Giraffe Incubator Carestation CS1

K213553 · Datex Ohmeda, Inc. · FMZ · Mar 2, 2022 · General Hospital

Device Facts

• Record ID: K213553
• Device Name: Giraffe Incubator Carestation CS1
• Applicant: Datex Ohmeda, Inc.
• Product Code: FMZ · General Hospital
• Decision Date: Mar 2, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5400
• 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 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 Story

Giraffe OmniBed Carestation CS1 functions as both infant incubator (closed mode) and radiant warmer (open mode). In incubator mode, device circulates heated air; operator selects air or skin temperature control. In warmer mode, infrared heat source warms patient. Device includes optional weighing scale, Servo O2, UPS, and various mounting accessories. Used in NICU, labor and delivery, radiology, and OR by clinicians. Device provides thermal support and oxygen delivery to neonates. Modifications include redesigned porthole latches (rotate-to-open) and wall latches (added secondary catch). Output includes temperature and oxygen concentration data displayed on 10.4-inch color touch screen. Clinical decision-making supported by continuous monitoring and alarm systems (IEC 60601-1-8 compliant). Benefits include stable thermal environment and controlled oxygen delivery for vulnerable neonates.

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing, design verification, and summative usability testing. Bench testing included mechanical reliability, rough handling (IEC 60601-1/2-19), and latch performance under worst-case conditions.

Technological Characteristics

Combination incubator/radiant warmer. Materials: Polyurethane laminated fabric mattress cover, plastic latches. Energy: Electrical (100-240V). Dimensions: 68cm width (modified from 66cm), 114cm depth, 152cm height. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-2-19, IEC 60601-2-21, IEC 60601-1-2. Sterilization: Non-sterile.

Indications for Use

Indicated for neonates unable to thermo-regulate based on their own physiology. Provides heat in a controlled manner via incubator or radiant warmer modes. Provides stable oxygen concentration (21-65%) when equipped with Servo Controlled Oxygen Delivery System.

Regulatory Classification

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.

Predicate Devices

• Giraffe Omnibed Carestation CS1 (K152814)

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: 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 ([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)

K213553

Device Name Giraffe Incubator Carestation CS1

#### Indications for Use (Describe)

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%).

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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K213553

| 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 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 infant<br>incubator and an infant warmer. The device can be operated as<br>an incubator or as a warmer and can transition from one mode<br>to the other on user's demand. It cannot be operated in both<br>modes at the same time. Incubators and warmers provide heat<br>in a controlled manner to neonates who are unable to thermo-<br>regulate based on their own physiology.<br>Incubators provide an enclosed, temperature-controlled |
| to facilitate the neonate's transition from the uterus to the<br>external environment. | |
| This device may incorporate a Servo Controlled Oxygen<br>Delivery System. This is indicated to provide stable oxygen<br>concentration within the infant compartment at the value set by<br>the 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.

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.

### 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 | Predicate<br>Giraffe OmniBed<br>Carestation CS1<br>(K152814) | Proposed (Redesigned<br>Latches)<br>Giraffe OmniBed<br>Carestation CS1 | Discussion of Differences |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Giraffe OmniBed Carestation<br>CS1 is a combination of an infant<br>incubator and an infant warmer. The<br>device can be operated as an<br>incubator or as a warmer and can<br>transition from one mode to the other<br>on user's demand. It cannot be<br>operated in both modes at the same<br>time.<br>Incubators and warmers provide heat<br>in a controlled manner to neonates<br>who are unable to thermo- regulate<br>based on their own physiology.<br>Incubators provide an enclosed,<br>temperature-controlled environment<br>and warmers provide infrared heat in<br>an open environment. They may also<br>be used for short periods of time to<br>facilitate the neonate's transition from<br>the uterus to the external<br>environment.<br>This device may incorporate a Servo<br>Controlled Oxygen Delivery System.<br>This is indicated to provide stable<br>oxygen concentration within the<br>infant compartment at the value set by | The Giraffe OmniBed Carestation<br>CS1 is a combination of an infant<br>incubator and an infant warmer. The<br>device can be operated as an<br>incubator or as a warmer and can<br>transition from one mode to the other<br>on user's demand. It cannot be<br>operated in both modes at the same<br>time.<br>Incubators and warmers provide heat<br>in a controlled manner to neonates<br>who are unable to thermo- regulate<br>based on their own physiology.<br>Incubators provide an enclosed,<br>temperature-controlled environment<br>and warmers provide infrared heat in<br>an open environment. They may also<br>be used for short periods of time to<br>facilitate the neonate's transition from<br>the uterus to the external<br>environment.<br>This device may incorporate a Servo<br>Controlled Oxygen Delivery System.<br>This is indicated to provide stable<br>oxygen concentration within the<br>infant compartment at the value set by | Identical |
| Sterility | the operator (21-65%).<br>non-sterile device | the operator (21-65%).<br>non-sterile device | Identical |
| Specification | Predicate | Proposed (Redesigned | Discussion of Differences |
| | Giraffe OmniBed | Latches) | |
| | Carestation CS1 | Giraffe OmniBed | |
| | (K152814) | Carestation CS1 | |
| 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,<br>colors) and sounds (tones, volumes,<br>and frequencies) in compliance with<br>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,<br>colors) and sounds (tones, volumes,<br>and frequencies) in compliance with<br>IEC 60601-1-8<br>Power Fail Indicator LED | Identical |
| Environment of use | Labor and Delivery, NICU,<br>Radiology, and Operating Room. | Labor and Delivery, NICU,<br>Radiology, and Operating Room. | Identical |
| Dimensions | Weight: $149 \pm 1$ kg<br>Mattress Size: 48.8cm x 64.8cm<br>Height: 152 cm (canopy closed, bed<br>lowered)<br>Width: 66 cm<br>Depth: 114 cm | Weight: $149 \pm 1$ kg<br>Mattress Size: 48.8cm x 64.8cm<br>Height: 152 cm (canopy closed, bed<br>lowered)<br>Width: 66 cm<br>Depth: 114 cm | Different. The proposed change had increased the product<br>dimension in Width. All other dimensions and weight<br>remain the same.<br>Weight: $149 \pm 1$ kg<br>Mattress Size: 48.8cm x 64.8cm<br>Height: 152 cm (canopy closed, bed lowered)<br>Width: 68 cm<br>Depth: 114 cm<br>With this change, the device performance remains the same<br>and does not raise different questions of safety and<br>effectiveness. |
| Bed Tilt | Mattress tilt angle: 12° | Mattress tilt angle: 12° | Identical |
| 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 |
| Specification | Predicate<br>Giraffe OmniBed<br>Carestation CS1<br>(K152814) | Proposed (Redesigned<br>Latches)<br>Giraffe OmniBed<br>Carestation CS1 | Discussion of Differences |
| Primary Electrical Safety<br>Standards | IEC 60601-1<br>IEC 60601-2-19<br>IEC 60601-2-21<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-2-19<br>IEC 60601-2-21<br>IEC 60601-1-3 | Identical |
| Humidity | Servo control accuracy: ± 10 %<br>Ramp-up time: ≤50 minutes<br>Operating time without refill: >12<br>hours | Servo control accuracy: ± 10 %<br>Ramp-up time: ≤50 minutes<br>Operating time without refill: >12<br>hours | Identical |
| System Performance | -Temp Control accuracy: ± 1.0ºC<br>(Control Temp vs. Avg. Incubator<br>Temp)<br>-Variability: ± 0.5°C (Incubator Temp<br>vs. Avg. Incubator Temp)<br>-Warm-up time: < 50 min. (Time to<br>reach 39℃ control temp from cold<br>Start)<br>-Patient temp measurement accuracy:<br>± 0.3°C @ 30°C to 42°C (Accuracy<br>of patient 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<br>performance items | -Temp Control accuracy: ± 1.0°C<br>(Control Temp vs. Avg. Incubator<br>Temp)<br>-Variability: ± 0.5°C (Incubator Temp<br>vs. Avg. Incubator Temp)<br>-Warm-up time: < 50 min. (Time to<br>reach 39℃ control temp from cold<br>Start)<br>-Patient temp measurement accuracy:<br>± 0.3ºC @ 30ºC to 42ºC (Accuracy<br>of patient 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<br>performance items | Identical |
| Specification | Predicate<br>Giraffe OmniBed<br>Carestation CS1<br>(K152814) | Proposed (Redesigned<br>Latches)<br>Giraffe OmniBed<br>Carestation CS1 | Discussion of Differences |
| Port Hole Latches | User action is to press the Latch<br>toward the omnibed to open the Port<br>hole door.<br><br>The Latch design allows clinical user<br>to push close the door. | User action to open the Port hole door<br>is to Rotate the Knob Clockwise or<br>counter clockwise.<br><br>The Latch design allows user to turn<br>the Port hole Latch or Knob to close<br>the Port hole door. | Different. The porthole latch now utilizes rotate to open<br>action instead of press to open. The Port hole functionality<br>and device performance remains the same and does not raise<br>different questions of safety and effectiveness. |
| Wall Latches | East Side Wall & West Side wall<br>have two wall latches, one on South<br>side and one on North side.<br><br>The Wall latch assembly is common<br>for all 4 side North East Side, North<br>West Side, South East side and South<br>West side. Each Latch assembly<br>contains one Latching point which is<br>operated via pinch to open<br>mechanism. | East Side Wall & West Side wall<br>have two Wall latches, one on South<br>side and one on North side.<br><br>The South side wall latches are<br>common and unchanged from the<br>predicate. North side latches each<br>have two latching points, a primary<br>latch and secondary latch. All latches<br>are operated via pinch to open<br>mechanism which is unchanged from<br>the predicate. | Similar. The secondary latching mechanism provides<br>additional secondary catch mechanism. The functionality of<br>the latches to secure the side panels and the pinch to open<br>operation remain unchanged and meet all performance and<br>standards requirements. |
| User Control Settings | • Patient control temperature 35-<br>37.5°C in 0.1° increments<br>• Air control temperature 20-39°C in<br>0.1 increments<br>• Radiant heat power 0-100% in 5%<br>increments<br>• Humidity Servo - % relative<br>humidity 30-95% in 5% increments | • Patient control temperature 35-<br>37.5°C in 0.1° increments<br>• Air control temperature 20-39°C in<br>0.1 increments<br>• Radiant heat power 0-100% in 5%<br>increments<br>• Humidity Servo - % relative<br>humidity 30-95% in 5% increments | Identical |
| Operating Environment | Temperature: 20° to 30° C<br>Humidity: 10 to 95% RH (non-<br>condensing)<br>Air Velocity: Up to 0.3 m/sec | Temperature: 20° to 30° C<br>Humidity: 10 to 95% RH (non-<br>condensing)<br>Air Velocity: Up to 0.3 m/sec | Identical |
| Specification | Predicate<br>Giraffe OmniBed<br>Carestation CS1<br>(K152814) | Proposed (Redesigned<br>Latches)<br>Giraffe OmniBed<br>Carestation CS1 | Discussion of Differences |
| Mattress Cover Material | -Polyurethane Laminated Fabric<br>-Silkscreened GE branding logo ink<br>type…