product width to 68 cm. All other dimensions and weight remain the same. The change does not raise new questions of safety and effectiveness.
Bed Tilt	Mattress tilt angle: 12°	Mattress tilt angle: 12°	Identical
Electrical Power Ratings Requirements	11.5 @ 100V ~ 50/60 Hz; 9.5A @ 115V ~ 50/60 Hz; 5.5A @ 220/230/240V ~ 50/60 Hz.	11.5 @ 100V ~ 50/60 Hz; 9.5A @ 115V ~ 50/60 Hz; 5.5A @ 220/230/240V ~ 50/60 Hz.	Identical
Primary Electrical Safety Standards	IEC 60601-1, IEC 60601-2-19, IEC 60601-2-21, IEC 60601-1-2.	IEC 60601-1, IEC 60601-2-19, IEC 60601-2-21, IEC 60601-1-3.	Identical (The provided document lists IEC 60601-1-3 for "Proposed" but the discussion is "Identical". This seems to be a typo in the FDA submission, as 1-3 refers to radiographic equipment). Assuming that it is identical as per the discussion.
Humidity	Servo control accuracy: ± 10 %; Ramp-up time: ≤50 minutes; Operating time without refill: >12 hours.	Servo control accuracy: ± 10 %; Ramp-up time: ≤50 minutes; Operating time without refill: >12 hours.	Identical
System Performance	-Temp Control accuracy: ± 1.0ºC -Variability: ± 0.5°C -Warm-up time: < 50 min. -Patient temp measurement accuracy: ± 0.3°C @ 30°C to 42°C -Air Velocity: <10 cm/sec - CO2 level: 0.3% Maximum - Sound level < 50 dbA -Alarms associated with key performance items.	-Temp Control accuracy: ± 1.0ºC (Control Temp vs. Avg. Incubator Temp) -Variability: ± 0.5°C (Incubator Temp vs. Avg. Incubator Temp) -Warm-up time: < 50 min. (Time to reach 39℃ control temp from cold Start) -Patient temp measurement accuracy: ± 0.3ºC @ 30ºC to 42ºC (Accuracy of patient temperature Measurement) -Air Velocity: <10 cm/sec - CO2 level: 0.3% Maximum CO2 level measured per IEC 60601-2-19 - Sound level < 50 dbA -Alarms associated with key performance items.	Identical
Port Hole Latches	User action is to press the Latch toward the omnibed to open the Port hole door. The Latch design allows clinical user to push close the door.	User action to open the Port hole door is to Rotate the Knob Clockwise or counter clockwise. The Latch design allows user to turn the Port hole Latch or Knob to close the Port hole door.	Different. The porthole latch now utilizes a rotate-to-open action instead of press-to-open. The functionality and device performance remain the same.
Wall Latches	East Side Wall & West Side wall have two wall latches, one on South side and one on North side. The Wall latch assembly is common for all 4 sides: North East Side, North West Side, South East side and South West side. Each Latch assembly contains one Latching point which is operated via pinch to open mechanism.	East Side Wall & West Side wall have two Wall latches, one on South side and one on North side. The South side wall latches are common and unchanged from the predicate. North side latches each have two latching points, a primary latch and secondary latch. All latches are operated via pinch to open mechanism which is unchanged from the predicate.	Similar. A secondary latching mechanism was added to the wall latches, providing an additional catch. The functionality and pinch-to-open operation remain unchanged and meet all performance and standards.
User Control Settings	• Patient control temperature 35-37.5°C in 0.1° increments • Air control temperature 20-39°C in 0.1 increments • Radiant heat power 0-100% in 5% increments • Humidity Servo - % relative humidity 30-95% in 5% increments	• Patient control temperature 35-37.5°C in 0.1° increments • Air control temperature 20-39°C in 0.1 increments • Radiant heat power 0-100% in 5% increments • Humidity Servo - % relative humidity 30-95% in 5% increments	Identical
Operating Environment	Temperature: 20° to 30° C; Humidity: 10 to 95% RH (non-condensing); Air Velocity: Up to 0.3 m/sec.	Temperature: 20° to 30° C; Humidity: 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
Biocompatibility	ISO 10993-1	ISO 10993-1	Identical