Giraffe Omnibed Carestation CS1

K213551 · Datex Ohmeda, Inc. · FMT · Mar 2, 2022 · General Hospital

Device Facts

• Record ID: K213551
• Device Name: Giraffe Omnibed Carestation CS1
• Applicant: Datex Ohmeda, Inc.
• Product Code: FMT · General Hospital
• Decision Date: Mar 2, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Giraffe OmniBed Carestation is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the 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 Story

Enclosed infant bed providing thermal support; circulates heated air for temperature control; operator selects air or skin temperature control method. Includes color touchscreen UI, Hands-Free Alarm Silence (HFAS), mattress, optional weighing scale, Servo O2, UPS, and storage accessories. Used in NICU, labor and delivery, radiology, and OR by clinical staff. Provides stable thermal environment; helps neonates transition from uterus to external environment. Output includes patient/air temperature monitoring and alarm notifications. Benefits include maintenance of infant body temperature and controlled oxygen delivery.

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing (mechanical reliability, shock, vibration, and latch performance) and summative usability testing.

Technological Characteristics

Infant incubator with heated air circulation; color touchscreen UI; plastic latch components. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-19. Biocompatibility per ISO 10993-1. Non-sterile.

Indications for Use

Indicated for neonates unable to thermo-regulate based on their own physiology. Provides controlled thermal support via incubator or radiant warmer modes and optional servo-controlled oxygen delivery (21-65%).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Giraffe Incubator (K152809)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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%).

| 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.<br>9900 Innovation Drive<br>Wauwatosa, WI 53226 |
| Primary Contact<br>Person: | Shiwani Zalpuri<br>Regulatory Affairs Leader<br>GE Healthcare<br>Phone: [phone]<br>Email: [e-mail] |
| Secondary Contact<br>Person: | Lee Bush<br>Regulatory Affairs Director<br>GE Healthcare<br>Phone: [phone]<br>Email: [e-mail] |
| 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.<br>Incubators provide heat in a controlled manner to neonates<br>who are unable to thermo-regulate based on their own<br>physiology. They achieve this by providing an enclosed<br>temperature-controlled environment to the infant. This device<br>may incorporate a Servo Controlled Oxygen Delivery System.<br>This is indicated to provide a stable oxygen concentration<br>within the infant compartment at the value set by the operator<br>(21-65%). |

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#### 5.1 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.

#### 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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| 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 Infant<br>Incubator. Incubators provide heat in a<br>controlled manner to neonates who are<br>unable to thermo-regulate based on their own<br>physiology. They achieve this by providing<br>an enclosed temperature controlled<br>environment to the infant. This device may<br>incorporate a Servo Controlled Oxygen<br>Delivery System. This is indicated to provide<br>a stable oxygen concentration within the<br>infant compartment at the value set by the<br>operator (21-65%). | The Giraffe Incubator Carestation is an Infant<br>Incubator. Incubators provide heat in a<br>controlled manner to neonates who are<br>unable to thermo-regulate based on their own<br>physiology. They achieve this by providing<br>an enclosed temperature controlled<br>environment to the infant. This device may<br>incorporate a Servo Controlled Oxygen<br>Delivery System. This is indicated to provide<br>a stable oxygen concentration within the<br>infant compartment at the value set by the<br>operator (21-65%). | Identical |
| Sterility | non-sterile device | non-sterile device | Identical |
| Display<br>Manual Control | 10.4" Color LCD<br>10.4" Touch Screen | 10.4" Color LCD<br>10.4" Touch Screen | Identical |
| Alarm Silence | Two Options:<br>· Touch Screen Silence<br>· Hands free Alarm silence (HFAS) | Two Options:<br>· Touch Screen Silence<br>· Hands free Alarm silence (HFAS) | Identical |
| Device Indicators | White Device Indicator light<br>Updates to alarm display (enhanced<br>presentation on the touch screen, colors) and<br>sounds (tones, volumes, and frequencies) in<br>compliance with IEC 60601-1-8<br>Power Fail Indicator LED | White Device Indicator light<br>Updates to alarm display (enhanced<br>presentation on the touch screen, colors) and<br>sounds (tones, volumes, and frequencies) in<br>compliance with IEC 60601-1-8<br>Power Fail Indicator LED | Identical |
| Environment of use | Labor and Delivery, NICU, Radiology, and<br>Operating Room. | Labor and Delivery, NICU, Radiology, and<br>Operating Room. | Identical |
| Dimensions | Weight: 138 ± 1 kg<br>Mattress Size: 48.8cm x 64.8cm Height: 152<br>cm<br>Width: 66 cm<br>Depth: 114 cm | Weight: 138 ± 1 kg<br>Mattress Size: 48.8cm x 64.8cm Height: 152<br>cm<br>Width: 66 cm<br>Depth: 114 cm | Identical |
| Bed Tilt | Mattress tilt angle: 12° | Mattress tilt angle: 12° | Identical |
| Specification | Predicate Device (K152809)<br>Giraffe Incubator Carestation<br>CS1 | Proposed Device<br>Giraffe Incubator Carestation<br>CS1 | Discussion of Differences |
| Electrical Power ratings<br>Requirements | 11.5 @ 100V ~ 50/60 Hz<br>9.5A @ 115V ~ 50/60 Hz<br>5.5A @ 220/230/240V ~ 50/60 Hz | 11.5 @ 100V ~ 50/60 Hz<br>9.5A @ 115V ~ 50/60 Hz<br>5.5A @ 220/230/240V ~ 50/60 Hz | Identical |
| Primary Electrical Safety<br>Standards | IEC 60601-1<br>IEC 60601-2-19<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-2-19<br>IEC 60601-1-2 | Identical |
| Humidity | Servo control accuracy: ± 10 % Ramp-up<br>time: <50 minutes<br>Operating time without refill: >12 hours | Servo control accuracy: ± 10 % Ramp-up<br>time: <50 minutes<br>Operating time without refill: >12 hours | Identical |
| System Performance | Temp Control accuracy: ± 1.0℃ (Control<br>Temp vs. Avg. Incubator Temp)<br>Variability: ± 0.5℃ (Incubator Temp vs.<br>Avg. Incubator Temp) Warm-up time: < 50<br>min. (Time to<br>reach 39°C control temp from cold<br>Start)<br>Patient temp measurement accuracy: ± 0.3°C<br>@ 30°C to 42°C (Accuracy of patient<br>temperature Measurement)<br>Air Velocity: <10 cm/sec<br>CO2 level: 0.3% Maximum CO2<br>level measured per IEC<br>60601-2-19<br>Sound level < 50 dbA<br>Alarms associated with key performance<br>items | Temp Control accuracy: ± 1.0℃ (Control<br>Temp vs. Avg. Incubator Temp)<br>Variability: ± 0.5℃ (Incubator Temp vs.<br>Avg. Incubator Temp) Warm-up time: < 50<br>min. (Time to<br>reach 39°C control temp from cold<br>Start)<br>Patient temp measurement accuracy: ± 0.3°C<br>@ 30°C to 42°C (Accuracy of patient<br>temperature Measurement)<br>Air Velocity: <10 cm/sec<br>CO2 level: 0.3% Maximum CO2<br>level measured per IEC<br>60601-2-19<br>Sound level < 50 dbA<br>Alarms associated with key performance<br>items | Identical |
| User Control Settings | • Patient control temperature 35- 37.5℃ in<br>0.1º increments<br>• Air control temperature 20-39°C in 0.1<br>increments<br>• Humidity Servo - % relative<br>humidity 30-95% in 5% increments | • Patient control temperature 35- 37.5℃ in<br>0.1° increments<br>• Air control temperature 20-39°C in 0.1<br>increments<br>• Humidity Servo - % relative<br>humidity 30-95% in 5% increments | Identical |
| Specification | Predicate Device (K152809)<br>Giraffe Incubator Carestation | Proposed Device<br>Giraffe Incubator Carestation | Discussion of Differences |
| | CS1 | CS1 | |
| Port Hole Latches | User action is to Press the Latch toward the<br>incubator to open the Port hole door.<br><br>The Latch design allows clinical user to push<br>the door closed. | User action to open the Port hole door is to<br>Rotate the Knob Clockwise or<br>Counterclockwise.<br><br>The Latch design allows user to turn the Port<br>Hole Latch or Knob to close the Port Hole<br>Door. | Different. The porthole latch now<br>utilizes rotate to open action instead of<br>press to open. The Port hole<br>functionality and device performance<br>remains the same and does not raise<br>different questions of safety and<br>effectiveness. |
| Wall Latches | East Side Wall & West Side wall have two<br>wall latches, one on South side and one on<br>North side.<br><br>The Wall latch assembly is common for all 4<br>side North East Side, North West Side, South<br>East Side, and South West Side. Each Latch<br>assembly contains one Latching point which<br>is operated via pinch to open mechanism. | East Side Wall & West Side wall have two<br>Wall latches, one on South side and one on<br>North side.<br><br>The South side wall latches are common and<br>unchanged from the predicate. North side<br>latches each have two latching points, a<br>primary latch and secondary latch. All latches<br>are operated via pinch to open mechanism<br>which is unchanged from the predicate. | Similar. The secondary latching<br>mechanism provides additional<br>secondary catch mechanism. The<br>functionality of the latches to secure<br>the side panels and the pinch to open<br>operation remain unchanged and meet<br>all performance and standards<br>requirements. |
| Operating Environment | Temperature: 20° to 30° C<br>Humidity: 10 to 95% RH (non- condensing)<br>Air Velocity: Up to 0.3 m/sec | Temperature: 20° to 30° C<br>Humidity: 10 to 95% RH (non- condensing)<br>Air Velocity: Up to 0.3 m/sec | Identical |
| Mattress Cover Material | • Polyurethane Laminated Fabric<br>• Silkscreened GE branding logo ink type | • Polyurethane Laminated Fabric<br>• Silkscreened GE branding logo ink type | Identical |
| Latch Materials | Plastic | Plastic | Identical |
| Accessories | Disposable patient probe, Reusable patient<br>probe, Heat reflecting patch, Giraffe In-Bed<br>Scales Gravity Zone Specific, Corner trays,<br>Giraffe monitor shelf, Swivel instrument<br>shelf, High frequency vent porthole cover,<br>Giraffe tubing management arm, Giraffe silo<br>support, Patient restraint, Giraffe pressure<br>diffusing mattress and sheet, Dovetail basket<br>assembly, Dovetail rail extension, Ventilator<br>mounting pole, IV pump mounting post, IV<br>poles, Utility post, Dovetail handle, Cord wrap holders, Retaining clips, Giraffe | Disposable patient probe, Reusable patient<br>probe, Heat reflecting patch, Giraffe In-Bed<br>Scales Gravity Zone Specific, Corner trays,<br>Giraffe monitor shelf, Swivel instrument<br>shelf, High frequency vent porthole cover,<br>Giraffe tubing management arm, Giraffe silo<br>support, Patient restraint, Giraffe pressure<br>diffusing mattress and sheet, Dovetail basket<br>assembly, Dovetail rail extension, Ventilator<br>mounting pole, IV pump mounting post, IV Identical | |
| Specification | Predicate Device (K152809)<br>Giraffe Incubator Carestation<br>CS1 | Proposed Device<br>Giraffe Incubator Carestation<br>CS1 | Discussion of Differences |
| | Incubator Hood Cover, Giraffe OmniBed<br>Hood Cover, Articulating arm for<br>monitor/display mount, Resuscitation bag<br>and mask holder, Cylinder Holders, Giraffe<br>Stand-Alone Resuscitation System T-Piece or<br>Bag & Mask, Giraffe Exam light, Giraffe<br>Blue Spot PT Lite, BiliSoft Phototherapy<br>Light, Giraffe Shuttle | Incubator Hood Cover, Giraffe OmniBed<br>Hood Cover, Articulating arm for<br>monitor/display mount, Resuscitation bag<br>and mask holder, Cylinder Holders, Giraffe<br>Stand-Alone Resuscitation System T-Piece or<br>Bag & Mask, Giraffe Exam light, Giraffe<br>Blue Spot PT Lite, BiliSoft Phototherapy<br>Light, Giraffe Shuttle | |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |

# 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)
- 2. 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
- 3. 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 | Verification<br>Method |
|----------------------------------------------------------------------------------------------------------|------------------------|
| Rough Handling Testing as per IEC60601-1 Cl 15.3.5a and IEC<br>60601-2-19 - Ascending Step Shock | Test |
| Rough Handling Testing as per IEC60601-1 Cl 15.3.5b and IEC<br>60601-2-19 - Descending Step Shock | Test |
| Rough Handling Testing as per IEC60601-1 Cl 15.3.5c and IEC<br>60601-2-19 - Door Frame Shock | Test |
| Check for Rough surfaces, sharp corners and edges (IEC 60601-1<br>Clause 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-<br>2-19 Clause 201.9.8.3.101) | Test |
| Porthole latch mechanism as Barriers (IEC 60601-2-19 Clause<br>201.9.8.3.101) | 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 Threshold<br>Test | 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 Secondary<br>Latch 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.